Sofosbuvir with velpatasvir

eMC §4.2 (Sofosbuvir/Velpatasvir Gilead 200 mg/50 mg film-coated tablets, previously known as Epclusa). Treatment should be initiated and monitored by a physician experienced in the management of patients with HCV infection. DURATION, ALL HCV GENOTYPES (Table 1): patients without cirrhosis and patients with compensated cirrhosis - sofosbuvir/velpatasvir for 12 weeks (addition of ribavirin may be considered for genotype 3 infected patients with compensated cirrhosis); patients with decompensated cirrhosis - sofosbuvir/velpatasvir PLUS ribavirin for 12 weeks. This includes patients co-infected with HIV and patients with recurrent HCV post-liver transplant. ADULTS WHO HAVE PREVIOUSLY FAILED AN NS5A-CONTAINING REGIMEN: sofosbuvir/velpatasvir plus ribavirin for 24 weeks may be considered. RIBAVIRIN DOSING WHEN CO-ADMINISTERED IN ADULTS WITH DECOMPENSATED CIRRHOSIS (Table 2, ribavirin divided into two daily doses and given with food): Child-Pugh-Turcotte (CPT) Class B cirrhosis pre-transplant - 1,000 mg per day for patients under 75 kg and 1,200 mg for those weighing 75 kg or more; CPT Class C pre-transplant and CPT Class B or C post-transplant - starting dose 600 mg, which can be 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 the starting dose is not well tolerated. If ribavirin is used in genotype 3 infected adults with compensated cirrhosis (pre- or post-transplant), the recommended ribavirin dose is 1,000 mg (under 75 kg) or 1,200 mg (75 kg or more). Refer to the ribavirin SPC for dose modifications. VOMITING: 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 and take the next dose at the usual time; if after 18 hours, wait and take the next dose at the usual time. Never take a double dose. ELDERLY: no dose adjustment. HEPATIC IMPAIRMENT: no dose adjustment for mild, moderate or severe impairment (CPT Class A, B or C); safety and efficacy have been assessed in CPT Class B cirrhosis but not in CPT Class C. §4.4: must not be administered concurrently with other medicinal products containing sofosbuvir; HBV screening should be performed in all patients before initiation because of the risk of HBV reactivation. PAEDIATRIC (Table 3, aged 3 to under 18 years, regardless of genotype, tablets): body weight 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); body weight 17 to under 30 kg - one 200 mg/50 mg tablet once daily (200 mg/50 mg per day); both for 12 weeks. For patients weighing under 17 kg refer to the SPC for the Epclusa 200 mg/50 mg or 150 mg/37.5 mg GRANULES; a granule formulation is available for children aged 3 years and above who have difficulty swallowing tablets. Safety and efficacy in children under 3 years have not been established. These are fixed weight-band doses, not per-kg doses - verify all under-18 dosing against a children's formulary.