1. Protease Inhibitors or NNRTIs as First-Line HIV-1 Treatment in West Africa (PIONA): A Randomized Controlled Trial.
- Author
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Jespersen S, Hønge BL, Krarup H, Medstrand P, Sørensen A, Medina C, Té DDS, Correira FG, Erikstrup C, Østergaard L, Wejse C, and Laursen AL
- Subjects
- Adolescent, Adult, Antiretroviral Therapy, Highly Active adverse effects, Drug Resistance, Viral, Drug-Related Side Effects and Adverse Reactions epidemiology, Drug-Related Side Effects and Adverse Reactions pathology, Female, Guinea-Bissau, HIV Protease Inhibitors adverse effects, HIV-1 isolation & purification, Humans, Male, Middle Aged, Pregnancy, RNA, Viral analysis, Reverse Transcriptase Inhibitors adverse effects, Sustained Virologic Response, Treatment Outcome, Viral Load, Young Adult, Antiretroviral Therapy, Highly Active methods, HIV Infections drug therapy, HIV Protease Inhibitors therapeutic use, Reverse Transcriptase Inhibitors therapeutic use
- Abstract
Background: Nonnucleoside reverse transcriptase inhibitors (NNRTIs) are recommended as part of first-line treatment for HIV-1 in Africa. However, NNRTI-based regimens are more prone to resistance development than protease inhibitors (PIs) in a context in which drug interruptions are frequent. The aim of this study was to compare the efficacy and tolerability of NNRTIs with PIs in HIV-1-infected patients in Guinea-Bissau., Methods: This open-label randomized, 2-arm superiority trial compared the use of 2 NRTIs plus either one NNRTI (efavirenz or nevirapine) or one PI (lopinavir/ritonavir) in treatment-naive HIV-1-infected adults in the Bissau HIV Cohort (ClinicalTrials.gov, NCT0019235). The primary endpoint was HIV-1 RNA <400 copies per milliliter after 12 months of treatment., Results: Between May 5, 2011, and April 26, 2013, 400 patients were included in the study. In an intention-to-treat analysis, the proportions of patients with viral suppression were similar in the NNRTI [65/197 (33.0%)] and PI [68/203 (33.5%)] arms (P = 0.92). No PI resistance was detected, but high-level NNRTI resistance was seen in 17/30 (56.7%) of NNRTI vs. 3/26 (11.5%) of PI-treated patients, P < 0.01. After 1 year of follow-up, 65 patients died (16.3%) and 93 were lost to follow-up (23.3%). There was no difference in mortality (hazard ratio 0.84, 95% confidence interval: 0.51 to 1.36) or frequency of clinical adverse events between treatment arms [NNRTI: 73/197 (37.1%); and PI: 69/203 (34.0%); P = 0.52]., Conclusions: In patients at an HIV clinic in Guinea-Bissau, treatment with PIs led to less development of resistance compared with NNRTIs but was not superior in terms of viral suppression, CD4 cell increment, mortality, or severe adverse events.
- Published
- 2018
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