HCV: SOF/VEL/VOX yields sustained PRO gain

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Takeaway

  • HCV treatment with sofosbuvir/velpatasvir (SOF/VEL) ± voxilaprevir (VOX) yields continued gain in patient-reported outcomes (PRO) after end of treatment.

Why this matters

  • PRO benefit was similar for SOF/VEL/VOX vs SOF/VEL.

Study design

  • PRO data from phase 3 POLARIS-2 and POLARIS-3 randomized trials of SOF/VEL/VOX (n=611) vs SOF/VEL (n=549).
  • PRO scale of 1-100 included domains from the Short Form-36 version 2 survey, Functional Assessment of Chronic Illness Therapy, Chronic Liver Disease Questionnaire-Hepatitis C Version, and Work Productivity and Activity Impairment Instrument: Specific Health Problem.
  • Funding: Gilead Sciences.

Key results

  • Mean age was 52.2 years; 55.9% of patients were male, 75.4% were treatment-naïve, and 33.9% had cirrhosis.
  • Rate of sustained virologic response at 12 weeks posttherapy ranged from 95%-98%.
  • Gastrointestinal adverse events were more common with SOF/VEL/VOX (29.6% vs 14.8%; P<.0001).
  • PRO scores improved significantly in 22/26 domains by end-of-treatment (mean Δ, +2.3 to +15.0); benefit was similar for SOF/VEL/VOX vs SOF/VEL (all P>.05).
  • All but 1 PRO measure (absenteeism) showed significant (P<.001) continued gain at post-treatment week 12 (mean Δ, +2.7 to +16.7) and 24 (mean Δ, +3.9 to +20.1).
  • PRO improvements were similar or more pronounced in patients with cirrhosis (post-treatment week 24, +4.4 to +23.5).

Limitations

  • Open-label design.