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Application to Add Entecavir to the Essential List of Medicines As an Essential Medicine for the Treatment of Chronic Hepatitis B Virus Infection

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Application to Add Entecavir to the Essential List of Medicines As an Essential Medicine for the Treatment of Chronic Hepatitis B Virus Infection Application for WHO Model List of Essential Medicines: Entecavir Application to add entecavir to the Essential List of Medicines as an essential medicine for the treatment of chronic hepatitis B virus infection 1 Contents 1. Summary statement of the proposal for inclusion ............................................................................... 3 2. Name of the focal point in WHO submitting or supporting the application (where relevant) ............. 3 3. Name of the organization(s) consulted and/or supporting the application ........................................... 3 4. International Nonproprietary Name (INN, generic name) of the medicine ......................................... 3 5. Formulation proposed for inclusion; including adult and paediatric (if appropriate) .......................... 3 6. International availability - sources, if possible manufacturers and trade names .................................. 4 7. Whether listing is requested as an individual medicine or as an example of a therapeutic group ........ 4 8. Information supporting the public health relevance ............................................................................ 4 9. Treatment details ................................................................................................................................. 6 10. Summary of comparative effectiveness in a variety of clinical settings: ........................................ 12 11. Summary of comparative evidence on safety: ................................................................................ 14 12. Summary of available data on comparative cost and cost-effectiveness within the pharmacological class or therapeutic group: ..................................................................................................................... 16 13. Summary of regulatory status of the medicine (in country of origin, and preferably in other countries as well) .................................................................................................................................. 18 14. Availability of pharmacopoeial standards (British Pharmacopoeia, International Pharmacopoeia, United States Pharmacopoeia, European Pharmacopoeia) ................................................................... 18 15. Proposed (new/adapted) text for the WHO Model Formulary ........................................................ 18 References: ............................................................................................................................................ 19 2 Application for WHO Model List of Essential Medicines: Entecavir 1. Summary statement of the proposal for inclusion Hepatitis B virus (HBV) infection is a significant contributor to global burden of disease, accounting for an estimated 786 000 deaths each year. Effective medicines exist that can suppress HBV replication, slow or even reverse the degree of fibrosis, and thereby reduce the risk of death from hepatocellular carcinoma (HCC) and cirrhosis and prolong life. Despite this, the number of persons with HBV infection who receive treatment is very low. One of the reasons for this is the lack of WHO guidelines for the treatment of HBV infection. To fill this gap, WHO’s Global Hepatitis Programme (GHP) is finalizing the development of hepatitis B treatment guidelines. These guidelines, which will be released in March 2015, will recommend that HBV infection be treated with either tenofovir or entecavir. Currently, tenofovir (TDF) is included in the 18th edition of WHO Model List of Essential Medicines (EML), but entecavir is not included. Entecavir is highly effective and relatively inexpensive, and having this medicine on the EML will help to facilitate the scale-up of HBV treatment. 2. Name of the focal point in WHO submitting or supporting the application (where relevant) Dr Philippa Easterbrook, Global Hepatitis Programme, Department of HIV/AIDS, World Health Organization Geneva, Switzerland [email protected] 3. Name of the organization(s) consulted and/or supporting the application World Hepatitis Alliance Médecins sans Frontières Coalition to end Viral Hepatitis in the Western Pacific (CEVHAP) Asia and Pacific Alliance to Eliminate Viral Hepatitis (APAVH) Hepatitis B Foundation Bristol-Meyers Squibb Corporation 4. International Nonproprietary Name (INN, generic name) of the medicine Entecavir 5. Formulation proposed for inclusion; including adult and paediatric (if appropriate) Entecavir: Oral tablets of 0.5mg and 1mg Entecavir: Oral solution of 0.05 mg/mL 3 Application for WHO Model List of Essential