Patient-reported outcomes among people living with HIV switching to dual therapy with dolutegravir/lamivudine: results from the PROBI study

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Background: Simplification of antiretroviral regimens has the potential to improve both patient-reported outcomes (PROs) and therapeutic adherence in people living with HIV (PLWH). Dual therapy with dolutegravir (DTG) plus lamivudine (3TC) demonstrated good safety and efficacy, but its impact on PROs remains to be documented. Objectives: . Design: A non-comparative, 6-month observational study in 25 French medical centers. Methods: Sociodemographic and biomedical data were collected from medical records and PROs from self-administered questionnaires at treatment switch (Day, D0) and at months (M) 1 and 6. Primary endpoints included changes between D0 and M6 in perceived toxicity, treatment acceptability, PLWH's preferences, and the score value of the treatment impact dimension of health-related quality of life (HRQL) (PROQOL-HIV) during follow-up. Secondary endpoints encompassed scores in other HRQL dimensions and self-reported symptoms. Multivariable standard and mixed-effects linear regression models were used to identify factors associated with PRO values and changes over time. Additionally, binary logistic regression was used to identify factors associated with the discontinuation of combined DTG/3TC regimen. Results: In the study population (260 PLWH, 64.6% male, mean ± SD age: 51 ± 12 years, 16 ± 10 years since HIV diagnosis), 20 individuals stopped treatment during follow-up, without resumption. Men, individuals previously receiving abacavir/3TC/DTG, and those with better daily comfort and perceived treatment efficacy were less likely to stop treatment. Treatment impact-related HRQL, acceptability of treatment, and number of self-reported symptoms significantly improved at M1 and M6. Mental and cognitive HRQL improved at M6. Conclusion: Dolutegravir and lamivudine dual oral therapy improved several dimensions in HRQL and delivered a simplified treatment regimen designed for eligible patients, supporting a patient-centered approach to managing HIV care. Attention should be maintained on the reasons for treatment discontinuation, especially among women. Trial registration: Patient-Reported Outcomes HV BItherapy (PROBI) was registered as number NCT04788784 on https://clinicaltrials.gov/study/NCT04788784?term=PROBI&rank=2.

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