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Background Tenofovir/lamivudine/dolutegravir (TLD) is the preferred first-line antiretroviral therapy (ART) regimen for people with HIV (PWH), including those who were previously virologically suppressed on nonnucleoside reverse transcriptase inhibitors (NNRTIs). We sought to estimate the real-world effectiveness of the TLD transition in Ugandan public-sector clinics. Methods We conducted a prospective cohort study of PWH aged ≥18 years who were transitioned from NNRTI-based ART to TLD. Study visits were conducted on the day of TLD transition and 24 and 48 weeks later. The primary end point was viral suppression (<200 copies/mL) at 48 weeks. We collected blood for retrospective viral load (VL) assessment and conducted genotypic resistance tests for specimens with VL >500 copies/mL. Results We enrolled 500 participants (median age 47 years; 41% women). At 48 weeks after TLD transition, 94% of participants were in care with a VL <200 copies/mL (n = 469/500); 2% (n = 11/500) were lost from care or died; and only 2% (n = 9/500) had a VL >500 copies/mL. No incident resistance to DTG was identified. Few participants (2%, n = 9/500) discontinued TLD due to adverse events. Conclusions High rates of viral suppression, high tolerability, and lack of emergent drug resistance support use of TLD as the preferred first-line regimen in the region. Clinical Trials Registration NCT04066036. [ABSTRACT FROM AUTHOR]

Background In 2019, the World Health Organization (WHO) recommended combined tenofovir disoproxil fumarate, lamivudine, and dolutegravir (TLD) as the preferred first-line regimen for adults and adolescents with human immunodeficiency virus (HIV), regardless of childbearing status. Nevertheless, final eligibility is determined by local policies, which may vary from WHO recommendations. We examined TLD transition by sex across 5 HIV care programs in sub-Saharan Africa supported by the United States President's Emergency Plan for AIDS Relief (PEPFAR) Methods The African Cohort Study (AFRICOS) enrolls people with HIV engaged in care in Uganda, Kenya (South Rift Valley and Kisumu West), Tanzania, and Nigeria. People with HIV with ≥1 study visit after the country introduced TLD were included. We generated Kaplan-Meier curves to compare TLD transition by sex from (1) the time countries introduced TLD and (2) the time of TLD eligibility according to local policies. Results Among 2476 participants enrolled through September 2021 at 4 sites in sub-Saharan Africa and eligible to transition to TLD, fewer women (68%) than men (80%; P <.001) were taking TLD. Kaplan-Meier analysis showed that time to transition varied by site, with women in Tanzania transitioning at the same rate as men. In Nigeria, women initially had a slower transition but caught up to men. After adjustment for local policies, women in Kisumu West transitioned at the same rate as men. In South Rift Valley and Uganda, women were less likely to be transitioned. Conclusions Although TLD has been the WHO's preferred regimen since 2019, transition of women to potentially lifesaving TLD has been slower than for men at certain clinical sites, even after accounting for local eligibility criteria. [ABSTRACT FROM AUTHOR]