Sex Differences in Patient‐Reported Outcomes Among People Living With HIV Switching to an Oral Dual Therapy: Results From the PROBI Study

Introduction Socioeconomic, behavioral, and psychosocial factors—beyond just biological and hormonal factors—drive sex differences in HIV outcomes. The PROBI study evaluated treatment acceptability, perceived toxicity, and health‐related quality of life (HRQL) among people living with HIV (PLWH) switching from multiple antiretroviral therapy to oral dual therapy. Higher treatment discontinuation rates were observed among women, prompting this analysis of sex‐based HRQL differences. Methods HRQL, treatment acceptability, and symptom burden data were collected at treatment switch (D0) and at 1 and 6 months afterward (M1 and M6). Higher scores indicated greater symptom burden (HIV‐SI), better HRQL (PROQOL‐HIV), or better treatment acceptability. Sex differences were analyzed using appropriate statistical tests, with overtime changes assessed via mixed‐effects linear regression models. Results The study included 260 PLWH (35% women, n = 92), with a mean age of 51 ± 12 years. Compared to men, women were more frequently born in sub‐Saharan Africa (46% vs. 12%), had lower educational attainment (20% vs. 41% with university degrees), and higher rates of obesity (29% vs. 9% with BMI ≥ 30). While no virologic failures occurred, treatment discontinuation was higher among women (15% vs. 5%). Over time, all participants showed improvements in symptom burden (−2 points), treatment‐related HRQL (+5 points), mental/cognitive HRQL (+4 points), and treatment acceptability (+6 points). However, women consistently demonstrated worse cognitive and mental HRQL scores compared to men (mean difference: −7 points). Conclusion While dual therapy improved treatment acceptability and HRQL for both sexes, women maintained lower mental and cognitive HRQL scores. Enhanced patient‐provider communication may help identify HRQL changes, especially among women who face higher treatment discontinuation risk. Trial Registration ClinicalTrials.gov identifier: NCT04788784