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EMA recommends new combination therapies against chronic hepatitis C

Saras Ramiya
10 months ago
The European Medicines Agency (EMA) recommends the granting of marketing authorizations in the European Union (EU) for two combination therapies against chronic hepatitis C.

The two combination therapies—sofosbuvir/velpatasvir and grazoprevir/elbasvir belong to a new generation of medicines known as direct-acting antivirals, that result in high rates of cure among patients with hepatitis C virus (HCV) infection. These antivirals block the action of proteins, which are essential for viral replication—sofosbuvir/velpatasvir targets the proteins NS5B and NS5A, while grazoprevir/elbasvir targets the proteins NS3/4A and NS5A. In the past few years, these antivirals have changed the way hepatitis C is treated.

A high proportion of patients (over 90% overall)—across all genotypes—had no detectable virus in their blood 12 weeks after the end of the treatment with sofosbuvir/velpatasvir. They were considered to be cured of HCV infection.

The safety and efficacy of sofosbuvir/velpatasvir was tested in clinical trials involving over 2,000 patients, to assess that the HCV was no longer detected in the blood 12 weeks after the end of treatment (sustained virologic response, SVR), with or without ribavirin. The SVR rate for patients with genotype 3 was slightly lower (around 90%). The safety profile of the medicine was considered generally favourable, and in line with what has been observed with sofosbuvir; the most common side effects reported in clinical trials were headache, fatigue and nausea.

The fixed-dose combination of grazoprevir/elbasvir targets genotypes 1 and 4 of HCV. The efficacy and safety of grazoprevir/elbasvir was evaluated in clinical trials involving approximately 2,000 patients. This combination also showed a high SVR rate of over 90%, and in particular demonstrated its efficacy in treating patients with chronic kidney disease. The safety profile of grazoprevir/elbasvir is also considered favourable; the most common side effects reported in clinical trials were fatigue, headache and nausea.

The opinions adopted by the Committee for Medicinal Products for Human Use (CHMP) at the meeting in May are an intermediary step on introducing the two combination therapies to patients. The CHMP opinions have been sent to the European Commission for the adoption of decisions on EU-wide marketing authorizations. Once the authorizations have been granted, decisions about price and reimbursement will take place at the level of each member state considering the potential role/use of these medicines in the context of the national health system of that country.

HCV infection is a major European public health challenge. It affects between 0.4% and 3.5% of the population in different EU member states and is the most common single cause of liver transplantation in the region.
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Most Read Articles
one year ago
Non-selective beta-blockers use is linked with decreased mortality rate in acute on chronic liver failure (ACLF) patients, as presented in a prospective, observational study.
Roshini Claire Anthony, one month ago

The introduction of direct antiviral agents (DAAs) substantially improved sustained virological response (SVR) in patients with hepatitis C virus (HCV), a recent study found.

Fiel Soliven, 2 years ago
The effects of entecavir 0.5 mg/day for 48 weeks in treatment-naïve patients were assessed in this retrospective study.
Jackey Suen, one year ago
Researchers from the Chinese University of Hong Kong (CUHK) have identified a seven-microRNA (miRNA) signature, which may be used to predict survival in patients with hepatocellular carcinoma (HCC). [PLos ONE 2015, doi:10.1371/journal.pone.0128628]