The safety and tolerability of sof/vel/vox for 8 or 12 weeks in > 1,000 patients treated in the polaris-1, polaris-2, polaris-3, and polaris-4 studies: An integrated analysis.
Manns MP, Gane E, Willems BE, Roberts SK, Flamm S, Bourliere M, Asselah T, Alric L, Hyland RH, Stamm LM, Huang KC, Brainard DM, Yip CSM, Huang HC, Khalili M, Foster GR, Gordon SC, Rajender RK, Zeuzem S, Jacobson IM, Cooper CL, Thompson AJ, Kowdley K, and Lawitz E. The safety and tolerability of sof/vel/vox for 8 or 12 weeks in > 1,000 patients treated in the polaris-1, polaris-2, polaris-3, and polaris-4 studies: An integrated analysis. Gut 2018; 67:A302-A303.
Background The once-daily fixed-dose combination tablet of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) was evaluated for the treatment of genotype 1–6 HCV infection in four phase 3 studies in patients with and without compensated cirrhosis. This analysis describes the safety of SOF/VEL/VOX across 4 Phase 3 studies.
Methods Treatment-emergent adverse events (AEs) and laboratory abnormalities were assessed in patients who received SOF/VEL/VOX or placebo for 12 weeks (POLARIS-1), SOF/VEL/VOX or SOF/VEL for 12 weeks (POLARIS-4), or SOF/VEL/VOX for 8 weeks or SOF/VEL for 12 weeks (POLARIS-2 and POLARIS-3). SAEs and deaths were followed until post-treatment Week 24. Data were pooled by treatment regimen.
Results 1056 patients were treated with SOF/VEL/VOX for 8 (n=611) or 12 (n=445) weeks, 700 received SOF/VEL for 12 weeks. 38% had compensated cirrhosis, 28% had a BMI≥30 kg/m2, 36% were female, and 12% were ≥65 years old. AEs are presented in the table. Two deaths were reported, one illicit drug overdose and one attributed to hypertension (on post-treatment Day 76), neither were related to treatment. SAEs and discontinuations were more frequent in the placebo group and occurred with similar frequency in the other groups; none were related to study treatment. Headache, fatigue, nausea, and diarrhoea were the most common AEs. Mild diarrhoea and nausea occurred more frequently in the SOF/VEL/VOX groups. Overall, 5.1%–6.6% of patients who received SOF/VEL/VOX or SOF/VEL had Grade 3 or 4 laboratory abnormalities. Among patients receiving VOX, one patient each had a Grade 3 elevation in ALT and bilirubin (table 1).