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Thursday, November 13 2014
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Tuesday, November 4 2014
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Thursday, October 23 2014
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What if today's jazz is a little bit Bill Frisell and a little bit Ornette Coleman?
Tuesday, October 21 2014
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Thursday, October 16 2014
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Tuesday, October 7 2014
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subset: commoncrawl


text: PRESS RELEASESan Antonio, TX (February 15, 2006)Grieving Family Files Suit Against County and Private Jail After Wife and Mother is Raped, Commits SuicideThe Texas Civil Rights Project filed suit today on behalf of the family of Mrs. Letisha Tapia. Mrs. Tapia was found hanging in the Val Verde County Jail on July 23, 2004 after she had been raped by a male inmate.The jail housed Mrs. Tapia in the same cell block as violent male inmates. Permissive guards allowed male and female inmates to have sexual relations. Mrs. Tapia told the warden about these sexual transgressions, but he ignored her pleas and male inmates remained in the cell block. Mrs. Tapia was raped by one of the male inmates after making her report to the warden. Mrs. Tapia reported the rape to the authorities, who refused to press charges. She received no psychiatric treatment after the rape, despite experiencing depression and anxiety. The night before she died, Mrs. Tapia was abused by a guard. Lt. Duggar interrogated Mrs. Tapia about a rules violation by forcing her to her knees and kicking her. He threatened her with rape, telling her �if you were my cellmate, I�d make you my bitch.� He called her a �low-life prostitute ho� and told her she would spend the next fifteen years in jail. He ordered three female officers to strip search Mrs. Tapia, and watched as they made her expose herself to him. Despite telling Lt. Duggar she would kill herself if placed in administrative segregation, Duggar threw Mrs. Tapia into a segregation cell and left her there, naked, without blankets for the entire night. Jail policy requires that every inmate see a psychiatrist before being placed in administrative segregation, but Mrs. Tapia never saw a doctor. The jail guards failed to inspect her cell every fifteen minutes (as required by policy), and Mrs. Tapia was found hanging in her cell that night. �The jail drove this young woman to kill herself,� said Scott Medlock, the Texas Civil Rights Project�s Prisoners� Rights Attorney. �From the minute she was booked into this facility, she was abused and ignored by jail officials.�Medlock said the private prison system was to blame for Mrs. Tapia�s death. Val Verde County and the US Marshals Service contract with GEO Group, formerly Wackenhut Security, to run the jail. �When prisons and jails are privatized the company�s bottom line is placed above inmate health and safety. GEO cuts corners by hiring poorly trained guards, providing inmates with cut rate medical care and running their facility in a grossly unprofessional manner. Mrs. Tapia�s family had their wife, mother and daughter sacrificed to corporate greed.� Mrs. Tapia�s family is seeking monetary damages, but that is little consolation. �No amount of money could bring her back,� her husband, Eliodoro Tapia, said. For more information, please contact Scott Medlock, at (512) 474-5073 ext. 105.


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With a stay at Platinum Palace Residence in Poznan, you'll be in the historical district and minutes from Hala Arena and close to Poznan Palm House. This 4-star hotel is close to Parish of St. Stanislaus Kostka and Old Town Square.
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After admittedly allowing the Utah Jazz to get the better of them in two meetings on the road earlier this season, the Dallas Mavericks confidently stepped onto their home floor Sunday ready to return the favor. Looking to avenge a 113-94 road loss on Oct. 31 and a 100-94 defeat at Energy Solutions Arena on Jan. 7, the Mavericks also had an opportunity to inch closer in the heated Western Conference playoff race, tying the Jazz for the ninth position in the standings if able to leave their home floor with a win. Meanwhile, the Mavs attempted to send the Jazz to a ninth straight road loss while building off Friday's 104-94 win over Boston, hoping to move to 2-1 on their current six-game homestand.
Inside Report: Mavs vs. Jazz
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Gilead Sciences, Inc. (NASDAQ:GILD)
March 07, 2012 4:30 pm ET
Susan Hubbard - Vice President of Investor Relations
Norbert W. Bischofberger - Chief Scientific Officer and Executive Vice President of Research & Development
Paul Sax -
Andrew Cheng - Senior Vice President of Development Operations
Michael E. Ulz - JP Morgan Chase & Co, Research Division
Mark J. Schoenebaum - ISI Group Inc., Research Division
Matthew Roden - UBS Investment Bank, Research Division
Yaron Werber - Citigroup Inc, Research Division
Sapna Srivastava - Goldman Sachs Group Inc., Research Division
Brian Abrahams - Wells Fargo Securities, LLC, Research Division
Robyn Karnauskas - Deutsche Bank AG, Research Division
M. Ian Somaiya - Piper Jaffray Companies, Research Division
Ladies and gentlemen, thank you for standing by, and welcome to the Gilead Sciences Conference Call. My name is Stacey, and I will be your conference operator for today. [Operator Instructions] As a reminder, this conference call is being recorded today, March 7, 2012. I would now like to turn the call over to Susan Hubbard, Vice President of Investor Relations. Please go ahead.
Susan Hubbard
Thank you, Stacey. And good afternoon, everyone. Thank you for joining us today to discuss the 48-week results from Study 102, the pivotal Phase III study of our Quad drug head-to-head versus ATRIPLA. You can find the press release detailing the study results, as well as a link to the slides presented here today on our website at gilead.com.
We have Dr. Paul Sax with us today, the lead investigator from the study. Dr. Sax will recap the presentation he just gave here in Seattle at the Conference on Retroviruses and Opportunistic Infections. Dr. Sax's comments today will reflect his own conclusions, opinion and analysis and do not necessarily reflect Gilead's conclusions, opinions, and analyses. We're also joined today by our Executive Vice President of R&D, Norbert Bischofberger; and Andrew Cheng , our Senior Vice President of HIV Therapeutic and Development Operations. Dr. Sax, Norbert and Andrew will be available to take your questions following the presentation.
As a reminder, the purpose of this call today is to cover the details of the Study 102 results and answer any questions you have on the data from either Study 102 or 103. Because the Quad is still an investigational agent not yet approved by FDA, we're not in the position to comment on this call how the data may translate into prescribing information or uptake in the market.
