‘Compassionate’ use of hep C combo
pharmafile | February 24, 2014 | News story | Research and Development, Sales and Marketing | CHMP, EMA, Gilead, hep C, ledipasvir, sovaldi
A key adviser to the European regulator has said that Gilead Sciences’ fixed-dose combination of Sovaldi and ledipasvir can be given as part of a compassionate-use programme for chronic hepatitis C virus (HCV).
The Committee for Medicinal Products for Human Use (CHMP) suggests it should be given to sufferers who are in urgent need of therapy to prevent progression of liver disease.
Gilead’s once-daily, oral hepatitis C treatment Sovaldi (sofosbuvir) was shown the green light by the European Commission in January, just a month after being approved in the US.
The combination would be used on the basis that patients with a long-lasting disease should be given access to treatments which are still under development and have not been given marketing authorisation.
Approximately 170 million people worldwide have HCV, a virus that infects the liver and can lead to cirrhosis and liver cancer, with nine million estimated to be living with the disease in the European Union.
Compassionate-use agreements are set up by member states – and this CHMP opinion was given following a request from Sweden.
The country’s authorities wanted to know under what circumstances it could grant early access to Sovaldi and ledipasvir – with or without ribavirin – for adults with genotype 1 HCV infection and advanced liver disease, who are at high risk of either their liver being no longer able to function normally or of dying within 12 months.
In trials the combination, whether added to ribavirin or not, has shown high efficacy in treating patients with genotype 1 virus over 12 or 24 weeks and advanced liver disease.
This includes patients with scarring of the liver but normal liver function (compensated cirrhosis) and patients for whom treatment with two protease inhibitors – Merck’s Victrelis (boceprevir) and Vertex Pharmaceuticals’ Incivek (telaprevir) – has not worked.
Last month the European Medicines Agency said it would conduct a speedy review of Bristol-Myers Squibb’s daclatasvir, an investigational NS5A replication complex inhibitor for HCV.
The submission includes the EU’s first all-oral and ribavirin-free investigational regimen – for use in treatment-naïve genotype 1, 2, 3 patients and protease inhibitor treatment failures.
It is a potentially lucrative area for manufacturers: the market for hepatitis C drugs could rise to more than $100 billion over the next decade, according to Bloomberg Industries.
Adam Hill
Related Content
Gilead’s HIV treatment meets primary trial endpoint
Gilead has announced positive topline results from its phase 3 ARTISTRY-2 trial, which evaluated a …
Gilead announces first shipments of HIV prevention drug to Eswatini and Zambia
Gilead has announced the first shipments of its HIV prevention drug lenacapavir to Eswatini and …
Rethinking oncology trial endpoints with generalised pairwise comparisons
For decades, oncology trials have been anchored to a familiar set of endpoints. Overall survival …
