MSD Posted on:12 Aug 10
12 August 2010, Hoddesdon – The National Institute for Health and Clinical Excellence (NICE) today issued a final appraisal determination (FAD) on the use of peginterferon alfa and ribavirin for the treatment of chronic hepatitis C, which includes MSD’s ViraferonPeg and Rebetol treatment regimen. The updated guidance recommends? combination therapy with peginterferon alfa and ribavirin as a treatment option for patients who are co-infected with HIV or patients with hepatitis C who require re-treatment (as they either did not respond to previous combination treatment, or peginterferon alfa monotherapy, or responded initially to treatment but subsequently relapsed).1
People co-infected with HIV and the hepatitis C virus (HCV) are at greater risk of developing liver disease than those infected with hepatitis C alone. The prevalence of HCV infection in HIV-positive individuals is higher than in the general population but varies among clinics according to risk factors for HIV acquisition. Around a third of people with HIV are estimated to have chronic HCV infection.
An estimated 200,000 to 500,000 people are infected with hepatitis C in England and Wales, with the majority unaware they have the condition. Hepatitis C is an infectious disease of the liver caused by HCV. The virus is acquired primarily through percutaneous exposure to contaminated blood. In approximately 80% of cases the virus will not be cleared and will develop into the chronic form of the disease.2
The final appraisal determination builds on existing guidance issued by NICE in 2004 and 2006 for the treatment of moderate-severe chronic hepatitis C and mild chronic hepatitis C respectively , and reinforces the importance of treating hepatitis C and HIV co-infection.
The previous NICE guidance (TA106 and TA75) recommend combination therapy with ribavirin and either peginterferon alfa-2a or peginterferon alfa-2b for adults with chronic hepatitis C. The previous guidance also recommends that monotherapy with peginterferon alfa-2a or peginterferon alfa-2b should be used only by people who are unable to tolerate ribavirin or for whom ribavirin is contraindicated.1
Treatment with peginterferon alfa and ribavirin aims to clear the virus from the blood.1 Successful treatment is usually indicated by a sustained virological response, which is considered to indicate permanent resolution of infection.1
Dr Harpal Lamba, MSD Medical Affairs, commented “We welcome NICE’s FAD for the use of peginterferon alfa and ribavirin for the treatment of chronic hepatitis C. This guidance will support healthcare professionals to consistently manage patients with hepatitis C when re-treatment is needed or where patients are co-infected with HIV.”
-ends-
About MSD
MSD is a trading name of Schering-Plough Limited and Merck Sharp & Dohme Limited in the UK. For more information on Merck Sharp & Dohme Limited and Schering-Plough Limited, please visit http://www.msd-uk.co.uk/.
Notes to editors:
About ViraferonPeg (peginterferon alfa-2b) and Rebetol (ribavirin)
ViraferonPeg is indicated for the treatment of adult patients with chronic hepatitis C who are positive for hepatitis C virus NRA (HCV-RNA), including patients with compensated cirrhosis and/or co-infected with clinically stable HIV.
The best way to use ViraferonPeg in this indication is in combination with Rebetol. This combination is indicated in naïve patients including patients with clinically stable HIV co-infection and in patients who have failed previous treatment with interferon alpha (pegylated or nonpegylated) and ribavirin combination therapy or interferon alpha monotherapy.
Combination therapy with peginterferon alfa (2a or 2b) and ribavirin is recommended as a treatment option for adults with chronic hepatitis C: who have been treated previously with peginterferon alfa (2a or 2b) and ribavirin in combination, or with peginterferon alfa monotherapy, and whose condition either did not respond to treatment or responded initially to treatment but subsequently relapsed or who are co-infected with HIV.1
The registered trademark holder for ViraferonPeg® and Rebetol® is Schering-Plough Limited in Switzerland. For more information refer to the Summary of Product Characteristics.
About hepatitis C1
Hepatitis C is an infectious disease of the liver caused by HCV. The virus is acquired primarily through percutaneous exposure to contaminated blood. People infected with HCV are often asymptomatic, but about 20% develop acute hepatitis. In approximately 80% of people who are infected, the virus is not cleared and they go on to develop chronic hepatitis C. Chronic hepatitis C is categorised as mild, moderate or severe depending on the extent of liver damage. The rate of progression from mild to severe disease is slow but variable, taking about 20 to 50 years from the time of infection. About 30% of infected people develop cirrhosis within 20 to 30 years, and some of these develop hepatocellular carcinoma. Some people with end-stage liver disease or hepatocellular carcinoma may require liver transplantation.
About the NICE guidance on peginterferon alfa and ribavirin1
Peginterferon alfa and ribavirin for the treatment of chronic hepatitis C (part review of technology appraisal guidance 75 and 106) – Final appraisal determination
This guidance should be read in conjunction with the following NICE guidance:
• NICE technology appraisal guidance 75 (TA75) ‘interferon alfa (pegylated and non-pegylated) and ribavirin for the treatment of chronic hepatitis C’ (which covers moderate to severe hepatitis C)
• NICE technology appraisal guidance 106 (TA106) ‘peginterferon alfa and ribavirin for the treatment of mild chronic hepatitis C’.
Guidance [section 1]:
Combination therapy with peginterferon alfa (2a or 2b) and ribavirin is recommended as a treatment option for adults with chronic hepatitis C;
• who have been treated previously with peginterferon alfa (2a or 2b) and ribavirin in combination, or with peginterferon alfa monotherapy, and whose condition either did not respond to treatment or responded initially to treatment but subsequently relapsed; or
• who are co-infected with HIV.
Shortened courses of combination therapy with peginterferon alfa (2a or 2b) and ribavirin are recommended for the treatment of adults with chronic hepatitis C who:
• have a rapid virological response to treatment at week 4 that is identified by a highly sensitive test; and
• are considered suitable for a shortened course of treatment.
When deciding on the duration of combination therapy, clinicians should take into account the licensed indication of the chosen drug (peginterferon alfa-2a or peginterferon alfa-2b), the genotype of the hepatitis C virus, the viral load at the start of treatment and the response to treatment (as indicated by the viral load).
Overview of previous guidance [section 2.5]:
Previous NICE guidance (TA106 and TA75) recommends combination therapy with ribavirin and either peginterferon alfa-2a or peginterferon alfa-2b for adults with chronic hepatitis C. The previous guidance also recommends that monotherapy with peginterferon alfa-2a or peginterferon alfa-2b should be used only by people who are unable to tolerate ribavirin or for whom ribavirin is contraindicated. The recommended duration of treatment is 24 or 48 weeks depending on a combination of factors, including the HCV genotype, the viral load at the start of treatment and whether a person has a rapid virological response to treatment. For people with mild HCV infection, the person and their clinician should decide whether to treat immediately or adopt an approach of ‘watchful waiting’ (see TA106). The use of peginterferon alfa and ribavirin combination therapy is also considered suitable for people who are co-infected with HCV and HIV, unless it is contraindicated.
http://guidance.nice.org.uk/TA106/Guidance
http://www.nice.org.uk/nicemedia/pdf/TA075guidance.pdf
http://guidance.nice.org.uk/TA/WaveR/20
For more information:
http://www.msd-uk.co.uk/
Editor's Details
Anna Radnavale
http://www.msd-uk.co.uk/
Source
No comments:
Post a Comment