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Starro as seen in Brave and the Bold #28 (February–March 1960).
Art by Mike Sekowsky.
|Publication information
|DC Comics
|First appearance
|Brave and the Bold #28 (February–March 1960)
|Created by
|Gardner Fox
|In-story information
|Alter ego
|Place of origin
|Star Planet
|Team affiliations
|Secret Society of Super Villains
Starro as seen in Brave and the Bold #28 (February–March 1960).
Art by Mike Sekowsky.
|Publication information
|DC Comics
|First appearance
|Brave and the Bold #28 (February–March 1960)
|Created by
|Gardner Fox
|In-story information
|Alter ego
|Place of origin
|Star Planet
|Team affiliations
|Secret Society of Super Villains
Starro (a.k.a. Starro the Conqueror) is a fictional supervillain that appears in comic books published by DC Comics. The character first appeared in Brave and the Bold #28 (February–March 1960), and was created by Gardner Fox and Mike Sekowsky.
Starro is the first villain to face the original Justice League of America. Debuting in the Silver Age of Comic Books, the character has appeared in both comic books and other DC Comics-related products such as animated television series; and trading cards.
The character debuted in The Brave and the Bold #28 (Feb.-March 1960) in a story called "Starro the Conqueror", which was also the first appearance of the Justice League of America. Starro reappeared in an 11-page Aquaman story in Adventure Comics #451 (May–June 1977) and a two-part story in Justice League of America #189–190 (April–May 1981).
The character returned in an alternate universe story in Captain Carrot & His Amazing Zoo Crew #1 (March 1982) and appeared briefly in Crisis on Infinite Earths #9 (Dec. 1985).
In the post-Crisis DC universe, Starro appeared in a five-part story in Justice League Europe #24–28 (March–July 1991) and was revamped and reintroduced in JLA Secret Files #1 (Sept. 1997) and JLA #22–23 (Sept. – Oct. 1998). Another version featured in the intercompany crossover JLA/Avengers #1–4 (Sept. 2003 – May 2004); Teen Titans vol. 3, #51–54 (Nov. 2007 – Feb. 2008) and Green Lantern/Sinestro Corps: Secret Files #1 (Feb. 2008) and Booster Gold #13–14 (Dec. 2008 – Jan. 2009).
A humanoid version starred in a 13-issue story arc in R.E.B.E.L.S #1–13 (April 2009 – April 2010) and a special "origin" issue in R.E.B.E.L.S Annual #1 (Dec. 2009).
Starro is an intelligent alien lifeform resembling a giant starfish with a central eye and prehensile extremities. In his first appearance, Starro came to Earth and gave his powers to three starfish. One stole and exploded an atom bomb, then absorbed its energy; another kidnapped scientists to absorb their brain power; the last placed the residents of Happy Harbor and Rhode Island under its mental control. The heroes Aquaman, the Flash, Hal Jordan, Martian Manhunter, and Wonder Woman teamed up to defeat the alien, after defeating his three accomplices. Starro was defeated by coating him with quicklime, which nullified his abilities.[1] A segment of that Starro survived, and regenerated into a complete creature, but was stopped by Aquaman before he was able to renew his plan of conquest.[2]
Starro reappeared to threaten Earth again, having once more regenerated from a small piece of his former body. He took mental control of a young boy who found him while fishing, and subsequently dominated the boy's family, who fed him enough to regenerate his full starfish anatomy. Starro forced them to transport him to New York, where he displayed for the first time his ability to asexually spawn millions of miniature duplicate "spores" of himself, which attach to the faces of humans and render them under his mental control. Starro used these starfish spores to control several members of the Justice League while enslaving the entire population of New York, but was defeated with extreme cold before he could carry his plan to spread his spores across the planet.[3]
When Superman investigates a strange phenomenon causing the citizens of Metropolis to begin acting like apes, he is accidentally transported to an alternate universe and arrives on the parallel Earth called Earth-C. Meeting sentient animals called Captain Carrot and his Amazing Zoo Crew, Superman aids the animal heroes to defeat Starro, who is based on the Earth-C universe's planet Pluto. Superman then takes the defeated Starro back to their original universe.[4]
In a later appearance, Starro convinces Justice League Europe that he is dying and wishes to return to space. Aided by ex-Green Lantern Kilowog, Starro returns to his original ship, which, once repaired, is launched out of Earth's atmosphere. Starro, however, betrays the Justice League when he programs the vessel to explode, freeing Starro from his large body and releasing thousands of his smaller "spore" versions over Western Europe. Assuming control of thousands of humans, Starro seizes power, with several members of Justice League Europe opposing the alien. The team suffers a setback when Starro takes control of the Martian Manhunter, although Starro is finally defeated when Justice League member Ice freezes the original creature.[5]
During the Infinite Crisis, Starro appears as a member of Alexander Luthor, Jr.'s Secret Society of Super Villains.[6]
Starro returns to Earth-C (now called Earth-26) to spark a conflict between aquatic and terran creatures. Despite the efforts of the Zoo Crew, Starro floods the planet and defeats the team. They are then transported off world with the surviving refugees by another animal team, Just'a Lotta Animals. Zoo Crew member Pig Iron apparently sacrifices himself and battles Starro underwater as they escape.[7]
Starro reappears in the Titans Tomorrow storyline as a member of the Sinestro Corps, wielding five power rings and controlling several supervillains. He is destroyed again by a future version of the Flash (although he points out that Starro will eventually regrow again).[8]
In post-Infinite Crisis DC continuity, it was retroactively established that Starro belonged to an entire race of parasites that travel around the universe conquering planets with "motherstars" releasing spores to take mental control of a population. When one such motherstar arrived on the planet Hatorei and enslaved its psychically gifted native humanoids, the race's sole surviving boy manages to take control of an infant starro queen which fuses to his chest, thus empowering him to mentally dominate her entire parasitic race, assuming the name "Starro the Conqueror", himself. Empowered by a huge army of drone soldiers taken from conquered worlds and controlled by starro spores, and led by an elite guard who retain their free will including Astrild Storm-Daughter and Smite, this starfish-fused-humanoid "Starro" conquers entire galaxies and derives power from all those mentally linked by his spores.[9] It was thus retconned that the originally-established Starro who had faced Earth's superheroes several times was merely a "probe" dispatched by this humanoid conqueror.[10]
In The New 52 (a reboot of the DC Comics universe), Starro appears on the cover of the book titled "Justice League: Gods Among Men" written by David Graves after Darkseid's invasion that introduces the team as the Justice League. The cover is an homage to the classic Brave and the Bold #28 but replacing it with the current incarnation of the League. [11] In Forever Evil a Human possessed Starro is among the villains recruited in the Secret Society.[12]
Referring to itself only as "It", a different version of Starro with green skin and a slit pupil takes control of the Flash and the population of Blue Valley using so-called "face-huggers" virtually identical to Starro's spores. Although the JLA intend to intervene, they are advised against doing so by the Spectre, who reveals the alien's intention is to capture and control the heroes and use them to form an army to conquer the galaxy. The JLA request the Spectre temporarily remove their powers—thus eliminating the potential threat they might pose if the plan goes wrong—allowing them to distract "It" while Batman sneaks past "It"'s defences—designed for superhumans rather than normal humans—and disables it with extreme cold.[13] This Starro-like green "It" creature later returns and is revealed to be a scout for several huge versions of the creature, collectively called the "Star Conqueror". Covering entire continents with its giant starfish bodies, "It" psychically enslaves the human race as they sleep. Dream of the Endless aids the JLA, with several members battling the alien in the dreamworld. Another small team of the JLA distract "It" by attacking its physical form. Assisted by a homeless man resisting "It"'s control, the heroes free mankind from the alien's influence. Dream captures the giant "It"s and store the aliens with his other keepsakes.[14] The name "Starro" is never used in this storyline, nor is any connection acknowledged apart from one fleeting reference by the Flash to reading a file that an older incarnation of the JLA had battled "similar creatures" in the past, yet oddly even those characters who were present for said confrontations such as Aquaman, Martian Manhunter, Batman and Superman do not make note of any similarity between "It" and Starro. When dissecting one of "It"'s spore-like "face-huggers", Batman discovers that they are "some kind of parasitical machine", with circuitry inside its fleshy outer surface,[15] something inconsistent with the wholly organic Starro.
In the DC/Marvel Comics crossover JLA/Avengers, another version of Starro battles the alternate universe superhero team the Avengers, when the villain Krona briefly merges two universes, causing various intruders from each universe to appear in the other. Starro appears over New York City in the Marvel Universe, and brainwashes thousands of people, including Avengers team members Quicksilver, She-Hulk, Yellowjacket, Triathlon, and Thor. Quicksilver is set free by the Scarlet Witch and Ms. Marvel, and after explaining that Starro desires order, the Vision comes up with the idea of placing a starfish spawn on the Scarlet Witch's face, which causes Starro to flee when it finds itself unable to cope with her chaos magic.[16]
A future version of Starro mentally enthralls the Time Master Rip Hunter, using his time-travelling technology to retroactively conquer Earth. Booster Gold successfully undoes Starro's action, and the creature is also foiled in the future with the assistance of the villain Lady Chronos.[17]
When Aqualad and Lagoon Boy go to "underwater pet club", many Starros are shown to be the "pets" of Star-Spangled Kid. He offers them one, which they decline from, and tells them, "He really likes to be worn on your face". When the rest of the club puts Starros on their faces, Lagoon Boy and Aqualad leave. [18]
Starro is an alien and resembles a giant terran starfish. An asexual creature, Starro is capable of generating clones that act in accordance with the original's will. The clones are parasites by nature, and can attach themselves to a humanoid's face, and subsequently take control of the host's central nervous system, thereby controlling the host. Control of the host is lost once removed from the victim.
The creature is also capable of energy projection; flight; changing colour and has a high degree of invulnerability.
