FDA-Approved Hepatitis C Drugs

When the drug Sovaldi (sofosbuvir) was first introduced in September 2014, it not only marked a sea change in how hepatitis C infection was treated, it made obsolete earlier generation medications which were nowhere near as effective. Within months of Sovaldi's arrival, such hepatitis C mainstays as Incivek (telaprevir) and Victrelis (boceprevir) were quickly yanked from the market, never to be seen again.

Following fast on Sovaldi's heels was the introduction of five additional drug formulations able to treat an ever-widening range of hepatitis C genotypes. These newer drugs not only offered fewer side effects, but they also reduced the course of therapy by as much as three months.

With cure rates now exceeding 95 percent in many cases, the only real challenge is how to expand access to the 130 to 150 million people chronically infected with hepatitis C worldwide.

Drug Discontinuations

As treatment durations decreased and cure rates climbed, less competitive direct-acting antivirals quickly lost popularity and were voluntarily withdrawn from the marketplace.

These included the drug Olysio (simeprevir), which was pulled in May 2018, and the combination drugs Technivie (ombitasvir/paritaprevir/ritonavir) and Viekira Pak (ombitasvir/paritaprevir/ritonavir plus dasabuvir), both of which were discontinuation on January 1, 2019.

The remaining mainstays of hepatitis C treatment are listed by the order of their FDA approval.

1

Mavyret

Courtesy of Abbvie

Approved by the U.S. Food and Drug Administration (FDA) in August 2017, Mavyret (glecaprevir/pibrentasvir) is a combination drug comprised of two viral protein inhibitors. By blocking these proteins, hepatitis C viral RNA replication cannot take place. Mavyret is effective at clearing all six hepatitis C genotypes in as little of eight weeks. The recommended dosage is three tablets taken once daily with food. 

The average wholesale price (AWP) of Mavyret is $26,400 for an 8-week course and $39,600 for a 12-week course.

2

Vosevi

Courtesy of Gilead

 

Approved in July 2017 by the FDA, Vosevi (sofosbuvir/velpatasvir/voxilaprevir) is used to treat any genotype of the hepatitis C virus. Vosevi is intended for people who have been previously treated with sofosbuvir but didn't achieve viral clearance (known as a sustained viral response, or SVR). The recommended dosage is one tablet one pill taken once daily with food for 12 weeks.

The average wholesale price (AWP) of Vosevi is $74,760 for a 12-week course.

3

Epclusa

epclusa bottle and pill
Photo courtesy Gilead Sciences

Approved on June 28, 2016, Epclusa (sofosbuvir/velpatasvir) is a two-in-one combination tablet able to treat all six major hepatitis C genotypes. It can be used to treat people with cirrhosis (including decompensated cirrhosis). Epclusa is prescribed in a once-daily dose for a period of 12 weeks.

The average wholesale price (AWP) of Epclusa is $89,700 for an 8-week course.

4

Zepatier

zepatier pill box
Courtesy Merck

Approved in January 2016, Zepatier (elbasvir/grazoprevir) is a fixed-dose combination drug used to treat genotypes 1 and 4 with or without cirrhosis. Zepatier is a single-pill therapy that does not need to be administered with any other drug. It is taken once daily with or without food for 12 to 16 weeks, depending on the type of genotype a person has and whether or not the person has been previously treated for hepatitis C.

The average wholesale price (AWP) of Zepatier is $54,000 for a 12-week course.

5

Daklinza

daklinza pills

Courtesy Bristol Myer Squibb

Approved in July 2015, Daklinza (daclatasvir) is used in combination therapy to treat hepatitis C genotype 3 infection. Daklinza was the first direct-acting antiviral able to treat genotype 3 without the addition of peginterferon or ribavirin. Daklinza is taken along with Sovaldi once daily with or without food for a period of 12 weeks.

The average wholesale price (AWP) of Daklinza is $25,200 for a 12-week course.

6

Harvoni

harvonia bottle and pill

 Photo courtesy Gilead Sciences

Approved in October 2014, Harvoni (ledipasvir, sofosbuvir) is a fixed-dose combination drug used to treat genotype 1 and 4 infections with or without cirrhosis. It can also be used in some cases of genotype 3. Harvoni was the first, all-in-one drug formulation that didn't require co-administration with peginterferon or ribavirin. The recommended dosage is one tablet daily taken with or without food. The treatment duration is from 12 to 24 weeks.

The average wholesale price (AWP) of Harvoni is $94,500 for a 12-week course.

7

Sovaldi

sovaldi bottle and pill
Courtesy Gilead Sciences

Approved in December 2013, Sovaldi (sofosbuvir) is a novel direct-acting antiviral drug used to treat genotypes 1, 2, 3 and 4. The recommended dosage is one tablet daily taken with or without food. Depending on the genotype, ribavirin may be incorporated into the therapy. For genotype 3 infection, Sovaldi is co-administered with Daklinza. The treatment duration is from 12 to 24 weeks.

The average wholesale price (AWP) of Sovaldi is $84,000 for a 12-week course.

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Article Sources

  • AASLD-IDSA HCV Guidance Panel. Hepatitis C Guidance 2018 Update: AASLD-IDSA Recommendations for Testing, Managing, and Treating Hepatitis C Virus Infection. Clin Infect Dis. 2018:67(10):1477-92. DOI: 10.1093/cid/ciy585.