Phamaceutical Update

The Food and Drug Administration approved a 500-milligram formulation of the protease inhibitor Invirase in December. The new formulation reduces the dosage from 10 pills to four pills daily.

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The FDA approved a generic version of Bristol-Myers Squibb's nucleoside reverse transcriptase inhibitor Videx EC in December. The generic version, made by Barr Laboratories, will be used in developing countries.

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Prialt, a new drug by Elan Pharmaceuticals used to fight severe pain, including that of HIV patients, was approved by the FDA in December. The drug is part of a class of medications known as N-type calcium channel blockers.

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Bristol-Myers Squibb warned health care providers in January that prescribing the protease inhibitor Reyataz along with stomach-acid-control agents, particularly Prilosec, can significantly reduce the amount of Reyataz absorbed into the bloodstream and can possibly lead to the development of drug-resistant virus.

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The FDA issued a warning in January that the nonnucleoside reverse transcriptase inhibitor Viramune can cause severe liver damage, particularly among women and HIV patients with high CD4-cell counts.

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Bio-Rad Laboratories in January received FDA approval for its Multispot HIV-1/HIV-2 Rapid Test for HIV antibodies. It can be used on fresh or frozen serum and plasma samples and produces results in about 10 minutes.

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Bristol-Myers Squibb and Gilead Sciences announced a joint venture in December to develop a single pill taken once daily that will combine BMS nonnucleoside reverse transcriptase inhibitor Sustiva and Truvada, Gilead's combination of the nucleoside reverse transcriptase inhibitor Emtriva and nucleotide Viread. Work on the coformulation is expected to continue into 2005.

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A study in the November 19 edition of the journal AIDS has shown that the protease inhibitor Kaletra does not increase the risk for liver toxicity in HIV patients or in people coinfected with HIV and hepatitis C.

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Viread is not linked with kidney dysfunction more often than other antiretroviral drugs, says a study published in the December 1 issue of Journal of Acquired Immune Deficiency Syndromes.

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An antiretroviral regimen containing Combivir and Viread results in a surprisingly low rate of treatment failure when compared to other regimens also containing only nucleoside and nucleotide reverse transcriptase inhibitors, according to a study published in the January 3 issue of the journal AIDS.

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Researchers reported in the December 15 issue of Journal of Infectious Diseases that the nucleoside reverse transcriptase inhibitor Zerit, dosed with or without Epivir, is an effective alternative to Retrovir for HIV-positive pregnant women.

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Improvements in body fat percentages, mitochondrial DNA levels, and fat-cell death rates were seen in HIV patients switching from Zerit to either Retrovir or Ziagen, according to a study published in the January 3 issue of AIDS.

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Researchers reported in a study published in the January 1 issue of Journal of Acquired Immune Deficiency Syndromes that a two-drug regimen containing Kaletra and Viramune was as effective as standard three-drug therapy among treatment-experienced adults with sustained viral suppression.

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Dosing fusion inhibitor Fuzeon at two milligrams per kilogram of weight in children 5 or older provides drug exposure similar to that in adults taking a standard 90-milligram dose, notes a study in the December edition of Pediatric Infectious Disease Journal.

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A study published in the American Journal of Clinical Dermatology has shown that the lipoatrophy treatment Sculptra is safe and effective for most HIV-positive adults.

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French researchers reported in the December 1 issue of Journal of Acquired Immune Deficiency Syndromes that four days of treatment with Viramune plus a one-month regimen of two nucleoside reverse transcriptase inhibitors is effective in preventing HIV infections when given as postexposure prophylaxis.

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Phase II and III trials are under way in Botswana and Thailand and a Phase II trial has begun in the United States to evaluate the effectiveness of Viread in preventing HIV infections among injection-drug users and sexually active heterosexuals and gay men, the Centers for Disease Control and Prevention reported in December.

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GlaxoSmithKline granted a license in December to the South African unit of Indian generic drug company Cipla to make generic copies of its drugs Epivir and Retrovir.

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Early tests show that a French therapeutic HIV vaccine that uses viral samples and dendritic cells from individual HIV patients to prime the immune system can suppress HIV for up to a year. Additional studies are planned.

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A Phase I safety trial of a preventive HIV vaccine developed by the Aaron Diamond AIDS Research Center began in January in New York City and Rochester, N.Y.