CHMP Backs Two Pan-Genotypic Antivirals for Hep C

Megan Brooks

June 23, 2017

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of two new drugs, Maviret and Vosevi, for the treatment of chronic hepatitis C virus (HCV) infection in adults.

Maviret (AbbVie Ltd), administered once daily as three oral tablets, contains the NS3/4A protease inhibitor glecaprevir (100 mg) and the NS5A inhibitor pibrentasvir (40 mg).

Vosevi (Gilead Sciences) is a once-daily single tablet that contains the nucleotide analogue nonstructural protein NS5B polymerase inhibitor sofosbuvir (400 mg), the HCV NS5A inhibitor velpatasvir (100 mg), and the novel pan-genotypic HCV NS3/4A protease inhibitor voxilaprevir (100 mg).

"Both Maviret and Vosevi are active against all genotypes of the virus and, with some differences between the two medicines, may be specifically useful in some patients who failed or cannot use previously available therapies," the EMA said in a news release.

"As this is considered to be of major public health interest in terms of therapeutic innovation, both medicines were evaluated under the EU's accelerated assessment mechanism, which aims to speed up patients' access to new medicines where there is an unmet medical need," they note.

Efficacy and Safety Data

The efficacy of Maviret was demonstrated in more than 2300 patients who participated in eight pivotal and three supportive clinical trials.

In one analysis, treatment with Maviret for 8 weeks led to sustained virologic response at 12 weeks (SVR12) in 807 of 828 (97.5%) treatment-naive patients with chronic HCV infection who were without cirrhosis, AbbVie noted in a news release.

In an integrated analysis of 2265 patients, fewer than 0.4% of the patients discontinued treatment. Side effects seen with Maviret were generally mild and included headache, fatigue, diarrhea, nausea, and abdominal pain.

"If approved, Maviret will be a once-daily, ribavirin-free, 8-week option for patients without cirrhosis and who are new to treatment across all genotypes (GT1-6), who comprise the majority of people living with HCV," AbbVie said in the release.

The effects of Vosevi were studied in four main clinical trials involving more than 1700 patients. Two trials were conducted in previously untreated patients, and two were conducted in patients in whom previous treatment (in some cases with an NS5A inhibitor) had not cleared the virus.

Vosevi was given for 12 weeks in the previously treated patients and for 8 weeks in the untreated patients. SVR12 was achieved in more than 90% of patients after the end of treatment, the EMA said.

"The data included in the application support the use of [Vosevi] in patients with and without compensated cirrhosis, with all genotypes (GT1-6) of HCV infection regardless of prior therapy, including 8 weeks of treatment for HCV direct-acting antiviral (DAA)-naive patients without cirrhosis, as well as 12 weeks of treatment for patients who have previously failed therapy with a DAA-containing regimen," Gilead Sciences added in a news release.

Mild nausea, headache, and diarrhea were the most common side effects observed with Vosevi. Other potentially related adverse effects were decreased appetite, vomiting, muscle spasms, and rash.

Detailed recommendations for the use of Maviret and Vosevi will be provided in the summary of product characteristics, which will be published in the European public assessment report and will be made available in all official European Union languages after the European Commission grants marketing authorization.

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