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Switching treatment-experienced, integrase inhibitor-naive, virally suppressed HIV-1 infected adults from ritonavir-boosted protease inhibitors to dolutegravir: design, methods, and baseline results of a randomized, open-label, non-inferiority trial

Article scientifique 2022 Anglais

Résumé

Background: Most HIV-positive adults in Kenya with prior non-nucleoside reverse transcriptase inhibitor (NNRTI) failure are currently on ritonavir-boosted protease inhibitors (PI/r). Dolutegravir (DTG) has shown good efficacy among treatment-experienced adults. Objective: Our study is the first to evaluate the efficacy of switching from ritonavir-boosted protease inhibitor (PI/r) to DTG among virally suppressed adults with prior NNRTI failure and with no knowledge of susceptibility to nucleoside reverse transcriptase inhibitors (NRTIs). Methods: This open-label, randomized, active-controlled, non-inferiority trial was conducted at four sites in Kenya. Virally suppressed HIV-1 positive adults (≥ 18 years) on a second-line regimen of PI/r and 2 NRTIs were randomized (1:1) to switch to DTG or continue their pre-enrollment PI/r. The primary endpoint is proportion of participants with HIV-1 RNA ≥ 50 copies/mL at week 48 with a 4% non-inferiority margin. ClinicalTrials.gov registration: NCT04229290. Results: Between Feb 10 and Sep 3, 2020, 1,114 adults were screened, 795 were randomized and 791 treated (397 DTG, 394 baseline PI/r). All participants were black, 66.3% were female, median age was 46 years, and median CD4 count was 423 cells/μl. Grade 2 or higher laboratory abnormalities at baseline included 44.6% with reduced creatinine clearance and 9.7% with elevated lipids. Conclusions: This is the first randomized trial evaluating a switch strategy from PI/r to DTG for virally suppressed adults who have previously failed NNRTI, and is expected to provide critical evidence to inform large HIV programs in sub-Saharan Africa. We found high rates of baseline laboratory abnormalities that were not detected during routine care.

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Penner, J., Ombajo, L., Nkuranga, J., Mecha, J., Owuor, K., Odhiambo, C., Mburu, M., Ndinya, F., Aksam, R., Njenga, R., Wahome, S., Muiruri, P., Eshiwani, S., Kimani, M., Ngugi, C., Pozniak, A. (2022). Switching treatment-experienced, integrase inhibitor-naive, virally suppressed HIV-1 infected adults from ritonavir-boosted protease inhibitors to dolutegravir: design, methods, and baseline results of a randomized, open-label, non-inferiority trial. https://doi.org/10.12688/f1000research.122266.1

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Auteur(s)

Jeremy Penner Loice Achieng Ombajo Joseph Nkuranga Jared Mecha Kevin Owuor Collins Odhiambo Margaret Mburu Florentius Ndinya Rukia Aksam Richard Njenga Simone Wahome Peter Muiruri Sheila Eshiwani Maureen Kimani Catherine Ngugi Anton Pozniak

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