The association of adherence with treatment outcomes and correlates of non-adherence among persons receiving DAA therapy for HCV are limited. ACTG A5360 (MINMON) was a single-arm, open-label, multinational trial to evaluate the safety and efficacy of 12 weeks of Sofosbuvir/Velpatasvir (SOF/VEL) with reduced in-person visits and laboratory monitoring. This analysis evaluated the association of adherence with sustained virologic response (SVR) and correlates of adherence.
399 HCV treatment-naïve participants without decompensated cirrhosis were enrolled from Brazil, South Africa, Thailand, Uganda and US, and received 84 tablets of SOV/VEL at entry, with first dose observed. Adherence at week 4 (Wk 4) was self-reported remotely and grouped as ALL vs. Ninety-five percent (379/399) of participants achieved SVR. At Wk 4, 93% (368/395) reported taking ALL SOFV/VEL doses; only 27 participants (7% of total) reported Overall, self-reported adherence in this trial was high. Self-reported adherence during the first 4 weeks of SOF/VEL was associated with achieving SVR. Programs seeking to scale up the minimal monitoring strategy may consider additional support for younger individuals or those reporting current or past substance use. Week 4 self-reported adherence may also help identifying those who may need additional support.