Drug: Sovaldi (soh-VAHL-dee)
Sovaldi is a polymerase inhibitor that is taken in combination with ribavirin. It is taken once-a-day with or with or without food. Sovaldi is approved by the Food and Drug Administration (FDA) to treat adults infected with hepatitis C (HCV) genotype 2 and 3. Sovaldi is manufactured by Gilead Sciences Inc. Note: Sovaldi is also approved in combination pegylated interferon to treat genotype 1 and 4. This review will only discuss Sovaldi plus ribavirin to treat genotype 2 and 3.
Initial FDA Approval: 2013
The wholesale acquisition cost (WAC) for Sovaldi is $84,000 for a 12-week course of therapy. It is taken for 12 or 24 weeks based on clinical trial data based on clinical trial data approved by the FDA.
Patient Support: Support Path – 1-855-769-7284 – www.mysupportpath.com
Common Drug Interactions: The herb St. John’s wort should be avoided. Antacids and other products to relieve heartburn (stomach problems) can affect how well Sovaldi works. Talk to your medical provider about any medications, supplements, herbs or over-the-counter medications you are taking to prevent any possible problems that may interfere how well Sovaldi will work.
See the Highlights of Prescribing Information for a complete listing of drug interactions.
Note: The Food and Drug Administration (FDA) is requiring that hepatitis C (HCV) medication guides (package inserts) list a warning about a possible risk of hepatitis B (HBV) reactivation while on HCV antiviral therapy. Reactivation of HBV can cause possible liver damage. However, the risk is extremely rare. The reactivation has been reported with interferon and direct-acting antiviral medications.
Side Effects: The most common side effects of Sovaldi that occurred in more than 10% of patients in the clinical trials were fatigue and headache.
Pregnancy: There are no studies of Sovaldi in pregnant women. Ribavirin can cause birth defects and miscarriages. If you are a male taking ribavirin you and your female sexual partner must use two types of effective birth control. Your female sexual partner will have to take a pregnancy test before and during treatment and 6 months after treatment ends. If you are a female taking ribavirin you and your male sexual partner must use two types of effective birth control. You will also have to take a pregnancy test before, during and 6 months after treatment ends.
Pediatric Patients: Sovaldi is approved to treat pediatric patients 12 years of age and older or weighing at least 35 kg infected with genotype 2 or 3 chronic HCV infection without cirrhosis or with compensated cirrhosis in combination with ribavirin. The cure rate for pediatric patients with genotype 2 who were treated for 12 weeks was 100% (13 of 13 patients); the cure rate for those with genotype 3 who were treated for 24 weeks was 97% (36 of 37 patients).
HIV/HCV Coinfection: The dosage recommendation is the same for people coinfected as for those who are monoinfected with HCV
Recommended Treatment Duration – Cure Rates
Genotype 2 and 3:
|Patient Characteristics||Medications/Duration||Cure Rates|
|Genotype 2*||Sovaldi plus ribavirin for 12 weeks||82% to 97%|
|Genotype 3**||Sovaldi plus ribavirin for 24 weeks||60% to 93%|
*Genotype 2 patients included treatment naïve, treatment experienced, non-cirrhotic and cirrhotic patients
**Genotype 3 patients included treatment naïve, treatment experienced and non-cirrhotic patients. In genotype 3 patients who had cirrhosis,the cure rates were 60%.
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