Velpanat Adverse Reactions

Summary of the safety profile: The safety assessment of Sofosbuvir and Velpatasvir tablets was based on pooled Phase 3 clinical study data from patients with genotype 1, 2, 3, 4, 5 or 6 HCV infection (with or without compensated cirrhosis) including 1,035 patients who received Sofosbuvir and Velpatasvir tablets for 12 weeks.
The proportion of patients who permanently discontinued treatment due to adverse events was 0.2% and the proportion of patients who experienced any severe adverse events was 3.2% for patients receiving Sofosbuvir and Velpatasvir tablets for 12 weeks. In clinical studies, headache, fatigue and nausea were the most common (incidence ≥ 10%) treatment emergent adverse events reported in patients treated with 12 weeks of Sofosbuvir and Velpatasvir tablets. These and other adverse events were reported at a similar frequency in placebo treated patients compared with Sofosbuvir and Velpatasvir tablets treated patients.
Patients with decompensated cirrhosis: The safety profile of Sofosbuvir and Velpatasvir tablets has been evaluated in one open-label study in which patients with CPT Class B cirrhosis received Sofosbuvir and Velpatasvir tablets for 12 weeks (n = 90), Sofosbuvir and Velpatasvir tablets + RBV for 12 weeks (n = 87) or Sofosbuvir and Velpatasvir tablets for 24 weeks (n = 90). The adverse events observed were consistent with expected clinical sequelae of decompensated liver disease, or the known toxicity profile of ribavirin for patients receiving Sofosbuvir and Velpatasvir tablets in combination with ribavirin.
Among the 87 patients who were treated with Sofosbuvir and Velpatasvir tablets + RBV for 12 weeks, decreases in haemoglobin to less than 10 g/dL and 8.5 g/dL during treatment were experienced by 23% and 7% patients, respectively. Ribavirin was discontinued in 15% of patients treated with Sofosbuvir and Velpatasvir tablets + RBV for 12 weeks due to adverse events.
Description of selected adverse reactions: Cardiac arrhythmias: Cases of severe bradycardia and heart block have been observed when sofosbuvir used in combination with another direct acting antiviral, is used with concomitant amiodarone and/or other medicinal products that lower heart rate (see Precautions and Interactions).