PASO DOBLE sub‑analysis indicates metabolic differences between 2‑drug and 3‑drug HIV regimens

PASO DOBLE sub‑analysis indicates metabolic differences between 2‑drug and 3‑drug HIV regimens

Patients with HIV showed lower cases of steatotic liver disease when switched to ViiV Healthcare’s Dovato compared to Biktarvy.

New 96-week sub-group data from the PASO DOBLE study show that adults with virologically suppressed HIV who switched to Dovato experienced significantly lower rates of steatotic liver disease than tho...

: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.

Switching to a two-drug regimen of dolutegravir / lamivudine (Dovato) resulted in significantly less weight gain after 96 weeks compared to a switch to tenofovir alafenamide / emtricitabine / bictegra...

Switching to a two-drug regimen of dolutegravir / lamivudine (Dovato) resulted in significantly less weight gain after 96 weeks compared to a switch to tenofovir alafenamide / emtricitabine / bictegra...

New 96-week results from ViiV Healthcare’s PASO DOBLE study show that Dovato is as effective as Biktarvy in maintaining viral suppression in adults with HIV, while leading to less weight gain and fewe...