The humanoid "Starro the Conqueror" possesses telepathy great enough to control the Starro alien race, and strength drawn from the victims of the Starro probes.


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Copegus 200mg Film-coated Tablets
Last Updated on eMC 06-May-2014 View changes | Roche Products Limited Contact details
- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Fertility, pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
Method of AdministrationCopegus film-coated tablets are administered orally in two divided doses with food (morning and evening). Due to the teratogenic potential of ribavirin, the tablets should not be broken or crushed.
PosologyCopegus is used in combination with peginterferon alfa-2a or interferon alfa-2a. The exact dose and duration of treatment depend on the interferon product used.Please refer to the SPC of peginterferon alfa-2a or interferon alfa-2a for further information on dosage and duration of treatment when Copegus is to be used in combination with either of these products.
Posology in combination with peginterferon alfa-2a:
Dose to be administeredThe recommended dose of Copegus in combination with peginterferon alfa-2a solution for injection depends on viral genotype and the patient's body weight (see Table 1).
Duration of treatmentThe duration of combination therapy with peginterferon alfa-2a depends on viral genotype. Patients infected with HCV genotype 1 who have detectable HCV RNA at week 4 regardless of pre-treatment viral load should receive 48 weeks of therapy. Treatment for 24 weeks may be considered in patients infected with - genotype 1 with low viral load (LVL) (≤800,000 IU/ml) at baseline or - genotype 4 who become HCV RNA negative at week 4 and remain HCV RNA negative at week 24. However, an overall 24 weeks treatment duration may be associated with a higher risk of relapse than a 48 weeks treatment duration (see section 5.1). In these patients, tolerability to combination therapy and additional prognostic factors such as degree of fibrosis should be taken into account when deciding on treatment duration. Shortening the treatment duration in patients with genotype 1 and high viral load (HVL) (>800, 000 IU/ml) at baseline who become HCV RNA negative at week 4 and remain HCV RNA negative at week 24 should be considered with even more caution since the limited data available suggest that this may significantly negatively impact the sustained virologic response. Patients infected with HCV genotype 2 or 3 who have detectable HCV RNA at week 4, regardless of pre-treatment viral load should receive 24 weeks of therapy. Treatment for only 16 weeks may be considered in selected patients infected with genotype 2 or 3 with LVL (≤800,000 IU/ml) at baseline who become HCV negative by week 4 of treatment and remain HCV negative by week 16. Overall 16 weeks of treatment may be associated with a lower chance of response and is associated with a higher risk of relapse than a 24 week treatment duration (see section 5.1). In these patients, tolerability to combination therapy and the presence of additional clinical or prognostic factors such as degree of fibrosis should be taken into account when considering deviations from standard 24 weeks treatment duration. Shortening the treatment duration in patients infected with genotype 2 or 3 with HVL (>800,000 IU/ml) at baseline who become HCV negative by week 4 should be considered with more caution as this may significantly negatively impact the sustained virological response (see Table 1).Available data for patients infected with genotype 5 or 6 are limited; therefore combination treatment with 1000/1200 mg of ribavirin for 48 weeks is recommended.
|Table 1 Copegus Dosing Recommendations in Combination with Peginterferon alfa-2a for HCV patients
|Daily Copegus Dose
|Duration of treatment
|Number of 200/400 mg tablets
|Genotype 1 LVL with RVR*
|<75 kg = 1000 mg ≥75 kg = 1200 mg
|24 weeks or 48 weeks
|5 x 200 mg (2 morning, 3 evening) 6 x 200 mg (3 morning, 3 evening)
|Genotype 1 HVL with RVR*
|<75 kg = 1000 mg ≥75 kg = 1200 mg
|48 weeks
|5 x 200 mg (2 morning, 3 evening) 6 x 200 mg (3 morning, 3 evening)
|Genotype 4 with RVR*
|<75 kg = 1000 mg ≥75 kg = 1200 mg
|24 weeks or 48 weeks
|5 x 200 mg (2 morning, 3 evening) 6 x 200 mg (3 morning, 3 evening)
|Genotype 1 or 4 without RVR*
|<75 kg = 1000 mg ≥75 kg = 1200 mg
|48 weeks
|5 x 200 mg (2 morning, 3 evening) 6 x 200 mg (3 morning, 3 evening)
|Genotype 2 or 3 LVL with RVR**
|800 mg(a)
|16 weeks(a) or 24 weeks
|4 x 200 mg (2 morning, 2 evening) or 2 x 400 mg (1 morning, 1 evening)
|Genotype 2 or 3 HVL with RVR**
|800 mg
|24 weeks
|4 x 200 mg (2 morning, 2 evening) or 2 x 400 mg (1 morning, 1 evening)
|Genotype 2 or 3 without RVR**
|800 mg
|24 weeks
|4 x 200 mg (2 morning, 2 evening) or 2 x 400 mg (1 morning, 1 evening)
Chronic hepatitis C treatment-experienced patientsThe recommended dose of Copegus, in combination with 180 micrograms once weekly of peginterferon alfa-2a, is 1000 mg daily or 1200 mg daily for patients <75 kg and ≥75 kg, respectively, regardless of genotype.Patients who have detectable virus at week 12 should stop therapy. The recommended total duration of therapy is 48 weeks. If patients infected with virus genotype 1, not responding to prior treatment with peginterferon and ribavirin are considered for treatment, the recommended total duration of therapy is 72 weeks (see section 5.1).
HIV-HCV Co-infectionThe recommended dosage for Copegus in combination with 180 micrograms once weekly, for 48 weeks, of peginterferon alfa-2a is as follows:- patients infected with HCV genotype 1 <75 kg: 1000 mg daily- patients infected with HCV genotype 1 ≥75 kg: 1200 mg daily- patients infected with HCV genotype other than 1 should receive 800 mg dailyA duration of therapy less than 48 weeks has not been adequately studied.
Predictability of response and non-response treatment-naive patientsEarly virological response by week 12, defined as a 2 log viral load decrease or undetectable levels of HCV RNA has been shown to be predictive for sustained response (see Table 2).
|Table 2 Predictive Value of Week 12 Virological Response at the Recommended Dosing Regimen while receiving Copegus and peginterferon Combination Therapy
|No response by week 12
|No sustained response
|Predictive Value
|Response by week 12
|Sustained response
|Predictive Value
|Genotype 1 (N= 569)
|95% (97/102)
|58% (271/467)
|Genotype 2 and 3 (N=96)
|100% (3/3)
|87% (81/93)
Predictability of response and non-response treatment-experienced patientsIn non-responder patients re-treated for 48 or 72 weeks, viral suppression at week 12 (undetectable HCV RNA defined as <50 IU/ml) has been shown to be predictive for sustained virological response. The probabilities of not achieving a sustained virological response with 48 or 72 weeks of treatment if viral suppression was not achieved at week 12 were 96% (363 of 380) and 96% (324 of 339), respectively. The probabilities of achieving a sustained virological response with 48 or 72 weeks of treatment if viral suppression was achieved at week 12 were 35% (20 of 57) and 57% (57 of 100), respectively.
Posology in combination with interferon alfa-2a:
Dose to be administeredThe recommended dose of Copegus in combination with interferon alfa-2a solution for injection depends on the patient's body weight (see Table 3).
Duration of treatmentPatients should be treated with combination therapy with interferon alfa-2a for at least six months. Patients with HCV genotype 1 infections should receive 48 weeks of combination therapy. In patients infected with HCV of other genotypes, the decision to extend therapy to 48 weeks should be based on other prognostic factors (such as high viral load at baseline, male gender, age >40 years and evidence of bridging fibrosis).
|Table 3 Copegus Dosing Recommendations in Combination with Interferon alfa-2a
|Patient weight (kg)
|Daily Copegus dose
|Duration of treatment
|Number of 200 mg tablets
|1,000 mg
|24 or 48 weeks
|5 (2 morning, 3 evening)
|1,200 mg
|24 or 48 weeks
|6 (3 morning, 3 evening)
Dosage modification for adverse reactionsPlease refer to the SPC of peginterferon alfa-2a or interferon alfa-2a for further information on dose adjustment and discontinuation of treatment for either of these products.If severe adverse reactions or laboratory abnormalities develop during therapy with Copegus and peginterferon alfa-2a or interferon alfa-2a, modify the dosages of each product, until the adverse reactions abate. Guidelines were developed in clinical trials for dose modification (see Table 4).If intolerance persists after dose adjustment, discontinuation of Copegus or both Copegus and peginterferon alfa-2a or interferon alfa-2a may be needed.
|Table 4 Dosage Modification Guidelines for Management of Treatment-Emergent Anaemia
|Laboratory Values
|Reduce only Copegus dose to 600 mg/day* if:
|Discontinue Copegus if:**
|Haemoglobin in Patients with No Cardiac Disease
|<10 g/dl
|<8.5 g/dl
|Haemoglobin: Patients with History of Stable Cardiac Disease
|≥2 g/dl decrease in haemoglobin during any 4 week period during treatment (permanent dose reduction)
|<12 g/dl despite 4 weeks at reduced dose
Special populationsUse in renal impairment: The recommended dose regimens (adjusted by the body weight cutoff of 75 kg) of ribavirin give rise to substantial increases in plasma concentrations of ribavirin in patients with renal impairment. There are insufficient data on the safety, efficacy and pharmacokinetics of ribavirin in patients with serum creatinine >2 mg/dl or creatinine clearance <50 ml/min, whether or not on haemodialysis, to support specific recommendations for dose adjustments (see section 5.2). Therefore, ribavirin should be used in such patients only when this is considered to be essential. Therapy should be initiated (or continued if renal impairment develops while on therapy) with extreme caution and intensive monitoring of haemoglobin concentrations, with corrective action as may be necessary, should be employed throughout the treatment period. (see section 4.4).Use in hepatic impairment: Hepatic function does not affect the pharmacokinetics of ribavirin (see section 5.2). Therefore, no dose adjustment of Copegus is required in patients with hepatic impairment. The use of peginterferon alfa-2a and interferon alfa-2a is contraindicated in patients with decompensated cirrhosis and other forms of severe hepatic impairment.Use in elderly patients over the age of 65: There does not appear to be a significant age-related effect on the pharmacokinetics of ribavirin. However, as in younger patients, renal function must be determined prior to administration of Copegus.Use in patients under the age of 18 years: Treatment with Copegus is not recommended for use in children and adolescents (<18 years) due to insufficient data on safety and efficacy in combination with peginterferon alfa-2a and interferon alfa-2a. Only limited safety and efficacy data are available in children and adolescents (6-18 years) in combination with peginterferon alfa-2a (see section 5.1).
