1. Lopinavir/ritonavir monotherapy after virologic failure of first-line antiretroviral therapy in resource-limited settings.
- Author
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Bartlett JA, Ribaudo HJ, Wallis CL, Aga E, Katzenstein DA, Stevens WS, Norton MR, Klingman KL, Hosseinipour MC, Crump JA, Supparatpinyo K, Badal-Faesen S, Kallungal BA, and Kumarasamy N
- Subjects
- Acquired Immunodeficiency Syndrome epidemiology, Acquired Immunodeficiency Syndrome immunology, Adenine administration & dosage, Adult, Africa epidemiology, Deoxycytidine administration & dosage, Drug Administration Schedule, Drug Therapy, Combination, Emtricitabine, Female, Health Resources supply & distribution, Humans, India epidemiology, Male, Medication Adherence, Middle Aged, Mutation, Patient Selection, Pilot Projects, RNA, Viral immunology, Reverse Transcriptase Inhibitors adverse effects, Surveys and Questionnaires, Tenofovir, Thailand epidemiology, Treatment Failure, Viral Load, Acquired Immunodeficiency Syndrome drug therapy, Adenine analogs & derivatives, Anti-HIV Agents administration & dosage, Deoxycytidine analogs & derivatives, Lopinavir administration & dosage, Organophosphonates administration & dosage, RNA, Viral drug effects, Ritonavir administration & dosage
- Abstract
Objective: To evaluate virologic response rates of lopinavir/ritonavir (LPV/r) monotherapy as second-line antiretroviral treatment (ART) among adults in resource-limited settings (RLSs)., Design: An open-label pilot study of LPV/r monotherapy in participants on first-line nonnucleoside reverse transcriptase inhibitor three-drug combination ART with plasma HIV-1 RNA 1000-200 000 copies/ml., Methods: Participants were recruited from five sites in Africa and Asia within the AIDS Clinical Trials Group (ACTG) network. All participants received LPV/r 400/100 mg twice daily. The primary endpoint was remaining on LPV/r monotherapy without virologic failure at week 24. Participants with virologic failure were offered addition of emtricitabine and tenofovir (FTC/TDF) to LPV/r., Results: Mutations associated with drug resistance were encountered in nearly all individuals screened for the study. One hundred and twenty-three participants were enrolled, and 122 completed 24 weeks on study. A high proportion remained on LPV/r monotherapy without virologic failure at 24 weeks (87%). Archived samples with HIV-1 RNA levels less than 400 copies/ml at week 24 (n=102) underwent ultrasensitive assay. Of these individuals, 62 had levels less than 40 copies/ml and 30 had levels 40-200 copies/ml. Fifteen individuals experienced virologic failure, among whom 11 had resistance assessed and two had emergent protease inhibitor mutations. Thirteen individuals with virologic failure added FTC/TDF and one individual added FTC/TDF without virologic failure. At study week 48, 11 of 14 adding FTC/TDF had HIV-1 RNA levels less than 400 copies/ml., Conclusion: In this pilot study conducted in diverse RLS, LPV/r monotherapy as second-line ART demonstrated promising activity.
- Published
- 2012
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