Sanne Jespersen1,2, Bo Langhoff Hønge1,2,3, Henrik Krarup4, Patrik Medstrand5, Allan Sørensen1, Candida Medina6, David da Silva Té6, Faustino Gomes Correira6, Christian Erikstrup3, Lars Østergaard2, Christian Wejse1,2,7, Alex Lund Laursen2. 1. Bandim Health Project, Indepth Network, Bissau, Guinea-Bissau. 2. Department of Infectious Diseases, Aarhus University Hospital, Denmark. 3. Department of Clinical Immunology, Aarhus University Hospital, Denmark. 4. Section of Molecular Diagnostics, Clinical Biochemistry, Aalborg University Hospital, Denmark. 5. Department of Translational Medicine, Clinical Virology, Lund University, Malmö, Sweden. 6. National HIV Programme, Ministry of Health, Bissau, Guinea-Bissau. 7. GloHAU, Center for Global Health, School of Public Health, Aarhus University, Denmark.
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.
RCT Entities:
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-infectedpatients 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 patientsdied (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.
Authors: George A Yendewa; Foday Sahr; Sulaiman Lakoh; Marta Ruiz; Lucia Patiño; Andrés Tabernilla; Gibrilla F Deen; Momodu Sesay; Robert A Salata; Eva Poveda Journal: J Antimicrob Chemother Date: 2019-07-01 Impact factor: 5.790
Authors: Joakim Esbjörnsson; Marianne Jansson; Sanne Jespersen; Fredrik Månsson; Bo L Hønge; Jacob Lindman; Candida Medina; Zacarias J da Silva; Hans Norrgren; Patrik Medstrand; Sarah L Rowland-Jones; Christian Wejse Journal: AIDS Res Ther Date: 2019-09-05 Impact factor: 2.250
Authors: S Jespersen; F Månsson; J Lindman; C Wejse; C Medina; Z J da Silva; DdS Te; P Medstrand; J Esbjörnsson; B L Hønge Journal: AIDS Res Ther Date: 2020-02-04 Impact factor: 2.250