We will also be making forward-looking statements regarding the Quad. These statements are subject to risks and uncertainties that may cause actual results to differ from those expressed in any forward-looking statements. These risks include the possibility that the FDA, the European Medicines Agency and other regulatory agencies may not approve the Quad and risks related to the anticipated timelines or any regulatory review and approval.
In addition, even if approved, physicians may not see the advantages of the Quad over other therapies. Description of these and other risks can be found on our latest SEC disclosure documents and recent press releases. In addition, please note that we undertake no duty to update or revise them.
I will now turn the call over to Norbert for opening comments.
Norbert W. Bischofberger
Thank you, Susan. As Susan mentioned, we're very pleased to have Dr. Paul Sax joining us today to present the 48-week results of Study 102. By way of introduction, Dr. Sax is the Director of the HIV Program and Division of Infectious Diseases at Brigham and Women's Hospital in Boston. He is an Associate Professor at Harvard Medical School and has been on the faculty for more than 14 years. Dr. Sax received his M.D. from Harvard Medical School in 1987. He fulfilled his residency in Internal Medicine at Brigham and Women's Hospital by continuing his postdoctoral education with fellowships at Harvard and the Infectious Disease Unit of the Mass [Massachusetts] General Hospital. Dr. Sax is board certified in internal medicine and infectious disease. Apart from his clinical and teaching work, Dr. Sax is also involved in many professional societies, such as the Mass Medical Society; the Infectious Disease Society of America; and the Massachusetts Infectious Disease Society. He serves on editorial boards of AIDS Clinical Care; Infectious Disease Special Edition; UpToDate; and Medscape. He is on the core faculty of the International AIDS Society-USA and the New England AIDS Education and Training Center.
Gilead has worked with Paul for more than 10 years and he is an investigator in many of our clinical studies.
I will now turn over the call to Paul to present the study results. Paul?
Paul Sax
Thank you very much, Norbert. So I'm going to go through the slide presentation that I just presented at the Retrovirus Conference. Slide #2 provides a bit of background. We know that the standard of care treatment right now, HIV therapy is the co-formulated non-inferior FTC efavirenz tablet, one pill a day, also called ATRIPLA. And also there's an investigational single-tablet regimen that includes the integrase inhibitor elvitegravir, the PK booster cobicistat and the nucleoside analog tenofovir and FTC. This is the so-called Quad. Phase II data, published last year demonstrated that these 2 approaches were comparable, which led to the Phase III data that I'll be presenting now.
Next slide shows the study design. It's a randomized double-blind placebo-controlled trial. Treatment-naïve HIV infected patients with any CD4 cell count and HIV RNA greater than 5,000 were enrolled and then randomized to receive either the Quad once daily or the efavirenz-based regimen [Audio Gap] daily. They also received matching placebos. It was protocol-specified stratification by HIV RNA. The randomization was one-to-one and the study was conducted at sites in the United States and Puerto Rico.
The primary endpoint, with the portion of patients to the HIV RNA less than 50 copies at week 48 using an FDA snapshot analysis and the intention to treat approach of analysis. There is a 12% non-inferiority margin for meeting their non-inferiority thresholds. And as Norbert mentioned, there's also a Study 103, which was done in parallel. This is the Quad comparing to a boosted atazanavir or boosted ritonavir regimen.
On the next slide, we see the baseline characteristics. 348 patients received Quad, 352 patients received ATRIPLA. The study population was well balanced overall. They're predominantly male. There was a significant proportion who are nonwhite. Approximately 1/3 had HIV RNA greater than 100,000 and the mean CD4 cell count was in the high 300s.
The next slide shows the study disposition through week 48. 917 patients were screened for the -- 700 were involved. The most common reason for screen failure was HIV RNA less than 5,000. In the Quad arm, 11% discontinued before week 48; in the ATRIPLA arm, 13%. And the reasons for discontinuation are roughly similar between the 2 study arms.
We'll now move on to the next slide to the primary results. At week 48, 88% of the Quad-treated subjects and 84% of the ATRIPLA-treated subjects had an HIV RNA below the limits of detection. On the right side of this slide, this one bit difference of 3.6% is plotted. You'll note that the lower bound of the 95% confidence interval is a minus 1.6. This is well within the minus 12 range of meeting non-inferiority threshold. So clearly, Quad was not inferior to ATRIPLA at week 48. Approximately equal numbers of patients had virologic failure, 7% in each treatment arm, and equal numbers had no week 48 data. Most of these were lost to follow-up.
We're going to look at the next slide, on the efficacy results based on protocol-specified baseline characteristics. This figure, the top line, is the overall results. Results that are to the right favor the Quad, results that are subluxed favor the ATRIPLA arm. The top line, as I said, is the overall and this is similar to the same data that I showed you in the previous slide. And then along the vertical axis, we have age, less than or greater than 40, sex, race, baseline HIV RNA from the H diff of 100,000 strata, baseline CD4 cell count and study drug adherence.
As you can see, the point estimates for each of these baseline characteristics tend to favor the Quad. Above 95% confidence intervals on these estimates tend to cross 0.
Looking at the next slide now, we see stratification based on HIV RNA less than or greater than 100,000 and CD4 cell count less than or greater than 350 cells. The focus on the middle 2 comparisons, the greater than 100,000 and the less than 350 cells, these are the harder-to-treat patients, and you'll see that the greater than 100,000 group, 84% of the Quad arm and 82% of the efavirenz arm showing virologic success. With the less than 350, again, very similar proportions, 83% and 84%. This is an area of vulnerability for some regimens as there's high viral load, but it clearly was not the case with Quad.
On the next slide, we have the immunologic response. At week 48, the Quad-treated subjects had gained 239 cells and the ATRIPLA-treated subjects had gained 206 cells. This is a statistically significant difference at P equals 0.009.
Then the next slide, looks at the resistance analysis. Patients who had a suboptimal virologic response, either never suppressing their viral load or rebounding and had an HIV RNA greater than 400 copies were eligible to undergo resistance analysis. Virologic failure of this magnitude was rare in both study arms, 4% in the Quad and 5% in the ATRIPLA arm. Among these patients who had virologic failure to this degree, half of them had evidence of resistance, 2% from Quad and 2% in ATRIPLA. Among the Quad-treated subjects, all 8 developed nucleoside resistance mutations, and 7 of the 8 developed resistance to the integrase inhibitor, most commonly the E92Q. Among the ATRIPLA arm, all 8 developed resistance to the NNRTIs, most commonly K103N, and 2 developed resistance to the nucleoside analogs.
