{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,22]],"date-time":"2026-10-22T02:29:51Z","timestamp":1792636191198,"version":"4.5.0"},"reference-count":47,"publisher":"MDPI AG","issue":"4","license":[{"start":{"date-parts":[[2023,4,10]],"date-time":"2023-04-10T00:00:00Z","timestamp":1681084800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Viruses"],"abstract":"<jats:p>Background: The high effectiveness and safety of the two-drug (2DRs) strategy using dolutegravir (DTG) plus lamivudine (3TC) have led to international guidelines recommending their use for treatment-naive HIV patients. In virologically suppressed patients, de-escalating from 3DRs to DTG plus either rilpivirine (RPV) or 3TC has shown high rates of virological suppression. Objectives: This study aimed to compare the real-life data of two multicenter Spanish cohorts of PLWHIV treated with DTG plus 3TC (SPADE-3) or RPV (DORIPEX) as a switch strategy, not only in terms of virological suppression, safety, and durability but also in terms of immune restoration. The primary endpoint was the percentage of patients with virological suppression on DTG plus 3TC and DTG plus RPV at weeks 24 and 48. The secondary outcomes included the proportion of patients who experienced the protocol-defined loss of virological control by week 48; changes in immune status in terms of CD4+ and CD8+ T lymphocyte counts and the CD4+\/CD8+ ratio; the rate, incidence, and reasons for discontinuation of treatment over the 48-week study period; and safety profiles at weeks 24 and 48. Methods: We conducted a retrospective, observational, multicenter study of 638 and 943 virologically suppressed HIV-1-infected patients in two cohorts who switched to 2DRs with DTG plus RPV or DTG plus 3TC. Results: The most frequent reasons for starting DTG-based 2DRs were treatment simplification\/pill burden or drug decrease. The virological suppression rates were 96.9%, 97.4%, and 99.1% at weeks 24, 48, and 96, respectively. The proportion of patients with virological failure over the 48-week study period was 0.01%. Adverse drug reactions were uncommon. Patients treated with DTG+3TC increased CD4, CD8, and CD4\/CD8 parameters at 24 and 48 weeks. Conclusions: We conclude that DTG-based 2DRs (combined with 3TC or RPV) in clinical practice were effective and safe as a switching strategy, with a low VF and high viral suppression rates. Both regimens were well tolerated, and ADR rates were low, including neurotoxicity and induced treatment discontinuations.<\/jats:p>","DOI":"10.3390\/v15040936","type":"journal-article","created":{"date-parts":[[2023,4,10]],"date-time":"2023-04-10T05:57:50Z","timestamp":1681106270000},"page":"936","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":15,"title":["Efficacy and Safety of Two-Drug Regimens with Dolutegravir plus Rilpivirine or Lamivudine in HIV-1 Virologically Suppressed People Living with HIV"],"prefix":"10.3390","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8943-1231","authenticated-orcid":false,"given":"Carlos","family":"Due\u00f1as-Guti\u00e9rrez","sequence":"first","affiliation":[{"name":"Infectious Diseases Division, Hospital Universitario Cl\u00ednico de Valladolid, 47003 Valladolid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4847-8014","authenticated-orcid":false,"given":"Luis","family":"Buz\u00f3n","sequence":"additional","affiliation":[{"name":"Infectious Diseases Division, Hospital Universitario de Burgos, 09006 Burgos, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0318-2981","authenticated-orcid":false,"given":"Roberto","family":"Pedrero-Tom\u00e9","sequence":"additional","affiliation":[{"name":"Infanta Leonor University Hospital Research and Innovation Foundation, 28031 Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jos\u00e9 A.","family":"Iribarren","sequence":"additional","affiliation":[{"name":"Infectious Diseases Department, Hospital Universitario de Donostia, 20014 San Sebasti\u00e1n, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7073-5211","authenticated-orcid":false,"given":"Ignacio","family":"De los Santos","sequence":"additional","affiliation":[{"name":"Infectious Diseases Division, Hospital Universitario de La Princesa, 28006 Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sara","family":"De la Fuente","sequence":"additional","affiliation":[{"name":"Infectious Diseases Division, Hospital Universitario Puerta de Hierro, 28222 Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2466-8094","authenticated-orcid":false,"given":"Guillermo","family":"Pousada","sequence":"additional","affiliation":[{"name":"Infectious Diseases Division, Hospital Universitario de Txagorritxu, 01009 Vitoria, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miguel Angel","family":"Moran","sequence":"additional","affiliation":[{"name":"Infectious Diseases Division, Hospital\u00c1lvaro Cunqueiro, 36312 Vigo, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Estela","family":"Moreno","sequence":"additional","affiliation":[{"name":"Infectious Diseases Division, Complejo Hospitalario de Navarra, 31008 Pamplona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eva","family":"Ferreira","sequence":"additional","affiliation":[{"name":"Infectious Diseases Division, Hospital de Segovia, 47002 Segovia, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julia","family":"G\u00f3mez","sequence":"additional","affiliation":[{"name":"Infectious Diseases Division, Hospital Universitario de Salamanca, 37007 Salamanca, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7323-114X","authenticated-orcid":false,"given":"Jes\u00fas","family":"Troya","sequence":"additional","affiliation":[{"name":"Internal Medicine Department, Hospital Universitario Infanta Leonor, 28031 Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2023,4,10]]},"reference":[{"key":"ref_1","unstructured":"Department of Health and Human Services (2021, September 06). 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