Doravirine/Islatravir (100/0.75 mg) Once-Daily Compared With Bictegravir/Emtricitabine/Tenofovir Alafenamide as Initial Human Immunodeficiency Virus Type 1 Treatment: 48-Week Results From a Phase 3, Randomized, Controlled, Double-Blind, Noninferiority Trial

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dc.contributor.authorRockstroh, Jürgen K.
dc.contributor.authorParedes, Roger
dc.contributor.authorCahn, Pedro
dc.contributor.authorMolina, Jean-Michel
dc.contributor.authorSokhela, Simiso M.
dc.contributor.authorHinestrosa, Federico
dc.contributor.authorKassim, Sheetal
dc.contributor.authorCunningham, Douglas
dc.contributor.authorGhosn, Jade
dc.contributor.authorBogner, Johannes R.
dc.contributor.authorGatanaga, Hiroyuki
dc.contributor.authorAsante-Appiah, Ernest
dc.contributor.authorZhang, Ying
dc.contributor.authorNwoke, Uchechukwu
dc.contributor.authorKlopfer, Stephanie O.
dc.contributor.authorEves, Karen
dc.contributor.authorSquires, Kathleen
dc.contributor.authorCorrell, Todd
dc.contributor.authorFox, Michelle C.
dc.contributor.authorPisculli, Mary L.
dc.date.accessioned2025-04-03T22:11:01Z
dc.date.available2025-04-03T22:11:01Z
dc.date.issued2025-03-13
dc.description.abstractBackground Doravirine/islatravir is an investigational regimen that is being studied for human immunodeficiency virus type 1 (HIV-1) treatment. Methods In this phase 3, double-blind, double-dummy trial (ClinicalTrials.gov NCT04233879), previously untreated adults with HIV-1 were randomized (1:1) and stratified by HIV-1 RNA (≤/>100 000 copies/mL) and CD4 count (</≥200 cells/μL) to doravirine/islatravir (100/0.75 mg) or bictegravir/emtricitabine/tenofovir alafenamide (50/200/25 mg) orally once-daily (primary endpoint: percentage of participants with HIV-1 RNA <50 copies/mL at week 48; US Food and Drug Administration snapshot, 10% noninferiority margin). Results Overall, 597 participants were treated; enrollment stopped early due to decreases in CD4 and lymphocyte counts observed in other islatravir studies. Doravirine/islatravir was noninferior to bictegravir/emtricitabine/tenofovir alafenamide: 265 of 298 (88.9%) versus 264 of 299 (88.3%) had HIV-1 RNA <50 copies/mL (difference, 0.5%; 95% confidence interval [CI]: −4.7, 5.6). Mean change from baseline in CD4 count was +182 and +234 cells/μL (difference, −50; 95% CI: −79, −21) with doravirine/islatravir versus bictegravir/emtricitabine/tenofovir alafenamide. Mean change in lymphocyte count was 0.01 and 0.21 × 109/L (difference, −0.20; 95% CI: −0.30, −0.10). Adverse events (AEs) occurred in 90.6% and 87.3% of participants, with coronavirus disease 2019 being most common (14.1%, 16.4%). Treatment-related AEs were similar (28.9%, 25.8%). AEs that led to discontinuations were higher with doravirine/islatravir (8.7%, 3.7%) due to protocol-specified criteria that required discontinuation for decreased CD4 and lymphocyte counts. Conclusions Doravirine/islatravir (100/0.75 mg) once-daily was noninferior to bictegravir/emtricitabine/tenofovir alafenamide through week 48 for initial HIV-1 treatment. Due to decreases in CD4 and lymphocyte counts, development of this dose of doravirine/islatravir was stopped.
dc.identifier.citationJürgen K Rockstroh, Roger Paredes, Pedro Cahn, Jean-Michel Molina, Simiso M Sokhela, Federico Hinestrosa, Sheetal Kassim, Douglas Cunningham, Jade Ghosn, Johannes R Bogner, Hiroyuki Gatanaga, Ernest Asante-Appiah, Ying Zhang, Uchechukwu Nwoke, Stephanie O Klopfer, Karen Eves, Kathleen Squires, Todd Correll, Michelle C Fox, Mary L Pisculli, Doravirine/Islatravir (100/0.75 mg) Once-Daily Compared With Bictegravir/Emtricitabine/Tenofovir Alafenamide as Initial Human Immunodeficiency Virus Type 1 Treatment: 48-Week Results From a Phase 3, Randomized, Controlled, Double-Blind, Noninferiority Trial, Clinical Infectious Diseases, 2025;, ciaf077, https://doi.org/10.1093/cid/ciaf077
dc.identifier.otherhttps://doi.org/10.1093/cid/ciaf077
dc.identifier.urihttps://repositorio.huesped.org.ar/handle/123456789/1448
dc.language.isoen
dc.publisherOxford University Press
dc.relation.ispartofseriesClinical Infectious Diseases
dc.titleDoravirine/Islatravir (100/0.75 mg) Once-Daily Compared With Bictegravir/Emtricitabine/Tenofovir Alafenamide as Initial Human Immunodeficiency Virus Type 1 Treatment: 48-Week Results From a Phase 3, Randomized, Controlled, Double-Blind, Noninferiority Trial
dc.typeArticle

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