Bristol-Myers Squibb Pharmaceuticals Limited (Bristol-Myers Squibb) has welcomed the decision by the Scottish Medicines Consortium (SMC) to accept Baraclude® (entecavir) for use within NHS Scotland for the treatment of chronic hepatitis B virus infection.
In its guidance, the SMC states that "Baraclude is accepted for use within NHS Scotland for the treatment of chronic hepatitis B virus infection in adults with compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase levels and histological evidence of active inflammation and or fibrosis. Clinical studies have shown that entecavir is more effective than lamivudine in nucleoside-naive HBeAg positive and negative patients and in lamivudine refractory patients." (1)
David Veitch, General Manager, Bristol-Myers Squibb said, "The recent launch of Baraclude supports our company's strategy for growth; to deliver new medicines in disease areas where there is a significant unmet medical need. The SMC's decision is great news for patients as it will provide them with a valuable new treatment option."
In patients with hepatitis B, a high or increasing viral load (the amount of virus in the blood) is an important predictor of progression to serious liver disease and liver cancer. Baraclude works by inhibiting the replication of the hepatitis B virus thereby reducing the viral load in a person's bloodstream in some cases to undetectable levels.
There have been three pivotal, phase III studies comparing Baraclude to lamivudine in nucleoside-naive HBeAg positive and HBeAg negative patients and in patients refractory (resistant) to lamivudine.
After 48 weeks of treatment - or two years for those with only a virological response initially - entecavir achieved responses higher or similar to lamivudine, with regard to improvement in liver inflammation and the degree of liver fibrosis (scarring) caused by hepatitis B virus, reduction in the amount of virus in the blood, normalisation of liver function and seroconversion (development of antibodies in blood due to infection).(2,3) Among patients who had not received previous antiviral treatment and without evidence of lamivudine resistance at baseline, no drug resistance has emerged through 96 weeks of treatment with Baraclude.(4)
In these studies, Baraclude was generally well tolerated and has a safety profile comparable to lamivudine. The overall frequency of adverse events and serious adverse events was comparable between Baraclude (0.5mg and 1mg) and lamivudine (100mg). The most common adverse events were headache, upper respiratory tract infection, fatigue, nausea and cough.(1)
The cost-utility for Baraclude for first line treatment of chronic hepatitis B virus in nucleoside-naive HBeAg positive and negative patients showed an estimated incremental cost per health related QALY gained (Quality Adjusted Life Year, a combined measure of survival and quality of life) of £12,000 to £15,000 respectively, compared to lamivudine. The cost-utility analysis for second line use of Baraclude vs lamivudine or adefovir in nucleoside-naive patients who become resistant to lamivudine showed an estimated cost per health related QALY gained of £9,000 and £17,000 respectively.(1) The generally accepted threshold of cost per health related QALY gained is £20,000-£30,000.(5)
Baraclude was approved by the European Medicines Evaluation Agency at the end of June 2006 and was launched in the UK in September 2006.
Chronic hepatitis B infection is a potentially life-threatening disease and is a serious public health issue. The Department of Health estimates that 0.3% of the UK population is chronically infected with hepatitis B, equivalent to some 180,000 people.(6) Chronic hepatitis B infection is the leading cause of hepatocellular carcinoma.(7)
Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life.
Baraclude® is a trademark of Bristol-Myers Squibb.
Refer to the Baraclude® Summary of Product Characteristics for further information
1. SMC guidance on entecavir 0.5 and 1mg tablets, http://www.scottishmedicines.org.uk, October 2006.
2. Lai C, et al. Entecavir versus lamivudine for patients with HBeAg-Negative chronic hepatitis B. The New England Journal of Medicine, 2006: 354:1011-1020.
3. Shouval D, et al. Continued virologic and biochemical improvement through 96 weeks of entecavir treatment in HBeAG(-) chronic hepatitis B patients (study ETV-027). 41st Annual Meeting of the European Association for the Study of Liver Disease (EASL), April 2006, Abstract 45.
4. Colonno R, et al. Entecavir two year resistance update: no resistance observed in nucleoside naive patients with low frequency of resistance in lamivudine refractory patients. 56th Annual Meeting of the American Association for the Study of Liver Disease (AASLD), November 2005, Poster 962.
5. NICE guide to the methods of technology appraisal , April 2004: p33
6. Hepatitis B: Out of the shadows: A report into the impact of hepatitis B on the nation's health. (2004) Foundation for Liver Research. London.
7. Lavanchy, D., Hepatitis B epidemiology, disease burden, treatment, and current and emerging prevention and control measures. Journal of Viral Hepatitis. 2004; 11(2):97.