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

by | Jun 29, 2026 | Publications

Int J Infect Dis. 2026 Jun 28:108933. doi: 10.1016/j.ijid.2026.108933. Online ahead of print.

ABSTRACT

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/day) or vitamin C (500 mg/day). 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.

PMID:42365921 | DOI:10.1016/j.ijid.2026.108933

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