First licensed drug to target the virus directly, helps clear the virus in almost 3 times as many patients who have failed previous treatment and nearly twice as many previously untreated patients compared to current therapy alone1
LONDON, [2nd August 2011] – 'Victrelis'® (boceprevir), the first licensed direct acting treatment for chronic hepatitis C (CHC) genotype 1 infection, is launched today in the UK, to be used in combination with current treatment (peginterferon alfa and ribavirin, known as standard therapy), in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.1
In clinical trials, the addition of boceprevir to standard therapy for those who had failed previous treatment, almost tripled (x2.8) the number of patients clearing the virus (achieving sustained virologic response, SVR) compared to standard therapy alone from 21% (17/80) to 59% (95/162).1 In previously untreated patients, the addition of boceprevir nearly doubled (x1.7) the number of patients clearing the virus compared to standard therapy alone from 38% (137/363) to 63% (233/368).1
The launch follows an accelerated assessment of boceprevir by the European Medicines Agency, due to its major public-health need.
Dr Ashley Brown, Consultant Hepatologist of St Mary's & Hammersmith Hospitals, commented “Over the last 10 years there has been little development in the treatment of HCV and a significant proportion of patients fail to respond to current standard of care. 'Victrelis' is the first licensed drug to directly target the virus. It offers improved outcomes for genotype 1 patients and new hope for those in whom previous treatment has been unsuccessful."
Around 250,000* people in the UK are chronically infected with hepatitis C.2,3,4,5 Many of those who are infected do not show symptoms for a long period and consequently diagnosis is often delayed.2,6 . As a result, hepatitis C is often described as the ‘silent epidemic’.2,6 A general practitioner with an average list of 1800 can expect to have eight to 20 patients with hepatitis C infection.7 "
Hepatitis C, caused by a blood-borne virus, can result in inflammation of the liver and subsequent fibrosis (scarring) of the liver tissue. Ultimately, the hepatitis C virus can cause significant liver damage including cirrhosis and liver cancer.3 The virus exists in different strains called genotypes. Genotype 1 is the most common in the UK, affecting 40-50% of patients,8 and is also the most difficult to clear with 40% SVR rates on current treatment versus around 80% for genotypes 2 and 3.9
The addition of boceprevir to standard therapy was investigated in two pivotal Phase III studies, HCV RESPOND-2 and HCV SPRINT-2, involving 403 patients who had failed previous therapy1 and 1,097 untreated patients respectively.1 The design of both studies included a 'response guided therapy' arm which investigated shortened therapy duration. Treatment could be stopped after 28 weeks for some previously untreated patients, which is 5 months less than 48 weeks of standard therapy alone.1
Boceprevir is a direct acting antiviral agent which interferes with the ability of the hepatitis C virus to replicate by inhibiting a key viral enzyme.1 This is in comparison to the current standard therapy which boosts the immune system to elicit a response. Treatment has a manageable side effect and tolerability profile with a low discontinuation rate due to adverse events.10,11 In clinical trials the most common adverse events were fatigue, headache, nausea, anaemia and dysgeusia (a metallic taste).1 Anaemia was observed in 49% of subjects treated with boceprevir and standard therapy, compared with 29% of subjects treated with standard therapy alone.1
Source: www.pharmiweb.com
