Dolutegravir improves physical health-related quality of life in adults with HTLV-1 infection: A randomized controlled trial.

OBJECTIVES

Human T-lymphotropic virus type 1 (HTLV-1) infection is associated with progressive neurological impairment and reduced health-related quality of life (HRQoL). We evaluated longitudinal changes in HRQoL over 96 weeks in adults with HTLV-1 receiving dolutegravir compared with vitamin C.

METHODS

This open-label, randomized controlled trial conducted in Brazil assigned participants to dolutegravir (50 mg/d) or vitamin C (500 mg/d). HRQoL was assessed using the RAND-36 questionnaire at baseline and week 96. Within-group changes were estimated using Cohen's d. Between-group comparisons for the Physical and Mental Component Summary scores (PCS and MCS) were performed using analysis of covariance adjusted for baseline values.

RESULTS

Sixty-one participants completed follow-up (dolutegravir n = 34; vitamin C n = 27). The dolutegravir group showed improvements in physical functioning and pain domains. After adjustment, PCS scores at week 96 were significantly higher in the dolutegravir group compared with vitamin C (adjusted mean difference 3.92; 95% CI 0.30-7.53; p = 0.034). No significant between-group difference was observed for MCS.

CONCLUSIONS

Dolutegravir was associated with improved physical HRQoL over 96 weeks in individuals with HTLV-1, while no benefit was observed in mental health domains. These findings support further investigation of integrase inhibitors in HTLV-1-associated disease.

CLINICAL TRIAL REGISTRATION: ReBEC RBR-5 × 7ccxp.