Overcoming barriers to access to hepatitis C treatment in a rapidly changing landscape

Transcription

1 Overcoming barriers to access to hepatitis C treatment in a rapidly changing landscape HIV/AIDS Department and Global Hepatitis Programme Dr. Stefan Wiktor

2 Outline Global Hepatitis Strategy New HCV treatment guidelines Overcoming barriers

3 Viral hepatitis - Situational analysis Big problem 7 th leading cause of death Effective prevention and treatment exist But, global funding missing and country action is still nascent Global momentum building driven by excitement about new HCV drugs

4 Sustainable Development Goals Goal 3: Ensure healthy lives and promote well-being for all at all ages Target 3.3: By 2030, end the epidemics of AIDS, tuberculosis, malaria and neglected tropical diseases and combat hepatitis, waterborne diseases and other communicable diseases

5 Draft WHO Global Health Sector Strategy on Hepatitis Vision : A world where viral hepatitis transmission is stopped and everyone has access to safe, affordable and effective treatment and care Goal: Eliminate viral hepatitis as a major public health threat by Framework: Universal health coverage and continuity of services

6 Impact targets for elimination 90% reduction in new cases of of chronic HBV and HCV infection 65% reduction in deaths from chronic HBV and HCV 6-10 million infections (in 2015) to 900,000 infections (by 2030) 1.4 million deaths (in 2015) to under 500,000 deaths (by 2030)

7 Service coverage targets to reach impact targets HBV vaccination HBV MTCT (mother to child) Intervention targets Indicator Baseline Childhood vaccine coverage 90% 90% 81% Birth dose vaccine coverage (or other approach to prevent MTC) 90% 50% 38% Safe injection Harm reduction Testing HBV Treatment HCV Treatment Safe infections (needs to cover in and out facility) Number of needles/pwid/year (as part of effective harm reduction package) Percent of persons with chronic HBV and HCV diagnosed Treatment eligible persons with chronic HBV treated Treatment eligible persons with chronic HCV treated 90% 50% coverage 5% 300 (75% coverage) 200 (50% coverage) 20 90% 30% 5% 80% 8 million treated (Est. 5m HBV, 3m HCV) <1% 80% <1%

8 WHO released its first HCV treatment guidelines in April 2014 Recommendations along continuum of care: Screening: Care: Whom to test Confirmation testing Screening for high alcohol use Fibrosis assessment Treatment: PEG-IFN/RBV, boceprevir, telaprevir, simeprevir and sofosbuvir

9 What has happened since release of guidelines New medicines approved: Asunaprevir Daclatasvir Ledipasvir/sofosbuvir Ombitasvir/paritaprevir/dasabuvir/ritonavir Revision of Model List of Essential Medicines Price reductions and introduction of generics Accumulating evidence Guidance needed on use of new medicines

10 Scope of 2016 guidelines update General recommendation about the use of direct-acting antivirals rather than PEG- IFN/RBV Review of recommendation for boceprevir and telaprevir Preferred regimens by genotype and patient characteristics

11 Study flow APASL 2016, Tokyo, 24 th Feb, 2016

12 APASL 2016, Tokyo, 24 th Feb, 2016 Network Diagrams Network diagram for the treatmentnaive genotypes 1 and 4 population Network diagram of the treatment groups for the treatment-naive genotypes 1 and 4 population SOF + SMV DSV 1-12 DCV + SOF OMB + PAR/r OMB + PAR/r +DSV + R 1-12 DSV + R 1-12 DCV + ASV SOF + R PR SOF + LDV SMV + PR SOF + PR TVR + PR Drug acronyms ASV: asunaprevir; BOC: boceprevir; DCV: daclatasvir; LDV: ledipasvir; OMB: ombitasvir; PAR/r: paritaprevir/ritonavir; PR: pegylated interferon/ribavirin; R: ribavirin; SOF: sofosbuvir; SMV: simeprevir; TVR: telaprevir BOC + PR PR 1-4, BOC + PR 4-28

13 APASL 2016, Tokyo, 24 th Feb, 2016 Sustained virological response for treatment-naive patients with genotypes 1 and 4 HCV infection 71 study arms PR TVR+PR BOC+PR SMV+PR SOF+PR SOF+R pegylated interferon + ribavirin telaprevir + pegylated interferon + ribavirin boceprevir + pegylated interferon + ribavirin simeprevir + pegylated interferon + ribavirin sofosbuvir + pegylated interferon + ribavirin sofosbuvir + ribavirin LDV+SOF ledipasvir + sofosbuvir DCV+SOF daclatasvir + sofosbuvir SMV+SOF simeprevir + sofosbuvir DCV+ASV asunaprevir + daclatasvir OMB+PAR/r ombitasvir + paritaprevir/ritonavir±dasabuvir % Sustained virological response

