ArticleTherapeutic advances in infectious disease
Patient-reported outcomes among people living with HIV switching to dual therapy with dolutegravir/lamivudine: results from the PROBI study.
Article in Therapeutic advances in infectious disease. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04788784 (Mixed-method Study to Evaluate Acceptability, Perceived Toxicity, Preference and Health-related Quality of Life Among HIV Patients Switching to a Dual Therapy Such as the Dovato Regimen), which is not on this map. Cited by 3 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Mixed-method Study to Evaluate Acceptability, Perceived Toxicity, Preference and Health-related Quality of Life Among HIV Patients Switching to a Dual Therapy Such as the Dovato Regimen
Who cites it
3 citing papers in PubMed.
- Patient-Reported Outcomes Among Virally Suppressed People Living with HIV Switching to Dolutegravir/Lamivudine vs. Continuing Bictegravir/Emtricitabine/Tenofovir Alafenamide from the Randomized DYAD Study.AIDS and behavior · 2026Article
- Narrative Review of Two-Drug Regimens in Modern HIV Care: Driving Innovation, Flexibility, and Quality of Life.Infectious diseases and therapy · 2026Review
- Sex Differences in Patient-Reported Outcomes Among People Living With HIV Switching to an Oral Dual Therapy: Results From the PROBI Study.AIDS research and treatment · 2025Article
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Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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: To evaluate PROs among adult PLWH switching from standard multi-drug therapy to the DTG/3TC combined therapy Dovato 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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