Medicines: Entecavir 6. International availability - sources, if possible manufacturers and trade names Sources Entecavir (Baraclude™) was originally manufactured by Bristol-Meyers Squibb (BMS). According to BMS, entecavir is licensed for use in over 60 countries. Entecavir is available in generic formulations and several generic manufactures produce the medicine (Table 1). As of August 2014, the only generics manufacturer of entecavir that has received U.S. Food and Drug Administration (FDA) approval is TEVA PHARMS USA.1 There are many generic medicines available in mainly Asia (Table 1). Table 1: Generics manufacturers of entecavir: Trade name, manufactures and country Trade name Manufacturers Country Baraclude Bristol-Myers Squibb (Originator) Entecavir TEVA PHARMS USA India Entehep Zydus Cadila Healthcare Ltd India Entaliv DrReddyLaboratories India Enteca Ranbaxy Malaysia Entegard Inogen Pharma Philippines Teneir Lab Dosa Argentina Entikawei Chia Tai Taiqing Pharmaceutical Limited China Raymos Dawnrays Pharmaceutical Limited China Leiyide Counster Pharmaceutical Co., LTD China Weiliqing Qingfeng Pharmaceutical Group China Enganding Anhui Biochem Pharmaceutical Co., LTD China Beishuangding Shangdong Lukang Pharmaceutical Co., LTD China Many Generics Multiple manufacturers Vietnam 7. Whether listing is requested as an individual medicine or as an example of a therapeutic group As an individual medicine, to be including in the section 6 -- Anti-infective medicines of the WHO EML. 8. Information supporting the public health relevance Epidemiological information on disease burden Hepatitis B virus (HBV) infection is a major cause of acute and chronic liver disease (e.g., cirrhosis and primary liver cancer) globally with an estimated 786 000 deaths annually1. It is estimated that a third of the world’s population (more than 2 billion people) have been infected with HBV and that 240 million people are living with chronic HBV infection2, 3, placing them at risk for serious illness and death from cirrhosis and (HCC). Worldwide, 30% of cirrhosis and 53% of all HCC deaths are attributable to HBV infection4. The burden of HBV remains disproportionately high in low- and middle- income countries. Approximately 1 (http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApp roved/DrugandBiologicApprovalReports/ANDAGenericDrugApprovals/ucm414067.htm. Accessed 14 August 2014 4 Application for WHO Model List of Essential Medicines: Entecavir 60% of the world's population lives in areas where HBV infection is highly endemic, particularly Asia and Africa. Additionally, even in low prevalence areas certain subpopulations such as indigenous populations, migrants, HIV-infected individuals, men who have sex with men (MSM) and persons who inject drugs (PWID) experience high levels of HBV infection. Acute HBV infection typically lasts two to four months. Approximately 30-50% of children aged ≥5 years and most adults are symptomatic5; infants, children <5 years, and immunosuppressed adults are more likely to be asymptomatic. Fulminant hepatitis occurs in 0.5% of cases6. Antiviral treatment is not indicated during acute infection as more than 95–99% of adults with acute HBV infection will recover spontaneously without antiviral therapy7. Fewer than 5 percent of adults acutely infected with HBV progress to chronic infection. Chronic HBV (CHB) infection (defined as hepatitis B surface antigen ([HBsAg] detectable for >6 months) is the most common cause of HCC in the world, increasing the risk of HCC compared with non-carriers by 100 fold8. The risk of complications associated with chronic HBV infection increases in co-infection with hepatitis C (HCV) 9, 10, hepatitis D (HDV) 11, 12, or HIV13. Chronic HBV infection is diagnosed by the presence of HBsAg in the serum. The HBsAg test is widely used for HBV screening, given its availability, low-cost and acceptability as a key marker of chronic HBV infection. HBV DNA test is crucial for initiation of treatment and monitoring drug efficacy. Several interventions have the potential to dramatically reduce the burden of HBV infection. The three-dose series of HBV vaccine for children, including a HBV birth dose plus at least two additional doses, is the most effective tool for preventing HBV infection and the chronic sequelae of cirrhosis and liver cancer. WHO recommended routine use of this vaccine in national immunization programs in 1992. By 2011, a total of 180 countries had introduced the HBV vaccine and rates of 3-dose hepatitis B vaccine coverage now reach 79%, and have lowered the incidence of chronic infection, most dramatically in Asia14. Efforts to improve the safety of blood transfusions and injections have reduced the risk of infection through these procedures. Despite these advances, in most countries, viral hepatitis is not being addressed in a systematic manner. Hepatitis surveillance programs are weak or non-existent, laboratory capacity
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