Important note: Information in this article was accurate in 2002. The state of the art may have changed since the publication date.
PRNewswire - November 20, 2002
VIRAMUNE is a non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. This indication is based on one principle clinical trial that demonstrated prolonged suppression of HIV-RNA and on two smaller supportive studies.
At 48 weeks, 90% of study participants who had switched to VIRAMUNE maintained viral load <50 copies/ml versus 92% who continued PI-based therapy.
Triglyceride levels significantly decreased in patients switched to a VIRAMUNE-containing regimen (mean decrease of 73 mg/dl; P = 0.01) and significantly increased in those continuing a PI-containing regimen (mean increase of 37 mg/dl; P = 0.03). Cholesterol values did not vary over time.
"Patients in this study who switched to a regimen containing VIRAMUNE maintained viral suppression while improving their triglyceride profile," said Dr. Franco Maggiolo of the Ospedali Riuniti in Bergamo, Italy.
In this prospective, randomized study, 124 patients (62 NVP; 62 PI) who had been chronically treated with PIs and maintained a stable viral load for at least 6 months, were randomized to either continue their PI treatment or substitute with VIRAMUNE. At baseline all patients had a viral load below the limit of detection (50 copies/ml) and the mean CD4+ counts were 554 in the VIRAMUNE arm and 592 in the PI arm. All patients in this study continued with their NRTI combinations. Demographic characteristics, time on a stable triple drug HAART and time with undetectable viral load were similar in the two groups.
Nine patients in the VIRAMUNE group and eighteen patients in the PI group interrupted their treatments due to adverse events. Adverse events in the NVP group were mainly due to intolerance or acute toxicity occurring in the first 2 months after treatment switch (rash 5 cases). The majority of adverse events in the PI group were related to metabolic alterations (lipodystrophy 5 cases, increased triglycerides 3 cases, increased cholesterol 1 case).
VIRAMUNE
The most clinically important adverse events associated with VIRAMUNE are rash (9%) and hepatic events. Other commonly reported events include fever, nausea and headache. Cases of hypersensitivity reactions have been observed.
Severe and life-threatening skin reactions and hepatotoxicity, including fatal cases of each, have occurred in patients treated with VIRAMUNE. Some events have occurred after short-term exposure. The first 12-16 weeks of therapy with VIRAMUNE are a critical period during which it is essential that patients be intensively monitored. VIRAMUNE should be discontinued and not restarted following severe hepatic, skin or hypersensitivity reactions.
The dose of VIRAMUNE for adults is one 200 mg tablet daily for the first 14 days (this lead-in period should be used because it has been found to lessen the frequency of rash), followed by one 200 mg tablet twice daily.
Resistant virus emerges rapidly and uniformly when VIRAMUNE is administered alone. For the treatment of HIV-1 infection, VIRAMUNE should always be administered in combination with other antiretroviral agents.
VIRAMUNE is a product of original research done at Boehringer Ingelheim Pharmaceuticals, Inc., a member of the Boehringer Ingelheim group of companies. For more information, visit http://www.VIRAMUNE.com.
References
Poster # P38: Nevirapine to simplify HAART in PI-experienced, successfully treated patients [F. Maggiolo]
SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
Web Site: http://www.VIRAMUNE.com
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