HIV/AIDS HAART: Time to virologic failure similar in HIV/AIDS patients taking 3- versus 4-drug regimens

AIDSWEEKLY Plus; Monday, October 16, 2006
Staff Medical Writers

"Three-drug antiretroviral regimens are standard of care for initial treatment of human immunodeficiency virus 1 (HIV-1) infection, but a 4-drug regimen could improve antiretroviral activity and be more effective than a 3-drug regimen." The "safety/efficacy of 3-drug versus 4-drug regimens for initial treatment of HIV-1 infection" was compared, wrote scientists in the United States.

According to researchers, "The AIDS Clinical Trials Group (ACTG) A5095 study" conducted a "randomized, double-blind, placebo-controlled study with enrollment and follow-up conducted from March 22, 2001, to March 1, 2005, and" enrolled "treatment-naive, HIV-1-infected patients with HIV-1 RNA levels of 400 copies/mL or greater from U.S. clinical trials units of the ACTG.

"Zidovudine/lamivudine plus efavirenz (3-drug regimen) vs. zidovudine/lamivudine/abacavir plus efavirenz (4-drug regimen)" was compared." Main outcome measures included time "to virologic failure (defined as time to first of 2 successive HIV-1 RNA levels greater than or equal to200 copies/mL at or after week 16), CD4 cell count changes, and grade 3 or 4 adverse events."

"HIV-1 RNA data were intent-to-treat, regardless of treatment changes. Seven hundred sixty-five patients with a baseline mean HIV-1 RNA level of 4.86 log₁₀ (72,444) copies/mL and CD4 cell count of 240 cells/mm³ were randomized," wrote R.M. Gulick and colleagues at Cornell University, Weill Medical College in New York.

"After a median 3-year follow-up," investigators reported, "99 (26%) of 382 and 94 (25%) of 383 patients receiving the 3-drug and 4-drug regimens, respectively, reached protocol-defined virologic failure; time to virologic failure was not significantly different (hazard ratio, 0.95; 97.5% confidence interval, 0.69-1.33; p=0.73).

"In planned subgroup analyses, increased risk for virologic failure was seen in non-Hispanic black patients (adjusted hazard ratio, 1.66; 95% confidence interval, 1.18-2.34; p=0.003)."

"At 3 years, the HIV-1 RNA level was less than 200 copies/mL in 152 (90%) of 169 and 143 (92%) of 156 patients receiving the 3-drug and 4-drug regimens, respectively (p=0.59), and less than 50 copies/mL in 144 (85%) of 169 and 137 (88%) of 156 patients (p=0.39). CD4 cell count increases and grade 3 or 4 adverse events were not significantly different.

"In treatment-naive patients," continued the authors, "there were no significant differences between the 3-drug and 4-drug antiretroviral regimens; overall, at least approximately 80% of patients had HIV-1 RNA levels less than 50 copies/mL through 3 years."

Gulick concluded, "These results support current guidelines recommending 2 nucleosides plus efavirenz for initial treatment of HIV-1 infection; adding abacavir as a fourth drug provided no additional benefit."

Gulick and colleagues published their study in Journal of the American Medical Association (Three- vs four-drug antiretroviral regimens for the initial treatment of HIV-1 infection - A randomized controlled trial. JAMA. 2006 Aug 16;296(7):769-81).

Additional information can be obtained by contacting R.M. Gulick, Cornell University, Weill Med College, Division International Med & Infectious Disease, Cornell HIV Clinic Trials Unit, Box 566, 525 E 68th St., New York City, NY 10021, USA.

The publisher of the Journal of the American Medical Association can be contacted at: American Medical Association, 515 N State St., Chicago, IL 60610-0946, USA.

Keywords: New York, New York, United States, HIV/AIDS, Three- & Four-Drug Regimens, HAART, Viral Load, Virologic Failure Risk.

This article was prepared by AIDS Weekly editors from staff and other reports.

Reference

Gulick RM, Ribaudo HJ, Shikuma CM, et al., “Three- vs four-drug antiretroviral regimens for the initial treatment of HIV-1 infection: a randomized controlled trial”, JAMA. 2006 Aug 16;296(7):769-81.

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