Dolutegravir in real life: Self‐reported mental and physical health outcomes after transitioning from efavirenz‐ to dolutegravir‐based antiretroviral therapy in a prospective cohort study in Lesotho

Introduction HIV programmes across many countries in Africa have recently transitioned people living with HIV from efavirenz (EFV)‐ to dolutegravir (DTG)‐containing antiretroviral therapy (ART). As both drugs are associated with neuropsychiatric adverse effects, this study assessed the mental health and HIV/ART‐associated symptoms of people living with HIV before and after transition to DTG. Methods The prospective DO‐REAL cohort enrolled people starting DTG‐based ART in Lesotho from February to December 2020. For this analysis within DO‐REAL, we included adults changing from tenofovir disoproxil fumarate (TDF)/lamivudine (3TC)/EFV to TDF/3TC/DTG within first‐line therapy. At transition and 16 weeks thereafter, participants completed the Patient Health Questionnaire‐9 (PHQ‐9; depression screening), the 12‐item Short‐Form Health Survey (SF‐12; mental and physical health), and a modified HIV Symptom Index (mHSI; HIV/ART‐related symptoms). We also assessed weight change. We used McNemar tests with Bonferroni corrections to assess binary outcomes. ClinicalTrials.gov: NCT04238767. Results Among 1228 participants, 1131 completed follow‐up. Of these, 60.0% were female, the median age was 46 years (interquartile range [IQR] 38–55), and the median time taking ART was 5.7 years (IQR 3.5–8.9). No change was observed for weight or overall PHQ‐9 or SF‐12 outcomes. However, three mHSI items decreased at follow‐up: ‘feeling sad/down/depressed’ (bothered 6.0% vs. 3.3% of participants at least ‘a little’ before vs. after transition; adjusted p = 0.048); ‘feeling nervous/anxious’ (7.4% vs. 3.4%; adjusted p = 0.0009); and ‘nightmares, strange/vivid dreams’ (6.3% vs. 3.5%; adjusted p = 0.027). Individual PHQ‐9 or SF‐12 items also improved. Being symptom free across all measures increased from 5.1% to 11.4% (p