This proportion of patients with resistance to the integrase inhibitor and the nucleoside analogs is similar to what was observed in the Phase III study comparing raltegravir or Isentress to ATRIPLA.
In the next slide, we look at common adverse events. Common in this table is defined as adverse events experienced by 10% or more of study subjects. Those that had an asterisk or other mark are statistically significant between study arms. Nausea occurred in 21% of the Quad-treated subjects and 14% in the ATRIPLA-treated subjects. This nausea was grade 1 nausea, meaning the mildest type, and led to study drug discontinuation in only one patient. Abnormal dreams, insomnia, dizziness and rash, all side effects known to be associated with efavirenz, a component of ATRIPLA, occurred more frequently in the ATRIPLA-treated subjects than in the Quad-treated subjects.
On the next slide, we have the study discontinuation due to adverse events. 4% of Quad and 5% of ATRIPLA-study subjects discontinued therapy. 1.4% of patients discontinued ATRIPLA due to rash or drug hypersensitivity. 1.4% of patients discontinued Quad due to renal abnormalities.
As you know, cobicistat is part of Quad and cobicistat has a small effect on serum creatinine through inhibition of creatinine tubular secretion. Among these patients who discontinued due to renal abnormalities, one had this minor elevation of serum creatinine and the study investigator elected to discontinue the patient. The other patients in this group developed what was characteristic tubular toxicity from tenofovir. On cessation of the study drug, the abnormalities reverted back to baseline.
In the next slide, we have grade 3 and 4 laboratory abnormalities. These are the more severe laboratory abnormalities. And as noted here, these occurred for more than 5 subjects in any treatment arm. Rates of these severe laboratory abnormalities were infrequent in both the Quad and the ATRIPLA arm.
This next slide shows the median change from baseline in serum creatinine and further delineates the cobicistat effect. The Quad-treated subjects at week 48 had a 0.14 milligram per deciliter increase in serum creatinine. The bulk of this increase occurred within the first 2 to 4 weeks of treatment and then stabilized. The Quad -- the ATRIPLA-treated subject had a 0.01 milligram per deciliter increase. The lines around these lines, vertical lines, are the interquartile ranges.
And then last, on the next slide, the median change from baseline in fasting lipids through week 48. The total cholesterol, LDL cholesterol and HDL cholesterol, all increased significantly more in the efavirenz or ATRIPLA-treated subjects than in the Quad-treated subjects. The total to HDL cholesterol ratio was not different and the triglyceride changes were not different as well.
So in the next slide, I summarize by noting that the Quad demonstrates in this study non-inferiority to ATRIPLA, and this is the first fully powered study comparing one tablet daily HIV regimens.
Virologic suppression rates were 88% versus 84% for Quad and ATRIPLA, respectively. Importantly, the non-inferiority in the virologic suppression was consistent across protocol-specified subgroups including HIV RNA greater than 100,000 copies. Quad was overall well tolerated with a similar rebound rate. Treatment discontinuations to ATRIPLA, fewer reports of abnormal dreams, insomnia, dizziness and rash, a higher rate of grade 1, but not higher grades than that nausea, and a median 0.14 milligram per deciliter increase in serum creatinine. There are 1.4% of patients discontinued Quad due to renal events and smaller increases with Quad in total cholesterol and LDL.
On the next slide, I mention briefly about Study 103. At this conference, Quad is also demonstrated to be non-inferior to atazanavir or ritonavir in the Phase III Study 103. Quad responses were 90% versus atazanavir response -- ritonavir response into the 87%. And in this study, 0.3% of subjects in both arms discontinued due to renal events.
The full results of these 2 studies, both Study 102 and Study 103, have been submitted for peer review publication. And health authority filings for the Quad have been submitted in Europe, Australia, Canada, Switzerland and in the United States.
So that brings me to the end of the presentation.
Susan Hubbard
At this point operator, we'll open up the call to the question-and-answer session.
Paul Sax
Thanks, Susan.
Question-and-Answer Session
[Operator Instructions] Your first question comes from the line of Geoff Meacham with JPMorgan.
Michael E. Ulz - JP Morgan Chase & Co, Research Division
It's actually Mike in for Geoff. Just curious if Dr. Sax could maybe comment on the nausea for the Quad. I know he's mentioned it was mostly grade 1, but what was kind of the distribution? Is it something that generally occurs?
Paul Sax
So mostly grade 1. In fact, the only area where there was a difference between the 2 study arms was grade 1. There was no difference between 2 study arms in higher grades of nausea, and only one patient discontinued due to the side effect.
Michael E. Ulz - JP Morgan Chase & Co, Research Division
And was that mostly seen when you started dosing, or is that something that was sort of persistent over time?
Paul Sax
It was seen when dosing was started and did not necessarily persist over time.
Your next question comes from the line of Mark Schoenebaum with ISI.
Mark J. Schoenebaum - ISI Group Inc., Research Division
Dr. Sax, given how apparently clean the data set looks, as you know, the FDA is -- plans to convene a panel. I was just wondering, from your perspective, what do you think might be discussed in a panel like that? I realize you can't speak for the FDA, but just when you look at the data, what kind of issues or questions do you think merit vetting by a panel of your peers?
Paul Sax
I really can't speak on behalf of the FDA. I have to say that's an excellent question, but I have not been involved in any FDA reviews. So I'll maybe ask some of my colleagues here.
Norbert W. Bischofberger
Yes, Mark, as you may know, we contacted the FDA when we heard about their plans for a panel meeting. And we asked them this question and they said there were no concerns about safety or efficacy. It had to do with the policy that these are 2 new drugs that are approved at the same time, and they felt it would be warranted to have a panel meeting. That's what we heard from the clinical reviewer at the FDA.
Your next question comes from the line of Matt Roden with UBS.
