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Double Room
Orbital Suite
Family Room
Modern hotel near the Fira de Barcelona
Collect 200 points.*
Simply enter your Nectar card number on the confirmation page. Your points will be credited 30 days after your trip is complete. *Offers may apply
By metro station
Barceló Sants is strategically situated next to Sants station and within 1 mile (1.7 kilometers) of Plaça d'Espanya, Fira Barcelona, Camp Nou, and the National Art Museum of Catalonia.
Healthy hotel
Barceló Sants features innovative gastronomic menus, free wireless Internet, extensive meeting and business facilities, a fitness center, massage service, and a sauna.
Futuristic flair
All Barceló Hotel Sants' non-smoking guestrooms have views of the surrounding mountains and city. Renovated in 2011, Orbital Rooms feature futuristic furnishings and 42-inch TVs with satellite service.Information missing or incorrect? Tell us!
Hotel Amenities
- General
Barceló Hotel Sants has direct access to AVE (high-speed train), the metro station, and train system, with connection to Barcelona International Airport (BCN).
The Barceló Hotel Sants provides extensive facilities for conferences, conventions, banquets and weddings. All 14 fully equipped conference rooms, with a capacity of up to 1,500 people, have a dedicated reception area where food can be served and cocktails prepared. Complimentary high-speed wireless Internet access is available, as well as printing photocopying and faxing facilities. There is also the option of video conferencing.
The hotel's own fitness center (surcharge) features a sauna and solarium, as well as a wide selection of weight machines and a varied timetable of fitness classes. A range of shops in the station below are easily accessed directly from the hotel by elevator.
Limited parking is available (surcharge).
- Sauna
- Technology helpdesk
- Concierge desk
- Complimentary newspapers in lobby
- Health club
- Bar/lounge
- Coffee shop or café
- Exhibit space
- Banquet facilities
- Business center
- Multiple large conference rooms
- Event catering
- Multiple small meeting rooms
- Audiovisual equipment
- Cell phone/mobile rental
- Secretarial services
- Business services
- Computer rental
- Porter/bellhop
- Express check-out
- Doorman/doorwoman
- Multilingual staff
- 24-hour front desk
- Safe-deposit box at front desk
- ATM/banking
- Babysitting or childcare
- Medical assistance available
- Currency exchange
- Laundry facilities
- Dry cleaning/laundry service
- Coffee/tea in lobby
- Air-conditioned public areas
- Elevator/lift
- Wedding services
- Parking limited (surcharge)
- Tour assistance
- Total number of rooms - 378
- Breakfast available (surcharge)
- Gift shops or newsstand
- Half board rates available
- Free Wi-Fi
- Parking (surcharge)
- Room service (limited hours)
- Number of meeting/conference rooms - 20
- Shopping on site
- Internet
Available in all rooms: Free Wi-Fi
Available in some public areas: Free Wi-Fi
- Parking
Parking (surcharge), Parking limited (surcharge)
- Room Amenities
- Premium TV channels
- Hypo-allergenic bedding available
- Air conditioning
- Blackout drapes/curtains
- Soundproofed rooms
- Minibar
- Private bathroom
- Complimentary toiletries
- Hair dryer
- In-room childcare (surcharge)
- Iron/ironing board (on request)
- Desk
- In-room safe
- Satellite TV service
- Cribs/infant beds available
- Coffee/tea maker
- Complimentary newspaper
- Climate control
- Daily housekeeping
- Slippers
- Rainfall showerhead
- Free Wi-Fi
- Down comforter
- Dining
Oxygen - Healthy buffet restaurant.
Hydrogen - A la carte restaurant.
Orbital Bar - A selection of cocktails, gins, vodkas and light snacks.
Brain Food - Innovative health food.
- Recreation
The hotel's fully equipped and staffed fitness center has free weights, running, step and rowing machines, as well as static bikes, and stretching mats. The center also offers a comprehensive timetable of fitness classes and has a sauna and solarium.
The recreational activities listed below are available either on site or near the hotel; fees may apply.
- Golfing nearby
- Running track/path nearby
- Playground nearby
- Aerobics on site
- Pilates classes on site
- Yoga classes/instruction on site
Policies & Fees
- Check-in
Check-in time starts at 2 PM
Special check-in instructions:
A tourist tax will be collected directly at the property upon arrival. The tax applies up to a maximum of 7 nights per person per stay.
- Check-out
Check-out time is noon
- Payment types
Accepted at this hotel: American Express, Diners Club, JCB International, MasterCard, Visa
- General
Extra-person charges may apply and vary depending on hotel policy.
Government-issued photo identification and a credit card or cash deposit are required at check-in for incidental charges.
Special requests are subject to availability upon check-in and may incur additional charges. Special requests cannot be guaranteed.
Hotel Registry Number - HB-003954
- Fees
- Unless otherwise indicated, the charges below are not included in the overall room price. If not included in the overall room price, they will be charged by the property at check-in or check-out. Charges can vary, for example, based on length of stay or the room you book. This property told us they will charge you for the following:
We have included all charges provided to us by the property. However, charges can vary, for example, based on length of stay or the room you book.The following fees and deposits are charged by the property at time of service, check-in, or check-out.
- A tax is imposed by the city: EUR 1.21 per person, per night. This tax does not apply to children under 17 years of age.
The above list may not be comprehensive. Fees and deposits may not include tax and are subject to change.
- Breakfast fee: EUR 15 per person (approximately)
- Self parking fee: EUR 25 per day
- Additional Details
Cash transactions at this property cannot exceed EUR 2500, due to national regulations. For further details, please contact the property using information in the booking confirmation. Reservations are required for massage services. Reservations can be made by contacting the hotel prior to arrival, using the contact information on the booking confirmation.


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Two wipes tops and all of that cake up is gone. This is my all time favorite make up remover especially for water proof make up. Once it's off, it's off and you don't have to kill your eyelashes taking off mascara. Swoon*
This is my absolute favorite eye makeup remover of all time! No mascara is left behind (even waterproof). A little goes a long way though, otherwise you may get a little oily residue left over!
This is the BEST eye makeup remover! It removes everything with just one swipe. Its worth every penny. It lasts a long time because you only use a small amount each time.
During the summer, the only way to wear make-up is waterproof because otherwise sweat takes over and you look like you've been crying for the past hour. The problem with that is when it's time to wash your face at night, it still doesn't want to come off. This product cuts right through the waterproof stuff and gets it off quick and easy for you. Perfect!
I really like this makeup remover-I don't usually use a liquid remover as they ALWAYS sting my eyes, but this was a super gentle formula, and It made the skin around my eyes softer to the touch and surprisingly hydrated.
I LOVE this makeup remover! I have used it for 20+ years, and have tried others, but nothing works as well as this one. I have to use waterproof eye makeup because my eyes tend to water a lot. Sometimes with other removers, it would be difficult to remove the waterproof products, but not with this! I love it, and was so glad to be able to order it through Birchbox!
I don't want to use anything harsh on my eyes, and I love that this product gently but effectively removes all my eye makeup. Very sad that on a recent vacation I found the bottle had drained in my suitcase :(
I don't. I'm not sure what it is about this product that makes me hesitant on giving it another star. It might be the smell. It might be the fact that it doesn't always get off all my makeup. It could also be the residue it leaves behind on my skin. I'm not sure...it could just all be in my head...
I love getting Lancome's BI-FACIL samples whenever I go to the Lancome counter! It's a pretty good makeup remover, but the bottle's design isn't that hot. The sample is awesome because you have about a 0.75-inch circular opening to moisten your cotton ball. However, in the full-size product, the bottle's opening has significantly shrunk to a size smaller than a pea, which seriously limits how much remover you get on your cotton ball. And to me, it doesn't make it very effective to get enough on your cotton ball (without spending 10 minutes applying it to the ball) to remove waterproof mascara easily. So, two stars down for the poor design, which to me, is super important in beauty products!
I feel like this product has been around since I first started wearing makeup. It definitely gets the job done however it leaves my skin feeling a little oily.

subset: commoncrawl


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Market Insights
Realogics Sotheby's International Realty is pleased to present this combined open house showcase to be hosted on September 8 & 9 from 1:00 to 4:00pm (or by appointment). In addition to our featured new construction properties that will include Olive 8, Fifteen Twenty-One Second Avenue, The Lakeside, The Residences at Fairview and Harvard & Highland we'll be featuring a select number of our resale listings as well.
A proposed program would make developers buy development rights for farms and forests; in return, developers would be able to build bigger buildings. If they buy the rights, that protects the farms and forestlands from development
The in-city condo market has continued to tighten as rising demand struggles with dwindling supply. In total we estimate there are now only 234 condominiums available to choose from (including both resale and new construction) in downtown Seattle. Of this inventory 141 units are listed on the NWMLS with a median asking price of $573,000 (100 units are resale while 41 are new construction with additional inventory not listed). In all there are just 134 new construction condominiums that remain unsold in the center city primarily within four primary buildings (in order of inventory most to least): Escala, Olive 8, Fifteen Twenty-One Second Avenue and Four Seasons Private Residences.
Realogics Sotheby's International Realty is proud to offer Seattle's best new construction inventory available – below is an update on each project:


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All Boards
Got a question? Something on your mind? Talk to your community, directly.
Posts awaiting your approval 0
Brenda Wendelken April 16, 2014 at 02:16 PM
It seems to me that the senior community in the Town of Oyster Bay could be considered a voting…Read Morebloc if we joined forces to get a senior bus system throughout the township. Perhaps our children who live here, and are looking out for parents and grandparents can so some sleuthing online to see how we can get the bus back.
Monielaine Sparx April 09, 2014 at 07:23 AM
Good advise. Thanks for posting it. Really a great help.
Alleign Curstanham April 09, 2014 at 10:24 PM
Thanks for sharing this one.Thumbs up!


