Janssen UK’s Incivo (telaprevir) has been recommended in final draft guidance as a treatment option for genotype 1 chronic hepatitis C (CHC) in adults with compensated liver disease.

NICE has recommended the treatment in combination with peginterferon alfa and ribavirin after it demonstrated significant improvements in sustained virological response rates.

Meindert Boysen, Programme Director Technology at NICE, said Incivo “represents a major benefit for people with chronic hepatitis C”.

It was estimated that in 2009 around 250,000 people in England and Wales were carrying the hepatitis C virus. Approximately 146,000 people were chronically infected.

Genotype 1 is the most common subtype of hepatitis C in England and Wales, affecting between 40% and 50%. It is also the subtype most resistant to treatment.

Poor diagnosis and compliance rates coupled with a high incidence of new infection means that CHC presents a major public health issue, despite the availability of treatments.

The final draft guidance recommends Incivo as an option for the treatment of genotype 1 chronic hepatitis C in adults with compensated liver disease who have not received treatment, or in whom treatment with peginterferon alfa and ribavirin has failed.

Dr Martin Price, External Affairs Director, Janssen UK commented: “We welcome this final appraisal determination from NICE and we expect that genotype-1 hep C patients will now be able to access this treatment which will offer them a greater chance of clearing the hep C virus and potentially a shorter treatment duration than is available with standard treatment.”

NICE has issued final draft guidance recommending the use of MSD’s Victrelis (boceprevir) in combination with peginterferon alfa and ribavirin to treat genotype 1 chronic hepatitis C.

The recommendation was based on two Phase III trials that highlighted the effectiveness of Victrelis compared to existing treatment options.

Meindert Boysen, Programme Director Technology Appraisals, NICE, says the “significant improvement in sustained virological response rates” represents a “major benefit” for patients.

Existing NICE guidance recommends pegylated interferon and ribavirin combination therapy for people with genotype 1 chronic hepatitis C.

Approximately 15% of people infected with the virus will naturally recover and experience no long-term effects from the infection.

But the remaining 85% will develop a chronic infection which can cause significant damage to the liver and may eventually lead to liver cancer.

Genotype 1 is the most common subtype of hepatitis C in England and Wales and the most resistant to treatment.

The primary aims of treatment are to remove the virus from the blood in order to prevent progression of liver disease and to prevent the transmission of the hepatitis C virus.

The pivotal studies, HCV RESPOND-2 and HCV SPRINT-2, involved 403 patients who had failed previous therapy and 1,097 untreated patients, respectively. They found that treatment with Victrelis could be stopped after 28 weeks for some previously untreated patients – some five months less than the standard therapy course of 48 weeks.

“In the past, patients have declined treatment because the perceived chance of a sustained virological response with peginterferon alfa plus ribavirin was too low for them to accept the associated side effects,” said Meindert Boysen. “We are therefore very pleased to be able to recommend boceprevir as a cost-effective use of NHS resources.”

US pharma giant Merck & Co (MSD in Europe) has warned that its hepatitis C drug Victrelis (boceprevir) significantly reduces the effectiveness of some major HIV medications.

Trials have shown that Victrelis, which was approved by the European Commission in July 2011 as part of a triple combination therapy for liver disease, has been shown to reduce blood levels of the protease inhibitors Reyataz, Prezista and Kaletra by around half.

The efficacy of Victrelis is also severely reduced by these drugs.

Since an estimated 10–15% of patients with hepatitis C also have HIV, the finding is likely to affect sales of Victrelis significantly.

In a letter to US healthcare professionals, Merck said: “These drug interactions may be clinically significant for patients infected with both chronic hepatitis C virus and HIV by potentially reducing the effectiveness of these medicines when co-administered.”

Hepatitis C affects up to 300 million people worldwide, causing long-term and potentially fatal liver damage.

Merck and Roche have co-promoted a triple combination therapy for Hepatitis C consisting of Victrelis, peginterferon alfa and ribavirin in Europe, Asia and Latin America following the EC approval.

The drug interaction study, which used healthy volunteers, showed that Victrelis reduced blood levels of Reyataz (atazanavir), Prezista (darunavir) and Kaletra (lopinavir/ritonavir) by 49%, 59% and 43% respectively.

