Virologic outcomes among people living with HIV on dolutegravir-based antiretroviral therapy in Kenya, 2018–2024: a comparison retrospective longitudinal analysis

Background Long-term virologic outcome data of tenofovir fumarate disoproxil-lamivudine-dolutegravir (TLD) versus tenofovir fumarate disoproxil-lamivudine-efavirenz (TLE) from resource-constrained settings remain limited. This study evaluates virologic suppression (VS) among people living with HIV (PLWH) ≥15 years in Kenya following TLD introduction in 2019. Methods We analyzed Kenya's National AIDS and STIs Control Programme data (2018–2024) including ART-naïve and treatment-experienced PLWH initiating TLD (TLD1), transitioning to TLD (TLD2), or initiating TLE (TLE1). Outcomes included virologic suppression (VS: <1000 copies/mL)–including undetectable (UD: <50 copies/mL), durable undetectable (durable UD: <50 copies/mL for the three most recent results), and low-level viremia (LLV: 50–999 copies/mL), viral load non-suppression (VLNS: ≥1000 copies/mL), and virologic failure (VF: ≥2 consecutive VLNS). We fit logistic regression models to assess associations with virologic outcomes. Findings Among 1,072,209 PLWH records, 758,398 (70.7%) had ≥1 VL. VS was highest in TLD2 (96.3–97.1%), followed by TLD1 (94.4–96.2%) and TLE1 (91.1–92.7%). Long-term VS (at 24–36 months) exceeded 95% for TLD1 and TLD2 but remained approximately 92% for TLE1 (p < 0.0001). Durable UD was higher in TLD2 (aOR) 1.95 [95% CI 1.88–2.01] and TLD1 (aOR 1.56 [95% CI 1.51–1.61]; p < 0.0001) versus TLE1, even with initial VLNS: TLD1 (aOR 2.31 [95% CI 1.94–2.76] and TLD2 aOR 2.39 [95% CI 2.00–2.85]). Even with initial VS, adolescents (15–19 years) had higher odds of VF: females aOR 2.07 [95% CI 1.49–2.87] and males aOR 5.39 [95% CI 3.64–7.98]. Pre-transition and initial LLV increased the risk of post-transition VLNS (aOR 1.51 [95% CI 1.42–1.60]; p < 0.0001) and VF, highest at 500–999 copies/mL (aOR 3.88 [95% CI 3.33–4.53]; p < 0.0001). Interpretation Kenya's ART optimization with TLD was associated with superior outcomes compared to TLE, with higher early and sustained VS, better re-suppression post-VF, and improved durability of UD. Targeted interventions are needed for adolescents, those with LLV, and higher pre-transition VL to enhance long-term virologic control and end HIV as a public health threat. Funding No specific funding was received for the analysis. HIV program support was provided by the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) through the CDC.