text: Josh Flint The Organic Enthusiasts Are After Me Prairie Gleanings First, let's produce enough food, then we can argue what type we need to produce. Published on: April 1, 2011 When I wrote my April column (http://magissues.farmprogress.com/PRA/PF04Apr11/pra013.pdf), I had an inclination that the organic enthusiasts weren't going to like it. Just a week after it hit mailboxes, I've received several letters telling me how wrong I am about organic production. The main theme seems to be that I'm a lackey of corporate ag who is simply reciting their dribble about how necessary chemicals are. For some reason, I thought the concept of working harder to produce less food is fairly easy to understand. Silly me. Some folks discussed how important the "lifestyle" of organic production is. Another claimed to be able to get close to current yield levels, albeit the process described to do so was quite labor intense. A recent study, "Map the Meal Gap", found that 44 counties in the U.S. have a significant portion of hungry people. It says one in four was "food insecure" (I like to say hungry, but maybe that's not politically correct). According to the study, folks in the U.S. pay an average of $2.54 per meal. The study comes from Feeding America, a conglomeration of corporations dedicated to, well, feeding America. It was funded by the Howard G. Buffett Foundation and the Nielson Co. Regardless of your position on organic production, I think it's hard to deny the fact that there are hungry people in the U.S. Of course, the problem is worse in the rest of the world. Once again, I realize some folks don't mind spending $2.54 for a piece of organic fruit. But, don't forget that not everyone has that luxury. Just remember that even if you're working hard to adhere to an organic "lifestyle" some folks are simply trying to find enough to eat. At yesterday's conference on waterhemp's evolved resistance to HPPD inhibitors, Iowa State University's Mike Owen made a great point. He explained that agriculture is one of the only industries where consumers actually do not prefer efficiency. In nearly all other cases, industry is praised for doing more with less. In ag, affluent folks hunger for food that is harder to produce. Sorry, but in this case, I think we need to make sure everyone has food to begin with. Then we can decide what type of food is best. Registered users may comment on this blog.


