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| |  ICAAC: Protease Inhibitor-Sparing Regimen Suppresses HIV In Majority Of Patients SAN DIEGO, CA -- Sept. 29, 1998 -- A simplified anti-HIV treatment cocktail requiring few pills is an effective first-line treatment for HIV/AIDS, according to a study presented at an international conference on infectious diseases this week. The study combination includes the potent non-nucleoside reverse transcriptase inhibitor (NNRTI) Viramune(R) (nevirapine) and the nucleoside analogues d4T (Zerit(R), stavudine) and ddI (Videx(R), didanosine). This treatment strategy excludes the third class of AIDS drugs, protease inhibitors, which are potent but can involve complicated regimens and long-term side effects. "This study is important because it shows that a protease-sparing regimen of Viramune, d4T and ddI achieves significant viral load reductions," explained Dr. Francois Raffi, professor at the Centre Hospitalier Regional et Universitaire de Nantes (France) who presented the six-month study findings at the 38th Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Diego. "With this twice-daily regimen, requiring only six to seven pills, we're seeing results comparable to those achieved with protease inhibitors." Dr. Raffi's findings show that patients taking Viramune, d4T and ddI have maintained undetectable levels of the HIV virus in the blood while increasing infection-fighting immune cells. At six months, 64 percent (30/47) of patients have levels of HIV that cannot be detected by a viral load test that measures lower than 50 copies/ml in the blood. The mean viral load reduction from baseline (4.6 log(10) copies/ml) was 2.1 log(10) at six months. Mean CD4+ increase from baseline (429 cells/ml) was 162 cells/ml. "This regimen has no cross resistance with protease inhibitors, which means that patients starting therapy with Viramune, d4T and ddI can still benefit from protease inhibitor therapy in future treatment combinations," Dr. Raffi said. All anti-HIV drugs have side effects, however the long-term side effects -- diabetes, abnormal fat distribution, high cholesterol and triglyceride levels -- that have recently been reported by more and more patients taking protease inhibitors, have only rarely been seen in patients taking NNRTIs and nucleoside analogues. Dr. Raffi said the study regimen is generally well tolerated and requires only a few pills taken twice daily. Viramune requires only two pills per day -- the lowest daily intake of any NNRTI. Viramune has been available since August 1996 and has been used in more than 50,000 patients. Viramune is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. This indication is based on analysis of changes in surrogate end-points. At present, there are no results from controlled clinical trials evaluating the effect of Viramune in combination with other antiretroviral agents on the clinical progression of HIV-1 infection, such as, the incidence of opportunistic infections or survival. Viramune is generally well tolerated. The most commonly reported adverse events associated with Viramune are rash, fever, nausea, headache and abnormal liver function tests. Severe and life-threatening skin reactions and hepatotoxicity, including fatal cases of each, have occurred in patients treated with Viramune. Related Links: Viramune
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