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Clin Infect Dis. 2015 May 15;60(10):1552-8. doi: 10.1093/cid/civ109. Epub 2015 Feb 18.

Lopinavir/Ritonavir Monotherapy as Second-line Antiretroviral Treatment in Resource-Limited Settings: Week 104 Analysis of AIDS Clinical Trials Group (ACTG) A5230.

Author information

1
YRG CARE Medical Centre, VHS Chennai, India.
2
Center for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, Massachusetts.
3
Lancet Laboratories, Johannesburg, South Africa.
4
Stanford University, Palo Alto, California.
5
University of the Witwatersrand, Johannesburg, South Africa.
6
AbbVie, North Chicago, Illinois.
7
Division of AIDS, National Institutes of Health, Bethesda, Maryland.
8
Kamuzu Central Hospital, Lilongwe, Malawi.
9
Kilimanjaro Christian Medical Centre, Moshi, Tanzania.
10
Chiang Mai University, Thailand.
11
Duke University Medical Center, Durham, North Carolina.

Abstract

BACKGROUND:

The AIDS Clinical Trials Group (ACTG) A5230 study evaluated lopinavir/ritonavir (LPV/r) monotherapy following virologic failure (VF) on first-line human immunodeficiency virus (HIV) regimens in Africa and Asia.

METHODS:

Eligible subjects had received first-line regimens for at least 6 months and had plasma HIV-1 RNA levels 1000-200 000 copies/mL. All subjects received LPV/r 400/100 mg twice daily. VF was defined as failure to suppress to <400 copies/mL by week 24, or confirmed rebound to >400 copies/mL at or after week 16 following confirmed suppression. Subjects with VF added emtricitabine 200 mg/tenofovir 300 mg (FTC/TDF) once daily. The probability of continued HIV-1 RNA <400 copies/mL on LPV/r monotherapy through week 104 was estimated with a 95% confidence interval (CI); predictors of treatment success were evaluated with Cox proportional hazards models.

RESULTS:

One hundred twenty-three subjects were enrolled. Four subjects died and 2 discontinued prematurely; 117 of 123 (95%) completed 104 weeks. Through week 104, 49 subjects met the primary endpoint; 47 had VF, and 2 intensified treatment without VF. Of the 47 subjects with VF, 41 (33%) intensified treatment, and 39 of 41 subsequently achieved levels <400 copies/mL. The probability of continued suppression <400 copies/mL over 104 weeks on LPV/r monotherapy was 60% (95% CI, 50%-68%); 80%-85% maintained levels <400 copies/mL with FTC/TDF intensification as needed. Ultrasensitive assays on specimens with HIV-1 RNA level <400 copies/mL at weeks 24, 48, and 104 revealed that 61%, 62%, and 65% were suppressed to <40 copies/mL, respectively.

CONCLUSIONS:

LPV/r monotherapy after first-line VF with FTC/TDF intensification when needed provides durable suppression of HIV-1 RNA over 104 weeks.

CLINICAL TRIALS REGISTRATION:

NCT00357552.

KEYWORDS:

ACTG 5230; intensification; protease inhibitor monotherapy; second-line antiretroviral therapy

PMID:
25694653
PMCID:
PMC4425828
DOI:
10.1093/cid/civ109
[Indexed for MEDLINE]
Free PMC Article

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