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EMA recommends new combination therapies against chronic hepatitis C

Saras Ramiya
27 Jun 2016
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
Elvira Manzano, 5 days ago
Bisphosphonates have proven antifracture efficacy and remain to be the cornerstone of osteoporosis treatment. However, a drug holiday is of particular importance with bisphosphonates due to some signals with long-term use of the drug, including rare incidence of atypical femoral fracture (AFF) and osteonecrosis of the jaw (ONJ), says a leading endocrinologist at AFOS 2017.
2 days ago
Breast cancer patients have notably different microbiomes in the local breast tissue and urinary tract, a recent study reveals. Particularly, species in the Methylobacterium genus are reduced in the local breast tissue while the urinary tract is enriched in gram-positive bacteria.
Tristan Manalac, 2 days ago
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