|Psychiatric and Central Nervous System (CNS): Severe CNS effects, particularly depression, suicidal ideation and attempted suicide have been observed in some patients during Copegus combination therapy with peginterferon alfa-2a or interferon alfa-2a, and even after treatment discontinuation mainly during the 6-month follow-up period. Other CNS effects including aggressive behaviour (sometimes directed against others such as homicidal ideation), bipolar disorders, mania, confusion and alterations of mental status have been observed with alpha interferons. Patients should be closely monitored for any signs or symptoms of psychiatric disorders. If such symptoms appear, the potential seriousness of these undesirable effects must be borne in mind by the prescribing physician and the need for adequate therapeutic management should be considered. If psychiatric symptoms persist or worsen, or suicidal ideation is identified, it is recommended that treatment with Copegus and peginterferon alfa-2a or interferon alfa-2a be discontinued, and the patient followed, with psychiatric intervention as appropriate. Patients with existence of, or history of severe psychiatric conditions: If treatment with Copegus in combination with peginterferon alfa-2a or interferon alfa-2a is judged necessary in patients with existence or history of severe psychiatric conditions, this should only be initiated after having ensured appropriate individualised diagnostic and therapeutic management of the psychiatric condition. Patients with substance use/abuse:HCV infected patients having a co-occurring substance use disorder (alcohol, cannabis, etc) are at an increased risk of developing psychiatric disorders or exacerbation of already existing psychiatric disorders when treated with alpha interferon. If treatment with alpha interferon is judged necessary in these patients, the presence of psychiatric co-morbidities and the potential for other substance use should be carefully assessed and adequately managed before initiating therapy. If necessary, an inter-disciplinary approach including a mental health care provider or addiction specialist should be considered to evaluate, treat and follow the patient. Patients should be closely monitored during therapy and even after treatment discontinuation. Early intervention for re-emergence or development of psychiatric disorders and substance use is recommended. Growth and development (children and adolescents): During the course of therapy lasting up to 48 weeks in patients aged 5 to 17 years, weight loss and growth inhibition were common (see sections 4.8 and 5.1). At 2 years post-treatment with Pegasys, 16% of paediatric patients remained 15 percentiles or more below their baseline weight curve and 11% remained 15 percentiles or more below their baseline height curve. Case by case benefit/risk assessment in childrenThe expected benefit of treatment should be carefully weighed against the safety findings observed for children and adolescents in the clinical trials (see sections 4.8 and 5.1). - It is important to consider that the combination therapy induced a growth inhibition. - This risk should be weighed against the disease characteristics of the child, such as evidence of disease progression (notably fibrosis), co-morbidities that may negatively influence the disease progression (such as HIV co-infection), as well as prognostic factors of response (HCV genotype and viral load). Whenever possible the child should be treated after the pubertal growth spurt, in order to reduce the risk of growth inhibition. There are no data on long term effects on sexual maturation.
Teratogenic risk: See section 4.6.Prior to initiation of treatment with ribavirin the physician must comprehensively inform the patient of the teratogenic risk of ribavirin, the necessity of effective and continuous contraception, the possibility that contraceptive methods may fail and the possible consequences of pregnancy should it occur during treatment with ribavirin. For laboratory monitoring of pregnancy please refer to Laboratory tests.Carcinogenicity: Ribavirin is mutagenic in some in vivo and in vitro genotoxicity assays. A potential carcinogenic effect of ribavirin cannot be excluded (see section 5.3). Haemolysis and Cardiovascular system: A decrease in haemoglobin levels to <10 g/dl was observed in up to 15% of patients treated for 48 weeks with Copegus 1000/1200 mg in combination with peginterferon alfa-2a and up to 19% of patients in combination with interferon alfa-2a. When Copegus 800 mg was combined with peginterferon alfa-2a for 24 weeks, 3% of patients had a decrease in haemoglobin levels to <10 g/dl. The risk of developing anaemia is higher in the female population. Although ribavirin has no direct cardiovascular effects, anaemia associated with Copegus may result in deterioration of cardiac function, or exacerbation of the symptoms of coronary disease, or both. Thus, Copegus must be administered with caution to patients with pre-existing cardiac disease. Cardiac status must be assessed before start of therapy and monitored clinically during therapy; if any deterioration occurs, stop therapy (see section 4.2). Patients with a history of congestive heart failure, myocardial infarction, and/or previous or current arrhythmic disorders must be closely monitored. It is recommended that those patients who have pre-existing cardiac abnormalities have electrocardiograms taken prior to and during the course of treatment. Cardiac arrhythmias (primarily supraventricular) usually respond to conventional therapy but may require discontinuation of therapy.Pancytopenia and bone marrow suppression have been reported in the literature to occur within 3 to 7 weeks after the administration of ribavirin and a peginterferon concomitantly with azathioprine. This myelotoxicity was reversible within 4 to 6 weeks upon withdrawal of HCV antiviral therapy and concomitant azathioprine and did not recur upon reintroduction of either treatment alone (see section 4.5).The use of Copegus and peginterferon alfa-2a combination therapy in chronic hepatitis C patients who failed prior treatment has not been adequately studied in patients who discontinued prior therapy for haematological adverse events. Physicians considering treatment in these patients should carefully weigh the risks versus the benefits of re-treatment.Acute hypersensitivity: If an acute hypersensitivity reaction (e.g. urticaria, angioedema, bronchoconstriction, anaphylaxis) develops, Copegus must be discontinued immediately and appropriate medical therapy instituted. Transient rashes do not necessitate interruption of treatment.Liver function: In patients who develop evidence of hepatic decompensation during treatment, Copegus in combination with peginterferon alfa-2a or interferon alfa-2a should be discontinued. When the increase in ALT levels is progressive and clinically significant, despite dose reduction, or is accompanied by increased direct bilirubin, therapy should be discontinued.Renal impairment: The pharmacokinetics of ribavirin are altered in patients with renal dysfunction due to reduction of apparent clearance in these patients. Therefore, it is recommended that renal function be evaluated in all patients prior to initiation of Copegus, preferably by estimating the patient's creatinine clearance. Substantial increases in ribavirin plasma concentrations are seen at the recommended dosing regimen in patients with serum creatinine >2 mg/dl or with creatinine clearance <50 ml/minute. There are insufficient data on the safety, efficacy and pharmacokinetics of Copegus in such patients to support specific recommendations for dose adjustments (see section 5.2). Copegus therapy should not be initiated (or continued if renal impairment occurs while on treatment) in such patients, whether or not on haemodialysis, unless it is considered to be essential. Extreme caution is required. Haemoglobin concentrations should be monitored intensively during treatment and corrective action taken as necessary (see section 4.2).Ocular changes: Copegus is used in combination therapy with alpha interferons. Retinopathy including retinal haemorrhages, cotton wool spots, papilloedema, optic neuropathy and retinal artery or vein obstruction which may result in loss of vision have been reported in rare instances with combination therapy with alpha interferons. All patients should have a baseline eye examination. Any patient complaining of decrease or loss of vision must have a prompt and complete eye examination. Patients with preexisting ophthalmologic disorders (eg, diabetic or hypertensive retinopathy) should receive periodic ophthalmologic exams during combination therapy with alpha interferons. Combination therapy with alpha interferons should be discontinued in patients who develop new or worsening ophthalmologic disorders.Transplantation: The safety and efficacy of peginterferon-alfa-2a and Copegus treatment have not been established in patients with liver and other transplantations. Liver and renal graft rejections have been reported with peginterferon-alfa-2a, alone or in combination with Copegus.HIV/HCV Co-infection: Please refer to the respective Summary of Product Characteristics of the antiretroviral medicinal products that are to be taken concurrently with HCV therapy for awareness and management of toxicities specific for each product and the potential for overlapping toxicities with peginterferon alfa-2a with or without ribavirin. In study NR15961, patients concurrently treated with stavudine and interferon therapy with or without ribavirin, the incidence of pancreatitis and/or lactic acidosis was 3% (12/398).Chronic hepatitis C patients co-infected with HIV and receiving Highly Active Anti-Retroviral Therapy (HAART) may be at increased risk of serious adverse effects (e.g. lactic acidosis; peripheral neuropathy; pancreatitis).Co-infected patients with advanced cirrhosis receiving HAART may also be at increased risk of hepatic decompensation and possibly death if treated with Copegus in combination with interferons. Baseline variables in co-infected cirrhotic patients that may be associated with hepatic decompensation include: increased serum bilirubin, decreased haemoglobin, increased alkaline phosphatase or decreased platelet count, and treatment with didanosine (ddI). Caution should therefore be exercised when adding peginterferon alfa-2a and Copegus to HAART (see section 4.5).The concomitant use of ribavirin with zidovudine is not recommended due to an increased risk of anaemia (see section 4.5).During treatment co-infected patients should be closely monitored for signs and symptoms of hepatic decompensation (including ascites, encephalopathy, variceal bleeding, impaired hepatic synthetic function; e.g., Child-Pugh score of 7 or greater). The Child-Pugh scoring may be affected by factors related to treatment (i.e. indirect hyperbilirubinemia, decreased albumin) and not necessarily attributable to hepatic decompensation. Treatment with Copegus in combination with peginterferon alfa-2a or interferon alfa-2a should be discontinued immediately in patients with hepatic decompensation. Co-administration of Copegus and didanosine is not recommended due to the risk of mitochondrial toxicity (see Section 4.5). Moreover, co-administration of Copegus and stavudine should be avoided to limit the risk of overlapping mitochondrial toxicity. Laboratory tests: Standard haematologic tests and blood chemistries (complete blood count [CBC] and differential, platelet count, electrolytes, serum creatinine, liver function tests, uric acid) must be conducted in all patients prior to initiating therapy. Acceptable baseline values that may be considered as a guideline prior to initiation of Copegus in combination with peginterferon alfa-2a or interferon alfa-2a:
|≥12 g/dl (females); ≥13 g/dl (males)
|Neutrophil Count
HIV-HCV co-infected patientsNo apparent evidence of drug interaction was observed in 47 HIV-HCV co-infected patients who completed a 12 week pharmacokinetic substudy to examine the effect of ribavirin on the intracellular phosphorylation of some nucleoside reverse transcriptase inhibitors (lamivudine and zidovudine or stavudine). However, due to high variability, the confidence intervals were quite wide. Plasma exposure of ribavirin did not appear to be affected by concomitant administration of nucleoside reverse transcriptase inhibitors (NRTIs).Exacerbation of anaemia due to ribavirin has been reported when zidovudine is part of the regimen used to treat HIV, although the exact mechanism remains to be elucidated. The concomitant use of ribavirin with zidovudine is not recommended due to an increased risk of anaemia (see section 4.4). Consideration should be given to replacing zidovudine in a combination ART regimen if this is already established. This would be particularly important in patients with a known history of zidovudine induced anaemia.
