Important note: Information in this article was accurate in 2003. The state of the art may have changed since the publication date.
PRNewswire - December 10, 2003
The results of the study illustrate that the combination and order of antiretroviral drugs makes a significant difference for those starting HIV/AIDS treatment. The regimen of Combivir(R), a combination of Epivir(R) (lamivudine, known as 3TC) and Retrovir(R) (zidovudine, known as ZDV) and efavirenz was more effective in delaying first regimen failure than other three-drug regimens. NIAID's findings provide important data to assist physicians in making treatment decisions when starting patients on an HIV drug regimen. The results of this study extend the findings of the other studies that have shown that Combivir and efavirenz can help to control HIV.
A total of 980 HIV-positive previously untreated patients participated in the study, which compared the performance of the Combivir/efavirenz combination against five other anti-HIV drug regimens. ACTG384 represents the first study to address the impact of first line regimens on the sequencing of future regimens. The total amount of time it took to experience treatment failure with both the first and second lines of therapy was the primary endpoint of the study. The overall results of the study suggest that of the six initial treatment arms, the combination of Combivir plus efavirenz was the best choice for first line therapy.*
With more than 20 antiretroviral drugs now available to treat HIV and AIDS, selecting a treatment regimen is an increasingly complex decision. The prescribing and drug sequencing recommendations from this study have now been incorporated into the U.S. Department of Health and Human Services HIV/AIDS Treatment Guidelines, and will help physicians in making treatment decisions.
GSK has collaborated on this ACTG study since 1997, supplying Combivir (and other medications) for the drug regimens and financial support, along with the other companies whose drugs were involved.
We are gratified that the results of ACTG384 are so supportive of Combivir. We are proud to have developed a drug that contributes positively to the regimens available for people being treated for HIV/AIDS.
Combivir was approved by the U.S. Food and Drug Administration in 1997 and was the first combination tablet of two anti-HIV drugs to be formulated. Combivir or its components (lamivudine and zidovudine) is the proven cornerstone of the 10 most commonly prescribed first-line antiretroviral regimens currently used in the United States. It has been prescribed for tens of thousands of patients and is the most studied and prescribed nucleoside backbone of the HIV antiretrovirals.
*Details on ACTG 384 are available at http://www.niaid.nih.gov and http://www.nejm.org .
GlaxoSmithKline is one of the world's leading research-based pharmaceutical and healthcare companies and an industry leader in HIV research and therapies. The company is engaged in basic research programs designed to investigate new targets to treat HIV.
Product Information
HIV medicines do not cure HIV infection/AIDS or prevent passing HIV to others. Combivir is a combination tablet containing Epivir(R) (lamivudine, 3TC) and Retrovir(R) (zidovudine, AZT, ZDV).
Combivir is indicated in combination with other antiretroviral agents for the treatment of HIV infection.
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported. Zidovudine has been associated with hematologic toxicity including neutropenia and severe anemia, especially in advanced HIV disease, and with symptomatic myopathy after prolonged use.
Redistribution/accumulation of body fat has been observed in patients receiving anti-retroviral therapy. The causal relationship, mechanism, and long-term consequences of these events are currently unknown.
Most frequent adverse events are headache (35%), nausea (33%), malaise/fatigue (27%), and nasal signs and symptoms (20%).
The recommended dose of Combivir is one tablet (3TC 150mg/ZDV 300mg) twice a day. Combivir may be taken without regard to meals.
SOURCE GlaxoSmithKline
Web Site: http://www.niaid.nih.gov http://www.nejm.org
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