Dolutegravir plus lamivudine for initial treatment of HIV-1-infected participants with HIV-1 RNA <500 000 copies/mL: week 48 outcomes from ACTG 5353
Year: 2018
Type: article
Abstract: BACKGROUND: The AIDS Clinical Trials Group study A5353 demonstrated the efficacy and safety of dolutegravir and lamivudine for initial treatment of HIV-1 infection at week 24 in individuals with HIV-1 RNA 1000-500 000 copies/mL. Optimal ART for treatment-naive individuals must be durable. OBJECTIVES: The aim of this study was to estimate the efficacy and safety of dolutegravir plus lamivudine at week 48 and compare the efficacy in participants with baseline HIV-1 RNA ≤100 000 copies/mL versus >100 000 copies/mL. METHODS: Virological success was defined as HIV-1 RNA <50 copies/mL by FDA Snapshot criteria. Definition of virological failure included confirmed HIV-1 RNA >200 copies/mL at week 24 or later. The proportion of participants with virological success was estimated using two-sided exact Clopper-Pearson 95% CI. Comparison between screening HIV-1 RNA (≤100 000 versus >100 000 copies/mL) strata was carried out by Fisher's exact test. The study was registered with ClinicalTrials.gov, number NCT02582684. RESULTS: A total of 120 enrolled eligible participants were included in the analysis. At week 48, 102 of the 120 participants (85%; 95% CI 77%-91%) had virological success. Virological success was similar between screening HIV-1 RNA groups. Six (5%) participants had virological non-success and one additional participant experienced virological failure while on study but off study treatment. No new drug resistance mutations were observed. Six (5%) participants had study-related grade 3 or higher adverse events and none discontinued study treatment. CONCLUSIONS: These results add to the evidence that dolutegravir plus lamivudine is a safe and effective option for initial ART in individuals with HIV-1 RNA <500 000 copies/mL.
DOI: 10.1093/jac/dky564
Authors: Amesika N Nyaku, Lu Zheng, Roy M Gulick, Maxine Olefsky, Baiba Berzins, Carole L Wallis, Catherine Godfrey, Paul E Sax, Edward P Acosta, David W Haas, Kimberly Y Smith, Beverly E Sha, Cornelius N Van Dam, Babafemi O Taiwo, ACTG A5353 Study Team, Elizabeth Hawkins, Johnstone Kumwenda, Angel Hernandez, Belinda Ha, Bernadette Jarocki, Gerald Tegha, Tanisha Sullivan
Institutions: Rutgers, The State University of New Jersey, Harvard University, Weill Cornell Medicine, Northwestern University, Lancet Laboratories, National Institute of Allergy and Infectious Diseases, Brigham and Women's Hospital, University of Alabama at Birmingham, Meharry Medical College, Vanderbilt University, Rush University Medical Center, Cone Health
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
Awards: G1032411263, G1050281965, G1118287939, G1125781002, G1225594167, G183157880, G185513119, Vanderbilt HIV Clinical Trials Unit, G2127051194, G215709867, G2268686290, G2501702145, G2737559749, Cornell Clinical Trials Unit, UCLA Clinical and Translational Science Institute, G3441327761, G374818150, G375632836, G3922356, North Carolina Translational & Clinical Sciences Institute (NC TraCS), G4099673573, Harvard Medical School Vaccine Clinical Trials Unit, G4553935269, G5046654427, Integrated University of Puerto Rico Clinical Trials Unit, G5469398932, G547379174, UCSD Department of Medicine HIV/AIDS Clinical Trials Unit, G681742546, UCLA Center for AIDS Research (CFAR), G857487509, G867868940, G876475942, G878552033, G9000039438, G9000047228, G9000182931, G9000292181, Clinical and Translational Science Center, Vanderbilt Institute for Clinical and Translational Research (VICTR), AIDS Clinical Trial Group Laboratory Center, Center for AIDS Research at Emory University, The University of North Carolina Center for AIDS Research, Columbia Collaborative HIV/AIDS Clinical Trials Unit, University of North Carolina Global HIV Prevention and Treatment Clinical Trials Unit, G926868656, G95160140, G961682679
OpenAlex ID: W2909810032