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In this 48 week extension phase, raltegravir was dosed at 1200 mg\/day and lamivudine 300 mg\/day. Primary outcome was the proportion of PWH with treatment failure at Week 48. Secondary outcomes were changes in ultrasensitive plasma HIV RNA, HIV DNA in CD4 cells, serum IL-6, ultrasensitive C-reactive protein and sCD14, body composition, sleep quality, quality of life and adverse effects.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Between May 2018 and June 2019, 33 PWH were enrolled. One participant experienced virological failure without resistance mutations and re-achieved sustained virological suppression without therapy discontinuation, and two others discontinued therapy due to adverse effects. Treatment failure was 9% (95% CI 2%\u201324%) and 3% (95% CI 0%\u201317%) in the ITT and on-treatment populations. There were significant changes between baseline and Week 48 in serum cytokines but not in other secondary outcomes.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Switching to raltegravir and lamivudine in PWH with virological suppression maintains efficacy and is well tolerated. This maintenance regimen might be a cost-effective option for PWH at risk of drug\u2013drug interactions or needing to avoid specific toxicities of certain antiretroviral drugs or their negative impact on comorbidities.<\/jats:p><\/jats:sec>","DOI":"10.1093\/jac\/dkad364","type":"journal-article","created":{"date-parts":[[2023,12,1]],"date-time":"2023-12-01T20:29:48Z","timestamp":1701462588000},"page":"255-261","source":"Crossref","is-referenced-by-count":2,"title":["Efficacy and safety of raltegravir plus lamivudine maintenance therapy"],"prefix":"10.1093","volume":"79","author":[{"given":"Beatriz","family":"Borjabad","sequence":"first","affiliation":[{"name":"Internal Medicine Service, Hospital Moises Broggi , Sant Joan Desp\u00ed , Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alexy","family":"Inciarte","sequence":"additional","affiliation":[{"name":"Infectious Diseases Unit, Hospital Cl\u00ednic, University of Barcelona 08036, Barcelona , 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