Access to HCV treatment in Eastern Europe and Central Asia. Natalia Kravchenko (Alliance for Public Health) Liudmyla Maistat (Medicines Patent Pool)

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1 Access to HCV treatment in Eastern Europe and Central Asia Natalia Kravchenko (Alliance for Public Health) Liudmyla Maistat (Medicines Patent Pool)

2 Disclosure Presenter: Natalia Kravchenko FINANCIAL DISCLOSURE: No relevant financial relationship exists

3 Overview HIV and viral hepatitis B and C in Eastern Europe and Central Asia (EECA) Access to HCV diagnostics and treatment Survey on the progress made Remaining challenges

4 HIV and viral hepatitis in EECA HIV EECA - one of the fastest growing HIV/AIDS epidemic in the world with a 57% increase in annual new HIV infections between 2010 and 2015 The vast majority (85%) of PLHIV in the region live in Russia and Ukraine. Russia also accounts for 80% of new HIV infections Hepatitis More than 11 Mill. people infected with HCV and over 6 mill. people with HBV (country estimates) 80% of HCV cases - Russia, Ukraine and Uzbekistan Injecting drug use a main driver of the epidemics

5 Hepatitis C: key challenges Low awareness No reliable surveillance systems High treatment and testing prices No sufficient funding for treatment Lack of political commitment No national strategies

6 Introduction of the Survey Hepatitis B&C in EECA: Response to the epidemic (July 2017) Purpose: - identify key aspects of HCV and HBV epidemic and response - outline advocacy tools and activities - identify gaps in response - provide recommendations to key stakeholders Methods: - data collected through questionnaires - 11 countries: Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Ukraine and Uzbekistan - data was cross-referenced with open-source information - patent information obtained from Medicines Patent Pool s data base (MedsPal) Results: Data consolidated into the report Hepatitis B and C in Eastern Europe and Central Asia: Response to the Epidemic (as of July 2017, available at or direct link).

7 Estimations for HIV, HCV and HBV prevalence

8 HCV and HBV in EECA IWHO estimated HCV prevalence differs from country estimates HCV prevalence among general population ranges from 0,01% (Tajikistan) to 8% (Ukraine) HCV prevalence among PWID ranges from 20,9% in Uzbekistan to >95% in Belarus HBV prevalence is lower than HCV prevalence, with the highest reported rate in Uzbekistan (8%) Key affected populations: PWIDs, MSMs, medical workers, blood/tissue recipients

9 HCV prevalence among PWIDs Country Reported HCV prevalence in PWIDs Belarus Up to 95% Georgia 69% Russia 69% Moldova Up to 65% Azerbaijan 62.8% Kyrgyzstan 60.6% Ukraine 55.9%

10 Availability of HCV Treatment Guidelines Inclusion of DAAs (June 2017) Country Date Key treatment schemes Comments Armenia According to the respondent, WHO guidelines on HCV are used PEG-INF/RBV Azerbaijan 2009 PEG-INF/RBV Recommendations will be updated Belarus 2015 SOF/PEG-INF/RBV, SIM/PEG-INF/RBV, SOF/LDV±RBV, 3D±RBV, SOF/SMV±RBV, Recommendations will be updated SOF/DCV±RBV, SOF±RBV, SMV/PEG-INF/RBV Georgia 2015 SOF/PEG-INF±RBV, SOF/LDV±RBV SOF-based regimen is indicated in the national program implemented since April 2015 Kazakhstan D, SOF/LED, SOF/DCV, SOF/VEL, SOF/RBV Recommended by the Expert Council of the Republican Healthcare Development Center of the Ministry of Health and Social Development of Kazakhstan, Protocol no. 21 dated Kyrgyzstan 2017 SOF/DCV, SOF/LED, SOF±RBV Moldova 2015 SOF/DCV±RBV, SOF/LDV±RBV, SOF/SMV±RBV; 3D±RBV; SOF/PEG-INF±RBV, SOF/RBV, SMV/PEG-INF/RBV Russia 2017 SOF/PEG-INF/RBV, SIM/PEG-INF/RBV, 3D±RBV, SOF/SMV±RBV, SOF/DCV±RBV, SMV/PEG-INF/RBV, DCV/ASV/PEG-INF/RBV, DCV/ASV, NPV/PEG-INF/RBV/RTV Order no dated , published 2016 Recommendations for diagnostics and treatment of HCV in adults Tajikistan n/a n/a Ukraine 2016 PEG-INF/RBV (alternative regimen), SOF/PEG-INF/RBV, SOF/LDV±RBV, 3D±RBV, Approved by Order of the MoH of Ukraine no. 729, dated SOF/SMV, SOF/SMV/RBV, SMV/PEG-INF/RBV: SOF/RBV (2 12 weeks genotype, 3 24 weeks genotype); BOC and TPV are not recommended anymore as preferred options Uzbekistan 2013 Alpha-interferon Will be revised in 2018 or upon availability of new evidence Guidelines under development in Tajikistan DAA included : Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia and Ukraine Not included but used for treatment: Armenia, Tajikistan, Uzbekistan and Azerbaijan

11 Registration of DAAs Country sofosbuvir sofosbuvir/ ledipasvir daclatasvir originator generic originator generic originator generic elbasvir/ grazoprevir ombitasvir/ paritaprevir/ ritonavir/ dasabuvir ombitasvir/ paritaprevir/ ritonavir dasabuvir simeprevir asunaprevir narlaprevir Armenia Azerbaijan 2X X X Belarus 2X X Georgia X X Kazakhstan 3X X pending X X Kyrgyzstan 6X X 6X X Moldova 3x x X X X Russia X X X X X X Tajikistan X Ukraine X X X X X X Uzbekistan X Registration of one or more second-generation DAA in 10/11 (91%) countries Uzbekistan: SOF/LED, DAC not registered but generics available at commercial market (Gilead VLs and MPP/BMS VLs)

