{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T05:16:01Z","timestamp":1787030161322,"version":"build-2736575974"},"reference-count":32,"publisher":"MDPI AG","issue":"3","license":[{"start":{"date-parts":[[2022,3,4]],"date-time":"2022-03-04T00:00:00Z","timestamp":1646352000000},"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>Brief: Real-world data in na\u00efve HIV-1 patients demonstrate that dolutegravir plus lamivudine in a multiple tablet regimen is effective, safe, and satisfactory; it causes moderately increasing weight and abdominal circumference and is administrable on a test-and-treat strategy. Background: Our objectives were to determine the real-life effectiveness and safety of DT with dolutegravir (50 mg\/QD) plus lamivudine (300 mg\/QD) in a multiple-tablet regimen (MTR) in na\u00efve PLHIV followed up for 48 weeks and to evaluate the compliance and satisfaction of patients. Material and methods: An open, single-arm, multicenter, non-randomized clinical trial from May 2019 through September 2020 with a 48-week follow-up. Results: The study included 88 PLHIV patients (87.5% male) with a mean age of 35.9 years; 76.1% were MSM patients. The mean baseline CD4 was 516.4 cells\/uL, with a viral load (VL) of 4.49 log10, and 11.4% were in the AIDS stage. DT started within 7 days of first specialist consultation in all patients and the same day in 84.1%; 3.4% had baseline resistance mutations (K103N, V106I + E138A, and V108I); 12.5% were lost to follow-up. At week 48, 86.3% had VL &lt; 50 cop\/uL by intention-to-treat analysis and 98.7% by per-protocol (PP) analysis. Virological failure (VF) was recorded in 1.1%, with no resistance mutation. One blip was detected in 5.2% without VF. Three reported anxiety, dizziness, and cephalgia, respectively, at week 4 and one reported insomnia at week 24; none reported adverse events at week 48. The mean weight was 4 kg higher at 48 weeks (p = 0.0001) and abdominal circumference 3 cm larger at 24 weeks (p = 0.022). No forgetfulness occurred in 98.7% of patients. Patient satisfaction was 90\/100 at 4, 24, and 48 weeks. Conclusion: Real-world data demonstrate that dolutegravir plus lamivudine in MTR is effective, safe, and satisfactory, moderately increasing weight and abdominal circumference and administrable on a test-and-treat strategy.<\/jats:p>","DOI":"10.3390\/v14030524","type":"journal-article","created":{"date-parts":[[2022,3,6]],"date-time":"2022-03-06T20:40:38Z","timestamp":1646599238000},"page":"524","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":20,"title":["DOLAVI Real-Life Study of Dolutegravir Plus Lamivudine in Naive HIV-1 Patients (48 Weeks)"],"prefix":"10.3390","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6394-5728","authenticated-orcid":false,"given":"Carmen","family":"Hidalgo-Tenorio","sequence":"first","affiliation":[{"name":"Unit of Infectious Diseases, Virgen de las Nieves University Hospital, 18014 Granada, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juan","family":"Pasquau","sequence":"additional","affiliation":[{"name":"Unit of Infectious Diseases, Virgen de las Nieves University Hospital, 18014 Granada, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Vinuesa","sequence":"additional","affiliation":[{"name":"Unit of Infectious Diseases, University Hospital San Cecilio, 18016 Granada, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4054-3491","authenticated-orcid":false,"given":"Sergio","family":"Ferra","sequence":"additional","affiliation":[{"name":"Unit of Infectious Diseases, Torrec\u00e1rdenas University Hospital, 04009 Almer\u00eda, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alberto","family":"Terr\u00f3n","sequence":"additional","affiliation":[{"name":"Unit of Infectious Diseases, Hospital de Jerez, 11407 Jerez de la Frontera, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Isabel","family":"SanJoaqu\u00edn","sequence":"additional","affiliation":[{"name":"Unit of Infectious Diseases, Hospital Lozano Blesa, 50009 Zaragoza, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antoni","family":"Payeras","sequence":"additional","affiliation":[{"name":"Internal Medicine Service, Hospital Son Llatzer, 07198 Palma, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Onofre Juan","family":"Mart\u00ednez","sequence":"additional","affiliation":[{"name":"Unit of Infectious Diseases, Hospital Santa Lucia, 30300 Cartagena, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miguel \u00c1ngel","family":"L\u00f3pez-Ruz","sequence":"additional","affiliation":[{"name":"Unit of Infectious Diseases, Virgen de las Nieves University Hospital, 18014 Granada, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohamed","family":"Omar","sequence":"additional","affiliation":[{"name":"Unit of Infectious Diseases, Hospital Complex of Ja\u00e9n, 23007 Ja\u00e9n, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Javier","family":"de la Torre-Lima","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Hospital Costa del Sol, 29603 Marbella, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ana","family":"L\u00f3pez-Lirola","sequence":"additional","affiliation":[{"name":"Unit of Infectious Diseases, University Hospital Canarias, 38320 San Crist\u00f3bal de La Laguna, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jes\u00fas","family":"Palomares","sequence":"additional","affiliation":[{"name":"Internal Medicine Service, Hospital Santa Ana, 18600 Motril, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4268-0150","authenticated-orcid":false,"given":"Jos\u00e9 Ram\u00f3n","family":"Blanco","sequence":"additional","affiliation":[{"name":"Unit of Infectious Diseases, Hospital San Pedro, 26006 Logro\u00f1o, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3432-5394","authenticated-orcid":false,"given":"Marta","family":"Montero","sequence":"additional","affiliation":[{"name":"Service of Infectious Diseases, Hospital de La Fe, 46026 Val\u00e8ncia, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Coral","family":"Garc\u00eda-Vallecillos","sequence":"additional","affiliation":[{"name":"Unit of Infectious Diseases, Virgen de las Nieves University Hospital, 18014 Granada, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2022,3,4]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"1525","DOI":"10.1016\/S0140-6736(13)61809-7","article-title":"The end of AIDS: HIV infection as a chronic disease","volume":"382","author":"Deeks","year":"2013","journal-title":"Lancet"},{"key":"ref_2","doi-asserted-by":"crossref","unstructured":"Zicari, S., Sessa, L., Cotugno, N., Ruggiero, A., Morrocchi, E., Concato, C., and Palma, P. (2019). Immune Activation, Inflammation, and Non-AIDS Co-Morbidities in HIV-Infected Patients under Long-Term ART. Viruses, 11.","DOI":"10.3390\/v11030200"},{"key":"ref_3","first-page":"220","article-title":"Nuke-Sparing Regimens for the Long-Term Care of HIV Infection","volume":"17","author":"Pasquau","year":"2015","journal-title":"AIDS Rev."},{"key":"ref_4","doi-asserted-by":"crossref","unstructured":"Pasquau, J., Hidalgo-Tenorio, C., Montes, M.L., Romero-Palacios, A., Vergas, J., Sanjoaqu\u00edn, I., Hern\u00e1ndez-Quero, J., Aguirrebengoa, K., Orihuela, F., and Imaz, A. (2018). High quality of life, treatment tolerability, safety and efficacy in HIV patients switching from triple therapy to lopinavir\/ritonavir monotherapy: A randomized clinical trial. PLoS ONE, 13.","DOI":"10.1371\/journal.pone.0195068"},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"1689","DOI":"10.1093\/cid\/cix1083","article-title":"ACTG A5353, A Pilot Study of Dolutegravir Plus Lamivudine for Initial Treatment of Human Immunodeficiency Virus-1 (HIV-1)-infected Participants With HIV-1 RNA < 500,000 Copies\/mL","volume":"66","author":"Taiwo","year":"2018","journal-title":"Clin. Infect. Dis."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"21678","DOI":"10.7448\/IAS.20.01.21678","article-title":"Dolutegravir-lamivudine as initial therapy in HIV-1 infected, ARV-naive patients, 48-week results of the PADDLE (Pilot Antiretroviral Design with Dolutegravir LamivudinE) study","volume":"20","author":"Cahn","year":"2017","journal-title":"J. Int. AIDS Soc."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"839","DOI":"10.1016\/S0140-6736(17)33095-7","article-title":"Efficacy, safety, and tolerability of dolutegravir-rilpivirine for the maintenance of virological suppression in adults with HIV-1, phase 3, randomised, non-inferiority SWORD-1 and SWORD-2 studies","volume":"391","author":"Llibre","year":"2018","journal-title":"Lancet"},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"2325958218760847","DOI":"10.1177\/2325958218760847","article-title":"Safety and Efficacy of Dolutegravir Plus Rilpivirine in Treatment-Experienced HIV-Infected Patients: The DORIVIR Study","volume":"17","author":"Palacios","year":"2018","journal-title":"J. Int. Assoc. Provid. AIDS Care"},{"key":"ref_9","doi-asserted-by":"crossref","unstructured":"Pasquau, J., de Jesus, S.E., Arazo, P., Crusells, M.J., R\u00edos, M.J., Lozano, F., de la Torre, J., Galindo, M.J., Carmena, J., and Santos, J. (2019). Effectiveness and safety of dual therapy with rilpivirine and boosted darunavir in treatment-experienced patients with advanced HIV infection: A preliminary 24 week analysis (RIDAR study). BMC Infect. Dis., 19.","DOI":"10.1186\/s12879-019-3817-6"},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"e16813","DOI":"10.1097\/MD.0000000000016813","article-title":"DOLAMA study: Effectiveness, safety and pharmacoeconomic analysis of dual therapy with dolutegravir and lamivudine in virologically suppressed HIV-1 patients","volume":"98","author":"Santos","year":"2019","journal-title":"Medicine"},{"key":"ref_11","doi-asserted-by":"crossref","unstructured":"Borghetti, A., Lombardi, F., Gagliardini, R., Baldin, G., Ciccullo, A., Moschese, D., Emiliozzi, A., Belmonti, S., Lamonica, S., and Montagnani, F. (2019). Efficacy and tolerability of lamivudine plus dolutegravir compared with lamivudine plus boosted PIs in HIV-1 positive individuals with virologic suppression: A retrospective study from the clinical practice. BMC Infect. Dis., 19.","DOI":"10.1186\/s12879-018-3666-8"},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"1461","DOI":"10.1093\/jac\/dkz009","article-title":"Virological efficacy of dual therapy with lamivudine and dolutegravir in HIV-1-infected virologically suppressed patients: Long-term data from clinical practice","volume":"74","author":"Baldin","year":"2019","journal-title":"J. Antimicrob. Chemother."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"1920","DOI":"10.1093\/cid\/ciz1243","article-title":"Efficacy and Safety of Switching to Dolutegravir\/Lamivudine Fixed-Dose 2-Drug Regimen vs Continuing a Tenofovir Alafenamide\u2013Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living with Human Immunodeficiency Virus Type 1, Phase 3, Randomized, Noninferiority TANGO Study","volume":"71","author":"Ajana","year":"2020","journal-title":"Clin. Infect. Dis."},{"key":"ref_14","unstructured":"Llibre, J.M., Brites, C.A., Cheng, C.Y., Osiyemi, O., Galera, C., Hocqueloux, L., Maggiolo, F., Degen, O., Blair, L., and Wynne, B. (2021, January 18\u201321). Switching to the 2-drug regimen of dolutegravir\/lamivudine (DTG\/3TC) fixed-dose combination (FDC) is non-inferior to continuing a 3-drug regimen through 24 weeks in a randomized clinical trial (SALSA). Proceedings of the IAS 2021, 11th IAS Conference on HIV Science, Berlin, Germany."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"143","DOI":"10.1016\/S0140-6736(18)32462-0","article-title":"Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 and GEMINI-2): Week 48 results from two multicentre, double-blind, randomised, non-inferiority, phase 3 trials","volume":"393","author":"Cahn","year":"2019","journal-title":"Lancet"},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"39","DOI":"10.1097\/QAD.0000000000003070","article-title":"Three-year durable efficacy of dolutegravir plus lamivudine in antiretroviral therapy-naive adults with HIV-1 infection","volume":"36","author":"Cahn","year":"2022","journal-title":"AIDS"},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"1033","DOI":"10.1002\/pds.4297","article-title":"Good practices for real-world data studies of treatment and\/or comparative effectiveness: Recommendations from the joint ISPOR-ISPESpecial Task Force on real-world evidence in health care decision making","volume":"26","author":"Berger","year":"2017","journal-title":"Pharmacoepidemiol. Drug Saf."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"127","DOI":"10.1007\/s40258-017-0310-5","article-title":"EQ-5D and the EuroQol Group: Past, Present and Future","volume":"15","author":"Devlin","year":"2017","journal-title":"Appl. Health Econ. Health Policy"},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"605","DOI":"10.1097\/00002030-200203080-00012","article-title":"GEEMA Study Group Validation of a simplified medication adherence questionnaire in a large cohort of HIV-infected patients: The GEEMA Study","volume":"16","author":"Knobel","year":"2002","journal-title":"AIDS"},{"key":"ref_20","first-page":"81","article-title":"How much sholud I weigh? Quetelet\u00b4s equation, upper weight limits, and BMI prime","volume":"70","author":"Gadzik","year":"2006","journal-title":"Conn. Med."},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"803","DOI":"10.1093\/jac\/dkl092","article-title":"HIV-1 viral load blips are of limited clinical significance","volume":"57","author":"Lee","year":"2006","journal-title":"J. Antimicrob. Chemother."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"1230","DOI":"10.1093\/infdis\/jis104","article-title":"Magnitude of virologic blips is associated with a higher risk for virologic rebound in HIV-infected individuals: A recurrent events analysis","volume":"205","author":"Grennan","year":"2012","journal-title":"J. Infect. Dis."},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"3110","DOI":"10.1093\/cid\/ciz1213","article-title":"Darunavir\/ Cobicistat\/ Emtricitabine\/Tenofovir Alafenamide in a Rapid-Initiation Model of Care for Human Immunodeficiency Virus Type 1 Infection: Primary Analysis of the DIAMOND Study","volume":"71","author":"Huhn","year":"2020","journal-title":"Clin. Infect. Dis."},{"key":"ref_24","unstructured":"Rolle, C.P., Berhe, M., Singh, T., Ortiz, R., Wurapa, A., Ramgopal, M., Leone, P.A., Matthews, J.E., Dalessandro, M., and Underwood, M.R. (2021, January 18\u201321). Feasibility, efficacy, and safety of dolutegravir\/lamivudine (dtg\/3tc) as a first-line regimen in a test-and-treat setting for newly diagnosed people living with hiv (plwh): 48-week results of the stat study. Proceedings of the 11th IAS Conference on HIV Science, Berlin, Germany."},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"17","DOI":"10.1097\/QAD.0000000000001671","article-title":"Benefits and risks of rapid initiation of antiretroviral therapy","volume":"32","author":"Ford","year":"2018","journal-title":"AIDS"},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"2501","DOI":"10.1093\/jac\/dkab168","article-title":"Redefining therapeutic success in HIV patients: An expert view","volume":"76","author":"Antela","year":"2021","journal-title":"J. Antimicrob. Chemother."},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"825","DOI":"10.1097\/QAD.0000000000002124","article-title":"RAPID antiretroviral therapy: High virologic suppression rates with immediate antiretroviral therapy initiation in a vulnerable urban clinic population","volume":"33","author":"Coffey","year":"2019","journal-title":"AIDS"},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"1103","DOI":"10.1001\/jama.2018.1818","article-title":"Effect of Offering Same-Day ART vs Usual Health Facility Referral During Home-Based HIV Testing on Linkage to Care and Viral Suppression Among Adults with HIV in Lesotho: The CASCADE Randomized Clinical Trial","volume":"319","author":"Labhardt","year":"2018","journal-title":"JAMA"},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"44","DOI":"10.1097\/QAI.0000000000001134","article-title":"The Effect of Same-Day Observed Initiation of Antiretroviral Therapy on HIV Viral Load and Treatment Outcomes in a US Public Health Setting","volume":"74","author":"Pilcher","year":"2017","journal-title":"J. Acquir. Immune Defic. Syndr."},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"486","DOI":"10.1089\/aid.2020.0276","article-title":"Short Communication: Efficacy and Safety of Dolutegravir Plus Lamivudine as a First-Line Regimen in Clinical Practice","volume":"37","author":"Cicculo","year":"2021","journal-title":"AIDS Res. Hum. Retrovir."},{"key":"ref_31","doi-asserted-by":"crossref","first-page":"794","DOI":"10.1097\/QAI.0000000000002655","article-title":"Brief Report: Improvement in Metabolic Health Parameters at Week 48 After Switching From a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen to the 2-Drug Regimen of Dolutegravir\/Lamivudine: The TANGO Study","volume":"87","author":"Santos","year":"2021","journal-title":"J. Acquir. Immune. Defic. Syndr."},{"key":"ref_32","doi-asserted-by":"crossref","first-page":"10","DOI":"10.1097\/QCO.0000000000000616","article-title":"Weight gain and integrase inhibitors","volume":"33","author":"Eckard","year":"2020","journal-title":"Curr. Opin. Infect. Dis."}],"container-title":["Viruses"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/1999-4915\/14\/3\/524\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T22:31:50Z","timestamp":1760135510000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/1999-4915\/14\/3\/524"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,3,4]]},"references-count":32,"journal-issue":{"issue":"3","published-online":{"date-parts":[[2022,3]]}},"alternative-id":["v14030524"],"URL":"https:\/\/doi.org\/10.3390\/v14030524","relation":{"has-preprint":[{"id-type":"doi","id":"10.20944\/preprints202202.0134.v1","asserted-by":"object"}]},"ISSN":["1999-4915"],"issn-type":[{"value":"1999-4915","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,3,4]]}}}