Matthew Roden - UBS Investment Bank, Research Division
Dr. Sax, I wonder if you could put on your clinical hat and speak for your colleagues, and what I wanted to ask is how do you think the clinical community, the HIV clinical community, will interpret the efficacy and safety data across both studies here? Do you think that they'll simply look at the non-inferiority and the comparable data and think that this is pretty much the same? Or do you think that people will say that there's several favorable trends here, both on efficacy and safety, and maybe this adds up to an overall better profile? How do you think that this will be received?
Paul Sax
Yes, I mean, based on the data, and again I'm speaking now as sort of HIV treater as much as an HIV researcher, this is clearly as effective virologically as the standard of care treatment. So no concerns there. It has certain favorable properties. We've known for a while that ATRIPLA or efavirenz in ATRIPLA has central nervous system side effects and the rates were significantly lower. We know that, that drug can cause rash and the rates are significantly lower. So I would say that in most patients, this would be a very favorable option. Each person's individual and each treating physician with each of the individual patient will make those decisions. But these results are very, very, very favorable overall.
Matthew Roden - UBS Investment Bank, Research Division
Does any one characteristic stick out to you as being differentiated?
Paul Sax
Probably on the favorable side is the fact that it doesn't have as much central nervous system side effects or rash. And then for fair balance, any drug that has booster in it, either ritonavir or cobicistat, will have more drug interaction, that's inevitable.
Your next question comes from the line of Yaron Werber with Citi.
Yaron Werber - Citigroup Inc, Research Division
So Dr. Sax, just give us maybe a little bit of a sense as to -- there's been a lot of concern back in the Phase II data about the potential for creatinine -- serum creatinine elevation, and now we know it really is related to inhibition of clearance. And it's visibly significant over the ATRIPLA arm, but if you look at the mean change from baseline at week 48, it's very little. So do you have any sense of -- and it looks like it's not cumulative, it looks like it plateaued. Do you think you're going to need to monitor the patients? And how much of a challenge is this going to be, if at all?
Paul Sax
Yes, one thing that is probably well known to you guys and certainly is to HIV treaters, is that it's standard of care for any patients on a tenofovir-based regimen, or any regimen for that matter, to have their blood test monitored on at least a twice-yearly basis and that includes measurements of renal function. So if one were to do that, and that's just standard of care, and one were to have a very small increase in serum creatine that you knew was a predictable result of a drug you were given, I wouldn't be concerned at this. And these data are actually reassuring. There is the small chance of tenofovir-related toxicity. And we know from both this study and from many, many other studies since the drug was first investigated and then approved in 2001, that there are certain patients who are greater risk for tenofovir toxicity, and those are the people who have baseline renal insufficiency or on other nephrotoxic drugs. So I would say that in the totality that these are reassuring data, and monitoring is still recommended.
Your next question comes from the line of Sapna Srivastava with Goldman Sachs.
Sapna Srivastava - Goldman Sachs Group Inc., Research Division
I was curious as to how would you use Quad once it's commercially available, both in front-line regimen and potentially which regimen do you think you could switch the patients away from, and at what time point do you put them on the Quad pill?
Susan Hubbard
Sapna, this is Susan. As we sort of said upfront, this is still an investigational drug and we don't have approval yet. We really don't want to speculate on where the first uptake's going to be once it's approved. So if you like to ask a question specifically around the data set, that would be great.
Sapna Srivastava - Goldman Sachs Group Inc., Research Division
I mean, I guess, just my view of the data set is like how would you compare this to the other data sets that we have seen for other regimens which include either integrase inhibitors or protease inhibitors and how should we think about them compared to those data sets?
Paul Sax
That part is -- we now have had the first line raltegravir data available for us for some time in the Stark Merck Study. And on the one hand, that drug, it was a major advance in HIV therapeutics when it was approved in 2007. It has many advantages. The disadvantage of Isentress -- of raltegravir, is that it has to be given twice daily and there's no co-formulation available right now. So for me to compare the 2, I would say they have -- appear to have very comparable and excellent efficacy, both drugs. But this treatment would be more convenient certainly.
Sapna Srivastava - Goldman Sachs Group Inc., Research Division
And just your thoughts on the protease inhibitors?
Paul Sax
So protease inhibitors tend -- well, we know from the Study 103, if you could just look at the Study 103 results, you see that, that Quad performed just as well as the boosted atazanavir, which is another preferred initial regimen. One thing that was seen in that study and in this study, which is a pleasant surprise, is that even though this drug does contain cobicistat as a booster, lipid changes were actually better than ATRIPLA in this study and just as good and a little bit better than the boosted atazanavir, so that's good news. With protease inhibitors, one of the major benefits of those regimens for initial therapy is that when treatment failure occurs, resistance does not seem to be a problem, and that's distinct to the protease inhibitor class and is not seen with any other treatment approaches, including ATRIPLA, including Quad, including Isentress, including Rilpivirin, none of those. So that will remain an advantage of protease inhibitors. But as you saw from the data, actual treatment failure and resistance is still pretty rare.
Your next question comes from the line of Brian Abrahams with Wells Fargo Securities.
Brian Abrahams - Wells Fargo Securities, LLC, Research Division
A question for Dr. Sax on the barrier to resistance. You mentioned the greater NRTI mutation seen on the Quad arms, both in your study and in Study 103. Just wondering how important is this with respect to thinking about potential next line options for those few patients who do fail treatment. Would this give you pause at all in using an integrase-based regimen on the frontline?
Paul Sax
This is one of the issues where protease inhibitor, as I just mentioned in the previous question, continue to have an advantage. And again, speaking about other drug developments that the drug development potentially, which has been publicly announced of a single pill darunavir, ritonavir, cobicistat and 7340 is an exciting one for that reason. There's still a role for a protease inhibitor-based therapy, but the reality is that most people in clinical care do take their medicines quite faithfully and have an extremely low risk of developing virologic failure and resistance, so they're the exception rather than the rule.
Norbert W. Bischofberger
Brian , can I just add something? You said it was also observed in Study 103, that's not the case. We did not do any virologic -- we had virologic failures, but there was no resistance in Study 103. Andrew, was that correct?
Andrew Cheng
On the atazanavir arm, there's no resistance, but we didn't -- there were people who developed integrase resistance.
Brian Abrahams - Wells Fargo Securities, LLC, Research Division
I was referring to the NRTI resistance specifically.