12 Prices of HCV treatment (per pack) Country sofosbuvir sofosbuvir/ ledipasvir daclatasvir ombitasvir/ paritaprevir/ originator generic originator generic originator generic ritonavir/ dasabuvir Armenia 250 G 300 G Azerbaijan 365 R Belarus 210 Georgia Kazakhstan free of charges 6704 G free of charges 5000 P (112 tablets) 4620,6 P (112 tablets) ombitasvir/ paritaprevir/ ritonavir dasabuvir simeprevir Lowest available price for DAA-based, 12 weeks treatment course Kyrgyzstan 250 G 152 P 300 G 60 P ,77 G (1 pack) 2360,7 4705,9 free of charges Moldova 250 G 350 R 300 G 262 R 14639,64 R 1272,57 R 8468,42 R 2893,62 Russia 1830 P 5120 P 3459 R, 3012 P Tajikistan 250 G G Ukraine 250 G 300 G 512,9 P 2336,73 Uzbekistan 250 G 109 P 300 G 144 P 60 P «Р» - commercial market price «G» - governmental procurement price «R» - registered price The lowest price for generic SOF (109 USD) in Uzbekistan; the highest in Azerbaijan (365 USD); Lowest price for original SOF (250 USD) in Armenia, Georgia, Kyrgyzstan, Moldova, Tajikistan, Ukraine, Uzbekistan for state procurement; the highest price (USD 6704) was negotiated in Kazakhstan (as for April - May 2017)

13 Prices for HCV diagnostics Full diagnostics in patients undergoing DAA treatment Georgia: USD (average price, the state covering 70% for financially disadvantaged citizens and 30% for other population groups) Ukraine: 55 USD (average price, Fibroscan TM not included) or 98.2 USD (full price), the Fibroscan TM ranging between 33 and 69 USD PCR Kyrgyzstan: 36 USD (general public) Ukraine: free for PWIDs and other key populations (Alliance treatment program) or 23 USD (outside of Alliance agreement) In most EECA countries, diagnostics remain unaffordable for the majority of the population

14 Availability of HCV treatment programs Available: Armenia, Azerbaijan, Georgia, Belarus, Kazakhstan, Moldova, Ukraine, Tajikistan, Uzbekistan Different funding sources: national and local programs, donor programs, donations State-funded programs: Armenia (acute viral hepatitis infections), Azerbaijan (HCV), Georgia (HCV), Belarus (HCV), Kazakhstan, Moldova (hepatitis B,C,D), Ukraine (HCV, HBV), Tajikistan (HBV) Donor-funded programs: Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Ukraine, Uzbekistan (GF, MdM, MSF, AbbVie, etc) thousand people receive HCV treatment annually under treatment programs in EECA region

15 National and Donor-Driven HCV Treatment Programs Country National Hepatitis program/ separate legislative acts Key risk groups which are prioritized for treatment Number of people (received treatment from state) Armenia - PLHIV Absolute number unknown. Azerbaijan + Without limitation Absolute number unknown. Belarus - Treatmen is free of charges for children and posttransplantation patients Absolute number unknown. Georgia + Without limitation people annually during 10 years Kazakhstan - All patients with HCV and compensated liver diseases Average number of people who received hepatitis B and C treatment is 1200/year Kyrgyzstan - PLHIV Up to 100 annually Moldova + n/a Russia - n/a 3000 people received HCV treatment in It s expected to increase number of people up to in 2017 Number of patients who expected to receive 48-week course of PEG-IFN in 2017 is 540 and 290 treatment courses of SMV. Comments Donor program Number of people Treatment provided due to the general health policies Quantity of people on treatment is not limited by the state program Treatment provided due to the general health policies Up to GEL (about 8,3 mln USD from local and regional budgets for support diagnostic and service) Expected to increase number of people treated from HCV up to / year Treatment provided in the frames of National HIV response program > Up to Government announced HCV treatment procurement for total amount over 4,6 million USD - - Tajikistan - n/a n/a n/a - - Prioritized for treatment: people with >F2 fibrosis, PWID, woman Ukraine - who planned pregnancy, Government announced HCV treatment Alliance program up to HIV/HCV co-infected, people n/a procurement of DAAs (SOF, SOF/LED, 3D) which with extrahepatic syndroms, may cover up to treatment courses these who have freequent contacts with infected people Uzbekistan National treatment program is expected in > 200 Currently less than 1% of people in need receive treatment

16 Access to HCV services (testing, diagnostics, treatment) Is it possible in your country: Armenia Azerbaijan Belarus Georgia Kazakhstan Kyrgyzstan Moldova Russia Tajikistan Ukraine Uzbekistan 1) To get tested for HCV and/or HBV anonymously no yes yes (paid). Nonanonymous testing is free yes yes yes (paid) no yes (paid) no yes yes (paid) 2) compulsory testing for certain categories of population no no yes yes yes yes no yes yes no yes - medical workers (recommended) + - key populations + (recommended) (recommended) - people who got invasive procedures (recommended) 3) to get the diagnostics free of charges (for HIV - positive people, KPs) yes yes yes 70% of the cost of diagnostics for people in difficult financial situations is covered by the state yes no (unaffordable) yes yes (coinfection) yes no (unaffordable) only for PLHIV 4) receive treatment for free (for HIV - positive people, KPs) yes (for PLHIV and other categories ) yes yes (for people under 18 and those who have had a liver transplant) yes yes only for PLHIV yes only for PLHIV no yes only for PLHIV under a donorsponsored program Armenia, Moldova and Tajikistan: lack of anonymous testing Armenia, Belarus, Russia, Kyrgyzstan, