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EML Application Daclatasvir Final WHO Essential Medicines List Application DACLATASVIR 1. Summary statement of the proposal for inclusion, change or deletion This submission proposes daclatasvir as a new inclusion on the WHO EML. Daclatasvir (DCV) is a newly- approved direct acting antiviral (DAA) medicine for treatment of hepatitis C (HCV), a disease that affects approximately 170 million people globally, causing half a million deaths each year. Used in combination with other HCV medicines, DCV has pan-genotypic potential, results in high cure rates and is well-tolerated. The introduction of DAA-based HCV therapy has helped enable new 2014 WHO guidelines on the treatment of HCV disease and has also enabled greater interest on the part of national government and international actors to support programming to treat HCV. In order to facilitate the move to providing diagnosis, care and treatment for HCV globally, it will be critical that key DAAs are made available to populations in need. The most important DAAs are those that have high efficacy (including in special populations such as people living with HIV), safety, are pan-genotypic, and have low risk for drug-drug interactions with common medicines, such as antiretroviral drugs. Daclatasvir meets these criteria. Inclusion of DCV on the WHO Essential Medicines List will help provide a signal to manufacturers, generic producers, country programmes and international donors that this DAA will be a key medicine to help treat HCV. 2. Name of the focal point in WHO submitting or supporting the application (where relevant) Philippa Easterbrook 3. Name of the organization(s) consulted and/or supporting the application MSF/Médecins Sans Frontières - Access Campaign Rue de Lausanne 78 P.O Box 116 1211 Geneva, Switzerland Contact: Jennifer Cohn, Medical Coordinator ([email protected]) 4. International Nonproprietary Name (INN, generic name) of the medicine Daclatasvir (as dihydrochloride) 5. Formulation proposed for inclusion; including adult and paediatric (if appropriate) Daclatasvir (as dihydrochloride), Daklinza®, manufactured by Bristol Myers Squibb--BMS 30mg as oral administration (tablet), for adults. Each film-coated tablet contains daclatasvir dihydrochloride equivalent to 30 mg daclatasvir and contains 58 mg of lactose (as anhydrous). Daclatasvir (as dihydrochloride), Daklinza®, manufactured by Bristol Myers Squibb--BMS 60mg as oral administration (tablet), for adults. Each film-coated tablet contains daclatasvir dihydrochloride equivalent to 60 mg daclatasvir and contains 116mg of lactose (as anhydrous). 6. International availability - sources, of possible manufacturers and trade names Daclatasvir 30 mg tablet, as dihydrochloride (Trade name: Daklinza®; Manufacturer: Bristol Myers Squibb-- BMS), EMA approved on August 22nd 2014. Daclatasvir 60 mg tablet, as dihydrochloride (Trade name: Daklinza®; Manufacturer: Bristol Myers Squibb-- BMS), EMA approved on August 22nd 2014. 7. Whether listing is requested as an individual medicine or as an example of a therapeutic group The request for inclusion is for the single medicine Daclatasvir, both the 30mg and 60mg strengths. 1 8. Information supporting the public health relevance (epidemiological information on disease burden, assessment of current use, target population) Epidemiology and burden of disease Chronic Hepatitis C virus (HCV) infection is a major pandemic, affecting almost 170 million individuals worldwide and killing about 500,000 people each year (Kanda, Yokosuka, & Omata, 2013). The majority of these people live in resource-poor settings where there is currently little or no provision for diagnosis or treatment and low- and middle-income countries (L&MICs) alone account for over half of the HCV-related mortality (The Economist, 2012; Center of Disease Analysis). The prevalence rate of the disease varies depending on the global regions; regions with high prevalence rate (over 3.5%) include Central Asia covering Mongolia, China, South-East Asia, and North Africa. Regions with low prevalence rate (below 1.5%) include Asia covering South Korea and Japan, North America including the United States (US), and South America. (KASL clinical practice guidelines: Management of Hepatitis C, 2014). Studies estimate that between 3 and 4 million new patients are infected with HCV every year and that the disease burden will continue to grow (UNITAID Secretariat, 2013). In L&MICs, the transmission of HCV is mainly nosocomial - via contaminated blood transfusions or unsafe injection practices (Prati, 2006). Estimates suggest that up to 40% of all HCV infections worldwide are the result of unsafe medical practices (Papatheodoridis & Hatzakis, 2012). Other routes of transmission include sexual transmission, usually involving men who