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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]

: Introduction: We conducted a cohort study to understand patterns of anti‐retroviral therapy (ART) adherence during pregnancy, postpartum and non‐pregnancy follow‐up among women initiating ART in public clinics offering Option B+ in rural Uganda and urban South Africa. Methods: We collected survey data, continuously monitored ART adherence (Wisepill), HIV‐RNA and pregnancy tests at zero, six and twelve months from women initiating ART in Uganda and South Africa, 2015 to 2017. The primary predictor of interest was follow‐up time categorized as pregnant (pregnancy diagnosis to pregnancy end), postpartum (pregnancy end to study exit) or non‐pregnancy‐related (neither pregnant nor postpartum). Fractional regression models included demographics and socio‐behavioural factors informed by the Behavioral Model for Vulnerable Populations. We evaluated HIV‐RNA at 12 months by ever‐ versus never‐pregnant status. Results: In Uganda, 247 women contributed 676, 900 and 1274 months of pregnancy, postpartum and non‐pregnancy‐related follow‐up. Median ART adherence was consistently ≥90%: pregnancy, 94% (interquartile range [IQR] 78,98); postpartum, 90% (IQR 70,97) and non‐pregnancy, 90% (IQR 80,98). Poorer adherence was associated with younger age (0.98% [95% CI 0.33%, 1.62%] average increase per year of age) and higher CD4 cell count (1.01% [0.08%, 1.94%] average decrease per 50 cells/mm[sup.3]). HIV‐RNA was suppressed among 91% (N = 135) ever‐pregnant and 86% (N = 85) never‐pregnant women. In South Africa, 190 women contributed 259, 624 and 1247 months of pregnancy, postpartum and non‐pregnancy‐related follow‐up. Median adherence was low during pregnancy, 74% (IQR 31,96); postpartum, 40% (IQR 4,65) and non‐pregnancy, 77% (IQR 47,92). Poorer adherence was associated with postpartum status (22.3% [95%CI 8.6%, 35.4%] average decrease compared to non‐pregnancy‐related follow‐up) and less emotional support (1.4% [0.22%, 2.58%] average increase per unit increase). HIV‐RNA was suppressed among 57% (N = 47) ever‐pregnant and 86% (N = 93) never‐pregnant women. Conclusions: Women in rural Uganda maintained high adherence with 91% of ever‐pregnant and 86% of never‐pregnant women suppressing HIV‐RNA at 12 months. Women in urban South Africa struggled with adherence, particularly during postpartum follow‐up with median adherence of 40% and 57% of women with HIV‐RNA suppression at one year, suggesting a crisis for postpartum women with HIV in South Africa. Findings suggest that effective interventions should promote emotional support., INTRODUCTION In 2013, the WHO updated guidelines for prevention of mother to child transmission of HIV (PMTCT) to recommend antiretroviral treatment (ART) for pregnant or breastfeeding women living with HIV [...]