Sovaldi™ (sofosbuvir) and Hepatitis C

Are there any other warnings one should know regarding Sovaldi combination therapy?

• Pregnancy – Ribavirin may cause birth defects and/or death of the unborn baby. Pregnancy must be avoided in female patients as well as female partners of male patients. It is recommended that at least two forms of contraception be used during treatment and for at least 6 months after the completion of treatment. There is no data on the effectiveness of systemic hormonal contraceptives (birth control pills, vaginal rings, implants, or injections) for women taking Sovaldi. Therefore it is recommended alternative contraception options include intrauterine devices (IUD) and barrier methods (non-hormonal methods of contraception). If the female patient or female partner of the male patient should get pregnant during treatment or within 6 months of completing treatment, she should contact her healthcare provider right away.
• Use with Potent P-gp Inducers – Drugs that are potent P-gp inducers in the intestine may significantly decrease sofosbuvir plasma concentrations potentially reducing the therapeutic effect of Sovaldi. Therefore, rifampin and St. John’s wort should not be used with Sovaldi.

Risk of Hepatitis B Reactivation

The FDA has indicated that there is risk of the Hepatitis B virus becoming an active infection again in any patient who has a current or previous infection with Hepatitis B virus and is being treated with Sovaldi, a direct-acting antiviral medicine for Hepatitis C virus. In a few cases, Hepatitis B virus reactivation in patients treated with these types of medicines resulted in serious liver problems or death. In addition to a prominent warning being required on the medication’s labeling, healthcare professionals are being directed to also screen and monitor for the Hepatitis B virus in all patients receiving this treatment.

Last Updated: October 2016