In the UK, about 216,000 people suffer from a chronic infection of hepatitis C.5. The UK’s National Institute for Health and Clinical Excellence (NICE) has just issued a Final Appraisal Determination (FAD) for recommending ‘Victrelis’® (boceprevir), in combination with peginterferon alfa and ribavirin (‘dual therapy’), as a treatment option for adults with genotype 1 chronic hepatitis C (CHC), with compensated liver disease who had no previous treatment, or for those who were unreceptive to other treatments.

Boceprevir is the first direct acting anti-viral drug for CHC genotype 1 infection to receive a FAD that is said to “represent a cost-effective use of NHS resources.” The FAD is the final part of the NICE Appraisal Committee process and will be used as the NHS guidance for England and Wales, due to be published in April. Boceprevir was granted FAD approval through the NICEs accelerated assessment procedure, which means that by being available on the market, those suffering from CHC have a higher chance of being cleared of the virus, as compared with those who only receive a standalone dual therapy.

Professor Graham Foster, Professor of Hepatology at Barts and The London School of Medicine and Dentistry, declared:

“The new generation of drugs for patients with genotype 1 hepatitis C have shown very clearly that they can dramatically increase the proportion of patients who are able to clear the viral infection. In the first technology appraisal of these drugs, NICE has reviewed the clinical and cost-effectiveness of boceprevir and given a positive recommendation. It will now be important to ensure that patients have easy access to the high quality care that they need to give them the best chance of clearing the virus.”

The Committee acknowledged:

“The demands that living with genotype 1 chronic hepatitis C places on patients and concluded that treatments which enable patients to achieve a sustained virological response … and which consequently help to reduce HCV transmission are of significant importance.”

Under the normal process, the NHS usually has to provide funds and resources for a new drug within 3 months of the publication of the final guidance if a NICE technology appraisal is to recommend the use of a drug, treatment or technology.

NICEs recommendation was given after two pivotal Phase III studies, the HCV RESPOND-2 study, which evaluated the drug in 403 patients who were unresponsive to previous therapy, and the HCV SPRINT-2 study, which involved 1,097 untreated patients. Both studies were designed to include a ‘response guided therapy’ section that examined shortened therapy duration. The findings revealed that some previously untreated patients were able to discontinue the treatment after 28 weeks, which represents a timesaving of 5 months, in comparison with the 48 weeks of standard therapy alone.

The number of patients who were previously unresponsive to treatment and who cleared the virus, achieving a sustained virologic response (SVR) by adding boceprevir to the standard therapy nearly tripled (x2.8), in comparison with those on standard therapy alone 21% (17/80) to 59% (95/162), whilst clearing the virus in those who were previously untreated who received boceprevir, in addition to the standard therapy almost doubled (x1.7), compared with those on standard therapy alone from 38% (137/363) to 63% (233/368).

Boceprevir is a direct acting antiviral agent that works by preventing that the hepatitis C virus replicates a key viral enzyme. The dual therapy boosts the immune system to evoke a response.

The researchers observed manageable side effects during the treatment and noted that the tolerance profile had a comparable discontinuation rate caused by adverse events than dual therapy alone. The most common adverse events consisted of headache, nausea, fatigue, anemia and dysgeusia (a metallic taste). In comparison with 29% of participants in the standard therapy alone group, 49% of participants in the boceprevir group suffered from anemia.

Written by Petra Rattue