Virso Adverse Reactions

Summary of the safety profile: During treatment with sofosbuvir in combination with ribavirin or with peginterferon alfa and ribavirin, the most frequently reported adverse drug reactions were consistent with the expected safety profile of ribavirin and peginterferon alfa treatment, without increasing the frequency or severity of the expected adverse drug reactions.
Tabulated summary of adverse reactions: Sofosbuvir has mainly been studied in combination with ribavirin, with or without peginterferon alfa. In this context, no adverse drug reactions specific to sofosbuvir have been identified. The most common adverse drug reactions occurring in subjects receiving sofosbuvir and ribavirin or sofosbuvir, ribavirin and peginterferon alfa were fatigue, headache, nausea and insomnia.
The following adverse drug reactions have been identified with sofosbuvir in combination with ribavirin or in combination with peginterferon alfa and ribavirin (Table 20). (See Table 20.)

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Other special population(s): HIV/HCV co-infection: The safety profile of sofosbuvir and ribavirin in HCV/HIV co-infected subjects was similar to that observed in mono-infected HCV treated with sofosbuvir and ribavirin.
Patients awaiting liver transplantation: The safety profile of sofosbuvir and ribavirin in HCV infected subjects prior to liver transplantation was similar to that observed when treated with sofosbuvir and ribavirin.