14 Recommendation 1: Treatment with direct-acting antivirals Recommendation 1. It is recommended that DAA regimens be used for the treatment of persons with hepatitis C infection rather than regimens with pegylated-interferon and ribavirin* 2. The use of boceprevir- or telaprevircontaining regimens is no longer recommended for the treatment of persons with hepatitis C infection Strength of recommendation Strong Strong Evidence quality Moderate Moderate * pegylated interferon and ribavirin (with sofosbuvir) is still recommended as an alternative treatment option for GT3, 5, 6

15 Recommended preferred regimens for patients without cirrhosis Daclatasvir/ sofosbuvir Ledipasvir/ Sofosbuvir Genotype 1 12 weeks 12 weeks* Genotype 2 Sofosbuvir/ ribavirin 12 weeks Genotype 3 12 weeks 24 weeks Genotype 4 12 weeks 12 weeks Genotype 5 Genotype 6 12 weeks 12 weeks * Treatment may be shortened to 8 weeks if baseline HCV RNA <6x10 6 IU/mL Treatment duration based on AASLD and EASL 2015 guidelines

16 Recommended alternative regimens for patients without cirrhosis Simeprevir/s ofosbuvir Daclatasvir/ sofosbuvir Ombitasvir/p aritaprevir/ ritonavir/ dasabuvir Genotype 1 12 weeks 12 weeks Genotype 2 Genotype 3 12 weeks Ombitasvir/ paritaprevir/ ritonavir/ ribavirin Genotype 4 12 weeks 12 weeks Genotype 5 Genotype 6 Sofosbuvir/ Pegylated interferon/ ribavirin 12 weeks 12 weeks Treatment duration based on AASLD and EASL 2015 guidelines

17 A single all-daa, pan-genotypic regimen: not yet there Daclatasvir/sofosbuvir Ledipasvir/Sofosbuvir No cirrhosis Cirrhosis No cirrhosis Cirrhosis Genotype 1 12 weeks 24 weeks 12 weeks 24 weeks Genotype 2 12 weeks 12 weeks Genotype 3 12 weeks Genotype 4 12 weeks 24 weeks 12 weeks 24 weeks Genotype 5 12 weeks 24 weeks Genotype 6 12 weeks 24 weeks

18 Whom to treat No formal recommendation Everyone should be considered for treatment Prioritization for patients at increased risk of: Decompensation and death Morbidity Stigma and discrimination Transmitting virus

19 Access to the recommended regimens: where are we? Treatment access plan Voluntary licensing Regulatory approval Generics from non VL companies Sofosbuvir Ledipasvir/ Sofosbuvir Daclatasvir 11 companies/ 101 countries 11 companies/ 101 countries 14 VL countries 4 VL countries 4 companies/ 112 countries 0 VL countries Ombitasvir/ paritaprevir ritonavir/ dasabuvir Simeprevir 0 companies 0 companies ~ 20 LMIC 6 LMIC Yes? yes No No

20 Price of sofosbuvir in selected countries Hill et al. Journal of Virus Eradication 2016; 2: 28 31

21 Pakistan: Number of patients receiving DAA therapy by month Courtesy of Dr. Saeed Hamid

22 Barriers to treatment scale-up Affordability Accessibility regulatory approval Quality of medicines? How to finance treatment? Health-system barriers diagnosis, workforce, linkage to and retention in care

23 Key events Global Health Sector Strategy on Hepatitis World Hepatitis Day Focus on India World Hepatitis Summit, Brazil March 2017

24 Key documents 2016 Hepatitis Surveillance guidance and case definitions Hepatitis monitoring guide Update to hepatitis C treatment guidelines Hepatitis testing guidelines Report on overcoming barriers to accessing hepatitis C medicines

25 Moving toward implementation Identify focus countries Help promote national hepatitis planning Dissemination of guidelines Other technical assistance

26 What it will take to eliminate hepatitis? Energy, Commitment and Resources A public health approach (simplification, integration, decentralization, equitable access) Innovation: HBV cure, mother-to-child transmission, HCV vaccine Partnerships (governments, civil society, private sector,...) Concrete and tailored action in countries (guided by national plans)