Sofosbuvir is one of a number of new direct-acting antiviral drugs revolutionising the care of people living with hepatitis C. Combinations of two or three hepatitis C virus direct-acting antiviral drugs taken for 8-24 weeks can cure more than 90% of people treated. However, this breakthrough in clinical medicine comes at a cost.
Globally, it is estimated more than 80 million people are infected with hepatitis C. Each year, 700,000 people die from complications of the disease. In Australia, an estimated 230,000 people are living with chronic hepatitis C.
Complications of hepatitis C include cirrhosis, liver failure and liver cancer. Ensuring broad access to these ground-breaking therapies, including sofosbuvir, is vital to reduce liver deaths and prevent new infections.
The direct-acting antiviral drugs work by blocking the action of specific proteins or enzymes in the hepatitis C virus, which are essential for the virus to replicate and infect liver cells. Sofosbuvir blocks the action of an enzyme called “NS5B RNA-dependent RNA polymerase”.
With time and industry competition, drug costs have fallen marginally. Sofosbuvir combined with ledipasvir is US$94,500 (A$124,000) and the recently launched sofosbuvir combined with velpatasvir is US$64,700 (A$85,000) for a 12-week course.
INDICATIONS AND USAGE
SOVALDI is a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor indicated for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen.
- SOVALDI efficacy has been established in subjects with HCV genotype 1, 2, 3 or 4 infection, including those with hepatocellular carcinoma meeting Milan criteria (awaiting liver transplantation) and those with HCV/HIV-1 co-infection
The following points should be considered when initiating treatment with SOVALDI:
- Monotherapy of SOVALDI is not recommended for treatment of CHC.
- Treatment regimen and duration are dependent on both viral genotype and patient population
- Treatment response varies based on baseline host and viral factors
WARNINGS AND PRECAUTIONS
Use with Potent P-gp Inducers
Drugs that are potent P-gp inducers in the intestine (e.g., rifampin, St. John’s wort) may significantly decrease sofosbuvir plasma concentrations and may lead to a reduced therapeutic effect of SOVALDI. Rifampin and St. John’s wort should not be used with SOVALDI.
The most common adverse events (≥ 20%) for SOVALDI + ribavirin combination therapy were fatigue and headache. The most common adverse events (≥ 20%) for SOVALDI + peginterferon alfa + ribavirin combination therapy were fatigue, headache, nausea, insomnia and anemia.