What question did this study set out to answer?

To directly evaluate the efficacy, safety, and tolerability of once-daily abacavir/lamivudine compared with tenofovir DF/emtricitabine, each co-administered with lopinavir/ritonavir, in antiretroviral-naive HIV-1-infected adults.

July 15, 2009AIDS

Randomized, double-blind, placebo-matched, multicenter trial of abacavir/lamivudine or tenofovir/emtricitabine with lopinavir/ritonavir for initial HIV treatment

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Authors

KSKimberly Y. SmithAstraZeneca (United Kingdom)PPParul PatelNirma University DFDerek M. FineUniversity of Colorado Denver

Discussion

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Implication

Randomized double-blind trial demonstrates equivalent virologic suppression between two first-line regimens in HIV-1, indicating both options are effective initial therapies.

Key Points

To directly evaluate the efficacy, safety, and tolerability of once-daily abacavir/lamivudine compared with tenofovir DF/emtricitabine, each co-administered with lopinavir/ritonavir, in antiretroviral-naive HIV-1-infected adults.
Conducted a randomized, double-blind, placebo-matched, multicenter noninferiority trial in 688 antiretroviral-naive, HIV-1-infected individuals.
Participants received a once-daily regimen of either abacavir/lamivudine (600 mg/300 mg) or tenofovir DF/emtricitabine (300 mg/200 mg), each combined with lopinavir/ritonavir (800 mg/200 mg).
Assessed primary endpoints of virologic suppression (HIV-1 RNA <50 copies/ml) at week 48 using an intent-to-treat exposed (missing = failure, switch included) approach and safety over 96 weeks.
At week 48, 68% in the abacavir/lamivudine arm versus 67% in the tenofovir/emtricitabine arm achieved HIV-1 RNA <50 copies/ml (difference 95% CI: -6.63 to 7.40, P=0.913), establishing noninferiority.
Noninferiority persisted at week 96, with virologic suppression achieved in 60% of abacavir/lamivudine recipients versus 58% of tenofovir/emtricitabine recipients (95% CI: -5.41 to 9.32, P=0.603).
Safety and immunologic outcomes were equivalent across arms: protocol-defined virologic failure occurred in 14% of both groups, study discontinuations due to adverse events occurred in 6% of both groups, and median CD4 recovery by week 96 was +250 versus +247 cells/microl.

Cite This Study

Smith et al. (2009) studied this question.

synapsesocial.com/papers/6a7dff376ef7ec97ba7d954f https://doi.org/10.1097/qad.0b013e32832cbcc2

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Implication

Randomized double-blind trial demonstrates equivalent virologic suppression between two first-line regimens in HIV-1, indicating both options are effective initial therapies.

Randomized, double-blind, placebo-matched, multicenter trial of abacavir/lamivudine or tenofovir/emtricitabine with lopinavir/ritonavir for initial HIV treatment

Discussion

Member takes

Implication

Key Points

Cite This Study

Randomized, double-blind, placebo-matched, multicenter trial of abacavir/lamivudine or tenofovir/emtricitabine with lopinavir/ritonavir for initial HIV treatment

Discussion

Member takes

Implication

Key Points

Cite This Study

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