| Autor: |
Belinda Ha, Qiming Liao, Lynn Dix, Keith Pappa |
| Zdroj: |
HIV Clinical Trials; Mar2009, Vol. 10 Issue 2, p65-75, 11p |
| Abstrakt: |
Objective: We analyzed virologic response and safety data from six recent clinical studies conducted in antiretroviral-naïve subjects treated with ABC/3TC or its components to assess the impact of baseline viral load on efficacy and safety endpoints used in the ACTG5202 protocol. Methods: Primary endpoints were time to virologic failure (confirmed HIV-1 RNA ⩾1,000 copies/mL at 16–24 weeks or ⩾200 copies/mL at ⩾24 weeks) and time to first grade 3 or 4 adverse event or laboratory abnormality that was at least one grade higher than at baseline. The survival distributions of both endpoints were estimated using the Kaplan-Meier method overall and by baseline viral load (Results: For subjects with baseline HIV-1 RNA ⩾100,000 copies/mL, the rate of virologic survival ranged from 87% to 95% by 48 weeks. Few subjects treated with ABC/3TC developed grade 3 or 4 adverse events, laboratory toxicities, or changes in lipid levels. The weighted mean (CI) for the pooled virologic response was 91% (87%–96%). Conclusion: Based on the A5202 endpoints, ABC/3TC-containing regimens in this analysis had a high rate of virologic survival and were generally well tolerated in antiretroviral-naïve subjects regardless of baseline viral load. The pooled virologic response for ABC/3TC in our analysis is higher than the A5202 estimate. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Supplemental Index |
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