Levels of Victrelis itself were reduced by 45% when taken with Kaletra and by 32% when taken with Prezista.

According to ISI Group analyst Mark Schoenebaum, the drug interaction findings could reduce sales of Victrelis by as much as 25%.

Merck is conducting further drug-interaction studies of Victrelis with other HIV drugs, including Intelence (etravirine) and Isentress (raltegravir).

Janssen Pharmaceuticals’ protease inhibitor (PI) Incivo (telaprevir), to treat adults with genotype-1 chronic hepatitis C, has been launched in the UK.

The direct acting antiviral (DAA) PI uses telaprevir, a new class of medicine which directly targets the hepatitis C virus, offering patients further help with clearing the virus in combination with the current standard treatment of peginterferon alfa and ribavirin.

Professor Graham Foster at Queen Mary's University Hospital of London, said: “For many adults with chronic genotype-1 hep C, treatment with a telaprevir based regimen could provide a shorter treatment duration with improved response rates compared to standard treatment.”

The marketing authorisation of the therapy was based on clinical research gathered from three Phase III clinical trials involving more than 2,290 hep C patients. Results showed that Incivo cured the virus in almost twice as many previously untreated patients and in almost four times as many who had previously relapsed following treatment.

Incivio was co-developed by Vertex Pharmaceuticals and Tibotec, an affiliate of Janssen Pharmaceuticals and the company responsible for marketing telaprevir in Europe.

Approximately 216,000 to 466,000 people are infected with chronic hepatitis C in the UK, of which only 80,000 have been diagnosed. The standard treatment for hep C, peginterferon alfa and ribavirin, is successful in about 50% of patients with genotype 1, leaving the other 50% without a successful treatment outcome.

The European Commission approved use of Incivo for to treat genotype-1 chronic hepatitis C virus in combination with peginterferon alfa and ribavirin in September 2011.

The European Commission has approved Incivo (telaprevir) for the treatment of genotype-1 chronic hepatitis C virus (HCV) in combination with peginterferon alfa and ribavirin.

The decision follows data from clinical studies which showed the direct acting antiviral (DAA) protease inhibitor significantly improved cure rates.

Ramon Polo, Telaprevir Compound Development Team Leader, Tibotec Virco-Virology BVBA, is delighted patients have “a significantly improved treatment option”.

Tibotec Virco-Virology BVBA is a division of Janssen.

Incivo is a class of medicine which offers patients with genotype-1 chronic HCV patients more chance than ever of a cure.

Its approval offers an improved and efficacious therapy regimen when compared to standard treatment with the shortest duration course of medication which is currently available. The DDA protease inhibitor may also reduce the total therapy time by half in the majority of those previously untreated patients and those who have relapsed.

Before the introduction of these inhibitors, treatment for HCV “required a long duration and cured less than half of genotype-1 chronic HCV patients”, said Professor Graham Foster, Queen Mary's University Hospital of London.

MSD’s Victrelis (boceprevir) has been approved by the European Commission for the treatment of chronic hepatitis C (CHC) genotype 1 infection in adults with compensated liver disease.

The marketing authorisation approval is based on the positive efficacy and safety results from two Phase III studies that found patients receiving the medication were able to reduce their length of therapy.

Victrelis is the first in a new class of medicines, known as HCV protease inhibitors, and has been welcomed by healthcare professionals.

Dr Rafael Esteban, Head of the Internal Medicine and liver unit of the Hospital Universitario Val d'Hebron, Barcelona, Spain, says its approval is “very exciting”.

It has been approved in combination with peginterferon alfa and ribavirin in patients who are previously untreated or who have failed previous therapy.

Chronic hepatitis C virus (HCV) is a potentially serious viral infection of the liver that affects approximately four million people across Europe.

“Victrelis is the first major advancement for the treatment of chronic hepatitis C approved in the EU in a decade, and represents an important step forward for people living with this serious disease and the physicians who treat them,” said Bruno Strigini, President, Europe/Canada, Merck.

The marketing authorisation is valid in 27 EU Member States and also secures unified labelling applicable to the European Economic Area members, Iceland, Liechtenstein and Norway.