Sovaldi™ (sofosbuvir) and Hepatitis C

What if I have an adverse reaction to the Sovaldi™ combination therapy?

Reducing the dosage of Sovaldi™ is not recommended by Gilead. However, if a patient with genotype 1 or 4 experiences a serious adverse reaction that is possibly related to the peginterferon alfa and/or ribavirin, the peginterferon alfa and/or ribavirin dosage could be reduced or discontinued based on the information provided in these medications’ Package Inserts regarding how to reduce and/or discontinue peginterferon alfa and/or ribavirin dose.

If a patient with genotype 2 or 3 should experience a serious adverse reaction that is possibly related to the ribavirin, the ribavirin dosage could be modified or discontinued until the adverse reaction abates or decreases in its severity. Gilead provides ribavirin dosage modification information in their Prescribing Information.

If the other medications taken in combination with Sovaldi™ are discontinued, then Sovaldi must also be discontinued.

Last Updated: July 2014

What types of adverse reactions were reported when taking Sovaldi™? Are there any other warnings one should know regarding Sovaldi combination therapy?

References

"Full Prescribing Information." Gilead.com. Gilead Sciences, Inc., http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/sovaldi/sovaldi_pi.pdf. Retrieved December 31, 2013.

"Patient Information: Sovaldi™." Gilead.com. Gilead Sciences, Inc., http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/sovaldi/sovaldi_patient_pi.pdf. Retrieved December 31, 2013.

"Register for a SOVALDI Co-pay Coupon." Sovaldi.com. Gilead Sciences, Inc., https://www.sovaldi.com/copay-register.aspx. Retrieved December 31, 2013.

"Support Path." MySupportPath.com. Gilead Sciences, Inc., http://www.mysupportpath.com/. Retrieved December 31, 2013.

"U.S. Food and Drug Administration Approved Gilead's Sovaldi (Sofosbuvir) for the Treatment of Chronic Hepatitis C." Gilead.com. Gilead Sciences, Inc., http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=1882800&highlight=. Retrieved December 31, 2013.