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Several FDA-approved drug labels may be available for etravirine. AIDSinfo provides the following drug label solely as an example of the labels available for etravirine. Inclusion or absence of a drug label on the AIDSinfo site does not imply endorsement or lack thereof by AIDSinfo. Search Drugs@FDA to access more information on etravirine, including additional drug labels and any generic equivalents.
INTELENCE® is a human immunodeficiency virus type 1 (HIV-1) non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for treatment of HIV-1 infection in treatment-experienced patients 6 years of age and older with viral strains resistant to an NNRTI and other antiretroviral agents. (1)
In patients who have experienced virologic failure on an NNRTI-containing regimen, do not use INTELENCE® in combination with only N[t]RTIs. (1)
Treatment history and resistance testing should guide the use of INTELENCE®. (1)
25 mg tablets, 100 mg tablets and 200 mg tablets (3)
Severe, potentially life threatening and fatal skin reactions have been reported. This includes cases of Stevens-Johnson syndrome, hypersensitivity reaction, toxic epidermal necrolysis and erythema multiforme. Immediately discontinue treatment if severe hypersensitivity, severe rash or rash with systemic symptoms or liver transaminase elevations develops and monitor clinical status, including liver transaminases closely. (5.1)
The most common adverse drug reactions of moderate to severe intensity (at least 2%) which occurred at a higher rate than placebo in adults are rash and peripheral neuropathy. (6.1)
The most common adverse drug reactions in at least 2% of pediatric patients are rash and diarrhea. (6.2)
To report SUSPECTED ADVERSE REACTIONS, contact Janssen Products, LP at 1-800-JANSSEN (1-800-526-7736) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
INTELENCE® should not be co-administered with the following antiretrovirals:
Co-administration of INTELENCE® with drugs that inhibit or induce CYP3A, CYP2C9, and/or CYP2C19 may alter the therapeutic effect or adverse reaction profile of etravirine. (7)
Co-administration of INTELENCE® with drugs that are substrates of CYP3A, CYP2C9, and/or CYP2C19 or are transported by P-glycoprotein may alter the therapeutic effect or adverse reaction profile of the co-administered drug(s). (7)
Refer to the Full Prescribing Information for other drugs that should not be co-administered with INTELENCE® and for other drugs that may require a change in dose or regimen. (7)
INTELENCE®1, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced patients ages 6 years and older, who have evidence of viral replication and HIV-1 strains resistant to a non-nucleoside reverse transcriptase inhibitor (NNRTI) and other antiretroviral agents.
The indication for adult use is based on Week 48 analyses from 2 randomized, double-blind, placebo-controlled trials of INTELENCE®. Both studies were conducted in clinically advanced, 3-class antiretroviral (NNRTI, N[t]RTI, PI) treatment-experienced adults. The indication for pediatric use is based on 24-week analyses of a single-arm, Phase 2 trial in antiretroviral treatment-experienced pediatric subjects 6 years to less than 18 years of age [see Use in Specific Populations (8.4)].
In treatment-experienced adult and pediatric patients, the following points should be considered when initiating therapy with INTELENCE®:
The recommended oral dose of INTELENCE® tablets is 200 mg (one 200 mg tablet or two 100 mg tablets) taken twice daily following a meal [see Clinical Pharmacology (12.3)]. The type of food does not affect the exposure to etravirine.
The recommended dose of INTELENCE® for pediatric patients 6 years to less than 18 years of age and weighing at least 16 kg is based on body weight (see table below) not exceeding the recommended adult dose. INTELENCE tablet(s) should be taken orally, following a meal [see Clinical Pharmacology (12.3)]. The type of food does not affect the exposure to etravirine.
The safety and efficacy of INTELENCE® have not been established in children less than 6 years of age [see Clinical Pharmacology (12.3)].
Healthcare professionals should pay special attention to the accurate dose selection of INTELENCE®, the transcription of the medication order, the dispensing information and the dosing instructions to minimize the risk of medication errors, overdosing, and underdosing.
Patients should be instructed to swallow the INTELENCE® tablet(s) whole with a liquid such as water. Patients who are unable to swallow the INTELENCE® tablet(s) whole may disperse the tablet(s) in a glass of water. The patient should be instructed to do the following:
INTELENCE® 25 mg tablets are supplied as white to off-white, oval, scored tablets debossed with "TMC" on one side.
INTELENCE® 100 mg tablets are supplied as white to off-white oval tablets debossed with "TMC125" on one side and "100" on the other side.
INTELENCE® 200 mg tablets are supplied as white to off-white, biconvex, oblong tablets debossed with "T200" on one side.
Severe, potentially life-threatening, and fatal skin reactions have been reported. These include cases of Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme. Hypersensitivity reactions including Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) have also been reported and were characterized by rash, constitutional findings, and sometimes organ dysfunction, including hepatic failure. In Phase 3 clinical trials, Grade 3 and 4 rashes were reported in 1.3% of subjects receiving INTELENCE® compared to 0.2% of placebo subjects. A total of 2.2% of HIV-1-infected subjects receiving INTELENCE® discontinued from Phase 3 trials due to rash [see Adverse Reactions (6)]. Rash occurred most commonly during the first 6 weeks of therapy. The incidence of rash was higher in females [see Adverse Reactions (6)]
Discontinue INTELENCE® immediately if signs or symptoms of severe skin reactions or hypersensitivity reactions develop (including, but not limited to, severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial edema, hepatitis, eosinophilia, angioedema). Clinical status including liver transaminases should be monitored and appropriate therapy initiated. Delay in stopping INTELENCE® treatment after the onset of severe rash may result in a life-threatening reaction.
Redistribution/accumulation of body fat, including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and "cushingoid appearance" have been observed in patients receiving antiretroviral therapy. The mechanism and long-term consequences of these events are currently unknown. A causal relationship has not been established.
Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including INTELENCE®. During the initial phase of combination antiretroviral treatment, patients whose immune system responds may develop an inflammatory response to indolent or residual opportunistic infections (such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis jiroveci pneumonia (PCP) or tuberculosis), which may necessitate further evaluation and treatment.
Autoimmune disorders (such as Graves' disease, polymyositis, and Guillain-Barré syndrome) have also been reported to occur in the setting of immune reconstitution; however, the time to onset is more variable, and can occur many months after initiation of treatment.
The following adverse reactions are described in greater detail in other sections:
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety assessment is based on all data from 1203 subjects in the Phase 3 placebo-controlled trials, TMC125-C206 and TMC125-C216, conducted in antiretroviral treatment-experienced HIV-1-infected adult subjects, 599 of whom received INTELENCE® (200 mg twice daily). In these pooled trials, the median exposure for subjects in the INTELENCE® arm and placebo arm was 52.3 and 51.0 weeks, respectively. Discontinuations due to adverse drug reactions (ADRs) were 5.2% in the INTELENCE® arm and 2.6% in the placebo arm.
The most frequently reported ADR at least Grade 2 in severity was rash (10.0%). Stevens-Johnson syndrome, drug hypersensitivity reaction and erythema multiforme were reported in less than 0.1% of subjects during clinical development with INTELENCE® [see Warnings and Precautions (5.1)]. A total of 2.2% of HIV-1-infected subjects in Phase 3 trials receiving INTELENCE® discontinued due to rash. In general, in clinical trials, rash was mild to moderate, occurred primarily in the second week of therapy, and was infrequent after Week 4. Rash generally resolved within 1 to 2 weeks on continued therapy. The incidence of rash was higher in women compared to men in the INTELENCE® arm in the Phase 3 trials (rash ≥ Grade 2 was reported in 9/60 [15.0%] women versus 51/539 [9.5%] men; discontinuations due to rash were reported in 3/60 [5.0%] women versus 10/539 [1.9%] men) [see Warnings and Precautions (5.1)]. Patients with a history of NNRTI-related rash did not appear to be at increased risk for the development of INTELENCE®-related rash compared to patients without a history of NNRTI-related rash.
Common Adverse Reactions
Clinical ADRs of moderate intensity or greater (greater than or equal to Grade 2) and reported in at least 2% of subjects treated with INTELENCE® and occurring at a higher rate compared to placebo (excess of 1%) are presented in Table 1. Laboratory abnormalities considered ADRs are included in Table 2.
Less Common Adverse Reactions
Treatment-emergent ADRs occurring in less than 2% of subjects (599 subjects) receiving INTELENCE® and of at least moderate intensity (greater than or equal to Grade 2) are listed below by body system:
Cardiac Disorders: myocardial infarction, angina pectoris, atrial fibrillation
Ear and Labyrinth Disorders: vertigo
Eye Disorders: blurred vision
Gastrointestinal Disorders: gastroesophageal reflux disease, flatulence, gastritis, abdominal distension, pancreatitis, constipation, dry mouth, hematemesis, retching, stomatitis
General Disorders and Administration Site Conditions: sluggishness
Hematologic Disorders: hemolytic anemia
Hepatobiliary Disorders: hepatic failure, hepatomegaly, cytolytic hepatitis, hepatic steatosis, hepatitis
Immune System Disorders: drug hypersensitivity, immune reconstitution syndrome
Metabolism and Nutrition Disorders: diabetes mellitus, anorexia, dyslipidemia
Nervous System Disorders: paraesthesia, somnolence, convulsion, hypoesthesia, amnesia, syncope, disturbance in attention, hypersomnia, tremor
Psychiatric Disorders: anxiety, sleep disorders, abnormal dreams, confusional state, disorientation, nervousness, nightmares
Renal and Urinary Disorders: acute renal failure
Reproductive System and Breast Disorders: gynecomastia
Respiratory,Thoracic and Mediastinal Disorders: exertional dyspnea, bronchospasm
Skin and Subcutaneous Tissue Disorders: night sweats, lipohypertrophy, prurigo, hyperhidrosis, dry skin, swelling face
Additional ADRs of at least moderate intensity observed in other trials were acquired lipodystrophy, angioneurotic edema, erythema multiforme and haemorrhagic stroke, each reported in no more than 0.5% of subjects.
Laboratory Abnormalities in Treatment-Experienced Patients
Selected Grade 2 to Grade 4 laboratory abnormalities that represent a worsening from baseline observed in adult subjects treated with INTELENCE® are presented in Table 2.
Patients co-infected with hepatitis B and/or hepatitis C virus
In Phase 3 trials TMC125-C206 and TMC125-C216, 139 subjects (12.3%) with chronic hepatitis B and/or hepatitis C virus co-infection out of 1129 subjects were permitted to enroll. AST and ALT abnormalities occurred more frequently in hepatitis B and/or hepatitis C virus co-infected subjects for both treatment groups. Grade 2 or higher laboratory abnormalities that represent a worsening from baseline of AST, ALT or total bilirubin occurred in 27.8%, 25.0% and 7.1% respectively, of INTELENCE®-treated co-infected subjects as compared to 6.7%, 7.5% and 1.8% of non-co-infected INTELENCE®-treated subjects. In general, adverse events reported by INTELENCE®-treated subjects with hepatitis B and/or hepatitis C virus co-infection were similar to INTELENCE®-treated subjects without hepatitis B and/or hepatitis C virus co-infection.
The safety assessment in children and adolescents is based on the Week 24 analysis of the single-arm, Phase 2 trial TMC125-C213 in which 101 antiretroviral treatment-experienced HIV-1 infected subjects 6 years to less than 18 years of age and weighing at least 16 kg received INTELENCE in combination with other antiretroviral agents [see Clinical Studies (14.2)]. The frequency, type and severity of adverse drug reactions in pediatric subjects were comparable to those observed in adult subjects, except for rash which was observed more frequently in pediatric subjects. The most common adverse drug reactions in at least 2% of pediatric subjects were rash and diarrhea. Rash was reported more frequently in female subjects than in male subjects (rash ≥ Grade 2 was reported in 13/64 [20.3%] females versus 2/37 [5.4%] males; discontinuations due to rash were reported in 4/64 [6.3%] females versus 0/37 [0%] males). Rash (greater than or equal to Grade 2) occurred in 15% of pediatric subjects. In the majority of cases, rash was mild to moderate, of macular/papular type, and occurred in the second week of therapy. Rash was self-limiting and generally resolved within 1 week on continued therapy. The safety profile for subjects who completed 48 weeks of treatment was similar to the safety profile for subjects who completed 24 weeks of treatment.
The following events have been identified during postmarketing use of INTELENCE®. Because these events are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Immune System Disorders: Severe hypersensitivity reactions including DRESS and cases of hepatic failure have been reported [see Warnings and Precautions (5.1)].
Musculoskeletal and Connective Tissue Disorders: rhabdomyolysis
Skin and Subcutaneous Tissue Disorders: Fatal cases of toxic epidermal necrolysis have been reported [see Warnings and Precautions (5.1)].
Etravirine is a substrate of CYP3A, CYP2C9, and CYP2C19. Therefore, co-administration of INTELENCE® with drugs that induce or inhibit CYP3A, CYP2C9, and CYP2C19 may alter the therapeutic effect or adverse reaction profile of INTELENCE® (see Table 3). [See also Clinical Pharmacology (12.3).]
Etravirine is an inducer of CYP3A and inhibitor of CYP2C9, CYP2C19 and P-glycoprotein. Therefore, co-administration of drugs that are substrates of CYP3A, CYP2C9 and CYP2C19 or are transported by P-glycoprotein with INTELENCE® may alter the therapeutic effect or adverse reaction profile of the co-administered drug(s) (see Table 3). [See also Clinical Pharmacology (12.3).]
Table 3 shows the established and other potentially significant drug interactions based on which, alterations in dose or regimen of INTELENCE® and/or co-administered drug may be recommended. Drugs that are not recommended for co-administration with INTELENCE® are also included in Table 3.
In addition to the drugs included in Table 3, the interaction between INTELENCE® and the following drugs were evaluated in clinical studies and no dose adjustment is needed for either drug [see Clinical Pharmacology (12.3)]: didanosine, enfuvirtide (ENF), ethinylestradiol/norethindrone, omeprazole, paroxetine, raltegravir, ranitidine, and tenofovir disoproxil fumarate.
Pregnancy Category B
No adequate and well-controlled studies of INTELENCE® use in pregnant women have been conducted. In addition, no pharmacokinetic studies have been conducted in pregnant patients. INTELENCE® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Antiretroviral Pregnancy Registry
To monitor maternal-fetal outcomes of pregnant women exposed to INTELENCE®, an Antiretroviral Pregnancy Registry has been established. Physicians are encouraged to register patients by calling 1-800-258-4263.
Animal Data
Reproductive and developmental toxicity studies were performed in rabbits (at oral doses up to 375 mg per kg per day) and rats (at oral doses up to 1000 mg per kg per day). In both species, no treatment-related embryo-fetal effects including malformations were observed. In addition, no treatment-related effects were observed in a separate pre- and postnatal study performed in rats at oral doses up to 500 mg per kg per day. The systemic drug exposures achieved in these animal studies were equivalent to those at the recommended human dose (400 mg per day).
The Centers for Disease Control and Prevention recommend that HIV-infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV. It is not known whether etravirine is secreted in human milk. Because of both the potential for HIV transmission and the potential for adverse reactions in nursing infants, mothers should be instructed not to breastfeed if they are receiving INTELENCE®.
Treatment with INTELENCE® is not recommended in children less than 6 years of age. The pharmacokinetics, safety, tolerability and efficacy of INTELENCE® in children less than 6 years of age have not been established [see Clinical Pharmacology (12.3)].
The safety, pharmacokinetic profile, and virologic and immunologic responses of INTELENCE® were evaluated in treatment-experienced HIV-1-infected pediatric subjects 6 years to less than 18 years of age and weighing at least 16 kg [see Adverse Reactions (6.2), Clinical Pharmacology (12.3) and Clinical Studies (14.2)]. Frequency, type, and severity of adverse drug reactions in pediatric subjects were comparable to those observed in adults, except for rash [see Adverse Reactions (6.2)]. Please see Dosage and Administration (2.2) for dosing recommendations for pediatric subjects 6 years to less than 18 years of age and weighing at least 16 kg.
Clinical studies of INTELENCE® did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger subjects. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
No dose adjustment of INTELENCE® is required in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment. The pharmacokinetics of INTELENCE® have not been evaluated in patients with severe hepatic impairment (Child-Pugh Class C).
Since the renal clearance of etravirine is negligible (less than 1.2%), a decrease in total body clearance is not expected in patients with renal impairment. No dose adjustments are required in patients with renal impairment. As etravirine is highly bound to plasma proteins, it is unlikely that it will be significantly removed by hemodialysis or peritoneal dialysis.
There is no specific antidote for overdose with INTELENCE®. Human experience of overdose with INTELENCE® is limited. The highest dose studied in healthy volunteers was 400 mg once daily. Treatment of overdose with INTELENCE® consists of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient. If indicated, elimination of unabsorbed active substance is to be achieved by emesis or gastric lavage. Administration of activated charcoal may also be used to aid in removal of unabsorbed active substance. Because etravirine is highly protein bound, dialysis is unlikely to result in significant removal of the active substance.
INTELENCE® (etravirine) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) of human immunodeficiency virus type 1 (HIV-1).
The chemical name for etravirine is 4-[[6-amino-5-bromo-2-[(4-cyanophenyl)amino]-4-pyrimidinyl]oxy]-3,5-dimethylbenzonitrile. Its molecular formula is C20H15BrN6O and its molecular weight is 435.28. Etravirine has the following structural formula:
Etravirine is a white to slightly yellowish brown powder. Etravirine is practically insoluble in water over a wide pH range. It is very slightly soluble in propylene glycol and slightly soluble in ethanol. Etravirine is soluble in polyethylene glycol (PEG)400 and freely soluble in some organic solvents (e.g., N,N-dimethylformamide and tetrahydrofuran).
INTELENCE® 25 mg tablets are available as white to off-white, oval scored tablets for oral administration. Each 25 mg tablet contains 25 mg of etravirine and the inactive ingredients hypromellose, microcrystalline cellulose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and lactose monohydrate.
INTELENCE® 100 mg tablets are available as white to off-white, oval tablets for oral administration. Each 100 mg tablet contains 100 mg of etravirine and the inactive ingredients hypromellose, microcrystalline cellulose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and lactose monohydrate.
INTELENCE® 200 mg tablets are available as white to off-white, biconvex, oblong tablets for oral administration. Each 200 mg tablet contains 200 mg of etravirine and the inactive ingredients hypromellose, silicified microcrystalline cellulose, microcrystalline cellulose, colloidal silicon dioxide, croscarmellose sodium and magnesium stearate.
Etravirine is an antiviral drug [see Microbiology (12.4)].
Effects on Electrocardiogram
In a randomized, double-blind, active, and placebo-controlled crossover study, 41 healthy subjects were administered INTELENCE® 200 mg twice daily, INTELENCE® 400 mg once daily, placebo, and moxifloxacin 400 mg. After 8 days of dosing, etravirine did not prolong the QT interval. The maximum mean (upper 1-sided 95% CI) baseline and placebo-adjusted QTcF were 0.6 ms (3.3 ms) for 200 mg twice daily and -1.0 ms (2.5 ms) for 400 mg once daily dosing regimens.
Pharmacokinetics in Adults
The pharmacokinetic properties of INTELENCE® were determined in healthy adult subjects and in treatment-experienced HIV-1-infected adult and pediatric subjects. The systemic exposures (AUC) to etravirine were lower in HIV-1-infected subjects than in healthy subjects.
Note: The median protein binding adjusted EC50 for MT4 cells infected with HIV-1/IIIB in vitro equals 4 ng per mL.
Absorption and Bioavailability
Following oral administration, etravirine was absorbed with a Tmax of about 2.5 to 4 hours. The absolute oral bioavailability of INTELENCE® is unknown.
In healthy subjects, the absorption of etravirine is not affected by co-administration of oral ranitidine or omeprazole, drugs that increase gastric pH.
Effects of Food on Oral Absorption
The systemic exposure (AUC) to etravirine was decreased by about 50% when INTELENCE® was administered under fasting conditions, as compared to when INTELENCE® was administered following a meal. Therefore, INTELENCE® should always be taken following a meal. Within the range of meals studied, the systemic exposures to etravirine were similar. The total caloric content of the various meals evaluated ranged from 345 kilocalories (17 grams fat) to 1160 kilocalories (70 grams fat) [see Dosage and Administration (2)].
Etravirine is about 99.9% bound to plasma proteins, primarily to albumin (99.6%) and alpha 1-acid glycoprotein (97.66% to 99.02%) in vitro. The distribution of etravirine into compartments other than plasma (e.g., cerebrospinal fluid, genital tract secretions) has not been evaluated in humans.
In vitro experiments with human liver microsomes (HLMs) indicate that etravirine primarily undergoes metabolism by CYP3A, CYP2C9, and CYP2C19 enzymes. The major metabolites, formed by methyl hydroxylation of the dimethylbenzonitrile moiety, were at least 90% less active than etravirine against wild-type HIV in cell culture.
After single dose oral administration of 800 mg 14C-etravirine, 93.7% and 1.2% of the administered dose of 14C-etravirine was recovered in the feces and urine, respectively. Unchanged etravirine accounted for 81.2% to 86.4% of the administered dose in feces. Unchanged etravirine was not detected in urine. The mean (± standard deviation) terminal elimination half-life of etravirine was about 41 (± 20) hours.
Special Populations
Hepatic Impairment
Etravirine is primarily metabolized by the liver. The steady state pharmacokinetic parameters of etravirine were similar after multiple dose administration of INTELENCE® to subjects with normal hepatic function (16 subjects), mild hepatic impairment (Child-Pugh Class A, 8 subjects), and moderate hepatic impairment (Child-Pugh Class B, 8 subjects). The effect of severe hepatic impairment on the pharmacokinetics of etravirine has not been evaluated.
Hepatitis B and/or Hepatitis C Virus Co-infection
Population pharmacokinetic analysis of the TMC125-C206 and TMC125-C216 trials showed reduced clearance for etravirine in HIV-1-infected subjects with hepatitis B and/or C virus co-infection. Based upon the safety profile of INTELENCE® [see Adverse Reactions (6)], no dose adjustment is necessary in patients co-infected with hepatitis B and/or C virus.
Renal Impairment
The pharmacokinetics of etravirine have not been studied in patients with renal impairment. The results from a mass balance study with 14C-etravirine showed that less than 1.2% of the administered dose of etravirine is excreted in the urine as metabolites. No unchanged drug was detected in the urine. As etravirine is highly bound to plasma proteins, it is unlikely that it will be significantly removed by hemodialysis or peritoneal dialysis.
No significant pharmacokinetic differences have been observed between males and females.
Population pharmacokinetic analysis of etravirine in HIV-infected subjects did not show an effect of race on exposure to etravirine.
Geriatric Patients