Andrew Cheng
I actually agree that the NRTI resistance as a consequence of treatment failure in integrase regimens have been consistently observed now both in these 2 studies as well as in the raltegravir studies.
Your next question comes from the line of Robyn Karnauskas with Deutsche Bank.
Robyn Karnauskas - Deutsche Bank AG, Research Division
I was wondering if you could comment on RNA curves over time and whether or not they appear to come together or separate over time because that wasn't in the presentation.
Paul Sax
So we do have information on trends of virologic suppression, and as this is an integrase-based regimen, virologic suppression was faster with the Quad than it was with the ATRIPLA arm, and I believe it was faster through week 12 or 24. It's clearly the first phase of the study it was faster, and then the curves came together over time and became virtually superimposed by week 48. And this is an observation that's been seen now in multiple integrase studies.
Robyn Karnauskas - Deutsche Bank AG, Research Division
And can you just also clarify the creatinine clearance? I mean, can you just characterize that a little bit more in a relative basis to other drugs?
Paul Sax
Yes. So we now have learned about several other drugs that have this property that impair creatinine -- tubular creatinine secretion, including, interestingly, other investigational antiretroviral agents such as the integrase inhibitor, the raltegravir, and then the recently approved NNRTI, Rilpivirin. Looks like most patients did about 0.1 milligram per deciliter, between 0.1 and 0.2. This is a relatively small amount, and I have to say in clinical practice, one would probably not notice it very much. Suffice to say that if someone is treating a patient with baseline renal abnormalities, especially if they're on a tenofovir-based regimen, one has to be more vigilant in monitoring.
Susan Hubbard
Operator, due to time, we do need to let Dr. Sax get back to the conference. We probably have time for one more question and then we'll need to conclude.
Your next question comes from the line of Ian Somaiya with Piper Jaffray.
M. Ian Somaiya - Piper Jaffray Companies, Research Division
So a question for Norbert on the chart related to efficacy by baseline HIV RNA and CD4 subgroup. Did your statistical plan allow you to measure for superiority because, obviously, there's a difference, a more meaningful difference in patients with lower viral load and a higher CD4 cell count at baseline?
Andrew Cheng
Let me see if I can understand the question. This is the farthest plot that shows the results by baseline, viral load, or is this the -- do you want to discuss the bar graphs?
M. Ian Somaiya - Piper Jaffray Companies, Research Division
The bar graph.
Andrew Cheng
Okay. So the bar graph, the less than 100,000, 90% response in Quad and 85% response in ATRIPLA. If you go to the previous slide, you can see how it does actually meet -- no, it almost does. It's still the 95% confidence interval for that difference crosses 0, so it's not statistically significant.
M. Ian Somaiya - Piper Jaffray Companies, Research Division
Okay. And just related to the creatinine elevations, I don't know if there are plans to -- what potential strategies could you use to probably potentially mitigate that? I don't know if there are potential changes to the cobicistat formulation, dosing of cobicistat, or some other factors that we could consider that might remove that side effect?
Norbert W. Bischofberger
No, Ian, there's nothing really we can do. We need cobicistat on board to inhibit the degradation of elvitegravir in the liver, particularly. And cobicistat has the side effect that it competes with creatinine secretion, so this is something that is not -- it's difficult to envision how you would remedy this. This is something we just have to deal with. But it's, as Paul pointed out, it's not a primary clinical concern and can be dealt with fairly in a straightforward way.
Susan Hubbard
Okay. Well, thank you certainly, Dr. Sax, for joining us today. We really appreciate that time to run through the data for us. And thank you, all, I'm sorry that the call's a bit brief, but we'd be happy to take your follow-on calls after we conclude.
We thank you for your participation in today's conference. This does conclude your presentation. You may now disconnect, and have a great day.
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8 outrageous things we learnt at the inquiry into coal mine rehabilitation
While the word 'inquiry' might conjure up images of people sitting in a stuffy room speaking legalese, the revelations of the inquiry into coal mine rehabilitation have been anything but boring. In my role as Safe Climate Campaign Manager, I have been representing Environment Victoria at the judicial inquiry into mine rehabilitation in the Latrobe Valley – part of the re-opened Hazelwood Mine Fire Inquiry. As a result we have learnt some shocking details about the current plans for rehabilitation of brown coal mines in the Latrobe Valley.
|Above: The Yallourn coal mine and power station
The Background:
- There are three brown coal mines in the Latrobe Valley, Hazelwood (owned by GDF Suez), Yallourn (owned by EnergyAustralia) and Loy Yang (owned by AGL). Together they produce over 60 million tonnes of coal per year for power stations adjacent to the mines.
- Mine rehabilitation basically means repairing the damage caused by mining: covering up the exposed coal and turning the huge coal mines into something other than a massive toxic hole so that it won't catch on fire (again) or collapse (again), and ideally so that it becomes something the community can enjoy.
- In early 2014 a fire at Hazelwood mine raged for 45 days and blanketed the surrounding area in toxic smoke after disused parts of mine caught fire. A subsequent inquiry found that rehabilitation of disused mines was essential to prevent future fires.
- As a pre-election commitment in November 2014, Daniel Andrews promised to re-open the Hazelwood Mine Fire Inquiry firstly to consider emerging evidence that the smoke from the fire caused deaths in the Latrobe Valley (the report released last week showed that the fire 'likely' contributed to an increase in deaths) and secondly to determine how to improve coal mine rehabilitation. The re-opened inquiry also expanded the scope to include the other two mines in the Latrobe Valley.
- Up until now, the assumed solution for rehabilitation has been that the holes will just fill with water.
What we learnt…
1. The amount of water needed to fill the three Victorian coal mines is almost as much as all the environmental water to be recovered under the $13 billion Murray-Darling Basin Plan (about 2200 gigalitres).
Were Gippsland's water resources plentiful this might be less of a problem. But water is a valuable resource, and it appears nobody has clear answers to the inevitable questions. Is there enough water? Where will it come from? How long will it take to fill the pits? What will the water quality be like? Will rivers need to be diverted into the mines? What happens to the places that lose water as the mines fill? Astonishingly, it seems that neither the mine owners nor the regulator (who approves the rehabilitation plans) has had any substantive contact with the water authorities, and the water authorities are not even involved in the process of approving rehabilitation plans that will need enormous volumes of water.