Chronic hepatitis CThe most frequently reported adverse events with Copegus in combination with peginterferon alfa-2a 180 µg were mostly mild to moderate in severity. Most of them were manageable without the need for discontinuation of therapy.
Chronic hepatitis C in prior non-responder patientsOverall, the safety profile for Copegus in combination with peginterferon alfa-2a in prior non-responder patients was similar to that in naive patients. In a clinical trial of non-responder patients to prior pegylated interferon alfa-2b/ribavirin, which exposed patients to either 48 or 72 weeks of treatment, the frequency of withdrawal for adverse events or laboratory abnormalities from peginterferon alfa-2a treatment and Copegus treatment was 6% and 7%, respectively, in the 48 week arms and 12% and 13%, respectively, in the 72 week arms. Similarly, for patients with cirrhosis or transition to cirrhosis, the frequencies of withdrawal from peginterferon alfa-2a treatment and Copegus treatment were higher in the 72-week treatment arms (13% and 15%) than in the 48-week arms (6% and 6%). Patients who withdrew from previous therapy with pegylated interferon alfa-2b/ribavirin because of haematological toxicity were excluded from enrolling in this trial.In another clinical trial, non-responder patients with advanced fibrosisis or cirrhosis (Ishak score of 3 to 6) and baseline platelet counts as low as 50,000/mm3 were treated for 48 weeks. Haematologic laboratory abnormalities observed during the first 20 weeks of the trial included anaemia (26% of patients experienced a haemoglobin level of <10 g/dl), neutropenia (30% experienced an ANC <750/mm3), and thrombocytopenia (13% experienced a platelet count <50,000/mm3) (see section 4.4).
Chronic hepatitis C and Human Immunodeficiency Virus Co-infectionIn HIV-HCV co-infected patients, the clinical adverse event profiles reported for peginterferon alfa-2a, alone or in combination with ribavirin, were similar to those observed in HCV mono-infected patients. For HIV-HCV patients receiving Copegus and peginterferon alfa-2a combination therapy other undesirable effects have been reported in ≥1% to ≤ 2% of patients: hyperlactacidaemia/lactic acidosis, influenza, pneumonia, affect lability, apathy, tinnitus, pharyngolaryngeal pain, cheilitis, acquired lipodystrophy and chromaturia. Peginterferon alfa-2a treatment was associated with decreases in absolute CD4+ cell counts within the first 4 weeks without a reduction in CD4+ cell percentage. The decrease in CD4+ cell counts was reversible upon dose reduction or cessation of therapy. The use of peginterferon alfa-2a had no observable negative impact on the control of HIV viraemia during therapy or follow-up. Limited safety data are available in co-infected patients with CD4+ cell counts <200/µl (see peginterferon alfa-2a SPC). Table 5 shows the undesirable effects reported in patients who have received Copegus and peginterferon alfa-2a or interferon alfa-2a therapy.
|Table 5 Undesirable Effects Reported with Copegus in combination with Peginterferon alfa-2a for HCV Patients
|Body system
|Very common ≥1/10
|Common≥1/100 to <1/10
|Uncommon≥1/1000 to <1/100
|Rare≥1/10,000 to <1/1000
|Very rare<1/10,000
|Frequency not known*
|Infections and infestations
|Upper respiratory infection, bronchitis, oral candidiasis, herpes simplex
|Lower respiratory tract infection, pneumonia, urinary tract infection, skin infection
|Endocarditis, Otitis externa
|Neoplasms benign and malignant
|Malignant hepatic neoplasm
|Blood and lymphatic system disorders
|Thrombo-cytopenia, lymphadeno-pathy
|Aplastic anaemia
|Pure red cell aplasia
|Immune system disorders
|Sarcoidosis, thyroiditis
|Anaphylaxis, systemic lupus erythemato-sus, rheumatoid arthritis
|idiopathic or thrombotic thrombocyto-penic purpura
|Liver and renal graft rejection, Vogt-Koyanagi-Harada disease
|Endocrine disorders
|Hypo-thyroidism, hyper-thyroidism
|Metabolism and Nutrition Disorders
|Psychiatric disorders
|Depression, insomnia
|Mood alteration, emotional disorders, anxiety, aggression, nervousness, libido decreased
|Suicidal ideation, hallucina-tions, anger
|Suicide, psychotic disorder
|Mania, bipolar disorders, homicidal ideation
|Nervous system disorders
|Headache, dizziness, concentration impaired
|Memory impairment, syncope, weakness, migraine, hypoaesthesia, hyperaesthe-sia, paraesthesia, tremor, taste disturbance, nightmares, somnolence
|Peripheral neuropathy
|Coma, convulsions, facial palsy
|Eye disorders
|Vision blurred, eye pain, eye inflammation, xerophthalmia
|Retinal haemorrhage
|Optic neuropathy, papilloedema, retinal vascular disorder, retinopathy, corneal ulcer
|Vision loss
|Serous retinal detachment
|Ear and labyrinth disorders
|Vertigo, earache
|Hearing loss
|Cardiac disorders
|Tachycardia, palpitations, oedema peripheral
|Myocardial infarction, congestive heart failure, angina, supraventri-cular tachycardia arrhythmia, atrial fibrillation, pericarditis
|Vascular disorders
|Cerebral haemorrhage
|Respiratory, thoracic and mediastinal disorders
|Dyspnoea, cough
|Dyspnoea exertional, epistaxis, nasopharyn-gitis, sinus congestion, nasal congestion, rhinitis, sore throat
|Interstitial pneumonitis with fatal outcome, pulmonary embolism
|Gastrointestinal disorders
|Diarrhoea, nausea, abdominal pain
|Vomiting, dyspepsia, dysphagia, mouth ulceration, gingival bleeding, glossitis, stomatitis, flatulence, constipation, dry mouth
|Gastrointes-tinal bleeding, cheilitis, gingivitis
|Peptic ulcer, pancreatitis
|Hepato-biliary disorders
|Hepatic dysfunction
|Hepatic failure, cholangitis, fatty liver
|Skin and subcutaneous tissue disorders
|Alopecia, dermatitis, pruritus, dry skin
|Rash, sweating increased, psoriasis, urticaria, eczema, skin disorder, photosensitivity reaction, night sweats
|Toxic epidermal necrolysis, Stevens-Johnson syndrome, angioedema, erythema multiforme
|Musculoskeletal and connective tissue disorders
|Myalgia, arthralgia
|Back pain, arthritis, muscle weakness, bone pain, neck pain, musculoskeletal pain, muscle cramps
|Renal and Urinary Disorders
|Renal failure, nephrotic syndrome
|Reproductive system and breast disorders
|General disorders and administration site conditions
|Pyrexia, rigors, pain, asthenia, fatigue, injection site reaction, irritability
|Chest pain, influenza like illness, malaise, lethargy, hot flushes, thirst
|Weight decreased
|Injury and poisoning
|Substance overdose
Laboratory values for HIV-HCV co-infected patientsAlthough haematological toxicities of neutropenia, thrombocytopenia and anaemia occurred more frequently in HIV-HCV patients, the majority could be managed by dose modification and the use of growth factors and infrequently required premature discontinuation of treatment. Decrease in ANC levels below 500 cells/mm3 was observed in 13% and 11% of patients receiving peginterferon alfa-2a monotherapy and combination therapy, respectively. Decrease in platelets below 50,000/mm3 was observed in 10% and 8% of patients receiving peginterferon alfa-2a monotherapy and combination therapy, respectively. Anaemia (haemoglobin <10 g/dl) was reported in 7% and 14% of patients treated with peginterferon alfa-2a monotherapy or in combination therapy, respectively.
Clinical efficacy and safety
Copegus in combination with peginterferon alfa-2a
Predictability of responsePlease refer to section 4.2, Table 2.