Population pharmacokinetic analysis in HIV-infected subjects showed that etravirine pharmacokinetics are not considerably different within the age range (18 to 77 years) evaluated [see Use in Specific Populations (8.5)].
Pediatric Patients
The pharmacokinetics of etravirine in 101 treatment-experienced HIV-1-infected pediatric subjects, 6 years to less than 18 years of age and weighing at least 16 kg showed that the administered weight-based dosages (approximately 5.2 mg per kg twice daily up to the adult recommended doses) resulted in etravirine exposure comparable to that in adults receiving INTELENCE® 200 mg twice daily [see Dosage and Administration (2.2)] when administered at a dose corresponding to 5.2 mg per kg twice daily. The population pharmacokinetic estimates for etravirine AUC12h and C0h are summarized in the table below.
The pharmacokinetics of etravirine in pediatric subjects less than 6 years of age have not been established.
Drug Interactions
[See also Drug Interactions (7).]
Etravirine is a substrate of CYP3A, CYP2C9, and CYP2C19. Therefore, co-administration of INTELENCE® with drugs that induce or inhibit CYP3A, CYP2C9, and CYP2C19 may alter the therapeutic effect or adverse reaction profile of INTELENCE®.
Etravirine is an inducer of CYP3A and inhibitor of CYP2C9, CYP2C19 and P-glycoprotein. Therefore, co-administration of drugs that are substrates of CYP3A, CYP2C9 and CYP2C19 or are transported by P-glycoprotein with INTELENCE® may alter the therapeutic effect or adverse reaction profile of the co-administered drug(s).
Drug interaction studies were performed with INTELENCE® and other drugs likely to be co-administered and some drugs commonly used as probes for pharmacokinetic interactions. The effects of co-administration of other drugs on the AUC, Cmax, and Cmin values of etravirine are summarized in Table 5 (effect of other drugs on INTELENCE®). The effect of co-administration of INTELENCE® on the AUC, Cmax, and Cmin values of other drugs are summarized in Table 6 (effect of INTELENCE® on other drugs). For information regarding clinical recommendations, see Drug Interactions (7).
Mechanism of Action
Etravirine is an NNRTI of human immunodeficiency virus type 1 (HIV-1). Etravirine binds directly to reverse transcriptase (RT) and blocks the RNA-dependent and DNA-dependent DNA polymerase activities by causing a disruption of the enzyme's catalytic site. Etravirine does not inhibit the human DNA polymerases α, β, and γ.
Antiviral Activity in Cell Culture
Etravirine exhibited activity against laboratory strains and clinical isolates of wild-type HIV-1 in acutely infected T-cell lines, human peripheral blood mononuclear cells, and human monocytes/macrophages with median EC50 values ranging from 0.9 to 5.5 nM (i.e., 0.4 to 2.4 ng per mL). Etravirine demonstrated antiviral activity in cell culture against a broad panel of HIV-1 group M isolates (subtype A, B, C, D, E, F, G) with EC50 values ranging from 0.29 to 1.65 nM and EC50 values ranging from 11.5 to 21.7 nM against group O primary isolates. Etravirine did not show antagonism when studied in combination with the following antiretroviral drugs—the NNRTIs delavirdine, efavirenz, and nevirapine; the N(t)RTIs abacavir, didanosine, emtricitabine, lamivudine, stavudine, tenofovir, zalcitabine, and zidovudine; the PIs amprenavir, atazanavir, darunavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, and tipranavir; the fusion inhibitor enfuvirtide; the integrase strand transfer inhibitor raltegravir and the CCR5 co-receptor antagonist maraviroc.
In Cell Culture
Etravirine-resistant strains were selected in cell culture originating from wild-type HIV-1 of different origins and subtypes, as well as NNRTI resistant HIV-1. Development of reduced susceptibility to etravirine typically required more than one substitution in reverse transcriptase of which the following were observed most frequently: L100I, E138K, E138G, V179I, Y181C, and M230I.
In Treatment-Experienced Subjects
In the Phase 3 trials TMC125-C206 and TMC125-C216, substitutions that developed most commonly in subjects with virologic failure at Week 48 to the INTELENCE®-containing regimen were V179F, V179I, and Y181C which usually emerged in a background of multiple other NNRTI resistance-associated substitutions. In all the trials conducted with INTELENCE® in HIV-1 infected subjects, the following substitutions emerged most commonly: L100I, E138G, V179F, V179I, Y181C and H221Y. Other NNRTI-resistance associated substitutions which emerged on etravirine treatment in less than 10% of the virologic failure isolates included K101E/H/P, K103N/R, V106I/M, V108I, Y181I, Y188L, V189I, G190S/C, N348I and R356K. The emergence of NNRTI substitutions on etravirine treatment contributed to decreased susceptibility to etravirine with a median fold-change in etravirine susceptibility of 40-fold from reference and a median fold-change of 6-fold from baseline.
Site-Directed NNRTI Mutant Virus
Etravirine showed antiviral activity against 55 of 65 HIV-1 strains (85%) with single amino acid substitutions at RT positions associated with NNRTI resistance, including the most commonly found K103N. The single amino acid substitutions associated with an etravirine reduction in susceptibility greater than 3-fold were K101A, K101P, K101Q, E138G, E138Q, Y181C, Y181I, Y181T, Y181V, and M230L, and of these, the greatest reductions were Y181I (13-fold change in EC50 value) and Y181V (17-fold change in EC50 value). Mutant strains containing a single NNRTI resistance associated substitution (K101P, K101Q, E138Q, or M230L) had cross-resistance between etravirine and efavirenz. The majority (39 of 61; 64%) of the NNRTI mutant viruses with 2 or 3 amino acid substitutions associated with NNRTI resistance had decreased susceptibility to etravirine (fold-change greater than 3). The highest levels of resistance to etravirine were observed for HIV-1 harboring a combination of substitutions V179F + Y181C (187 fold-change), V179F + Y181I (123 fold-change), or V179F + Y181C + F227C (888 fold-change).
Clinical Isolates
Etravirine retained a fold-change less than or equal to 3 against 60% of 6171 NNRTI-resistant clinical isolates. In the same panel, the proportion of clinical isolates resistant to delavirdine, efavirenz and/or nevirapine (defined as a fold-change above their respective biological cutoff values in the assay) was 79%, 87%, and 95%, respectively. In TMC125-C206 and TMC125-C216, 34% of the baseline isolates had decreased susceptibility to etravirine (fold-change greater than 3) and 60%, 69%, and 78% of all baseline isolates were resistant to delavirdine, efavirenz, and nevirapine, respectively. Of subjects who received etravirine and were virologic failures in TMC125-C206 and TMC125-C216, 90%, 84%, and 96% of viral isolates obtained at the time of treatment failure were resistant to delavirdine, efavirenz, and nevirapine, respectively. Therefore, cross-resistance to delavirdine, efavirenz, and/or nevirapine is expected after virologic failure with an etravirine-containing regimen for the virologic failure isolates.
Treatment-naïve HIV-1-infected subjects in the Phase 3 trials for EDURANT (rilpivirine)
There are currently no clinical data available on the use of etravirine in subjects who experienced virologic failure on a rilpivirine-containing regimen. However, in the rilpivirine adult clinical development program, there was evidence of phenotypic cross-resistance between rilpivirine and etravirine. In the pooled analyses of the Phase 3 clinical trials for rilpivirine, 38 rilpivirine virologic failure subjects had evidence of HIV-1 strains with genotypic and phenotypic resistance to rilpivirine. Of these subjects, 89% (34 subjects) of virologic failure isolates were cross-resistant to etravirine based on phenotype data. Consequently, it can be inferred that cross-resistance to etravirine is likely after virologic failure and development of rilpivirine resistance. Refer to the prescribing information for EDURANT (rilpivirine) for further information.
Baseline Genotype/Phenotype and Virologic Outcome Analyses
In TMC125-C206 and TMC125-C216, the presence at baseline of the substitutions L100I, E138A, I167V, V179D, V179F, Y181I, Y181V, or G190S was associated with a decreased virologic response to etravirine. Additional substitutions associated with a decreased virologic response to etravirine when in the presence of 3 or more additional 2008 IAS-USA defined NNRTI substitutions include A98G, K101H, K103R, V106I, V179T, and Y181C. The presence of K103N, which was the most prevalent NNRTI substitution in TMC125-C206 and TMC125-C216 at baseline, did not affect the response in the INTELENCE® arm. Overall, response rates to etravirine decreased as the number of baseline NNRTI substitutions increased (shown as the proportion of subjects achieving viral load less than 50 plasma HIV RNA copies per mL at Week 48) (Table 7).
Response rates assessed by baseline etravirine phenotype are shown in Table 8. These baseline phenotype groups are based on the select subject populations in TMC125-C206 and TMC125-C216 and are not meant to represent definitive clinical susceptibility breakpoints for INTELENCE®. The data are provided to give clinicians information on the likelihood of virologic success based on pre-treatment susceptibility to etravirine in treatment-experienced patients.
The proportion of virologic responders (viral load less than 50 HIV-1 RNA copies per mL) by the phenotypic susceptibility score (PSS) of the background therapy, including enfuvirtide, is shown in Table 9.
Etravirine was evaluated for carcinogenic potential by oral gavage administration to mice and rats for up to approximately 104 weeks. Daily doses of 50, 200 and 400 mg per kg were administered to mice and doses of 70, 200 and 600 mg per kg were administered to rats in the initial period of approximately 41 to 52 weeks. The high and middle doses were subsequently adjusted due to tolerability and reduced by 50% in mice and by 50 to 66% in rats to allow for completion of the studies. In the mouse study, statistically significant increases in the incidences of hepatocellular carcinoma and incidences of hepatocellular adenomas or carcinomas combined were observed in treated females. In the rat study, no statistically significant increases in tumor findings were observed in either sex. The relevance of these liver tumor findings in mice to humans is not known. Because of tolerability of the formulation in these rodent studies, maximum systemic drug exposures achieved at the doses tested were lower than those in humans at the clinical dose (400 mg per day), with animal vs. human AUC ratios being 0.6-fold (mice) and 0.2–0.7-fold (rats).
Etravirine tested negative in the in vitro Ames reverse mutation assay, in vitro chromosomal aberration assay in human lymphocyte, and in vitro clastogenicity mouse lymphoma assay, tested in the absence and presence of a metabolic activation system. Etravirine did not induce chromosomal damage in the in vivo micronucleus test in mice.
Impairment of Fertility
No effects on fertility and early embryonic development were observed when etravirine was tested in rats at maternal doses up to 500 mg per kg per day, resulting in systemic drug exposure up to the recommended human dose (400 mg per day).
The clinical efficacy of INTELENCE® is derived from the analyses of 48-week data from 2 ongoing, randomized, double-blinded, placebo-controlled, Phase 3 trials, TMC125-C206 and TMC125-C216 (DUET-1 and DUET-2). These trials are identical in design and the results below are pooled data from the two trials.
TMC125-C206 and TMC125-C216 are Phase 3 studies designed to evaluate the safety and antiretroviral activity of INTELENCE® in combination with a background regimen (BR) as compared to placebo in combination with a BR. Eligible subjects were treatment-experienced HIV-1-infected patients with plasma HIV-1 RNA greater than 5000 copies per mL while on an antiretroviral regimen for at least 8 weeks. In addition, subjects had 1 or more NNRTI resistance-associated mutations at screening or from prior genotypic analysis, and 3 or more of the following primary PI mutations at screening: D30N, V32I, L33F, M46I/L, I47A/V, G48V, I50L/V, V82A/F/L/S/T, I84V, N88S, or L90M. Randomization was stratified by the intended use of enfuvirtide (ENF) in the BR, previous use of darunavir/ritonavir (DRV/rtv), and screening viral load. Virologic response was defined as HIV-1 RNA less than 50 copies per mL at Week 48.
All study subjects received DRV/rtv as part of their BR, and at least 2 other investigator-selected antiretroviral drugs (N[t]RTIs with or without ENF). Of INTELENCE®-treated subjects, 25.5% used ENF for the first time (de novo) and 20.0% re-used ENF. Of placebo-treated subjects, 26.5% used de novo ENF and 20.4% re-used ENF.
In the pooled analysis for TMC125-C206 and TMC125-C216, demographics and baseline characteristics were balanced between the INTELENCE® arm and the placebo arm. Table 10 displays selected demographic and baseline disease characteristics of the subjects in the INTELENCE® and placebo arms.
Efficacy at Week 48 for subjects in the INTELENCE® and placebo arms for the pooled TMC125-C206 and TMC125-C216 study populations are shown in Table 11.
At Week 48, 70.8% of INTELENCE®-treated subjects achieved HIV-1 RNA less than 400 copies per mL as compared to 46.4% of placebo-treated subjects. The mean decrease in plasma HIV-1 RNA from baseline to Week 48 was -2.23 log10 copies per mL for INTELENCE®-treated subjects and -1.46 log10 copies per mL for placebo-treated subjects. The mean CD4+ cell count increase from baseline for INTELENCE®-treated subjects was 96 cells per mm3 and 68 cells per mm3 for placebo-treated subjects.
Of the study population who either re-used or did not use ENF, 57.4% of INTELENCE®-treated subjects and 31.7% of placebo-treated subjects achieved HIV-1 RNA less than 50 copies per mL. Of the study population using ENF de novo, 67.3% of INTELENCE®-treated subjects and 57.2% of placebo-treated subjects achieved HIV-1 RNA less than 50 copies per mL.
Treatment-emergent CDC category C events occurred in 4% of INTELENCE®-treated subjects and 8.4% of placebo-treated subjects.
Study TMC125-C227 was a randomized, exploratory, active-controlled, open-label, Phase 2b trial. Eligible subjects were treatment-experienced, PI-naïve HIV-1-infected patients with genotypic evidence of NNRTI resistance at screening or from prior genotypic analysis. The virologic response was evaluated in 116 subjects who were randomized to INTELENCE® (59 subjects) or an investigator-selected PI (57 subjects), each given with 2 investigator-selected N(t)RTIs. INTELENCE®-treated subjects had lower antiviral responses associated with reduced susceptibility to the N(t)RTIs and to INTELENCE® as compared to the control PI-treated subjects.
TMC125-C213, a single-arm, Phase 2 trial evaluating the pharmacokinetics, safety, tolerability, and efficacy of INTELENCE® enrolled 101 antiretroviral treatment-experienced HIV-1 infected pediatric subjects 6 years to less than 18 years of age and weighing at least 16 kg. Subjects eligible for this trial were on an antiretroviral regimen with confirmed plasma HIV-1 RNA of at least 500 copies per mL and viral susceptibility to INTELENCE® at screening.
The median baseline plasma HIV-1 RNA was 3.9 log10 copies per mL, and the median baseline CD4 cell count was 385 × 106 cells per mm3.
At Week 24, 52% of all pediatric subjects had HIV-1 RNA less than 50 copies per mL. The proportion of pediatric subjects with HIV-1 RNA less than 400 copies per mL was 67%. The mean CD4 cell count increase from baseline was 112 × 106 cells per mm3.
INTELENCE® 25 mg tablets are supplied as white to off-white, oval, scored tablets containing 25 mg of etravirine. Each tablet is debossed with "TMC" on one side.
INTELENCE® 100 mg tablets are supplied as white to off-white, oval tablets containing 100 mg of etravirine. Each tablet is debossed with "TMC125" on one side and "100" on the other side.
INTELENCE® 200 mg tablets are supplied as white to off-white, biconvex, oblong tablets containing 200 mg of etravirine. Each tablet is debossed with "T200" on one side.
INTELENCE® tablets are packaged in bottles in the following configuration:
Store INTELENCE® tablets at 25°C (77°F); with excursions permitted to 15°to 30°C (59°to 86°F) [see USP controlled room temperature]. Store in the original bottle. Keep the bottle tightly closed in order to protect from moisture. Do not remove the desiccant pouches.
See FDA-approved patient labeling (Patient Information).
A statement to patients and healthcare providers is included on the product's bottle label: ALERT: Find out about medicines that should NOT be taken with INTELENCE® from your healthcare provider. A Patient Package Insert for INTELENCE® is available for patient information.
Patients should be informed that INTELENCE® is not a cure for HIV infection and that they may continue to develop opportunistic infections and other complications associated with HIV disease. Patients should be told that sustained decreases in plasma HIV RNA have been associated with a reduced risk of progression to AIDS and death. Patients should remain under the care of a physician while using INTELENCE®.
Patients should be advised to avoid doing things that can spread HIV-1 infection to others. Patients should be advised to practice safe sex and to use latex or polyurethane condoms to lower the chance of sexual contact with any body fluids such as semen, vaginal secretions or blood. Patients should also be advised to never re-use or share needles or other injection equipment, or share personal items that can have blood or body fluids on them, such as toothbrushes and razor blades.
Patients should be advised to take INTELENCE® following a meal twice a day as prescribed. The type of food does not affect the exposure to etravirine.
Patients should be instructed to swallow the INTELENCE® tablet(s) whole with a liquid such as water. Patients should be instructed not to chew the tablets. Patients who are unable to swallow the INTELENCE® tablet(s) whole may disperse the tablet(s) in a glass of water. The patient should be instructed to do the following:
INTELENCE® must always be used in combination with other antiretroviral drugs. Patients should not alter the dose of INTELENCE® or discontinue therapy with INTELENCE® without consulting their physician.
If the patient misses a dose of INTELENCE® within 6 hours of the time it is usually taken, the patient should take INTELENCE® following a meal as soon as possible, and then take the next dose of INTELENCE® at the regularly scheduled time. If a patient misses a dose of INTELENCE® by more than 6 hours of the time it is usually taken, the patient should not take the missed dose and simply resume the usual dosing schedule. Inform the patient that he or she should not take more or less than the prescribed dose of INTELENCE® at any one time.
INTELENCE® may interact with many drugs; therefore, patients should be advised to report to their healthcare provider the use of any other prescription or nonprescription medication or herbal products, including St. John's wort.
Patients should be informed that severe and potentially life-threatening rash has been reported with INTELENCE®. Rash has been reported most commonly in the first 6 weeks of therapy. Patients should be advised to immediately contact their healthcare provider if they develop rash. Instruct patients to immediately stop taking INTELENCE® and seek medical attention if they develop a rash associated with any of the following symptoms as it may be a sign of a more serious reaction such as Stevens-Johnson syndrome, toxic epidermal necrolysis or severe hypersensitivity: fever, generally ill feeling, extreme tiredness, muscle or joint aches, blisters, oral lesions, eye inflammation, facial swelling, swelling of the eyes, lips, mouth, breathing difficulty, and/or signs and symptoms of liver problems (e.g., yellowing of your skin or whites of your eyes, dark or tea colored urine, pale colored stools/bowel movements, nausea, vomiting, loss of appetite, or pain, aching or sensitivity on your right side below your ribs). Patients should understand that if severe rash occurs, they will be closely monitored, laboratory tests will be ordered and appropriate therapy will be initiated.
Patients should be informed that redistribution or accumulation of body fat may occur in patients receiving antiretroviral therapy, including INTELENCE®, and that the cause and long-term health effects of these conditions are not known at this time.
Product of BelgiumFinished Product Manufactured by:Janssen Cilag S.p.A., Latina, ItalyManufactured for:Janssen Therapeutics, Division of Janssen Products, LP, Titusville NJ 08560
© Janssen Pharmaceuticals, Inc. 2008
Patient InformationINTELENCE® (in-tel-ence)(etravirine) tablets
Important: Ask your doctor or pharmacist about medicines that should not be taken with INTELENCE®. For more information, see the section "What should I tell my doctor before taking INTELENCE®?".
Read this Patient Information before you start taking INTELENCE® and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. You and your doctor should discuss your treatment with INTELENCE® when you start taking it and at regular checkups. You should not change or stop treatment without first talking with your doctor.
What is INTELENCE®?
When used with other HIV medicines, INTELENCE® may:
INTELENCE® does not cure HIV infection or AIDS.
You must stay on continuous HIV therapy to control HIV infection and decrease HIV-related illnesses.
Avoid doing things that can spread HIV-1 infection to others:
Ask your doctor if you have any questions on how to prevent passing HIV to other people.
What should I tell my doctor before taking INTELENCE®?
Before taking INTELENCE® tell your doctor if you:
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements, including St. John's wort (Hypericum perforatum). Some medicines may interact with INTELENCE®.
INTELENCE® may affect the way other medicines work, and other medicines may affect how INTELENCE® works. Taking INTELENCE® and certain other medicines may cause serious side effects. If you take certain medicines with INTELENCE®, then the amount of INTELENCE® in your body may be too low and INTELENCE® may not work to help reduce your HIV viral load. The HIV virus in your body may become resistant to INTELENCE® or other HIV medicines that are like it.
Tell your doctor if you take other HIV medicines. Some HIV medicines should not be taken with INTELENCE®.
Tell your doctor if you take:
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Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.
Your doctor and your pharmacist can tell you if you can take these medicines with INTELENCE®. Do not start any new medicines while you are taking INTELENCE® without first talking with your doctor or pharmacist. You can ask your doctor or pharmacist for a list of medicines that can interact with INTELENCE®.
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INTELENCE® can cause serious side effects including:
In adults, common side effects of INTELENCE® include tingling, numbness, or pain in the hands or feet.
In children, diarrhea is a common side effect of INTELENCE®.
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all of the possible side effects with INTELENCE®. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store INTELENCE®?
Keep INTELENCE® and all medicines out of the reach of children.
General information about INTELENCE®
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use INTELENCE® for a condition for which it was not prescribed. Do not give INTELENCE® to other people even if they have the same condition you have. It may harm them.
This leaflet summarizes the most important information about INTELENCE®. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about INTELENCE® that is written for health professionals. For more information, you may also call Janssen Products, LP at 1-800-526-7736.
What are the ingredients in INTELENCE®?
Active ingredient: etravirine.
25 mg and 100 mg INTELENCE® tablets contain the following inactive ingredients: hypromellose, microcrystalline cellulose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and lactose monohydrate
200 mg INTELENCE® tablets contain the following inactive ingredients: hypromellose, silicified microcrystalline cellulose, microcrystalline cellulose, colloidal silicon dioxide, croscarmellose sodium and magnesium stearate.
This Patient Information has been approved by the U.S. Food and Drug Administration.
Product of BelgiumFinished Product Manufactured by:Janssen Cilag S.p.A., Latina, ITManufactured for:Janssen Therapeutics, Division of Janssen Products, LP, Titusville NJ 08560
INTELENCE® is the registered trademark of Tibotec Pharmaceuticals.
Revised February 2013
PRINCIPAL DISPLAY PANEL - 100 mg Bottle Label
120 TabletsNDC 59676-570-01
INTELENCE®(etravirine) tablets
100 mg
Each tablet contains100 mg of etravirine.
Rx only
PRINCIPAL DISPLAY PANEL - 200 mg Bottle Label
60 Tablets NDC 59676-571-01
200 mg
Each tablet contains200 mg of etravirine.
PRINCIPAL DISPLAY PANEL - 25 mg Bottle Label
120 TabletsNDC 59676-572-01
25 mg
Each tablet contains25 mg of etravirine.
Revised: 02/2013 Janssen Products LP


