STEPS

New Drug Reviews

Sofosbuvir/Velpatasvir (Epclusa) for Hepatitis C

 

Am Fam Physician. 2017 May 15;95(10):664-666.

Sofosbuvir/velpatasvir (Epclusa) is an oral medication labeled for the treatment of adults who have chronic infection with hepatitis C virus (HCV) genotypes 1 through 6. Unlike elbasvir/grazoprevir (Zepatier) and ledipasvir/sofosbuvir (Harvoni), sofosbuvir/velpatasvir can be used to treat patients with genotypes 2 and 3. It is also labeled for use in combination with ribavirin to treat patients with decompensated cirrhosis (Child-Pugh score of B or C).1,2

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DrugStarting dosageDose formCost*

Sofosbuvir/velpatasvir (Epclusa)

One tablet per day for 12 weeks

400-mg/100-mg tablet

$75,000 for a 12-week course


*—Estimated retail price of one month’s treatment based on information obtained at http://www.goodrx.com (accessed March 27, 2017).

DrugStarting dosageDose formCost*

Sofosbuvir/velpatasvir (Epclusa)

One tablet per day for 12 weeks

400-mg/100-mg tablet

$75,000 for a 12-week course


*—Estimated retail price of one month’s treatment based on information obtained at http://www.goodrx.com (accessed March 27, 2017).

SAFETY

The main safety concern with sofosbuvir/velpatasvir is reactivation of hepatitis B virus (HBV) in coinfected patients, which is unusual but may happen with any treatment of HCV infection. All patients should be tested for HBV before starting therapy by measuring hepatitis B surface antigen (HBsAg) and anti–hepatitis B core (anti-HBc) antibody. Patients with serologic evidence of HBV infection should be monitored for clinical and laboratory signs of hepatitis flare-up or HBV reactivation during treatment and posttreatment follow-up.1,2

Sofosbuvir/velpatasvir affects or is affected by numerous medications, and a suitable drug interaction reference should be consulted before beginning treatment or when considering additional medications during treatment.1,2 Liver enzyme inducers such as rifampin, St. John’s wort, and carbamazepine (Tegretol), along with others, will decrease the therapeutic effect of sofosbuvir/velpatasvir. Proton pump inhibitors should not be taken with sofosbuvir/velpatasvir; histamine H2 receptor blockers and antacids may be used, but there are specific timing guidelines in the product labeling. Interactions with antiarrhythmics (especially amiodarone) and anticonvulsants can cause significant adverse effects. Sofosbuvir/velpatasvir has not been studied in pregnant or

Address correspondence to Randi Sokol, MD, MPH, MMedEd, at rsokol@challiance.org. Reprints are not available from the author.

Author disclosure: No relevant financial affiliations.

REFERENCES

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1. DailyMed. Label: Epclusa – velpatasvir and sofosbuvir tablet, film coated [prescribing information]. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7f30631a-ee3b-4cfe-866b-964df3f0a44f. Accessed March 12, 2017....

2. Centers for Disease Control and Prevention. University of Washington, The University of Alabama at Birmingham, The International Antiviral Society–USA. Hepatitis C online. http://www.hepatitisc.uw.edu/. Accessed March 12, 2017.

3. Feld JJ, Jacobson IM, Hézode C, et al.; ASTRAL-1 Investigators. Sofosbuvir and velpatasvir for HCV genotype 1, 2, 4, 5, and 6 infection. N Engl J Med. 2015;373(27):2599–2607.

4. Foster GR, Afdhal N, Roberts SK, et al.; ASTRAL-2 Investigators; ASTRAL-3 Investigators. Sofosbuvir and velpatasvir for HCV genotype 2 and 3 infection. N Engl J Med. 2015;373(27):2608–2617.

5. Curry MP, O’Leary JG, Bzowej N, et al.; ASTRAL-4 Investigators. Sofosbuvir and velpatasvir for HCV in patients with decompensated cirrhosis. N Engl J Med. 2015;373(27):2618–2628.

STEPS new drug reviews cover Safety, Tolerability, Effectiveness, Price, and Simplicity. Each independent review is provided by authors who have no financial association with the drug manufacturer.

The series coordinator for AFP is Allen F. Shaughnessy, PharmD, MMedEd, Contributing Editor.

A collection of STEPS published in AFP is available at http://www.aafp.org/afp/steps.

 

 

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