Lars Jørgen Østergaard

Protease Inhibitors or NNRTIs as First-Line HIV-1 Treatment in West Africa (PIONA): a Randomised Controlled Trial

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  • Sanne Jespersen
  • Bo Langhoff Hønge
  • Henrik Krarup, Aalborg University
  • ,
  • Patrik Medstrand, Department of Translational Medicine, Clinical Virology, Lund University, Malmö, Sweden.
  • ,
  • Allan Sørensen, Bandim Health Project, INDEPTH Network, Bissau, Guinea-Bissau.
  • ,
  • Candida Medina, National HIV Programme, Ministry of Health, Bissau, Guinea-Bissau.
  • ,
  • David da Silva Té, National HIV Programme, Ministry of Health, Bissau, Guinea-Bissau.
  • ,
  • Faustino Gomes Correira, National HIV Programme, Ministry of Health, Bissau, Guinea-Bissau.
  • ,
  • Christian Erikstrup
  • Lars Østergaard
  • Christian Wejse
  • Alex Lund Laursen
  • Bissau HIV Cohort Study Group

BACKGROUND: 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 randomised, two-arm superiority trial compared the use of two NRTIs plus either one NNRTI (efavirenz or nevirapine) or one PI (lopinavir/ritonavir) in treatment-naïve HIV-1-infected adults in the Bissau HIV Cohort (, NCT0019235). The primary endpoint was HIV-1 RNA <400 copies/ml 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% CI 0.51-1.36) or frequency of clinical adverse events between treatment arms (NNRTI: 73/197 (37.1%); PI: 69/203 (34.0%); p=0.52).

CONCLUSION: 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.

Original languageEnglish
Article number8
JournalJ A I D S
Pages (from-to)386
Number of pages393
Publication statusPublished - Nov 2018

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