2. It will require more water than is in all of Sydney Harbour to fill Yallourn mine alone.
|That's A LOT of water... Credit: Deborah & Kevin
3. Southern Rural Water said that Loy Yang mine could take more than 85 years to fill.
For Hazelwood, it could take literally hundreds of years.
4. A letter from one of the government's main mine advisors said aspects of the rehabilitation plan for the Loy Yang coal mine were ''too silly to waste time explaining why".
Rehabilitation plan for Latrobe Valley coal mine 'too silly to explain', Hazelwood inquiry told https://t.co/SEzpMs434Q
— ABC News Melbourne (@abcnewsMelb) December 8, 2015
5. The bonds for mine rehabilitation are so low that, as one community witness said, it "almost invites miners to walk away."
Coal mines estimates of rehab costs:
Hazelwood: $73m
Loy Yang: $54
Yallourn: $46-91m
That's THEIR estimates. Still way above $15m bonds.
— Nicholas Aberle (@NickAberle) December 13, 2015
Bonds held by the government to ensure the mines are cleaned up after use are around $15 million per mine. Compare this with one independent expert's assessment that rehabilitation at the Hazelwood mine alone could run to $332 million. Even at more conservative estimates, the taxpayers of Victoria are chronically exposed to an enormous financial burden (and an environmental hazard) should a mine operator default on its obligations.
6. The government regulator says there's a 50/50 chance of a Victorian coal mine becoming insolvent and leaving costly rehabilitation work to be done at the expense of Victorian taxpayers.
#Hazelwood mine inquiry: Taxpayers may have to foot clean-up bill for Latrobe Valley coal #mines https://t.co/PbvOwmlnqM
— ABC News Melbourne (@abcnewsMelb) December 17, 2015
7. At the stroke of a pen, an area the size of the nearby town of Traralgon was permanently fenced off from the public.
In a stroke-of-midnight pre-inquiry move, a new work plan for AGL's Loy Yang mine was approved in which all mention of providing for community recreation was gone. Instead the mine would remain in private hands even after rehabilitation was complete – the exact opposite of the positive asset the community wanted.
8. There are no clear objectives or criteria for mine rehabilitation.
The regulator was criticised at the inquiry for appearing to have only recently realised that they need to be setting clear objectives or criteria for rehabilitation. For too long, mine operators have had insufficient guidance on what is required.
With global action to protect our climate gaining momentum the question isn't if these mines will need rehabilitation, but when. Given this inevitability, and the massive risks to the Latrobe Valley community, to our environment and to the Victorian taxpayer, there is a staggering list of unanswered questions over how mine rehabilitation is going to be achieved.
Rehabilitation ought to transform the mines into some other kind of community asset, and a failure to address this challenge would come at an enormous cost to the community who remains long after the miners have gone.
The local historian witness at the inquiry, David Langmore, summed up the situation best: how to rehabilitate these coal mines is arguably one of the biggest environmental problems facing Victoria over coming decades.
With a growing number of mines in need of rehabilitation across the country, the Hazelwood Mine Fire Inquiry has an opportunity to take a big step for all states to follow. A step towards managing these problems from the outset; towards ensuring mining companies can't shirk their responsibilities; and towards giving communities a proper say over their future.
Want more? Click here to read our policy report on mine rehabilitation in the Latrobe Valley Preventing the Preventable [October 2014]
By Dr Nicholas Aberle
Safe Climate Campaign Manager


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I started this as a sports blog a few years ago to try and share some humor in life and in sports. I think I accomplished that. Then, on September 9, 2013 at 10:22 PM, the world changed forever. It could have been a lot worse, but it took a lot of fighting, courage, pain and a miracle to make it through. This blog/ website became the forum of a great story. I wrote a book about it. Check it out, The Never Say Never Kid.
I still love me some sports and am starting to resume my old self with my annual mantra of loving and hating the Cowboys. I write about my life and am raw and edgy, and I am in the process of redefining myself at this point. I promise to keep it real, and if you do not like what you read, please don't read it!
Please check out my books. I have one that is very virtuous and one that is not. Please buy several copies of both of them! And if you need a really great Realtor, call me up! I am loving it, and I am good at it.


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This variety will grow well in most regions of the United States.
Pepper species are native to the Americas and have been cultivated for thousands of years. The Spanish and Portuguese brought them back to Europe and to their colonies in Africa and Asia. From there peppers continued to spread and develop.
The chemical in hot peppers that causes a burning sensation is known as capsaicin and can be found in the highest concentration in the white pith around the seeds.
This variety works for
This pepper is: MILD & SWEET
This is one of the best pepper varieties out there for drying and then grinding for fresh paprika.
Paprika (dry spice) is used to add flavor to chicken dishes, pork, fish, hummus, roasted potatoes, and much more.
The peppery flavor of this fruit is also good for fresh eating. Serve them as appetizers stuffed with cheese and herbs or place them on skewers and grill to enhance the flavor.
You should start plants indoors 8-12 weeks before the last frost date for transplanting them into the garden. Plant them outdoors 2-4 weeks after your last expected frost.
Plant your seeds 1/4-1/2 in. deep in soil trays or pots. Transfer them to 3-4 in. pots when their true leaves appear. When transplanting, bury seedlings up the stems up to their leaves.
Make sure that your soil is well fertilized as this crop is a heavy feeder and takes a lot of nutrients from the soil. Consider adding compost to the soil the year before you plant.
These plants prefer warm weather and soil so they should be grown when temperatures are over 68 degrees F.
Peppers need warm soil to germinate, so you'll have the best luck seeding them in soil trays or pots that have a heating mat under them. Start your seeds indoors about 8 weeks before your last frost and sow them 1/4 inch deep. It will take around 14 days for the seeds to germinate. The soil in your garden should have warmed enough to plant peppers outside a few weeks after your last frost. Place your plants 12-24 inches apart and full sun. The fruit will be mature 80-90 days after transplanting.
There are about 5k seeds in an ounce of Feher Ozon Paprika peppers.
Our customer service will happily help you with whatever you need!
Send a note or call 563.382.5990


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Winning this year's Australian Open conceivably paves the way for a great year for Roger Federer, allowing him to win his fifth Australian Open title in 12 years of hard-fought competition in Melbourne Park.
