Lopinavir/ritonavir monotherapy after virologic failure of first-line antiretroviral therapy in resource-limited settings.

Journal Article (Journal Article;Multicenter Study)

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.

Full Text

Duke Authors

Cited Authors

  • 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; Kumarasamy, N

Published Date

  • July 17, 2012

Published In

Volume / Issue

  • 26 / 11

Start / End Page

  • 1345 - 1354

PubMed ID

  • 22441252

Pubmed Central ID

  • PMC3443745

Electronic International Standard Serial Number (EISSN)

  • 1473-5571

Digital Object Identifier (DOI)

  • 10.1097/QAD.0b013e328353b066


  • eng

Conference Location

  • England