Study results in treatment-naive patientsEfficacy and safety of the combination of Copegus and peginterferon alfa-2a were established in two pivotal studies (NV15801 + NV15942), including a total of 2405 patients. The study population comprised interferon-naive patients with CHC confirmed by detectable levels of serum HCV RNA, elevated levels of ALT, and a liver biopsy consistent with chronic hepatitis C infection. Only HIV-HCV co-infected patients were included in the study NR15961 (see Table 14). These patients had stable HIV disease and mean CD4 T-cell count was about 500 cells/µl. Study NV15801 (1121 patients treated) compared the efficacy of 48 weeks of treatment with peginterferon alfa-2a (180 µg once weekly) and Copegus (1000/1200 mg daily) with either peginterferon alfa-2a monotherapy or combination therapy with interferon-alfa-2b and ribavirin. The combination of peginterferon alfa-2a and Copegus was significantly more efficacious than either the combination of interferon alfa-2b and ribavirin or peginterferon alfa-2a monotherapy. Study NV15942 (1284 patients treated) compared the efficacy of two durations of treatment (24 weeks with 48 weeks) and two dosages of Copegus (800 mg with 1000/1200 mg).For HCV monoinfected patients and HIV-HCV co-infected patients, for treatment regimens, duration of therapy and study outcome see tables 6, 7, 8 and 14, respectively. Virological response was defined as undetectable HCV RNA as measured by the COBAS AMPLICOR™ HCV Test, version 2.0 (limit of detection 100 copies/ml equivalent to 50 International Units/ml) and sustained response as one negative sample approximately 6 months after the end of therapy.
|Table 6 Virological Response in the overall population (including non-cirrhotic and cirrhotic patients)
|Study NV15942
|Study NV15801
|Copegus 1,000/1,200 mg & Peginterferon alfa-2a 180 µg
|Copegus 1,000/1,200 mg & Peginterferon alfa-2a 180 µg
|Ribavirin 1,000/1,200 mg & Interferon alfa-2b 3 MIU
|(N=436) 48 weeks
|(N=453) 48 weeks
|(N=444) 48 weeks
|Response at End of Treatment
|Overall Sustained Response
|Table 7 Sustained Virological Response based on Genotype and Pre-treatment Viral Load after Copegus Combination Therapy with peginterferon alfa-2a
|Study NV15942
|Study NV15801
|Copegus800 mg & PEG-IFN alfa-2a180 µg 24 weeks
|Copegus1000/1200 mg & PEG-IFN alfa-2a180 µg 24 weeks
|Copegus800 mg & PEG-IFN alfa-2a180 µg 48 weeks
|Copegus1000/1200 mg & PEG-IFN alfa-2a180 µg 48 weeks
|Copegus1000/1200 mg & PEG-IFN alfa-2a180 µg 48 weeks
|Ribavirin1000/1200 mg & Interferon alfa-2b3 MIU 48 weeks
|Genotype 1
|29 % (29/101)
|42 % (49/118)
|41 % (102/250)*
|52 % (142/271)*
|45 % (134/298)
|36 % (103/285)
|Low viral load
|41 % (21/51)
|52 % (37/71)
|55 % (33/60)
|65 % (55/85)
|53 % (61/115)
|44 % (41/94)
|High viral load
|16 % (8/50)
|26 % (12/47)
|36 % (69/190)
|47 % (87/186)
|40 % (73/182)
|33 % (62/189)
|Genotype 2/3
|84 % (81/96)
|81 % (117/144)
|79 % (78/99)
|80 % (123/153)
|71 % (100/140)
|61 % (88/145)
|Low viral load
|85 % (29/34)
|83 % (39/47)
|88 % (29/33)
|77 % (37/48)
|76 % (28/37)
|65 % (34/52)
|High viral load
|84 % (52/62)
|80 % (78/97)
|74 % (49/66)
|82 % (86/105)
|70 % (72/103)
|58 % (54/93)
|Genotype 4
|0 % (0/5)
|67 % (8/12)
|63 % (5/8)
|82 % (9/11)
|77 % (10/13)
|45 % (5/11)
|Table 8 Sustained Virological Response Based on Rapid Viral Response at week 4 for Genotype 1 and 4 after Copegus Combination Therapy with Peginterferon alfa-2a in HCV Patients
|Study NV15942
|Study ML17131
|Copegus1000/1200 mg & Peginterferon alfa-2a180 µg 24 weeks
|Copegus1000/1200 mg & Peginterferon alfa-2a180 µg 48 weeks
|Copegus1000/1200 mg & Peginterferon alfa-2a180 µg 24 weeks
|Genotype 1 RVRLow viral load High viral load
|90% (28/31) 93% (25/27) 75% (3/4)
|92% (47/51) 96% (26/27) 88% (21/24)
|77% (59/77) 80% (52/65) 58% (7/12)
|Genotype 1 non RVRLow viral load High viral load
|24% (21/87) 27% (12/44) 21% (9/43)
|43% (95/220) 50% (31/62) 41% (64/158)
|- - -
|Genotype 4 RVR
|92% (22/24)
|Genotype 4 non RVR
Low viral load= ≤800,000 IU/ml; High viral load= >800,000 IU/mlRVR = rapid viral response (HCV RNA undetectable) at week 4 and HCV RNA undetectable at week 24 Although limited, data indicated that shortening treatment to 24 weeks might be associated with a higher risk of relapse (see Table 9).
|Table 9 Relapse of Virological Response at the End of Treatment for Rapid Virological Response Population
|Study NV15942
|Study NV15801
|Copegus1000/1200 mg & Peginterferon alfa-2a180 µg 24 weeks
|Copegus1000/1200 mg & Peginterferon alfa-2a180 µg 48 weeks
|Copegus1000/1200 mg & Peginterferon alfa-2a180 µg 48 weeks
|Genotype 1 RVRLow viral load High viral load
|6.7% (2/30) 3.8% (1/26) 25% (1/4)
|4.3% (2/47) 0% (0/25) 9.1% (2/22)
|0% (0/24) 0% (0/17) 0% (0/7)
|Genotype 4 RVR
|0% (0/4)
|Table 10 Sustained Virological Response Overall and Based on Rapid Viral Response by Week 4 for Genotype 2 or 3 after Copegus Combination Therapy with Peginterferon alfa-2a in HCV Patients
|Study NV17317
|Copegus 800 mg & Peginterferon alfa-2a 180 µg 16 weeks
|Copegus 800 mg & Peginterferon alfa-2a 180 µg 24 weeks
|Treatment difference95%CI
|p value
|Genotype 2 or 3
|65% (443/679)
|76% (478/630)
|-10.6% [-15.5% ; -0.06%]
|Genotype 2 or 3 RVRLow viral loadHigh viral load
|82% (378/461)89% (147/166)78% (231/295)
|90% (370/410)94% (141/150)88% (229/260)
|-8.2% [-12.8% ; -3.7%]-5.4% [-12% ; 0.9%]-9.7% [-15.9% ; -3.6%]
|Table 11 Relapse of Virological Response after the End of Treatment in Genotype 2 or 3 Patients with a Rapid Viral Response
|Study NV17317
|Copegus 800 mg & Peginterferon alfa-2a 180 µg 16 weeks
|Copegus 800 mg & Peginterferon alfa-2a 180 µg 24 weeks
|Treatment difference95%CI
|p value
|Genotype 2 or 3 RVRLow viral loadHigh viral load
|15% (67/439)6% (10/155)20% (57/284)
|6% (23/386)1% (2/141)9% (21/245)
|9.3% [5.2% ; 13.6%]5% [0.6% ; 10.3%]11.5% [5.6% ; 17.4%]
Chronic hepatitis C prior treatment non-responder patientsIn study MV17150, patients who were non-responders to previous therapy with pegylated interferon alfa-2b plus ribavirin were randomised to four different treatments: • peginterferon alfa-2a 360 µg/week for 12 weeks, followed by 180 µg/week for a further 60 weeks • peginterferon alfa-2a 360 µg/week for 12 weeks, followed by 180 µg/week for a further 36 weeks • peginterferon alfa-2a 180 µg/week for 72 weeks • peginterferon alfa-2a 180 µg/week for 48 weeks All patients received Copegus (1000 or 1200 mg/day) in combination with peginterferon alfa-2a. All treatment arms had 24 week treatment-free follow-up. Multiple regression and pooled group analyses evaluating the influence of treatment duration and use of induction dosing clearly identified treatment duration for 72 weeks as the primary driver for achieving a sustained virological response. Differences in sustained virological response (SVR) based on treatment duration, demographics and best responses to previous treatment are displayed in Table 12.
|Table 12 Week 12 Virological Response (VR) and Sustained Virological Response (SVR) in Patients with Virological Response at Week 12 after Treatment with Copegus and Peginterferon alfa-2a Combination Therapy in Non-Responders to Peginterferon alfa-2b plus Ribavirin
|Copegus 1000/1200 mg & Peginterferon alfa-2a 360/180 or 180 µg 72 or 48 Weeks (N = 942) Pts with VR at Wk 12 a(N = 876)
|Copegus 1000/1200 mg & Peginterferon alfa-2a 360/180 or 180 µg72 Weeks (N = 473) SVR in Pts with VR at Wk 12 b(N = 100)
|Copegus 1000/1200 mg & Peginterferon alfa-2a 360/180 or 180 µg 48 Weeks (N = 469) SVR in Pts with VR at Wk 12 b(N = 57)
|Overall Low viral load High viral load
|18% (157/876) 35% (56/159) 14% (97/686)
|57% (57/100) 63% (22/35) 54% (34/63)
|35% (20/57) 38% (8/21) 32% (11/34)
|Genotype 1/4 Low viral load High viral load
|17% (140/846) 35% (54/154) 13% (84/663)
|55% (52/94) 63% (22/35) 52% (30/58)
|35% (16/46) 37% (7/19) 35% (9/26)
|Genotype 2/3 Low viral load High viral load
|58% (15/26) (2/5) (11/19)
|(4/5) (3/4)
|(3/10) (1/2) (1/7)
|Cirrhosis StatusCirrhosis Noncirrhosis
|8% (19/239) 22% (137/633)
|(6/13) 59% (51/87)
|(3/6) 34% (17/50)
|Best Response during Previous Treatment≥2log10 decline in HCV RNA <2log10 decline in HCV RNA Missing best previous response
|28% (34/121) 12% (39/323) 19% (84/432)
|68% (15/22) 64% (16/25) 49% (26/53)
|(6/12) (5/14) 29% (9/31)
|Table 13 Sustained Virological Response in HALT-C by Previous Treatment Regimen in Non-Responder Population
|Previous Treatment
|Copegus 1000/1200 mg & Peginterferon alfa-2a 180 µg 48 weeks
|27% (70/255)
|Pegylated interferon
|34% (13/38)
|Interferon plus ribavirin
|13% (90/692)
|Pegylated interferon plus ribavirin
|11% (7/61)
HCV patients with normal ALTIn study NR16071, HCV patients with normal ALT values were randomised to receive peginterferon alfa-2a 180 µg/week with a Copegus dose of 800 mg/day for either 24 or 48 weeks followed by a 24 week treatment free follow-up period or an untreated control group for 72 weeks. The SVRs reported in the treatment arms of this study were similar to the corresponding treatment arms from study NV15942.