Except for 2010, Federer's most productive years came when he started the year by winning the Australian Open.
Federer has won six Wimbledon titles, five U.S. Open Championships, four Australian Open titles and one French Open Championship.
Currently, Federer holds 16 career grand slam singles titles, a record for male tennis players.
During each of the past eight years, Federer has won at least one grand slam title, winning his first in 2003 and his last in 2010. Both years, he won only one major.
In 2004, Federer won three slams. In 2006 and 2007 Federer again won three of the four majors.
The act of winning in Melbourne re-focused Federer on his dream to win a career calendar year grand slam, like Aussie Rod Laver in 1969.
As he nears 30, Federer once again seeks to capitalize on his newfound confidence and zeal for the game by winning again in Australia.
The Swiss wishes to advance his current World No. 2 ranking.
Federer hopes to enhance his position during the remainder of 2011 when he has fewer ranking points to defend while Rafael Nadal, the current World No. 1, has many.


text:
Welcome to the Law Office of Paul Lynch
Since 1996 the Law Office of Paul Lynch has provided individuals and business clients with top quality legal representation. In doing so the firm has remained committed to achieving the highest level of client satisfaction through (1) Communication (2) Responsiveness combined with the highest quality advocacy and (3) Fair and Reasonable Billing.
IIn addition to twenty years as a sole practitioner Mr. Lynch has ten years experience practicing law in Massachusetts, California and Alaska. He has significant experience in a wide variety of civil matters handling cases in a many forums including mediation, arbitration, state and federal courts. If you or your business owes or is owed money or you are faced with a disputed claim, he will work with you to find a cost effective, sensible approach. Mr. Lynch guarantees that you will make informed decisions – you will know the expected costs, the risks, his best estimate as to the likelihood of success and you will both agree on a definite and well thought out plan of attack.
Practice Areas
- Auto Finance and Consumer Credit, Representing both direct and indirect lenders in state and federal regulatory requirements including Truth in Lending, Debt Collection, Consumer Credit, Motor Vehicle Installment Sales Contract issues and state licensing.
- Contract and Business Litigation commercial disputes, defending and suing on promissory notes and personal guarantees; real estate disputes including landlord-tenant issues.
- Collection and Creditor Rights involving pre judgment remedies such as attachment and trustee process of bank accounts, secured transactions and post judgment remedies.
You need an experienced, responsive, and trustworthy attorney who provides aggressive and intelligent representation. By keeping you involved and informed, you will receive the highest quality representation with the greatest likelihood of success.
Paul F. Lynch
The Law Office of Paul Lynch
185 Devonshire Street, Suite 301
Boston, MA 02110
(617) 426-1120
(617) 348-2147Â (Fax)


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Parents keep school bus saga going
"School bus transportation is still a hot topic in Oak Harbor, with a handful of community members turning out for Monday night's school board meeting to ask that certain routes not be cut.However, the routes as developed by Oak Harbor School District's transportation department for the 2001-2002 school year will remain in effect, said Kathy Jones, school board president. However, Jones called for the formation of an ad hoc transportation committee, to be made up of parents, district staff, community members and a school board member, to review the system prior to next year.The route cuts became a topic when when the district made the decision to discontinue bus service to to a select group of children living within a one-mile radius of their school, as the crow flies. These schoolchildren, living in the neighborhoods near Hillcrest Elementary School, had been receiving bus transportation to and from school, although hundreds of other children living in other parts of Oak Harbor, also within the one-mile radius, had never received bus transportation.The district's transportation director, Vonnie Edwards, determined that those routes should be cut to save money and provide all children with equal treatment. That decision prompted a flood of phone calls to Edwards' office from concerned, and sometimes angry, parents.I'm disappointed there were not more people at the (school board) meeting, Edwards said on Tuesday. Edwards had expected a big turnout of people wanting to address their concerns with the board, since she had received numerous complaint calls to her office, often including shouting and yelling. Instead, only three people addressed the school board at its regular meeting Monday night.That's where they needed to air their concerns, Edwards said.Now that the bus routes are firmed up for the year, Edwards' staff plugged them into a computer software program and generated route maps. Those maps will be laminated and posted outside of every school, with another copy in the school offices. Elementary schools will have the elementary bus maps, and the middle schools and high school will have the middle school/high school bus map, Edward said. The maps will be posted at all schools for public viewing beginning Friday, Aug. 31and they will show bus stop locations and times. You can reach News-Times reporter Christine Smith at email@example.com or call 675-6611 "
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Laboratory workstations from a different perspective.
This picture has been displayed at the Berlin's Museum of Technology from May to August 2015 for the exhibition called "Beyond the Blinds".
Issued from the series on the Robert-Koch-Forum.
Located in the Dorotheenstraße in Berlin, the Robert-Koch-Forum was built during the 19th century for the Humboldt University (still the Friedrich-Wilhelms University at the time). Created as part of a complex of four buildings, it was dedicated to the four main research areas of medicine: physiology, pharmacology, physics and chemistry.
Hahnemühle Photo Rag 308


text:
Scott B. Reline, 58, of Sunset Heights Bridgeport, died Thursday, July 31 2014 at his home.
He was born December 23, 1955 in Wheeling, WV, a son of the late William and Jackie (Jones) Reline.
He was the former owner of the Huston Handrail Co.
Scott is survived by brothers; William (Marla) Reline of Nashville, TN, and Bruce (Pat) Reline of Chesapeake, Va, and a sister Becky Karikas of Hilliard, OH, also several nieces and nephews.
Friends will be received at the Wilson Funeral Home, 920 National Road, Brookside on Monday August 4, 2014 from noon till time of service at 2 p.m. with Rev. Homer Harden officiating.
Interment in Union Cemetery St. Clairsville.
To leave a condolence please visit www. wilson funeralhomes.com.


text:
Call us at 1-877-683-1815
Margill - Loans, Lines of credit, APR
See also:
The dollar ($) has been used in these examples, but any other currency (€, £, F, ¥, R, DA, Rs... etc.) may be used.
Most of the calculations below may use Fixed (unique interest rates) or Variable rates.
