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

Kumarasamy, Nagalingeswaran

Aga, Evgenia

Ribaudo, Heather J

Wallis, Carole L

Katzenstein, David A

Stevens, Wendy S

Norton, Michael R

Klingman, Karin L

Hosseinipour, Mina C

Crump, John A

Supparatpinyo, Khuanchai

Badal-Faesen, Sharlaa

Bartlett, John A

United States

2017-03-02T19:04:07Z

2017-03-02T19:04:07Z

2015-05-15

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.

https://www.ncbi.nlm.nih.gov/pubmed/25694653

civ109

1537-6591

https://hdl.handle.net/10161/13768

eng

Oxford University Press (OUP)

Clin Infect Dis

10.1093/cid/civ109

ACTG 5230

intensification

protease inhibitor monotherapy

second-line antiretroviral therapy

Acquired Immunodeficiency Syndrome

Adult

Africa

Antiviral Agents

Asia

Developing Countries

Drug Therapy

Female

HIV-1

Humans

Lopinavir

Male

Middle Aged

Pilot Projects

Plasma

RNA, Viral

Ritonavir

Treatment Outcome

Viral Load

Young Adult

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

Journal article

https://www.ncbi.nlm.nih.gov/pubmed/25694653

1552

1558

10

Clinical Science Departments

Duke

Duke Cancer Institute

Duke Science & Society

Global Health Institute

Initiatives

Institutes and Centers

Institutes and Provost's Academic Units

Medicine

Medicine, Infectious Diseases

Pathology

School of Medicine

School of Nursing

School of Nursing - Secondary Group

University Institutes and Centers

Published

60