Important note: Information in this article was accurate in September 2006. The state of the art may have changed since the publication date.
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HIV/AIDS HAART: HIV RNA suppression improved with three-drug/two-class regimen including efavirenz
AIDSWEEKLY Plus; Monday, September 25, 2006
Staff Medical Writers
According to a recently published study from England, "Antiretroviral therapy has greatly reduced HIV mortality and morbidity. However, the best sequence of regimens and implications of initial regimen for long-term therapeutic success are not well defined."
"In INITIO, a large international randomized trial, we compared antiretroviral therapy with two nucleoside analogue reverse transcriptase inhibitors (didanosine + stavudine) plus either a non-nucleoside reverse transcriptase inhibitor (efavirenz, EFV) or a protease inhibitor (nelfinavir, NFV), or both (EFV/NFV), in patients with HIV-1 infection who had not previously received antiretroviral drugs.
"Primary outcomes were proportion with undetectable HIV RNA in plasma, and change in CD4 count from baseline at 3 years. Analyses were by intention-to-treat. This study is registered as an International Standard Randomized Controlled Trial, number ISRCTN44582462. We followed up 911 participants (297 EFV, 311 NFV, 303 EFV/NFV)," researchers said.
"At 3 years, the proportion with HIV RNA less than 50 copies per mL was highest in the EFV group (188 [74%] EFV, 162 [62%] NFV, 155 [62%] EFV/NFV, p=0.004). Mean (95% CI) increases in CD4 count were 316X106 cells per L (288-343) for EFV, 289X106 cells per L (262-316) for NFV, and 274X106 cells per L (231-291) for EFV/NFV (p=0.1).
"Fewer participants in the EFV group than in the other groups stopped adequate antiretroviral therapy for more than 30 days (p=0.005). Participants in the EFV/NFV group had shorter time to stopping the initial regimen (p<0.0001) and to a treatment modifying adverse event (p=0.04) than those in the other groups," reported P. Yeni and colleagues at MRC in London.
The authors continued, "Starting antiretroviral therapy with a three-drug/two-class regimen including efavirenz was better than starting with regimens including nelfinavir or efavirenz plus nelfinavir in terms of virological suppression and durability of the initial regimen."
"The shorter time on adequate antiretroviral therapy or to a treatment-modifying adverse event might explain the absence of additional benefit for the four-drug regimen," Yeni concluded.
Yeni and colleagues published their study in Lancet (Virological and immunological outcomes at 3 years after starting antiretroviral therapy with regimens containing non-nucleoside reverse transcriptase inhibitor, protease inhibitor, or both in INITIO: open-label randomised trial. Lancet. 2006 Jul 22;368(9532):287-98).
For more information, contact A.G. Babiker, MRC, Clinic Trials Unit, London NW1 2DA, England.
Publisher contact information for the journal Lancet is: Lancet Ltd., 84 Theobalds Rd., London WC1X 8RR, England.
Keywords: London, England, HIV/AIDS, HAART, Viral Suppression, Multiple Drug Class, Efavirenz.
This article was prepared by AIDS Weekly editors from staff and other reports.
Reference
INITIO Trial International Co-ordinating Committee; Yeni P, Cooper DA, et al., “Virological and immunological outcomes at 3 years after starting antiretroviral therapy with regimens containing non-nucleoside reverse transcriptase inhibitor, protease inhibitor, or both in INITIO: open-label randomised trial”, Lancet. 2006 Jul 22;368(9532):287-98.
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