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798 W Algonquin Rd, Arlington Heights, IL | Directions 6000542.050770 -87.991620
Mon-Thur:11am-11pm Fri - Sat:11am-12am Sun:11am-11pm
Pappadeaux Seafood Kitchen Westmont – Back in May my sister, mother and myself enjoyed a very nice lunch at the Westmont location, the decor was welcoming i especially liked the pathway leading into the restaurant. Our waiter was very attentive and everything he suggested was very tasty i was initially scared to try the fried alligator he suggested the sampler platter now i can't wait to go back and order that alligator to go everyone should try this restaurant and the prices were very reasonable oh yeah the gumbo is the best i have tasted
Horrible service -cooks were fistfighting – I have been to this restataurant a couple of years ago when it opened and was very excited because I loved the one in Dallas. But I went back there last week and our service was simply horrible. Waiter "Cory" was extremely rude and forgot everything. We had to get another waiter 5 times to get our stuff because Cory was nowhere to be found. Then on top of "not cooked enough food" we witnessed a fist fight between 2 cooks in the kitchen which our 2 children heard all the nasty swearwords that were exchanged. I will never go there again-simply awful
Decent Cajun seafood – Pappadeaux serves us pretty good Cajun flavored seafood. The service is very good but the restaurant semms to be overcrowded and noisy. The interior decor does not lend itself to a good dining experience. The food itself comes in large portions (as usual) and everything seemed fresh and seasoned. Overall it was a good dining experience.
Terrible service, mediocre food. – Based upon the good reviews that I read on this, and other sites, my husband and I took a friend who was visiting from the UK, to Pappadeaux's. Once we were seated, we waited for fifteen minutes before the waiter showed up. I ordered a cocktail before the meal--which arrived twenty minutes later with my sandy and lukewarm chowder. There was no bread brought to our table until we were almost done with our soup--which was ultimately no great loss, because it was over-soft, and chewy, as if it had been microwaved. I ordered the New Orleans fillet--a tilapia--which was a nice enough piece of fish, but covered in a gloppy sauce. Very overpriced. My husband ordered fried catfish which was fine and our friend ordered shrimp creole which had lots of shrimp but was nothing special. We ordered some mixed vegetables to go with our meal which we had to chase the waiter down to get. We had to chase them down for everything. We were very embarrassed to have taken our friend there and we will never go back.
goog – VERY NICE PLACE OK ALRIGHT OK OK OK OK OK OK OK OK OK OK OK OK OK OK OK OK OK OK OK OKOOK OK OKOKOKOKOKOKOKOKOOK OK OK OK OK OKOK OK OK OK
Always returning – This place is fantastic, both my wife and I enjoy it each return we have made.
Try the Fondou appetizer...its great.
You must always experience the "Swamp-Thing" when you arrive.
If you plan on taking kids, do not take them on a Friday or Saturday night, overwhelming packed sometimes.
We visit early when the kids are with us.
This lively seafood shanty attracts families and Creole cravers with its fresh catch fixes. – In Short
Nautical decor and a N'awlins vibe prevail at this boisterous chain known for its family-friendly atmosphere. Fried alligator is a popular beginner when available. Oysters Pappadeaux with crabmeat, spinach and hollandaise sauce offers an alternative. Gumbo, po boys, shrimp etouffee and crawfish are among the entree essentials. Desserts include bread pudding with bourbon sauce, sweet potato pecan pie and praline cheesecake.
Good Experience – A friend recommended us this place and we had a very good experience! The food and the service are excellent! We had to wait some time (20 min on a weekday) so Ill recommend you arrive a little early.
Great Experience – I have been here several times, and have been so pleased. The food (I've had shrimp, scallops, tuna and desserts) is wonderful, and the service is great. Make reservations, and on a very crowded night you'll only have to wait a half-hour or less, but lots more time w/out reservations (and you can wait at the bar). The shrimp caesar salad was incredible -- grilled smoky shrimp on top, and the shrimp cocktail has big and meaty shrimp. Scallops had a delicate sauce, and chocolate desserts are the best. It was romantic on Valentine's day and the server gave me a rose (great ambience upstairs especially). Good place!
Pretty Great...Overall – Pappadeaux is a great place to eat if Cajun is your flavor. The wait staff is very knowledgeable and attentive. I have Broiled Salmon Orleans and it is always so tender it melts in my mouth. Their dirty rice is a little spicy, much to my pleasure. One thing is lacking: the shrimp. It is Red Lobster quality for a much higher price. Its not meaty enough and kind of limp. The breading is not crispy has no real flavor. Fortunately, this was the only thing on Pappadeaux's menu that disappointed me. The fried alligator appetizer is hot 'n spicy and to die for. The desert tray boasts rich and flavorful delectibles. You have to try their sweet potato pecan pie. These are two flavors that I never imagined combining, but they thrive in unison. It is served warm with a generous scoop of Hagen Dazs vanilla ice cream... HEAVENLY!!!
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"N---a What N---a Who (Originator '99)" feat. Jaz-O and Amil
Wanna act loco? Don't do it anywhere in the vicinity of this track, one of Jay and Tim's first — and sharpest — collabos. The final single from Hov's 1999 album Vol. 2...Hard Knock Life, the song features a dizzying, stuttering beat and some of the quickest, most nimble flows Jay's ever committed to wax.
(Photo: Roc-A-Fella Records)
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Has anyone ever has this problem and how was it corrected?
If you told us what you are thinking about ...
When I transfer books they go to my desktop instead of my ereader. Kobo has told me it is software problem. This happened after I installed the new upgrade.
Could it be that your problem is related with Digital Editions and not with Reader? If so, you should post your question here:
I have been working on this problem for two weeks with Kobo and then this morning with Adobe. I am not quite sure how to ask the question on Adobe without being charged money. I will try again on the website you recommended. Thanks for your help
It's usually better to ask your questions about Adobe products in the appropriate Adobe forums - and you will not pay anything. I don't have any experience with ebooks, so I am not sure if yours is really a Reader problem, or it relates with another program such as Digital Editions.
At this point and time I am very frustrated. I do not know what Adobe forums I should be asking my questions. I have been connected to Digital Editions and that is when I was instructed to go to Adobe.com about the software problem.
I think I am not quite following you. Do you really mean that you posted your question in the Digital Editions forum (link in my message #3), and you were redirected from there to adobe.com?
As I said earlier, I am very frustrated. I am going to contact customer service via phone and have them walk me through the problem. Thank you for your interest in trying to help me.
I see that you are so frustrated that didn't even try visiting the Digital Editions forum. I have just been there, and I couldn't avoid seeing a link to this thread, which I think is the answer to your question:


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About Us
Our Vision
- Be a leader in educating students who with knowledge, skill and compassion dedicate their lives to the well being of their patients, their community and their profession.
Our Mission
- Provide a quality, broad-based medical education with an emphasis on family medicine.
- Encourage our graduates to serve medically underserved areas of South Dakota.
- Provide excellence in education, research and service through the Doctor of Medicine degree, Doctor of Philosophy degree and other degree programs.
- Address health care in the state by providing graduate and continuing education as well as undergraduate education.
- Serve as a technical resource in developing health care policy in the state.
Our Name
- We became the Sanford School of Medicine in 2006 after philanthropist T. Denny Sanford pledged $20 million to our school.
- We remain an entity of USD but closely collaborate with Sanford Health as well as the rest of our partners – Avera Health, Regional Health and the Veterans Administration.
- We use the Sanford gift to enhance faculty, training programs and development.
Our Economic Impact
- Last year awarded more than $17 million in external research grants and contracts.
- Play a major role in attracting biotech and biomedical companies to South Dakota.
- Critical role in the governor's initiative to boost research in the state.
- Integral role in the state's growth as a regional health care center.
- Our students come from 39 of South Dakota's 66 counties.
- More than 600 of our graduates serve our state.
Faculty Publications and Awards
Selected Research Publications
- Behavior-Psychology-Psychiatry
- Cardiology-Lipids-Vascular
- Diabetes-Endocrine
- Genetics
- Hematology-Oncology
- Infectious Disease
- Medical & Patient Education
- Neurology-Neuroscience
- Orthopedics & Sports Medicine
- Pediatrics
- Pharmacology
- Womens Health & Reproduction


