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INTRODUCTION: Dolutegravir/lamivudine (DTG/3TC) was first approved by the US Food and Drug Administration in 2019 for the treatment of antiretroviral therapy (ART)-naive people with HIV-1 based on results from the pivotal GEMINI-1/GEMINI-2 trials. Around that time, immediate initiation of treatment upon diagnosis was recommended in the US Department of Health and Human Services guidelines. Here we report results from 126 treatment-naive people with HIV-1 who initiated DTG/3TC as part of a test-and-treat strategy (n = 61) or with high baseline viral loads (HIV-1 RNA ≥ 100,000 copies/ml; n = 16) from the TANDEM study. METHODS: TANDEM was a US-based, retrospective chart review study that included a cohort of 126 individuals aged ≥ 18 years with no prior history of ART who initiated DTG/3TC before September 30, 2020, and had ≥ 6 months of follow-up. Test-and-treat was defined as ART initiation shortly after diagnosis without available viral load, CD4 + cell count, or HIV-1 resistance data. Outcomes included virologic suppression (HIV-1 RNA < 50 copies/ml; overall and by baseline viral load) and discontinuations. Analyses were descriptive. RESULTS: Among 61 individuals who initiated DTG/3TC in a test-and-treat setting (median [interquartile range (IQR)] treatment duration, 1.3 [0.9-1.7] years), 57 (93%) achieved virologic suppression, and 51 (84%) remained suppressed; 1 (< 1%) individual discontinued DTG/3TC due to persistent low-level viremia. The most common healthcare provider (HCP)-reported reason for initiating DTG/3TC was avoidance of long-term toxicities among individuals in the test-and-treat subgroup. Of 16 treatment-naive individuals with high baseline viral loads (median [IQR] treatment duration, 100,000-250,000 copies/ml: 1.2 [0.8-1.8] years; > 250,000 copies/ml: 1.0 [0.7-1.1] years), 14 (88%) achieved virologic suppression, 13 (81%) remained suppressed, and none discontinued DTG/3TC. Patient preference was the most common HCP-reported reason for initiating DTG/3TC in this subgroup. CONCLUSIONS: Results demonstrate real-world effectiveness of DTG/3TC, with few discontinuations, in people with HIV-1 in test-and-treat settings or with high baseline viral loads.
RESUMO
Background Advances in antiretroviral therapy (ART) enable people with HIV to live longer, healthier lives. However, older people with HIV (OPWH) are more susceptible to long-term toxicity and drug interactions associated with ART. Racial and ethnic minorities have specific social determinants of health, which increase their risks of negative outcomes. Objective To determine if there were differences in the safety and effectiveness of ART in White, Black, and Hispanic OPWH. Methods A retrospective observational study was conducted on patients receiving care between January 1, 2017, and December 31, 2022, at two affiliated HIV clinics in South Florida. The primary effectiveness endpoint was the percentage of OPWH with undetectable viral load (< 50 copies/mL) throughout the study. Secondary safety endpoints were changes in median metabolic, hepatic, and renal parameters. A two-way analysis of variance or the Chi-square test was used to determine differences between groups. Results A total of 116 White, 42 Black, and 40 Hispanic OPWH were included. Upon enrollment, most patients (90.7%) were receiving ART. Of these, the percentage with undetectable viral load was lower among Black (61.8%) compared with White (85.8%; P < 0.01) or Hispanic (83.3%; P < 0.05) patients. Similarly, throughout the study after the first visit, the percentage with undetectable viral load was lower among Black (61.6%) compared with White (84.7%; P < 0.05) or Hispanic (83.3%; P = 0.12) patients. However, there were no significant differences in the percentage of virally suppressed (< 200 copies/mL) participants throughout the study after the first visit between Black (88.5%), White (94.9%), and Hispanic (96.7%) patients. Additionally, no significant changes in safety endpoints were observed among the groups throughout the study. Conclusion Fewer Black OPWH had undetectable viral load upon enrollment and throughout the study compared with White or Hispanic OPWH, suggesting the need to provide more targeted interventions for Black patients.
