• Yes, Sovaldi does cure hepatitis C in most people when it is used in combination with at least one other hepatitis C treatment.
• A cure is defined as a sustained virologic response (SVR) for a certain period (usually 12 weeks) and is usually written as SVR12. This means that the hepatitis C virus is undetectable in the blood for that period.
• The SVR depends on genotype and other factors and trials reported an SVR12 of 90% for genotype 1, 95% for genotype 2, 84% for genotype 3, and 96% for genotype 4 in clinical trials.
• Cure rates ranged from 84% (genotype 3) to 96% (genotype 4).
• Higher cure rates are achieved in people with genotypes 1,2, and 4; without cirrhosis; with baseline C/C alleles; or who were not black.

How effective is Sovaldi?

Sovaldi is very effective in the treatment of hepatitis C (HCV) when used with at least one other hepatitis C treatment.

Its safety and efficacy has been evaluated in at least seven trials, including at least one in children three years of age and older.

• Treatment success is measured by the sustained virologic response (SVR) which means that hepatitis C is undetectable in the blood.
• The SVR after 12 weeks (SVR12) was 90% for genotype 1 (genotype 1a 92%/genotype 1b 83%), 95% for genotype 2, 84% for genotype 3, and 96% for genotype 4.
• This means that 90% of people given Sovaldi who had HCV genotype 1 were cured and 96% of people given Solvadi who had genotype 4 were cured.
• 9% of people with HCV 1 or 4, 5% of people with HCV 2, and 14% with HCV 3 relapsed after treatment had finished.
• Cure rates were overall higher in people with HCV 1 or 4 without liver cirrhosis (93% compared) with 79% in those with cirrhosis). A similar trend was seen for HCV 2 or 3.
• Cure rates were higher in nonblacks (91%) compared with blacks (87%). • Cure rates were also higher in people with genotype 1 or 4 hepatitis C and baseline IL28B C/C alleles (alleles are alternative forms of a gene that arise by mutation) being 99% compared to 87% in those with non-C/C alleles.

The recommended dose of Sovaldi is 400mg taken orally once a day, with or without food.

What is Sovaldi?

Sovaldi (sofosbuvir) is an antiviral medicine that is used to treat certain genotypes of chronic hepatitis C in adults and children who are at least 3 years old.

How does Sovaldi work?

Sofosbuvir interferes with the reproduction of genetic material of the hepatitis C virus, by inhibiting an RNA-dependent polymerase called HCV NS5B, which is also needed by the virus to replicate itself.

Sofosbuvir is a prodrug, which means it is metabolized in the body to its active component and incorporated into the DNA of the HCV virus. Sofosbuvir also works directly on viral RNA and does not inhibit human DNA or RNA.

Sovaldi (sofosbuvir) was a breakthrough medicine when it was FDA approved in 2013 for the treatment of patients with chronic hepatitis C, in combination with other medications (usually ribavirin). It was the first of its kind that offered people with certain genotypes of chronic hepatitis C the chance of a cure and represented a treatment option for those who could not tolerate or take an interferon-based treatment regimen and in participants with liver cancer awaiting transplantation, addressing unmet medical needs.

Sofosbuvir is primarily used now in fixed-dose combinations, such as Harvoni (which contains sofosbuvir in combination with Ledipasvir) or Epclusa ((which contains sofosbuvir in combination with velpatasvir). Traditionally it was given together with ribavirin and sometimes peginterferon alfa as well.

What are the side effects of Sovaldi?

The most common side effects of Sovaldi occurring in 10% or more of patients are:

• Headache
• Fatigue
• Itching
• Asthenia (lack of energy)
• Nausea.

Also, reactivation of hepatitis B has been reported in people who have a current or prior hepatitis B virus (HBV) infection before initiating treatment with Sovaldi. In some cases, this has resulted in severe and rapid liver disease, hepatic failure, and death.

For more information about Sovaldi see Oral Hepatitis C Treatments: The Evolving Landscape.