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Everett >Lodging > Extended Stay America Seattle Everett � Silverlake
1431 112th Street Se, Everett, WA | Directions 9820847.898277 -122.212628
Neighborhoods: Silver Lake
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101.9 AMP Radio IMPACT Artist: Jason Derulo Read More
Comic-Con 2011: The Top 10 Coolest Souvenirs At Comic-Con
Fans rule! We have a team on the ground of the ultimate fan convention: Comic-Con. Come back all weekend for the latest photos, video and swag from the convention. You won't want to miss it! […]


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Matthew T. Hall is the public engagement editor at U-T San Diego, where he's worked since 2001. With help from readers and social media, he compiles a daily blog and a Sunday column called "The Conversation," aiming for something between "cool" and "can't miss" by tapping into what San Diegans are talking about at any and every given moment. He has covered San Diego's neighborhoods and its politics, the Chargers' stadium search and the Padres' TV fiasco, east and north San Diego County. Most recently, he reported and wrote four columns a week. He was named the 2011 feature writer of the year and the 2013 critic of the year by the San Diego chapter of the Society of Professional Journalists and the columnist of the year by the San Diego Press Club in 2012 and 2013. He is married to a fellow writer, and they have two young daughters.
- matthewthall
- email@example.com
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- 619-293-1335
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Saints Edge Augusta State, Advance to NCAA Super Regionals
Tournament Website | Press Conference
DAHLONEGA, GA – The top-seeded North Georgia softball team advanced to their fourth straight NCAA Southeast Super Regional on Sunday defeating fourth-seeded Augusta State 1-0 in the Dahlonega Regional Championship at The Hill.
Jessica Coan (25-7) capped a perfect 2-0 weekend for the Saints (48-8), tossing her second complete game shutout of the regional, striking out eight and scattering just three hits. In 14 innings of this weekend's regional games, Coan allowed zero runs and just six hits, while striking out 19 batters.
The pitching of Coan and Melissa Dickie led the Saints to victory as their offense mustered just four runs, only one of which were earned.
"It's a tribute to the great pitching we saw this weekend," said North Georgia head coach Mike Davenport. "Emily Headrick kept us off balance all afternoon."
North Georgia capitalized on each of their opponents mistakes and limited their own, committing just three errors to their opponents six.
For the second straight day the Saints capitalized on early miscues, as a throwing error led to the eventual game-winning run crossing the plate.
In the home-half of the first with Rochelle Shuman on first, senior Hilary Cox lined a one-out single to left field. A bobble allowed Shuman to move up to third and an errant throw that missed the cut-off sent her racing home.
Emily Headrick (18-7) picked up the loss tossing a complete game, allowing one unearned run surrendering five hits and striking out three.
After getting the lead, Coan was in shutdown mode retiring the final 14 batters she faced.
North Georgia has now won 12 consecutive NCAA Regional games and will make yet an other appearance in the NCAA Super Regionals this coming weekend.
The 2012 senior class also picked up their 200th career win over the weekend, now holding an incredible win total of 202 wins. Cox, Coan and Pilar Harden will go down as one of the most successful senior classes in school history.
The Saints will take on Peach Belt Conference foe Flagler in the NCAA Southeast Super Regional next Friday and Saturday, May 11th and 12th.


