Makers of Androgel taken to court for attempting to block generics
CROI 2009 Conference Coverage
IL-2 fails to demonstrate clinical benefit in two, large trials
No cancer risk seen with Isentress
Indevus’ PRO 2000 becomes first microbicide to demonstrate efficacy
HIV linked to kidney function decline
Makers of Androgel taken to court for attempting to block generics
Solvay Pharmaceuticals, makers of the testosterone replacement gel known as Androgel, and generic drug producers Watson and Par are being taken to court by the U.S. Federal Trade Commission (FTC) for striking an agreement that would keep cheaper versions of the product off the market.
In 2003, Watson and Par separately sought regulatory approval to market generic versions of Androgel, which were developed in such a way that they did not infringe on Solvay’s patent of the product. The lawsuit, filed in the U.S. District Court for the Central District of California, alleges that Solvay paid off Watson and Par in company shares to keep these generic, less-expensive versions from impinging upon the annual $400 million in profits made from the sales of Androgel. The FTC considers this to be anticompetitive behavior.
“At a time of escalating health care costs, these unlawful agreements deny patients the benefit of competition between branded and generic pharmaceuticals and ultimately cost consumers hundreds of millions of dollars a year,” said acting FTC Bureau of Competition Director David Wales in regards to the lawsuit.
In defense of their business practices, Par Pharmaceuticals points out that the 2006 settlement agreement with Solvay was approved by the U.S. District Court for the Northern District of Georgia, which allegedly described the settlement as “a good faith final settlement agreement.” – Keith R. Green
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CROI 2009 Conference Coverage
IL-2 fails to demonstrate clinical benefit in two, large trials
Results from two large, randomized trials of IL-2 (interleukin-2) in which significant increases in CD4 T-cells were seen in those taking IL-2 injections in combination with antiretroviral therapy (ART) unfortunately did not translate into any clinical benefit, and showed no difference in rates of AIDS diagnoses or death for the IL-2 group versus those on ART alone.
Data from the two studies, ESPRIT and SILCAAT, were presented in Montreal last week at the 16th CROI (Conference on Retroviruses and Opportunistic Infections). Together, the two studies monitored around 6,000 individuals over a 7-year period. In one study, those taking IL-2 were found to be at greater risk for life-threatening adverse events (AEs), including DVT (deep vein thrombosis). While it is not yet clear exactly why the CD4 increases did not confer any benefit, some possible explanations offered were that the adverse events offset any benefit, or that the kind of T-cell being affected by IL-2 differs in function from the type of CD4 which is normally boosted when taking ART. The costly studies, while disappointing, may eventually, following further planned analyses, lead to deeper understanding of the immune system. – Jeff Berry
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No cancer risk seen with Isentress
David A. Cooper and colleagues presented reassuring news. In the past, studies with Isentress (generic name raltegravir) had shown an unclear relationship with the development of cancer. In a poster report, however, Cooper and colleagues reported no increase in cancer in people taking Isentress in five randomized clinical studies. (“Randomized” is a high standard for research. It basically means that people of equal medical status are put in one study group or another without bias.) The poster also showed no increase in cancer seen in expanded access use of the drug (medication given at no cost, before FDA approval, to people in great need of it). Isentress is an HIV integrase inhibitor. It’s a very popular drug known for its effectiveness and few, if any, side effects. In the poster, the researchers noted that, “Cancer is a known complication of HIV infection.” The follow-up in this review of clinical studies was 48 to 120 weeks. The expanded access data examined came from more than 5,400 patients with a median of 24-week follow-up (half of the individuals were on Isentress for less than 24 weeks and the other half for longer than that). – Enid Vázquez
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Indevus’ PRO 2000 becomes first microbicide to demonstrate efficacy
Research on an experimental microbicide known as PRO 2000 has demonstrated that the vaginal gel provides a small amount of protection against HIV in women, according to a study that was presented at CROI.
PRO 2000, manufactured by Indevus Pharmaceuticals, works by binding up HIV and preventing it from attaching to certain white blood cells. This preliminary study, designed to test the safety of the gel, found it to be 30% effective at preventing the onset of infection. These findings miss the mark of statistical significance by three percentage points; however, the study itself is the first to demonstrate the potential for microbicides to be effective.
Conducted by the Center for the AIDS Program of Research in South Africa, and funded by the National Institutes of Health (NIH), the study divided 3,000 women from the U.S. and four different regions in Africa into four groups. One group used the PRO 2000 gel, another used a different microbicide gel produced by Reprotect known as BufferGel, a third group used a placebo gel, and the remaining group used no gel at all. Comprehensive sex education was also provided to the women, and condom use was encouraged.
At the end of the study, 194 women had contracted HIV, 36 of whom were from the PRO 2000 group, 54 from the BufferGel group, 51 from the placebo group, and 53 from the group that used no microbicides. – Keith R. Green
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HIV linked to kidney function decline
A recent study conducted by the University of California, San Francisco found that while people whose viral loads are controlled by antiretrovirals lose kidney function at a slower rate than people with uncontrolled virus, even those with well-controlled virus experience kidney decline at a rate that is not explained by aging alone.
Investigators looked at 615 people in the SCOPE study, estimating kidney function by a method known as the Modification of Diet in Renal Disease (MDRD) equation, which factors in age, gender, race, and standardized serum creatinine (a marker of kidney function). Included in the study were people who had experience with antiretroviral drugs, and those who had none. The analysis did not, however, consider individual drugs or drug classes, nor were black patients (who are at higher risk for kidney aliments) compared to whites or other racial groups.
The results of the analysis showed that simply beginning antiretroviral therapy produced a yearly improvement in kidney function, but that blips or slight elevations in viral load could occur even in participants whose virus was considered to be controlled, and that these intermittent blips were strongly associated with decline in kidney function.
Scientists have noted that HIV gets into the kidneys upon initial infection, and that the virus causes inflammation which is associated with the development of co-morbidities such as kidney failure, in both HIV-positive and negative people. Treatment with antiretrovirals does not eliminate inflammation, even when the virus is completely suppressed. – Keith R. Green
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