have sex with men (MSM), and transmission among intravenous drug users (IVDUs) (UNITAID Secretariat, 2013). In some countries, HCV prevalances among IVDU’s reaches 90% (Papatheodoridis, 2012). Mother-to-child transmission has also been reported. The risk of perinatal HCV transmission was higher in female infants, HIV-positive mothers, and mothers with high blood HCV RNA levels. For example, among mothers who were positive for HCV-RNA there was a transmission rate of 4.3% versus 1.7% among all anti-HCV positive mothers (KASL, 2014). Six different HCV genotypes exist. This is significant as the different genotypes have different responses to HCV treatment, both for pegylated-interferon based treatment and direct acting antiviral (DAA) treatment. Globally genotype 1 is most common (42%), followed by genotype 3 (26%) and 2 (17%) (Razavi, 2013). Genotype 1a is most common in Northern Europe, North America and parts of Latin America while genotype 1b is most common in Central and Far East Asia and Central, East and Southern Europe. Genotype 3 is most common in South Asia and genotype 4 is most common in the Middle East, Egypt, and Central Africa. Genotype 5 is common in South Africa and genotype 6 is common in Hong Kong, Macau, and Vietnam (KASL, 2014). HCV/HIV co-infection 2 Between 4-5 million people with human immunodeficiency virus (HIV) and HCV are estimated to be co- infected, representing 16% of people living with HIV globally (UNITAID Secretariat, 2013). Common modes of transmission for HIV and HCV may lead to a high prevalence of co-infection in key populations such as IVDUs and MSM populations. In sub-populations like these, rates of co-infection can exceed 60% (Solomon et al., 2008). Co-infection of HIV and HCV have negative and reciprocal clinical implications for patients. HIV accelerates the progression of HCV. Those with co-infection progress to significant liver disease and cirrhosis much more quickly and more often than those only infected with HCV alone, with nearly 80% developing liver damage (Deng, 2009; Limketkai et al., 2012; Lo Re et al., 2012; Hadigan & Kottilil, 2011). Despite patients taking anti-retroviral therapy (ART), patients with HIV-HCV co-infection remain at significantly increased risk of overall mortality as compared to their HIV mono-infected peers (Anderson, Guest & Rimland, 2004). Further, co-infection with HCV in the era of ART is associated with worse HIV-related outcomes including weaker immune recovery with ART (lower mean CD4 counts), more rapid progression to AIDS, higher levels of HIV virus in the blood, poorer virological control on highly active antiretroviral therapy (HAART) (11% loss of ART efficacy in co-infected patients), and more common neurocognitive deficits (Greub et al., 2000; Pulido, van Delft & Moecklinghoff, 2012; Vivithanaporn et al., 2012). Chronic HCV infection is independently associated with a 50% increase in mortality among patients with a diagnosis of AIDS (Branch et al., 2012). Even in the era of ART, HCV represents a substantial cause of morbidity and mortality for people living with HIV/AIDS (PLWHA). In a multicentre cohort study of PLWHA in high-income countries, liver disease was considered the number one cause of non-AIDS related mortality, causing 14-18% of all deaths (Weber et al., 2006). This is not very far behind AIDS-related mortality in overall mortality for PLWHA. Another cohort showed that by 2005, HCV-associated liver- related mortality accounted for nearly 17% of deaths among PLWHA (Rotman & Liang, 2009; Vivithanaporn et al., 2012). HCV-related mortality is undoubtedly set to increase in light of the high prevalence of HCV/HIV co- infection now documented in some countries and the increased morbidity and mortality in these patients (Rotman & Liang, 2009; The Economist, 2012). Further, while safer injection practices may help to decrease HCV transmission in the future, given the natural history of HCV, morbidity and mortality related to HCV is likely to increase over the coming decades unless treatment becomes more widely available. Several models using data from high-income countries have shown that rates of HCV-related morbidity and mortality continue to rise several decades after HCV incidence has peaked (Deuffic-Burban et al., 2007). Thus, the burden of HCV in co-infected individuals will become more pronounced, both due to the natural history of the disease, and due to its increasing importance as other AIDS-related causes of death decrease with increasing ART use. In order to maximise the benefits from increased ART use globally, interventions 3 designed to address the growing burden of HCV in PLWHA must be rapidly rolled out. Without such interventions, many lives saved by ART will soon be lost to HCV. Current use Due to a range of factors,
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