Children and adolescentsIn the investigator sponsored CHIPS study (Chronic Hepatitis C International Paediatric Study), 65 children and adolescents (6-18 years) with chronic HCV infection were treated with peginterferon alfa-2a 100 µg/m2 sc once weekly and Copegus 15 mg/kg/day, for 24 weeks (genotypes 2 and 3) or 48 weeks (all other genotypes). Preliminary and limited safety data demonstrated no obvious departure from the known safety profile of the combination in adults with chronic HCV infection, but, importantly, the potential impact on growth has not been reported. Efficacy results were similar to those reported in adults.
HIV-HCV co-infected patientsThe virological responses of patients treated with Copegus and peginterferon alfa-2a combination therapy in relation to genotype and pre-treatment viral load for HIV-HCV co-infected patients are summarised below in Table 14.
|Table 14 Sustained Virological Response based on Genotype and Pre-treatment Viral Load after Copegus Combination Therapy with peginterferon alfa-2a in HIV-HCV co-infected patients
|Study NR15961
|Interferon alfa-2a 3 MIU & Copegus 800 mg48 weeks
|Peginterferon alfa-2a180 µg & Placebo48 weeks
|Peginterferon alfa-2a180 µg & Copegus 800 mg48 weeks
|All patients
|12% (33/285)*
|20% (58/286)*
|40% (116/289)*
|Genotype 1
|7% (12/171)
|14% (24/175)
|29% (51/176)
|Low viral load
|19% (8/42)
|38% (17/45)
|61% (28/46)
|High viral load
|3% (4/129)
|5% (7/130)
|18% (23/130)
|Genotype 2-3
|20% (18/89)
|36% (32/90)
|62% (59/95)
|Low viral load
|27% (8/30)
|38% (9/24)
|61% (17/28)
|High viral load
|17% (10/59)
|35% (23/66)
|63% (42/67)
Ribavirin in combination with interferon alfa-2aThe therapeutic efficacy of interferon alfa-2a alone and in combination with oral ribavirin was compared in clinical trials in naive (previously untreated) and relapsed patients who had virologically, biochemically and histologically documented chronic hepatitis C. Six months after end of treatment sustained biochemical and virological response as well as histological improvement were assessed.A statistically significant 10-fold increase (from 4% to 43%; p <0.01) in sustained virological and biochemical response was observed in relapsed patients (M23136; N=99). The favourable profile of the combination therapy was also reflected in the response rates relative to HCV genotype or baseline viral load. In the combination and interferon monotherapy arms, respectively, the sustained response rates in patients with HCV genotype-1 were 28% versus 0% and with genotype non-1 were 58% versus 8%. In addition the histological improvement favoured the combination therapy. Supportive favourable results (monotherapy vs combination; 6% vs 48%, p<0.04) from a small published study in naive patients (N=40) were reported using interferon alfa-2a (3 MIU 3 times per week) with ribavirin.
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Villa Orleans Yoga
| Yoga Classes in Rincon
|Villa Orleans Yoga
Rincon 00677
|Contact:luis ortiz
Beachfront vacation home, perfect for retreats or workshops. Villa Orleans has a 20 x 20 beachfront yoga deck, a terrace yoga deck, a swimming pool, and sleeps up to 16. We have a coordinator that will assist you with transportation, the right chef and line up things to do in this surf town Rincon. No passport required for Puerto Rico. The villa consists of 2 houses, 7 bedrooms: the first 4 bedrooms with 5 bath and 7 beds; the second has 3 bedrooms: a king bedroom apartment and two bedrooms with 4 twins. A few of the bedrooms. We have videos of our facilities.
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Dance, Issue 665
- Filtered by:
- Issue 665
- Dance
- Ballet
- Contemporary dance
17 articles
Sorted by popularity / date
The 2010 Festival in Numbers24 Aug 2010
Here are some statistics about this year's Festivals
We've very carefully and scientifically gathered some stunning numbers and statistics about this year's festivals.
Transformation24 Aug 2010
Harrowing but uplifting tale of survival
At first sight writer, director and performer Gemskii appears to have created a welcoming, informal atmosphere in her small space at the Roxy, handing out programmes and opening her show with a polite invitation to 'laugh, even though this story is…
5 Questions - Ricardo Garcia19 Aug 2010
One of the busiest men on the Fringe, Ricardo Garcia takes time out from his many performances to tell us about his interactive show, A Compas Flamenco. 5 things you love most about flamenco? I love the fact that it is the art of the people – not a…
Paco Peña Flamenco Dance Company19 Aug 2010
Where Spanish and African cultures collide
With its close proximity to Africa, Spain is often seen as a gateway to a better life. Some immigrants are successful, others not, but it is their desire for greener grass, followed by a longing for home, which inspired Paco Peña's latest show…
Pas Perdus19 Aug 2010
Delightful family-friendly clowning
The booming voiceover that introduces this charming piece of physical theatre is that of a hypnotist inducing the calm of sleep on its audience. What then transpires is the appearance of a dream world, though the night visions we experience are far from…
Maria De Buenos Aires19 Aug 2010
An Argentine feast for all five senses
A programme note warns audience members going into this anarchic reinterpretation of Astor Piazzolla's already surreal 1968 'tango opera' not to worry about following any sort of narrative. Thus released, you're free to let teeming chaos wash over…
Cape Dance Company19 Aug 2010
Pop star-slick, but patchy
The key to what doesn't quite work about this uneven showcase from one of Africa's most acclaimed young companies is right there in the first piece – Michael Thomas' pastoral/pop fusion Treasures of the Heart. They're technically superb on the…
La Lutte18 Aug 2010
Contemporary meets combat in a strong male duet
This is strong dance. This is male dance. But this is also the kind of dance that looks like two boys fighting over whose next on the Playstation. La Lutte (French for 'the wrestle') is the new duet from Belgium/UK-based choreographer Filip Van Huffel…
Pina Bausch's Tanztheater Wuppertal17 Aug 2010
The late great choreographer Pina Bausch lives on through her work and company, as the dancers of Germany's Tanztheater Wuppertal arrive in Edinburgh to perform Água. Inspired by Bausch's time in Brazil, the work is filled with striking video images…
Dance:Film10 brings dance on film to Edinburgh Festival15 Aug 2010
Pieces on Pina Bausch and Scottish Ballet films by Daniel Warren amongst highlights
The Edinburgh International Film Festival may no longer coincide with the rest of the August extravaganza, but the folks at Dance:Film are doing their best to fill the slot. Small but perfectly formed, this year's film fest features films about Scottish…
Tabú - I Will Be Bad14 Aug 2010
Contemporary circus flying in the face of fear
Watching contemporary circus outfit Nofit State is like stepping into the pages of a living, breathing pop-up book. Before the show starts, we are ushered into the big top by a babbling 12-strong international cast of characters who look straight out of…
Alonzo King Lines Ballet14 Aug 2010
Modern classical dance with an Indian beat
It's part of our make-up to search for the meaning in things. So it's no surprise that when an audience sits down in front of a piece of modern dance, the big question in most people's heads is 'what's it all about?'. Bringing two works to this…
Reel-to-Real: The Movies Musical14 Aug 2010
Less chat more dancin' and singin' please
Much has been made of Reel-to-Real's impressive technical credentials, which allows live performers to perform iconic song-and-dance numbers against a backdrop of footage from classic film musicals. In fact the background projections, while cleverly…
Intertwine14 Aug 2010
Works, and dancers, in progress
Collisions Dance Company are on the cusp. They're young enough – as a company and individuals – that they haven't quite found their own style yet, but they're also talented enough that watching even an uneven collection of small pieces like this feels…
Where Did It All Go Right?14 Aug 2010
Passion and fun in the nightclub
Presented by Dance Base in the backroom bar of an underground gay hotspot, this light and lively send-up of the mating rituals of clubbing must be one of the most accessible pieces of dance theatre on the Fringe. Devised by Ireland's ponydance…
The Regretrospective14 Aug 2010
The tiger who came to tea with his ex-lover, the horse
Under 'experiences that could only happen at the Fringe', chalk up 'watching a woman wearing a horse's head use flamenco to seduce her ex-lover, a large cuddly toy tiger, in a bedsit, to a trip hop soundtrack'. And yet, bizarrely, dancer and multimedia…
Mary & William14 Aug 2010
Intimate rendition is by turns humorous and poignant
Actress Mary MacDonald Hamill performs a biographical piece woven together with excerpts from Shakespeare which provide a lyrical commentary to the narrative. Following the story of her life and career from childhood, this intimate rendition is by turns…


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A bunch of evil math teachers that lost their jobs because whippersnappers these days no longer want an education, instead they spend their time catching Pokemon. Each grunt should have a Minun, because they are negative.