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— Christy Lemire, AP Movie Writer
"The Paperboy"—Soaked in sweat and reeking of cigarettes, director Lee Daniels' follow-up to the Oscar-winning "Precious: Based on the Novel 'Push' by Sapphire" is, quite literally, a hot Southern mess. It's got sleazy characters wallowing in bloody crimes and sloppy sex, all of which seems even more lurid during a steamy summer in the racially divided Florida swamps of the late 1960s. It's certainly never boring, led by an accomplished cast of actors including Nicole Kidman, Matthew McConaughey and John Cusack who seem all-too willing to get down and roll around in the muck. It's stylish trash, shot to look as if it were made during the period in which it takes place, with a mixture of gauzy, dreamlike imagery and startling, graphic intimacy. And yet, "The Paperboy" feels too scattered from a narrative perspective to have any kind of real emotional impact beyond simple, gratuitous shocks. Strong individual moments make you wish the vision as a whole had been more focused. Daniels and Pete Dexter co-wrote the script, based on Dexter's novel, about a hotshot Miami journalist (McConaughey) who returns to his hometown to investigate whether a greasy swamp rat named Hilary Van Wetter (Cusack) was placed wrongfully on death row for the murder of a local sheriff. He and his writing partner (David Oyelowo) are there at the urging of the tarty, boozy Charlotte Bless (Kidman), who's become Hilary's prison pen-pal and true love. Zac Efron, as McConaughey's younger brother, serves as the group's driver but mainly goes swimming and lies around in his tighty-whities all day. Because, you know, it's really hot out there. R for strong sexual content, violence and language. 106 minutes. Two and a half stars out of four.
— Christy Lemire, AP Movie Critic
"Taken 2"—Planning to pay out good money for this action sequel? To paraphrase Liam Neeson, you're about to be taken. Whatever novelty there was watching Neeson go commando in 2008's "Taken" is gone in the sequel, a mix of third-rate action, dreary family melodrama, laughable bad guys and even more laughable plot devices. Producer-writer Luc Besson and director Olivier Megaton ("Colombiana," "Transporter 3") draw giggles from the start with a graveside tableau of Albanians mourning their dead—all the thugs Neeson's ex-CIA Bryan Mills killed in the first movie for kidnapping his daughter in a prostitution ring. The family patriarch (Rade Sherbedgia) proclaims that the dead are crying out for justice—so he and a countless band of goons head off to Istanbul to exact revenge from Mills, his daughter (Maggie Grace) and ex-wife (Famke Janssen). There was something primal about "Taken," a father putting all his brains and brawn into saving his little girl, and doing it with startling ferocity and ingenious trade-craft. Neeson just looks like he's yawning his way through a light workout here, using one big Irish paw to snuff bad guys and holding the other one out to the studio for his paycheck. PG-13 for intense sequences of violence and action, and some sensuality. 92 minutes. One and a half stars out of four.
— David Germain, AP Movie Writer


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"Undersea – 3D, Vue Infinite" by CAC Member David Pasieka (@mysticenchantment)
[Want to see your art here? Click here for more info.]
I'm thinking of getting away for a little bit in August, which is something I haven't done in years. I have absolutely no idea where to go or what to do.
Where do you go and what do you do when you take a vacation? Is it ever arts related?
I'd love to hear about your creative holidays in the comments below and be sure to also check out the great list of job opportunities below.
Have a wonderful day!


text:
Jason C. Conley
Jason C. Conley is the author and illustrator of the new steam punk novel, The Kingdom of Vosh: The Chained Princess. Its a story filled with fantastical characters on a globe spanning adventure. Ogg the Furious, Captain Crews of the Sky-cleaver air fleet, Princess Jasper and her protector Vork, these are but a few of the heroes and villains in this amazing adventure. His extraordinary artwork combined with this rich, expansive fantasy, create an instant classic for every age.
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Lara Robby/Studio D
Special Offer
We all have one of those weeks every now and again when the pressure is rising and the stress barometer hits its max. There are plenty of different cures for relief massage, yoga, deep breathing. My number one elixir for anxiety? Comfort food. Best of all, this meal is as simple as it is soothing. Invite your boyfriend to join you, and after a bowl of chicken and dumplings and a foot rub, you'll be wondering What tension? Bonus: He'll think you're a domestic goddess!
Fennel Salad With Red Onions and Oranges
Crunchy, sweet, and savory this salad has all the elements to make it so satisfying.3 fennel bulbs, very thinly sliced
Toss fennel, onion, and orange with olive oil and lemon juice. Season with salt and pepper.
Quick 'n' Easy Chicken and Dumplings
I grew up eating chicken and dumplings in my grandma's kitchen. Making them from scratch can be time consuming, but with a couple adjustments, I managed to turn my favorite comfort food into a one-pot wonder that's done in a snap...and I think it's just as good as Grandma's is (but don't tell her I said that).2 c. biscuit mix (such as Bisquick)
In a small bowl, stir biscuit mix and milk until just combined. Set aside. In a medium pot, combine stock, thyme, bay leaf, salt, and pepper, and bring to a boil. In a small dish, whisk flour with water, and stir into chicken stock. Add chicken and mixed vegetables. Using a tablespoon or an ice-cream scoop, drop dumpling batter into boiling stock. Reduce heat to a simmer, and cook uncovered for 10 minutes. Cover and cook an additional 10 minutes. Garnish each serving with fresh parsley.
NEXT: Katie Lee's recipe for Cookies and Cream Truffles!
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Kosgei, of Richmond, Ky., completed the course in 17 minutes and six seconds, while Justyna Mudy, of Rome, Ga., finished second (17:33) and Auburn's Emily Ansick finished third (18:59).
"It feels great," Kosgei said. "I was here last year and finished fourth and ran a 17:45, so today, this year, I beat that by about 40 seconds. That's a big jump. I'm so happy about it."
Another reason for Kosgei's happiness was the consistency she's gained since injuring her Achilles' heel in February.
"After the injury in February, I haven't been able to train much, but I've done some things here and there," she said. "I've worked more on mileage than speed, so today I wasn't really tired.
"I'm getting back to running from the injury. That's why I'm so happy. I was running times that weren't that great earlier in the season, but I was going back and forth from relaxing and racing. Now I'm starting to run more consistently."
In Kosgei's first 5K since the injury, she recorded a time of 16:56, which is what she said she was shooting for Saturday. She said finishing right at 10 seconds longer is "not bad."
Kosgei, who is a graudate student at Eastern Kentucky, will return to campus later in the month. Classes start Aug. 21.
Anniston Star Sports Writer Brandon Miller can be reached at 256-235-3575 or follow him on Twitter @bmiller_star.


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Description: A multigenerational family of police officers dedicated to enforcing the law in New York.
What's happening around this tv show
Deborah Ann Gross is a fan of Blue Bloods.1 year agoDeborah Ann Gross likes this.
Michael A. Bennett is a fan of Blue Bloods.4 months ago
Mary Katharine White was watching Blue Bloods.5 months ago via iPhoneJames Anthony Moody likes this.From 11-22 on demand
Watch Blue Bloods Online
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Join Tunerfish to share your love for Blue Bloods, earn awards, and build influence!
Fans Are Saying...
Three generations of NYPD with Tom Selleck in the lead role and Donnie Wahlberg as the lead detective. Well acted and well scripted show.


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I have been working at Marriott full-time for more than 5 years
Pros – Great benefits. Ability to transfer to any job or company location in the world.
Cons – Very large company, so chain of command is counterproductive and redundant in key area's.
Advice to Senior Management – Better communication among staff of every level...
Yes, I would recommend this company to a friend – I'm optimistic about the outlook for this company
1 person found this helpful
I worked at Marriott full-time for more than 5 years
I worked at Marriott full-time for more than a year
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Raw Wood in the Bedroom
Inspiration Gallery
Examples via: Elle Decor, Remodelista & House Beautiful
9 Comments
I hope the first one is not a cat person.
the first one makes me dizzy, but I love the rest.
The first one is from Elle Decor I think. This room was the least "woody" room in that house. Looked like the sort of place where dinner was whatever animal the "man of the house" brought home from hunting.
I think a woodpecker would love that bed.
Bed #1 is to die for! I've been wanting to do this since childhood...the quintessential bed in the treetops, living in a treehouse, etc. Who needs Woods wallpaper when you've got birch tree posters. I like the birch side rails with the live edge...very classy finishing.
For only $15,000 you, too, can own this!
That first bed was hideous. I liked the rest.
I would feel like an elf, sleeping in #1, hahaha...
No, I meant a reindeer, lol!
(Blame it on English being my second language...) :)


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Tanning >Apollo Beachtan
6414 N Us Highway 41, Apollo Beach, FL | Directions 3357227.764344 -82.395106
Neighborhoods: Apollo Beach
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'Just such a clever idea - I've bought two Purflo mattresses for my grandson, one at his parent's house and...'
blackpepper10 - Sussex
In the market for baby wheels? Look no further. Shop our brilliant value Kiddicare pushchairs or big brands like Britax, Maclaren, Quinny and Phil and Teds. And remember, we offer a no-nonsense price promise that says: We'll match any competitor's price for up to 7 days after you've made your purchase. Guaranteed!
©Kiddicare 2014