The fixed combination of sofosbuvir / velpatasvir (trade name: Epclusa) has been approved in Germany since July 2016 for the treatment of chronic hepatitis C in adults.
Hepatitis C viruses (HCV) attack the liver, where they can cause acute inflammation. There are seven known forms of hepatitis C viruses, referred to as genotypes 1 to 7. In up to 80 out of 100 people with hepatitis C, the immune system is unable to fight the virus on its own. These people develop a permanent (chronic) inflammation of the liver which can cause cirrhosis. The liver then performs increasingly poorly. As long as the effect on liver performance is not noticeable, it is known as “compensated cirrhosis." Signs of advanced (decompensated) cirrhosis include fluid retention in the abdominal cavity, blood clotting problems, and neurological and psychiatric problems, possibly as severe as a coma. The risk of liver cancer increases too.
It is currently believed that patients who permanently have no detectable viruses in their blood following treatment are at lower risk of such secondary diseases. The combination of sofosbuvir / velpatasvir aims to keep the viruses from multiplying.
Sofosbuvir / velpatasvir is taken once a day in tablet form. One tablet contains 400 mg of sofosbuvir and 100 mg of velpatasvir. Depending on the genotype and the severity of the disease, these drugs can be combined with ribavirin. The fixed combination treatment usually lasts 12 weeks. It may be extended to 24 weeks, depending on other previous treatments.
People with hepatitis C can receive different combinations of antiviral drugs. The combination is determined by the genotype and extent of liver damage.
In 2016, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of sofosbuvir / velpatasvir compared with the standard treatments for chronic hepatitis C caused by the genotypes 1 to 6.
People with chronic hepatitis C can be divided into different groups based on the genotype of their virus, the stage of the disease, and their previous treatments. In total, IQWiG assessed sofosbuvir / velpatasvir in eight different groups of patients.
The manufacturer did not provide any suitable data for the following groups:
- People with HCV genotype 1
- People with HCV genotype 2 and decompensated cirrhosis
- People with HCV genotype 3 and decompensated cirrhosis
- People with HCV genotype 4
- People with HCV genotype 5
- People with HCV genotype 6
So it was not possible to find out whether sofosbuvir / velpatasvir has any advantages or disadvantages compared to standard treatment for these groups of people.
Data was available for the following two groups:
- People with chronic hepatitis C (genotype 2) with or without compensated cirrhosis
- People with chronic hepatitis C (genotype 3) with or without compensated cirrhosis
This information summarizes the main results of a review produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The review was commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of this review and the hearings received, G-BA passed a resolution on the added benefit of sofosbuvir / velpatasvir (Epclusa).
Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Sofosbuvir/velpatasvir (chronic hepatitis C) – Benefit assessment according to §35a SGB V; Dossier assessment; Commission A16-48. October 13, 2016. (IQWiG reports; Volume 448).
IQWiG health information is written with the aim of helping
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