Pharmaceutical Update

The Food and Drug Administration granted approval for the use of Reyataz (atazanavir), Bristol-Myers Squibb's protease inhibitor, on June 20. A study presented at the 16th International Conference on Antiviral Research showed that the investigational drug Ampligen, an immune modulator, may be helpful in delaying HIV viral load rebounds in people taking treatment breaks. Studies are ongoing. GlaxoSmithKline has obtained a licensing agreement from Swedish company Medivir to develop MIV-210, an experimental nucleoside reverse transcriptase inhibitor that in previous tests has successfully treated drug-resistant HIV and drug-resistant hepatitis B. Two studies in the May 29 issue of The New England Journal of Medicine indicated that the use of Fuzeon, Roche and Trimeris's fusion inhibitor, by people resistant to other anti-HIV medications can double the chance to achieve an undetectable viral load. A study in the June issue of the Journal of Clinical Endocrinology and Metabolism reported that testosterone replacement therapy using Testim gel, from Auxilium Pharmaceuticals, can be effective in treating low testosterone levels'as measured through increases in sexual motivation and desire. Testim use has also been linked to improvements in lean muscle mass. Data from an ongoing clinical trial presented at the XII International Drug Resistance Workshop showed that after nearly two years of treatment with a drug cocktail that includes Viread, Gilead Sciences' nucleotide reverse transcriptase inhibitor, less than 3% of previously treatment-naive patients develop resistance to the drug. A 48-week European study of Trizivir, a combination antiretroviral medication from GlaxoSmithKline, indicated that switching to Trizivir after successful multidrug treatment is as effective in suppressing HIV levels as continuing a regimen that includes a protease inhibitor or a nonnucleoside reverse transcriptase inhibitor. Trizivir also was shown to significantly lower cholesterol and triglyceride levels. A Brazilian study showed that Edronax, an antidepression drug, can be safe and effective for HIV-positive people suffering from major depressive disorder. Two studies in the May 1 edition of the Journal of Acquired Immune Deficiency Syndromes showed that switching from Bristol-Myers Squibb's Zerit to GlaxoSmithKline's Ziagen can result in modest improvements to lipoatrophy in the limbs. But because the rate of fat restoration is slow, researchers say visible results should not be expected within the first year of switching medications. A 24-week study reported in the February edition of the Journal of Acquired Immune Deficiency Syndromes indicated that treatment with the corticosteroid prednisone does not decrease the occurrence of rash associated with use of Viramune, Boehringer Ingelheim's nonnucleoside reverse transcriptase inhibitor. Researchers in New York report that a study of Lamictal, GlaxoSmithKline's antiepilepsy drug, demonstrated that the medication may be helpful in treating pain caused by HIV-related peripheral neuropathy. Boehringer Ingelheim has announced the launch of its Patient History Card program, through which HIV-positive inmates will be issued a foldable wallet-size card to help them manage their medical care both inside and outside of correctional facilities. The card has sections to record medications being taken, viral load measurements, CD4-cell counts, drug allergies, vaccinations, and other critical information. The cards can be ordered free of charge by any U.S. correctional facility. Canadian biotechnology firm Theratechnologies has announced the start of a Phase II clinical trial testing the use of ThGRF, a synthetic human growth hormone, to treat HIV-related lipodystrophy. ThGRF has previously been studied as a treatment for type 2 diabetes. GlaxoSmithKline has announced that it is cutting the price of its anti-HIV medications by as much as 47% for 63 developing nations, including all sub-Saharan African countries. The Pfizer Foundation has announced its Southern HIV/AIDS Prevention Initiative, through which the foundation will provide $3 million over three years for community-based HIV prevention groups operating in nine Southern states.