Ledipasvir with sofosbuvir

eMC §4.2 (Ledipasvir/Sofosbuvir Gilead 90 mg/400 mg film-coated tablets, previously known as Harvoni). Treatment should be initiated and monitored by a physician experienced in the management of patients with chronic hepatitis C. TREATMENT DURATION (SPC Table 1, adults and paediatric patients aged 3 years and above, including HIV co-infected patients): GENOTYPE 1, 4, 5 or 6 - without cirrhosis, 12 weeks (8 weeks may be considered in previously untreated genotype 1-infected patients, ION-3 study); with compensated cirrhosis, 12 weeks with ribavirin or 24 weeks without ribavirin (12 weeks without ribavirin may be considered for patients deemed at low risk of clinical disease progression who have subsequent retreatment options); post-liver transplant without cirrhosis or with compensated cirrhosis, 12 weeks with ribavirin (12 weeks without ribavirin in patients without cirrhosis, or 24 weeks in patients with cirrhosis, may be considered where ribavirin is not tolerated or contraindicated); decompensated cirrhosis irrespective of transplant status, 12 weeks with ribavirin (24 weeks without ribavirin may be considered where ribavirin is not tolerated or contraindicated). GENOTYPE 3 with compensated cirrhosis and/or prior treatment failure - 24 weeks with ribavirin. CO-ADMINISTERED RIBAVIRIN IN ADULTS: weight-based, less than 75 kg = 1,000 mg and 75 kg or more = 1,200 mg daily, administered orally in two divided doses with food; in decompensated cirrhosis (CPT class C pre-transplant, or CPT class B or C post-transplant) start at 600 mg daily and titrate up to a maximum of 1,000 mg (under 75 kg) or 1,200 mg (75 kg or more) if well tolerated, reducing as clinically indicated on haemoglobin levels if not tolerated. Ribavirin dose modification (SPC Table 5): reduce to 600 mg/day if haemoglobin falls below 10 g/dL (no cardiac disease) and discontinue if below 8.5 g/dL; in patients with a history of stable cardiac disease reduce if haemoglobin falls by 2 g/dL or more during any 4-week treatment period and discontinue if below 12 g/dL despite 4 weeks at the reduced dose. Refer also to the ribavirin SPC. PAEDIATRIC: the SPC gives weight-based dosing for patients aged 3 years and above (SPC Table 2 for tablets and Table 4 for co-administered ribavirin); patients below the lowest tablet weight band should not take tablets and a granule formulation is available for children aged 3 years and above who have difficulty swallowing tablets - obtain the exact paediatric bands from the SPC and a children's formulary rather than extrapolating. §4.4: must not be given concomitantly with other medicinal products containing sofosbuvir; clinical data supporting use in adults with HCV genotype 3 (and genotypes 2 and 6) are limited.