Rx+Research

GlaxoSmithKline and Pfizer have created a joint research and development company with the goal of creating new anti-HIV medications more quickly and efficiently than either company could on its own. The joint company has four anti-HIV drugs in Phase II clinical trials. --------------------- Bristol-Myers Squibb has announced it has created new copayment assistance programs for its medications Reyataz, Sustiva, and Atripla. The programs help people with private insurance who spend more than $50 in copays for the drugs, covering up to $200 per month. --------------------- Although current guidelines state Sustiva shouldn't be taken by pregnant women because of a risk of birth defects, data from a 17-year study reported in the journal AIDS has shown that birth-defect rates among infants born to women taking the drug were similar to rates among those born to women taking other anti-HIV drugs or taking no antiretrovirals.. --------------------- Interim data from a study of Kaletra and Isentress have shown that dual therapy with the two medications produces a faster decline in viral loads than a standard three-drug regimen. CD4-cell increases were similar through both treatment approaches. --------------------- A study presented at the 15th British HIV Association Meeting has shown that suboptimal adherence may be less hazardous with Prezista than with other protease inhibitors. About 76% of study subjects with suboptimal adherence on Prezista achieved undetectable HIV levels, compared to 53% of those with suboptimal adherence to another PI. --------------------- The Food and Drug Administration has ordered changes to the label of Kaletra to warn that it may raise the risk for heart rhythm abnormalities. The new label says Kaletra should be used with caution in patients with underlying heart disease or preexisting cardiac problems. --------------------- Research reported at the 10th International Workshop on Clinical Pharmacology of HIV Therapy has shown that Isentress reaches high concentrations in the genital tract, suggesting that the drug may be useful as preexposure prophylaxis to prevent transmission of HIV through heterosexual intercourse. --------------------- Data from a four-year study reported in the journal AIDS Research and Human Retroviruses has shown that Aquamid, a polyacrylamine hydrogel filler, is a safe and effective treatment for HIV-related facial wasting. Nearly 90% of the HIVers treated with Aquamid reported being 'very satisfied' or 'satisfied.' --------------------- Gilead Sciences has launched a Phase II clinical trial of its four-drug combination pill Quad, which contains Emtriva, Viread, the experimental integrase inhibitor elvitegravir, and a boosting agent known as GS9350. The study includes 75 treatment-naive HIVers at 50 U.S. sites. --------------------- Apricitabine, a new nucleoside analog in development by Avexa, was shown in human studies to be effective in suppressing viral loads with a minimal effect on blood lipids, no recorded resistance, and few adverse side effects after 96 weeks of treatment. --------------------- Tobira Therapeutics has launched a Phase IIa clinical trial of its experimental CCR5 antagonist TAK-652 that includes 40 treatment-experienced HIVers in the United States and Argentina. --------------------- Irreversible pepsin fraction, an experimental compound developed by Immunotech Laboratories, has been shown in lab tests to bind to and disable a key protein HIV uses to attach to and infect immune system cells. Human studies are planned. --------------------- Researchers have captured on video the direct transfer of HIV between immune system cells through bridge-like connections called virological synapses. It was thought that HIV spread only through free-roaming viral particles that attached to and infected the cells. The researchers hope their findings lead to new methods to block such transmissions. --------------------- A study in the Journal of Clinical Endocrinology and Metabolism has shown that the hormone leptin, produced by fat cells, can improve symptoms of HIV-related lipodystrophy, including lowering cholesterol and triglycerides in the blood, reducing abdominal fat, and improving insulin resistance. --------------------- A test developed by researchers at Imperial College London and the International AIDS Vaccine Initiative may help weed out ineffective HIV vaccine candidates. The test combines live HIV with blood samples from candidates inoculated with experimental vaccines to quickly determine whether the shots keep the virus from replicating. --------------------- The Food and Drug Administration has approved the use of PegIntron and Rebetol for second-line treatment of hepatitis C among patients who did not achieve a sustained response to first-line treatment. The combination is the first therapy approved for treatment-experienced individuals.