Sovaldi™ (sofosbuvir) and Hepatitis C

What types of adverse reactions were reported when taking Sovaldi™?

In the clinical studies the most common adverse reactions when Sovaldi™ was used in combination with ribavirin were fatigue and headache. The most common adverse effect when Sovaldi was used in combination with peginterferon alfa and ribavirin were fatigue, headache, nausea, insomnia and anemia. Of course, one should consult with the prescribing information for peginterferon alfa and ribavirin as well for descriptions of the adverse reactions when using these medications.

The FDA has warned that a serious slowing of the heart rate can occur when using amiodarone along with Sovaldi® (sofosbuvir) in combination with another direct acting antiviral for treatment of Hepatitis C.

Although less common, in addition to the adverse reactions mentioned above, the following adverse reactions were also reported:

• pruritus (itching)
• asthenia (weakness)
• rash
• decreased appetite
• chills
• influenza like illness
• pyrexia (fever)
• diarrhea
• neutropenia (lowered neutrophils – type of white blood cell that surrounds and destroys bacteria)
• myalgia (muscle pain)
• irritability

Less than 1% of the subjects in the clinical study receiving Sovaldi™ combination therapy reported:

• Hematologic effects – pancytopenia (particularly in subjects receiving concomitant pegylated interferon).
• Psychiatric disorders – severe depression (particularly in subjects with pre-existing history of psychiatric illness), including suicidal ideation and suicide.

The proportion of subjects in the studies who permanently discontinued treatment due to adverse events was:

• 4% for those receiving the placebo
• 1% for those receiving Sovaldi™ and ribavirin for 12 weeks
• less than 1% for those receiving Sovaldi™ and ribavirin for 24 weeks
• 11% for those receiving peginterferon alfa and ribavirin for 24 weeks
• 2% for those receiving Sovaldi™, peginterferon alfa and ribavirin for 12 weeks

Last Updated: May 2015