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Protease Inhibitors...
Protease Inhibitors or NNRTIs as First-Line HIV-1 Treatment in West Africa (PIONA) : A Randomized Controlled Trial
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- Jespersen, Sanne (author)
- Aarhus University Hospital,Bandim Health Project
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- Hønge, Bo Langhoff (author)
- Bandim Health Project,Aarhus University Hospital
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- Krarup, Henrik (author)
- Aalborg University
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- Medstrand, Patrik (author)
- Lund University,Lunds universitet,Klinisk virologi, Malmö,Forskargrupper vid Lunds universitet,Clinical Virology, Malmö,Lund University Research Groups
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- Sørensen, Allan (author)
- Bandim Health Project
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- Medina, Candida (author)
- Ministry of Health, Guinea-Bissau
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- Té, David da Silva (author)
- Ministry of Health, Guinea-Bissau
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- Correira, Faustino Gomes (author)
- Ministry of Health, Guinea-Bissau
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- Erikstrup, Christian (author)
- Aarhus University Hospital
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- Østergaard, Lars (author)
- Aarhus University Hospital
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- Wejse, Christian (author)
- Aarhus University,Bandim Health Project,Aarhus University Hospital
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- Laursen, Alex Lund (author)
- Aarhus University Hospital
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(creator_code:org_t)
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- 2018
- 2018
- English 8 s.
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In: JAIDS. - 1944-7884. ; 79:3, s. 386-393
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http://dx.doi.org/10...
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https://lup.lub.lu.s...
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https://doi.org/10.1...
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Abstract
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- 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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Infektionsmedicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Infectious Medicine (hsv//eng)
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JAIDS
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- By the author/editor
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Jespersen, Sanne
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Hønge, Bo Langho ...
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Krarup, Henrik
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Medstrand, Patri ...
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Sørensen, Allan
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Medina, Candida
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Té, David da Sil ...
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Correira, Fausti ...
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Erikstrup, Chris ...
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Østergaard, Lars
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Wejse, Christian
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Laursen, Alex Lu ...
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Infectious Medic ...
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JAIDS
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Lund University