Sofosbuvir / Velpatasvir

UK SPC (Sofosbuvir/Velpatasvir Gilead 200 mg/50 mg film-coated tablets, previously Epclusa) §4.2: the recommended dose in adults is one 400 mg/100 mg tablet taken orally once daily with or without food. Treatment should be initiated and monitored by a physician experienced in the management of patients with HCV infection. DURATION regardless of HCV genotype (Table 1): patients without cirrhosis and patients with compensated cirrhosis — 12 weeks (addition of ribavirin may be considered for genotype 3 infected patients with compensated cirrhosis); patients with decompensated cirrhosis — sofosbuvir/velpatasvir + ribavirin for 12 weeks. Adults who have previously failed therapy with an NS5A-containing regimen — sofosbuvir/velpatasvir + ribavirin for 24 weeks may be considered. RIBAVIRIN dosing when given with sofosbuvir/velpatasvir in decompensated cirrhosis (divided into two daily doses, with food, Table 2): CPT Class B cirrhosis pre-transplant — 1,000 mg per day for patients under 75 kg and 1,200 mg for those 75 kg or more; CPT Class C pre-transplant and CPT Class B or C post-transplant — starting dose 600 mg, titrated up to a maximum of 1,000 mg (under 75 kg) or 1,200 mg (75 kg or more) if well tolerated, reduced as clinically indicated based on haemoglobin if not tolerated. If ribavirin is used in genotype 3 patients with compensated cirrhosis (pre- or post-transplant) the recommended ribavirin dose is 1,000 mg (under 75 kg) / 1,200 mg (75 kg or more). ADMINISTRATION: swallow the tablet(s) whole; do not chew or crush (bitter taste). If vomiting occurs within 3 hours of dosing an additional tablet should be taken; if more than 3 hours after dosing, no further dose is needed. Missed dose: if within 18 hours of the normal time, take as soon as possible then take the next dose at the usual time; if after 18 hours, wait and take the next dose at the usual time — do not double dose. PAEDIATRIC (Table 3, aged 3 to under 18 years, weight-banded not per-kg): 30 kg or more — one 400 mg/100 mg tablet once daily or two 200 mg/50 mg tablets once daily (400 mg/100 mg per day) for 12 weeks; 17 to under 30 kg — one 200 mg/50 mg tablet once daily (200 mg/50 mg per day) for 12 weeks; for patients weighing under 17 kg refer to the SPC for the 200 mg/50 mg or 150 mg/37.5 mg granules. Safety and efficacy in children aged under 3 years have not been established. Elderly: no dose adjustment warranted. Hepatic impairment: no dose adjustment required for CPT Class A, B or C; safety and efficacy assessed in CPT Class B but not CPT Class C cirrhosis. NOTE: the §4.5 interactions section was not captured in the source bundle — the interactions listed below are drawn from §4.3 and §4.4 only and the full §4.5 must be checked.