Real-life examples:
Simple loan between two dates (simple interest)
Simple loan between two dates (compound interest)
Irregular loan : refund interest only, then of a fixed principal amount and a regular refund. Let's include missed and late payments and even a NSF check!
Loan that includes successive disbursements and reimbursements
Loan that includes unknown future interest rates with payments adjusted as these rates become known
Add-on interest loan (often used for car loans)
Calculation of the unknown interest rate applicable to a loan with irregular refunds (determination of the contractual rate)
APR (Annual Percentage Rate) calculation
Simple loan between two dates (simple interest)
Input screen:
Results screen:
Simple loan between two dates (compound interest)
Same features as simple interest but you can use compound interest with the following compounding periods : annually, semiannually, quarterly, monthly, every 4 weeks, twice monthly, biweekly (every 2 weeks), weekly, daily.
Loan with regular payments (refunds)
This example uses the 30/360 day count convention but other day count conventions may be used Actual/Actual (most precise), Actual/360 and Actual/365(Fixed).
Enter 3 of 4 variables (Interest, Principal, Number of payments or Payment) and the 4th will be calculated automatically.
Once a preliminary schedule is created, this may be totally changed to enter lump sum payments, extra payments, changing payments, new principal, etc. See the example in the next section.
APR can also be determined...
Irregular (complex) loan
This example uses the most precise calculation method (Actual/Actual or Actual/365) but other day count conventions may be used : 30/360, Actual/360 and Actual/365(Fixed).
The calculation will include the following : Refund interest only, then of a fixed principal amount and a regular refund. We'll then include missed and late payments and even a non sufficient funds (NSF) check!
Input screen:
We first reimburse the interest only and produce our payment schedule.
Here is the initial payment schedule:
We want to refund Interest only for 6 months and then refund a Fixed principal amount of $1000 per month for 6 months. We simply select those lines (payments) we wish to change. Margill recalculates afterwards.
For the two last years we refund normally (principal and interest) to provide a balance = 0.00. Margill calculates the payment automatically. In this example (see below), with a payment of $1990.00 for the 2 remaining years we finally reach a balance = 0.
Unfortunately, our debtor does not follow the payment schedule and make a few irregular payments:
The balance is recalculated automatically. The final yearly payments could also have been recalculated to give a $0.00 balance.
The payment schedule may then be saved and updated as time goes on.
Loan that includes successive disbursements and reimbursements
Example coming soon.
Loan that includes unknown future interest rates with payments adjusted as these rates become known
4-year loan based on Bank XYZ's prime lending rate + 3%. In June 2005, the rate is known for the next 6 months and is at 4.25% + 3% (for the sakes of this example, the compounding is daily). The next rate will only be known in 6 months.
A preliminary schedule is first created with the known interest rate of 7.25% and as the new rates are known, the payment table will be updated.
On December 15, 2005, the new rate to apply is 8.75%. The following window allow to insert the new rate and, if required to recalculate the equal amount payments to give a balance = 0.00 (or other amount. Margill will recalculate the payments.
The new payments are thus increased since the interest rate increases. The table may se saved and updated as new rates are known.
Add-on interest loan
Add-on interest is a peculiar calculation which Margill can do easily and compute its true interest rate (APR).
For example, a car seller advertises a rate of $12.50 per hundred per year on a $20,000 loan to be repaid in monthly payments over 4 years.
How much interest is payable? What is the interest rate (or APR) on this loan?
This will give us a total add-on of $10,000 in interest: 20,000/100 X 12.50 X 4. This $10,000 is added in the APR screen within the Recurring Payments (Amortization) calculation.
The total loan is thus $30,000 to be repaid in 48 equal payments at "0.00%" interest. The compounding period is not important since for the reimbursement, the interest rate is 0.00%.
The payment will be calculated by Margill ($625 per month) and the effective rate determined to be 21.5273% (thus the APR).
Line of credit
A line of credit can easily be calculated with Margill.
The schedule may then be saved and updated as time goes on.
Compound interest is charged in between each of the payments/refunds. The interest is automatically calculated every day (as provided by the normal actuarial method) even if the compounding period is not daily.
Calculation of the unknown interest rate applicable to a loan with irregular refunds (determination of the contractual rate)
A loan is made with regular or irregular payments but with an unknown interest rate. Margill can easily determine the rate applicable to this loan.
In the Fixed Rate Calculations, Recurring Payments date entry screen, simply leave the rate at 0.00%. The prompt will appear
The rate will then be calculated and the Results screen will appear:
Our nominal interest rate is 14.9915% compounded monthly. We can use the Rate converter to obtain the effective interest rate:
Now for a more complex example where the payments are irregular. We will use our previous example, customize the schedule with irregular payments and calculate the new interest that yield a balance = $0,00 or any other amount.
In this example, we increased or reduced payments, added new payments and even added a new loan (the minus $4000). All these changes are all highlighted here in gray... The new nominal interest rate is thus 33.2782% compounded monthly to reach a balance = $0.00. The balance could have been another amount...
Simply highlight all the lines (rates) to be recalculated or some of the lines (only the interest rates in these lines will be recalculated) and right click:
APR (Annual Percentage Rate) calculation
Margill easily calculates APR for regular and irregular loans and mortgages at fixed or variable interest rates. This is done in the "Recurring payments (Amortization)" calculation.
As can be seen in the screen shot below, the fees may be financed or paid up front. Depending on each case, the APR will vary slightly.
Margill includes APR (nominal APR as used in certain laws such as the US Truth in Lending Act) and the Effective APR that factors in the compounding period as required notably in European countries.
Lending laws usually allow between 1/8% to 1/4% tolerance (maximum discrepancy) between quoted APR and the true APR (based on the various legislative formulae).
Complex APR calculation
The APR can also be calculated for more complex loans that involve irregular payments, variable interest rates, additional principal, etc. As can be seen in the example below, Margill is very powerful for APR calculations.
This loan (only part of the loan is seen below) includes irregular payment dates, irregular payment amounts, a missed payment (0.00), additional principal (-25,000), lump sums (5000 and 10,000) and an interest rate that changes on July 1 (date format is DD/MMD/YYYY in this example but could be any other format).
The final lines of the loan appear below. In order to calculate APR, the formula requires that the balance = 0.00 (this way all finance charges are known).
The APR report can then be printed or saved:


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