Important note: Information in this article was accurate in 1998. The state of the art may have changed since the publication date.
PRNewswire - Monday September 28, 1998
The study compared the clinical and virologic events of 71 consecutively enrolled patients with acute primary HIV. Of these, 64 participants presented with symptoms and seven were asymptomatic but had seroconverted. All of the patients were seen within 90 days after the onset of symptoms or seroconversion. Twenty of those patients were treated immediately upon diagnosis with highly active antiretroviral therapy (HAART) of Epivir, also known as 3TC(R) (150 mg bid), Retrovir (300 mg bid) and indinavir (800 mg tid).
Plasma RNA at enrollment was comparable for the two groups (145,864 copies/mL HAART vs. 119,769 copies/mL controls), as were entry CD4 counts (697/dL vs. 624/dL). The 20 patients who started HAART experienced a rapid clearance of plasma RNA, with 19 of 20 patients achieving below the range of detection (<500 copies/mL; Chiron Quantiplex HIV RNA technique) by week 12 of therapy. By week 32, all of the patients on HAART for whom there were data available achieved <20 HIV-RNA copies in plasma using an investigational assay (Roche Ultrasensitive Assay).
"Being treated at the time of primary infection may be especially beneficial because there could be less immune system destruction over the long term. The data from this study suggest that it is important to begin triple combination therapy as soon as possible," said Lynn Smiley, M.D., vice president of antiviral clinical research at Glaxo Wellcome.
During the 52 weeks of follow up, absolute CD4+ cell counts in the treated patients increased a median of 11.5 cells per month, while the untreated patients lost a median of 18.1 cells per month. At 52 weeks, the mean absolute CD4+ cells for treated subjects was 785 cells/dL, while the mean for the untreated group was 445 cells/dL. The recovery of CD4+ cells was accompanied by an absence of any opportunistic infections in the treated group; the untreated subjects experienced persistent oral and vulvovaginal candidiasis, oral hairy leukoplakia and seborrheic dermatitis.
"The combination of Retrovir and Epivir is widely used as part of a multiple drug regimen as here with indinavir," said Dr. Smiley. "Together they form the foundation for many maximally suppressive triple combinations."
Retrovir is a nucleoside reverse transcriptase inhibitor (NRTI) that was cleared by the FDA for marketing in 1987 as the first treatment for HIV and AIDS. In 1994, the FDA cleared Retrovir for use in HIV-infected pregnant women and their newborns to reduce the risk of HIV transmission from mother to infant.
Epivir is also an NRTI and has been studied primarily in combination with Retrovir as the foundation for triple drug combination regimens.
Combivir, which received FDA clearance in September 1997, is the first product to combine two antiretroviral drugs in a single tablet for the treatment of HIV. For patients receiving the widely used nucleoside analogue combination of Epivir+Retrovir as part of a multiple drug regimen, Combivir offers significant dosing convenience -- dosing for Combivir is one tablet in the morning and one at night.
The most commonly reported side effects associated with treatment with Combivir or Epivir+Retrovir are headache, nausea, malaise and fatigue, runny nose and nasal congestion, diarrhea, low white blood cells and anemia. In addition, Epivir as well as Retrovir and other nucleoside analogues have been associated with rare but potentially life-threatening lactic acidosis and hepatomegaly.
Glaxo Wellcome Inc., the pharmaceutical industry leader in HIV research and therapies, manufactures and markets Combivir, Epivir and Retrovir. Glaxo Wellcome is also developing the investigational anti-HIV medications Ziagen(TM) (abacavir sulfate) and Agenerase(TM) (amprenavir), which are both in phase III clinical trials. Epivir was discovered by scientists at BioChem Pharma of Laval, Quebec, Canada, and was licensed to Glaxo Wellcome in 1990.
SOURCE: Glaxo Wellcome
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