Hopetavir: Each tablet contains Sofosbuvir INN 400 mg
- 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
- Should be used in combination with Ribavirin or in combination with Pegylated Interferon and Ribavirin for the treatment of CHC.
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
Extreme caution must be taken to avoid pregnancy in female patients and female partners of male patients while taking this combination. Women of childbearing potential and their male partners should not receive Ribavirin unless they are using two forms of effective contraception during treatment with Ribavirin and for 6 months after treatment has concluded.
Pregnancy Category B: Sofosbuvir monotherapy
There are no adequate and well-controlled studies with Sofosbuvir in pregnant women.
Lactation: It is not known whether Sofosbuvir and its metabolites are present in human breast milk. Because of the potential for adverse reactions from the drug in nursing infants, a decision must be made whether to discontinue nursing or discontinue treatment with Ribavirin-containing regimens, taking into account the importance of the therapy to the mother.
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Safety and effectiveness of Sofosbuvir in children less than 18 years of age have not been established.
Hopetavir Container Pack: Each container contains 28 tablets