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A bunch of evil math teachers that lost their jobs because whippersnappers these days no longer want an education, instead they spend their time catching Pokemon. Each grunt should have a Minun, because they are negative.
I somehow don't think there will be or if there is it probably won't show itself until late game(like TR did in Red/Blue)
Well from Gen 2 to 4 most villain team/organizations revealed themselves early Red/Blue was the only exception(didn't really show themselves in force until Saffron City)Quote:
That's just a Statue and doesn't really reveal much on who it is/nor who made/sculpted itQuote:
I think this could be something to do with the villain. In the trailer we see a statue of a trainer standing next to a Palpitoad, Eevee and a Golurk. It's mysterious at the moment, but, I believe it may have some relevance to the villain team/person
Team Axis love pokémon so mucn, they want to become one. So they plan to insect a pokémon's genes into theirs. The onky pokémon who has the genes powerful enough is the Y (not attempting to spell)
Team Codinate plan to rule the world, so they plan insect a pokémon's genes into theirs to become the ultimate lifeform and take over the region. The only pokémon's genes that'll work is the X (not attempting to spell that)
So yeah, thats the random plot I though up in about 10 seconds. Might as well put it in fanfiction.
Just give us a female team boss. That is all I am asking for.
how about Team Sigma a criminal organization vow to take over the world, using either Xerneas or Yveltal, lead by a male leader I called Walter (bases from deviantart.com), and like all villian grunts, they should use poison, and dark types like zubat, golbat, grimer, muk, ekans, arbok, houndour, houndoom, etc.
Attachment 83625 (click to zoom in)
PS: excuse my poor picture creating
Ok scratch my stupid idea up there and consider this.
Team Axis has 2 siblings as their leaders, Gene and Chrome (deal with it)
Pokémon X
Gene experiments on the X legendary, doing things with his genes. Player arrives and the usual stuff goes down. However, Gene's intentions were never truly stated.
Pokémon Y
Chrome experiments on the Y legendary, doing things with his genes. Player arrives and the usual stuff goes down. However, Chrome's intentions were never truly stated.
Pokémon Z
Sequel to X and Y, connects both games.
Gene and Chrome return, explaining after the thrawted plans in the previous games their experiment became unstable. They planned on creating the ultimate pokémon by combinding the genes of 2 different legendaries. However, both experiments were stopped before they were finished, by the X player and by the Y player. The pokémon therefore [fill in 30 minutes of random stuff] until the player captures the pokémon. The player then learns the pokémon has 3 forms (because why not)
-X and Y DNA
Edit: Just 1 form. X and Y DNA would just be the X legendaries themselves
The BW2 Team Plasma are supposedly Pirates, but aren't as obvious as Team Aqua were.
Abstergo Industries - The Assassin's Creed Wiki - Assassin's Creed, Assassin's Creed II, Assassin's Creed: Brotherhood, Assassin's Creed: Revelations, walkthroughs and more! I'd really like something like this for example.
How about....Team seXY?
It's seems there's a fair amount of people wishing for a female leader of a science organization... I guess Fennel's fallen a long way.
The profs could be the villains and Oak is the boss. XDD
Let's see the history of the villainous teams and their motivations:
Team Rocket
Description: Stereotypical mafia-based antics such as stealing people's Pokemon, selling Slowpoke tails and Cubone skulls on the black-market, and taking over Poke-product based companies and radio towers.
Leader: The aptly named Giovanni.
Goal: Money (R/B/Y and FRLG), Get back Giovanni (G/S/C and HGSS)
Team Aqua and Team Magma
Description: Environmentalists gone extreme with the former devoted to the importance of the sea while the latter are land-lovers. Both hate each other and perform petty crimes that contribute towards bigger plans involving volcanos and underwater secret bases.
Leader(s): Archie and Maxie, respectfully.
Goal: To use Kyogre to expand the sea (As if Hoenn didn't already have enough!) and Groudon to expand the land, respectfully.
Team Galactic
Description: A team whose hobbies include time, space and blowing up lakes in order to steal legendary being of emotions- because emotions are bad and make people weak. Cyrus told them so. Most team leaders aren't entirely sure why they follow their leader but, darn it, he's so persuasive.
Leader: The aforementioned dead-eyed Cyrus
Goal: To use the Creation trio to destroy universe and recreate it without any emotion, and with Cyrus as their God.
Team Plasma
Description: Medieval carnival rejects - and the later pirates - turned militant Pokemon-rights activists. Steal Pokemon with the purpose of "releasing" them but are actually enslaving them. Later break into two sections: the old Plasma and new Plasma (The former actually *do* want Pokemon liberation, the latter just want to rule Unova).
Leader: The mysterious N, puppeteered by his father Ghetsis.
Goal: For N, it's to create a Black and White world in which humans and Pokemon are separated. For Ghetsis, it's to use N's goodness and heroic qualities (and later Kyurem's power) to control Unova with the Pokemon he's nicked.
So basically we've had Mafia, Environmentalists, Cult-Like Religion and Pokemon-rights activists. It seems that Pokemon games do tend to choose groups from real-life who, to put it bluntly, can be corrupt and two-faced in their standards and plans. If we base it on the game titles of X and Y, then maybe it will be a Gender War of some kind? Maybe Yveltal represents masculinity (Y) often associated with the sky while Xerneas represents femininity (X) associated with the earth in Europeon Celtic mythology. It's hard for me not to look at Xerneas and not think of the Sacred Hart.
I think we could well have dual enemy teams again like in RSE and maybe the first female leader in a main series game.


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Incubus is pleased to announce that they will be be playing some European festivals in the summer of 2015:…Blog Incubus to Play at German and Austrian Festiv 8 Likes
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In spite of being doing five shows on television in just three years, actress Prerna Wanvari isn't worried bout over exposing herself on small screen.
In last three years she has been a part of shows like "Bandini", "Sapna Babul Ka... Bidaai", "Bairi Piya" and is being seen in ongoing family drama "Parichay - Nayee Zindagi Kay Sapno Ka".
She says that she believe that "over exposure is not going to do any harm".
"Deep down my passion about acting will always overcome the over exposing bit. Coming too much on TV never comes in your way. There are people who have been coming on TV for years, so there is no such thing (like over exposure)," Prerna told IANS.
Apart from wearing grease paint for TV shows, she is active in theatre and presently playing a pivotal part in a play called "Wake Up call".
Talking about the play, Prerna said: "It is basically about sending a message. There is a bomb blast and it affects the way people react. It teaches them to face such situations and not lose courage. And not commit suicide and be scared."
However, route to theatre is not to improve her acting skills, it is her passion for the craft that motivates her to straddle both worlds.
"It's (acting in plays) an experience. If it has to help somewhere, it will. But acting is what I like doing. I don't do it thinking that it will help me somewhere. I am doing it because I like acting and I wanted to experience theatre," she said.
As far as big screen goes, Prerna had been auditioned for "Life Of Pi", but "it didn't work out." But the actress is hopeful and said: "I think nowadays Indians have more scope in Hollywood cinema and international television."
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Popular Search Terms: prerna wanvari
Dear Readers,
Prerna...all d best for ur future ventures..God bless u...
hoping to watch a glimpse of ViRa in the show...bt i dont want them to be Negative
Parichay is awesome... Sinal Rocks... Love current track very much
Edited on:24 September 2012 at 8:33pm
Keep rocking prerna.pnzksk rockzz!
Parichay is rocking more now...sinal roxxx!!!!
Sinal r the power n Sole of Parichay..
Sameer Sir n Keerti the best jodi..
Love Our SINAL to the core..
I hope VIRA remain out of the picture
Good Luck for all ur projects and Parichay,SiNal roxx...
Don't care about your role as Raveena in Parichay.. but good luck for your future projects! Parichay is going great with Kunal-Siddhi office romance and parent trap about to start. Hope Richa gets lost somewhere and NEVER finds Kunal or Siddhi ever again! Hate her! Kunal-Siddhi, I love you both! Keep rocking!
yeah sameer in parichay rock
Hate your character Raveena// But you are a pretty decent actor
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Woodblock Chocolate will be pumping chocolate directly to every household in Portland by the end of 2013! With the whopping $800,000,000 raised by our Kickst...
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Hey Charley - reminds me of the plans Henry Weinhard had to pipe beer throughout downtown Portland to the public water fountains. I like yours better.
When you're done, let's do this in Manhattan!
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3 Top Hip-Hop Names Rewrite the Rulebook
Kanye West really is the nucleus, as he claimed in a recent New York Times interview.
I will be the leader of a company that ends up being worth billions of dollars, because I got the answers. I understand culture. I am the nucleus.
He sounds like a jerk, but perhaps no less so than founders of other billion-dollar companies. And he's right. On his new album, Yeezus, he is a modern-day Mercury, managing to focus all of society's broadest contradictions, lacing them to his feet like a winged pair of Nikes, to better bring the message directly to our ears, in one angry outburst.
