NICE одобрил Zepatier для лечения гепатита С генотипа 1a, 1b и 4

Cost regulators for the NHS in England and Wales are backing use of Merck, Sharp & Dohme's hepatitis C therapy Zepatier, potentially giving patients with certain types of the condition 'routine' access to another treatment option.

The National Institute for Health and Care Excellence has published draft guidelines endorsing Zepatier (elbasvir-grazoprevir) as an option to treat chronic hepatitis in adults with genotypes 1a, 1b or 4.

The appraisal committee concluded that all incremental cost effective ratios for the therapy were below £20,000 per QALY gained, regardless of genotype, treatment history or cirrhosis status, and could therefore be considered a cost-effective use of NHS resources.

Zepatier is a once-daily, fixed-dose combination tablet containing elbasvir (50mg) and protease inhibitor grazoprevir (100mg), administered for 12 weeks.

The drug belongs to the next-generation of hepatitis therapies called direct antivirals, which block the action of proteins essential for viral replication, in Zepatier's case NS3/4A and NS5A.

European approval, in August, was based on clinical trial data showing that sustained virologic response (SVR) 12 weeks after the completion of therapy was achieved in 96 percent (301/312) of chronic HCV GT1b-infected patients given MSD's therapy.

In chronic HCV GT1a-infected patients, 93 percent (483/519) and 95 percent (55/58) achieved cure following treatment with Zepatier for 12 weeks or Zepatier plus RBV for 16 weeks, respectively. Also, 94 percent (61/65) and 100 percent (8/8) of chronic HCV GT4-infected patients achieved cure in the treatment groups.

Chronic HCV infection, caused by a blood-borne virus, is a major public health concern affecting more than 170 million people globally, 15 million of whom are living in Europe. Of the six genotypes of chronic HCV infection, GT1 is the most common in Europe accounting for around 66 percent of cases.