• Loice A Ombajo, Jeremy Penner, Joseph Nkuranga, Jared Mecha, Margaret Mburu, Collins Odhiambo, Florentius Ndinya, Rukia Aksam, Richard Njenga, Simon Wahome, Peter Muiruri, Sheila Eshiwani, Maureen Kimani, Catherine Ngugi, and Anton Pozniak.
• From the Department of Clinical Medicine and Therapeutics (L.A.O., J.P., J.N., J.M., M.M., C.O.) and the Center for Epidemiological Modeling and Analysis (L.A.O.), University of Nairobi, the Institute of Mathematical Sciences, Strathmore University (C.O.), Kenyatta National Hospital (R.N., S.W., P.M., S.E.), and the National AIDS and STI Control Program, Ministry of Health (M.K., C.N.), Nairobi, and Jaramogi Oginga Odinga Teaching and Referral Hospital, Kisumu (F.N., R.A.) - all in Kenya; the Department of Family Practice, University of British Columbia, Vancouver, Canada (J.P.); and the London School of Hygiene and Tropical Medicine and Chelsea and Westminster Hospital, London (A.P.).
• N. Engl. J. Med. 2023 Jun 22; 388 (25): 234923592349-2359.

BackgroundData to inform the switch from a ritonavir-boosted protease inhibitor (PI) to dolutegravir in patients living with human immunodeficiency virus (HIV) infection who do not have genotype information and who have viral suppression with second-line therapy containing a ritonavir-boosted PI have been limited.MethodsIn a prospective, multicenter, open-label trial conducted at four sites in Kenya, we randomly assigned, in a 1:1 ratio, previously treated patients without genotype information who had viral suppression while receiving treatment containing a ritonavir-boosted PI to either switch to dolutegravir or continue the current regimen. The primary end point was a plasma HIV type 1 RNA level of at least 50 copies per milliliter at week 48, assessed on the basis of the Food and Drug Administration snapshot algorithm. The noninferiority margin for the between-group difference in the percentage of participants who met the primary end point was 4 percentage points. Safety up to week 48 was assessed.ResultsA total of 795 participants were enrolled, with 398 assigned to switch to dolutegravir and 397 assigned to continue taking their ritonavir-boosted PI; 791 participants (397 in the dolutegravir group and 394 in the ritonavir-boosted PI group) were included in the intention-to-treat exposed population. At week 48, a total of 20 participants (5.0%) in the dolutegravir group and 20 (5.1%) in the ritonavir-boosted PI group met the primary end point (difference, -0.04 percentage points; 95% confidence interval, -3.1 to 3.0), a result that met the criterion for noninferiority. No mutations conferring resistance to dolutegravir or the ritonavir-boosted PI were detected at the time of treatment failure. The incidence of treatment-related grade 3 or 4 adverse events was similar in the dolutegravir group and the ritonavir-boosted PI group (5.7% and 6.9%, respectively).ConclusionsIn previously treated patients with viral suppression for whom there were no data regarding the presence of drug-resistance mutations, dolutegravir treatment was noninferior to a regimen containing a ritonavir-boosted PI when the patients were switched from a ritonavir-boosted PI-based regimen. (Funded by ViiV Healthcare; 2SD ClinicalTrials.gov number, NCT04229290.).Copyright © 2023 Massachusetts Medical Society.

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