Is he batshit crazy? Full of himself? Pretentious? Best guess: All of the above. But that's not the point.That new album, Yeezus, debuted at No. 1 on Billboard's Hot 200 and was colorfully reviewed by Lou Reed, he of the once-and-eternally hip Velvet Underground. Reed gets it. Summing up the album as "Majestic and inspiring," Reed points out in an understatement:
WhatI talked about West having it both ways in my article in May, mentioning that touting his limited edition line of high-priced sneakers on Twitter and on Saturday Night Live seemed contrary to his rant against materialism in "New Slaves." But I also tried to show how that seeming contradiction is like an onion that we could peel away layer after layer and never really find the core. In his rambling review (really a joy to read, refreshing in a way that's more like a stand-up monologue) Reed notes that Yeezus is full of other contradictions: I can hold my liquor and I can't hold my liquor in the same song; throwing stones at the elite Hamptons houses when he lives like a king himself; this brilliant artist, businessman par excellence, son of a college professor, tossing out Y'all throwin' contracts at me/ You know that niggas can't read. " 'I'm great, I'm terrible, I'm great, I'm terrible.' That's all over this record," Reed writes, painting the contradictions in terms of manic depression. But if it is, it's our manic depression. Whatever West is, it is what we made him. Those two-faced mashups are our society's principal themes: Racism, classism, materialism, substance-love/abuse, art vs. money, artist vs. kingpin, business vs. crime, a respectful love for one woman vs. a misogyny-and-"bitches" trope. We built a national Olympus out of that pile of trash and now he is there on top of it, our god -- creating himself in our likeness. That is the proper role of the artist: To confront society with its own conflicts, its deepest concerns, to illustrate the nucleus. Yeezus is a beautiful, ground-breaking record and it debuted at No. 1 on Billboard. Lou Reed's signature on that review underscores the album's cultural importance. It may not be as revolutionary as The Beatles' 1967 Sergeant Pepper's Lonely Hearts Club Band -- but then again, it may be. It's brilliantly textured, startlingly fresh, nearly sublime in the breadth of imagination and the restraint, the economy of means. The deepest contradiction, between art and money, is devastatingly resolved: Artistry undeniably served, all investors undeniably wealthier. Doesn't usually work that way.
Westsays and what he does are often two different things.
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Free Khuda Se Mango Milega MP4 Video Download
Khuda Se Maango Milega (+lyrics By Dr) Hd.mp4
Khuda Se Maango Milega (+Lyrics By DR) HD Video Song.
Anil Kant-khuda Se Maango Mile Ga
ANIL KANT-khuda se maango mile ga.
Jagjit Singh - Hindi Christian Song-khuda Se Pyar Karo
Jagjit Singh-Hindi Christian Song-khuda se pyar karo....
Myself and my sister Divya Joyce singing for the glory of Christ...
Meri Rooh Khuda Ki By Jagjit Singh
India's famous Gazal Singer Mr Jagjit Singh.
Ambassadors Sings khuda Se Mango Milega.mp4
Singing Group "Ambassadors" of SDA London Asian Church in East London which includes Bro. Sunny Sadiq, Bro. Naqash tariq, Bro. Alvin McQueen, Bro. Shawn John...
Anil Kant - Khuda Se Maango Mile Ga
i love this song cause this song encourage me a lot to love more Jesus Christ :) i love my Savior how about you guys :)
via YouTube Capture.
Khuda Se Mango Milega - The Fellowship Church
Khuda Se Mango Milega - The Fellowship Church.
My cousin doing his thing with the Gospel music scene... -If you don't have God in your life... You have major things to worry about- Manu sang the song in H...
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editors: Ahsan Suleman & Yoel Tanveer Masih geet: Khuda se mango.
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spiritual song khuda se maango sung by ashish dayal.
khuda se pyaar karo.


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This item may be available at your local Harbor Freight Tools Store
This item can only be shipped within the 48 contiguous states via Standard Ground Shipping.
(based on 54 reviews)
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of respondents would recommend this to a friend.
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Most Liked Positive Review
Very Nice Light Duty Driver
Bought this with the intent to use only for 10mm bolts found on most import vehicles that i work on daily to remove air cleaner box screws, under carriage cover screws, etc. It...Read complete review
Bought this with the intent to use only for 10mm bolts found on most import vehicles that i work on daily to remove air cleaner box screws, under carriage cover screws, etc. It works just as I had expected, actually has more power than a snapon that my co-worker uses...and it has a light! Paid about 1/6th the price of the snapon!
Most Liked Negative Review
Mixed feelings, Good with some Flaws
OK so I got this because, well it was cheap and I figured for about the price of a new battery for my 18V (other brant #1)... And I lusted for an...Read complete review
OK so I got this because, well it was cheap and I figured for about the price of a new battery for my 18V (other brant #1)... And I lusted for an impact driver for the small size and large power.First the positives. It is cheap, pretty solid and worked well for almost a year of pretty heavy use.The cons are the battery overheats easily and then just stops. Part of this is a Li battery thing but usually you get some power drop then it just quits. This is also an issue for the (other brand #1) battery saws. I think it's just under capacity batteries. What I really compare this one to is my (other brand #2), which is also a 12v Li driver. The (other brand #2) is much slower and has less power, but the batteries last a LOT longer and don't have the sudden quit problem.Now after about a year, I should look at my receipt I may be under a warranty?, it has just given up. It goes into impact mode instantly and has a hard time with 1" screws in pine.Since I have the drill also and an extra battery I was thinking of buying another as a replacement.But I'm thinking I will go back to the (other brand #2) because of the battery issues with this driver and because it is a bit under powered ((other brand #2)is about 2.5X the torque).In fairness this driver was a workhorse for a year driving probably thousands of screws in a remodel project. Neither of the other brands were put to quite the same test, though #2 has come close.Under home use or probably shop use this little inexpensive driver probably would still be going.The battery sudden quit issue is a pain since it only comes with one battery (part of the reason I got the drill also). I would recommend getting a replacement battery if they have one (they were out of stock at my local for about six months). With a second battery it's just a nuisance, and not too big a one.Until mine keeled over I would have given it four stars. I'm still giving it three because the cost is so low and because I think most people will get a lot longer life out of theirs. Also the driver will go fast enough to use as a drill if needed, something my (other brand #2) couldn't do.BTW if you have never used Li tools before... You will LOVE that they can sit for weeks on the shelf and not lose their charge. That makes them perfect for the occasional user.
Reviewed by 54 customers
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(1 of 1 customers found this review helpful)
always smells like its catching fire....
By jake
from erie, pa
About Me Professional
Comments about Chicago Electric Power Tools Professional Series 12 Volt 1/4 in. Lithium-Ion Cordless Hex Impact Driver:
this thing is powerfull, it can loosen lug nuts, it always smells like fire, it is very suprisingly powerfull, keeps up with 20v milwalkees, i got the year warrenty just in case, the battery life is a little low, but thats expected with the in-handle battery the lithiums deliver a high amp punch these things need, i guess the worst thing is you dont know how long you have till it dies, puts out power then its just dead, very few impacts left, i would highly recommend this product.......
Bottom Line Yes, I would recommend this to a friend
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better than i thought
By daniel j
from wurtsboro ,ny
About Me Avid Do-It-Yourselfer
bought for light stuff on cars like dash screws and lights, but i find myself picking it up constantly.fills a big void between a cordless drill and my 18v impact.
(2 of 2 customers found this review helpful)
Good Driver for the money
By Dan
from Port Charlotte,FL
This is a great little driver for around the house and for the money. The 12v battery is good and last all day with an on/off useage
(4 of 4 customers found this review helpful)
one of favorite tools in my tool box
By jjv
from torrington ct
work full time at honda dealer. use everyday with almost no complaints. the led light serves no use to me, not bright enough. reverse torque could be more. some times air box screws are to tight and need a socket to brake loose. sometimes i toss the tool on the bench and it still works. the charger base is balanced on top of a 4 plug outlet and fell many times on a concert floor and still works, shake it and makes some noise tho. battery lasts all day and for a few days not plug in. yes it does smell sometimes but doesn't worry me.
(3 of 3 customers found this review helpful)
Works great
By BigBoyinMS
from Central Mississippi
This has worked great. Plenty of power for 1/4"... any more and it would break sockets and bits. In fact, it did break a bit.
(2 of 4 customers found this review helpful)
1/4" hex collett gives better holding pw
By Steve
from Berea, Ky.
See all my reviews
I build furniture and toys and high - end speaker cabinets. Many times a lot of screws or lag bolts are required to assemble or install this stuff. This companion to 69360 drill make a wonderful set. I use this for it's speed, power, light weight and good design, and because I wanted it for these jobs. I have had both for a couple months with nary a problem. They ren, work and charge as they are supposed to.Theu WON'T rip off 13/16" lugnuts from a rusty 4x4, but they will work all day in wood and never a problem. But that's what they're for. Use them for their designed purpose and care for them in the correct maner, and it will serve as well as anything out there for 4-5 times the price.It is another pearl ftom HF. Thanks guys.
(3 of 4 customers found this review helpful)
Crackle crackle pop pop
By Jesus
from Los Angeles, CA
Professional use. Taking the abuse of everyday work. Small and compact. Packs a punch. Light doesn't really do much.
Very Satisfied
By Brad
from NY
Have used to install studs on several snowmobiles, general light mechanical work and driving screws. Power and battery life is comperable to my Milwakee I have at work.
Great Driver!!
By Jack-pot
from Minnesota
Use this driver every day at work. Works better than the Snap=on one i had, and a 1/4 the price. perfect for smaller engine and body bolts on vehicles. Fast charging and long battery life. Great driver!!!
Great Tool!
By Greg
from North Carolina
I bought this tool over a month ago and I'm very satisifed. I had been wanting a cordless impact driver for a long while for driving screws, etc, but always felt they were over priced but then I found Harbor Freight. I used this impact driver to tighten the hardware while installing a chainlink fence and it worked better than expected. I want to get an additional lithium battery but HF never has them in stock and on line it states on order.
Most orders will be processed and leave our warehouses within 1-2 business days from the time your order is placed. Orders placed on Saturday or Sunday will be processed on Monday.
*Overweight items are shipped via freight delivery, please allow up to 15 business days for shipping. Standard Ground Shipping rates apply to deliveries within the continental Unites States.
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good job chimpy
Senior Member
as the heading states the TT fountain turret attacks out side of fountain on the purple side, the top right of the base, behind the shop keeper.
to reproduce
1. get a champion on the blue team
2. push the towers in the top lane/move past them until in base
3. click behind the shop keeper in the fountain spawn
4. get attacked by nexus obelisk
sorry posted this in wrong, yet right place, ignore if you don't really care
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