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

Bartlett, John A

Ribaudo, Heather J

Wallis, Carole L

Aga, Evgenia

Katzenstein, David A

Stevens, Wendy S

Norton, Michael R

Klingman, Karin L

Hosseinipour, Mina C

Crump, John A

Supparatpinyo, Khuanchai

Badal-Faesen, Sharlaa

Kallungal, Beatrice A

Kumarasamy, Nagalingeswaran

England

2017-03-02T19:21:47Z

2017-03-02T19:21:47Z

2012-07-17

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.

https://www.ncbi.nlm.nih.gov/pubmed/22441252

1473-5571

https://hdl.handle.net/10161/13791

eng

Ovid Technologies (Wolters Kluwer Health)

AIDS

10.1097/QAD.0b013e328353b066

Acquired Immunodeficiency Syndrome

Adenine

Adult

Africa

Anti-HIV Agents

Deoxycytidine

Drug Administration Schedule

Drug Therapy, Combination

Emtricitabine

Female

Health Resources

Humans

India

Lopinavir

Male

Medication Adherence

Middle Aged

Mutation

Organophosphonates

Patient Selection

Pilot Projects

RNA, Viral

Reverse Transcriptase Inhibitors

Ritonavir

Surveys and Questionnaires

Tenofovir

Thailand

Treatment Failure

Viral Load

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

Journal article

https://www.ncbi.nlm.nih.gov/pubmed/22441252

1345

1354

11

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

26