Sofosbuvir efficacy has been established in subjects with HCV genotype 1, 2, 3 or 4 infection, including those with hepatocellular carcinoma meeting Milan criteria (awaiting liver transplantation) and those with HCV/HIV-1 co-infection.
The following points should be considered when initiating treatment with Sofosbuvir:
- Monotherapy of Sofosbuvir is not recommended for treatment of CHC.
- Treatment regimen and duration are dependent on both viral genotype and patient population.
- Treatment response varies based on baseline host and viral factor.
Dosage & Administration
Recommended combination therapy: (HCV Mono-infected and HCV/HIV-1 Co-infected)-
- Genotype 1 or 4: Sofosbuvir + Peginterferon alfa + Ribavirin for 12 weeks
- Genotype 2: Sofosbuvir + Ribavirin for 12 weeks
- Genotype 3: Sofosbuvir + Ribavirin for 24 weeks
Sofosbuvir in combination with Ribavirin for 24 weeks can be considered for CHC patients with genotype 1 infection who are Interferon ineligible
Should be used in combination with Ribavirin for treatment of CHC in patients with hepatocellular carcinoma awaiting liver transplantation for up to 48 weeks or until liver transplantation whichever occurs first
A dose recommendation cannot be made for patients with severe renal impairment or end stage renal disease
Pregnancy & Lactation
Nursing Mothers: It is not known whether Sofosbuvir and its metabolites are present in human breast milk.
Precautions & Warnings
Use in Special Populations
Geriatric Use: Sofosbuvir was administered to 90 subjects aged 65 and over. The response rates observed for subjects over 65 years of age were similar to that of younger subjects across treatment groups. No dose adjustment of Sofosbuvir is warranted in geriatric patients.