Important note: Information in this article was accurate in February 2000. The state of the art may have changed since the publication date.AIDSWEEKLY Plus; Monday, February 14, 2000
Prepared by AIDS Weekly editors from staff and other reports
Findings show Viramune added to a combination of AZT and 3TC suppressed HIV in the blood for up to one year and longer in patients with advanced HIV disease and high baseline viral loads. The mean baseline viral load of these patients was very high - 138,986 copies/mL of blood and the mean CD4+ count was only 101 cells/mm3. Study participants had not previously been treated with antiretrovirals.
"Results presented ... demonstrate that Viramune - a drug most frequently studied in patients with low to moderate viral loads - is effective in patients with advanced HIV infection and high viral loads," explained Dr. Richard Pollard, University of Texas Medical Branch at Galveston, Texas. "This study is unique because the patients studied had extremely high viral loads, some having more than a million copies of virus per milliliter of blood."
The analysis presented evaluated 171 antiretroviral-naive patients randomized to receive AZT and 3TC plus either Viramune or placebo (77 Viramune and 94 placebo) as part of a large, international study (BI 1090). About 25% of patients in the study had baseline viral loads >500,000 copies/mL.
Forty-five percent of patients taking the triple drug combination (Viramune + AZT + 3TC) achieved suppression of HIV below the limit of detection at one year. This result was achieved using the most sensitive assay approved by the U.S. Food and Drug Administration, which can detect virus in the blood as low as 50 copies/mL, and using a strict "intent-to-treat analysis." This type of analysis accounts for all patients, including those who stopped treatment before the end of the study. Additionally, a mean 137 CD4+ cell increase was seen in these patients.
"These data show that Viramune + AZT + 3TC can suppress HIV levels to below the limit of detection for more than one year and substantially increase CD4 counts," noted Pollard. "The efficacy of the Viramune regimen was independent of the baseline viral load."
At 12 months, the percentage of Viramune patients with undetectable levels of HIV (<50 copies/mL) was similar in patients with baseline viral loads above the median, as compared to patients with baseline levels below the median (46% and 47%, respectively).
Since this trial was conducted, the triple combination of Viramune + AZT + 3TC has become available in a simple, twice-daily regimen (Viramune + Combivir) that requires a total of only four pills per day. There are no food or fluid restrictions associated with this combination.
"We're pleased that this trial provided results that are relevant today. It's important to note that this study was designed in 1995 and was based on the standard of treating AIDS patients at that time," explained Pollard. "With significant advances in the HIV/AIDS treatment arena since the trial's inception, the dual-therapy comparator arm in this study is no longer considered standard of care. However, this study demonstrates that the Viramune triple therapy regimen is a very viable treatment option for patients today, regardless of patients' viral load."
Viramune, the first member of the non-nucleoside reverse transcriptase inhibitor (NNRTI) class of anti-HIV/AIDS drugs to be approved, is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. This indication is based on analysis of changes in surrogate end-points, such as viral load or changes in CD4+ count. Viramune should always be administered in combination with other antiretroviral agents.
This article was prepared by AIDS Weekly editors from staff and other reports.
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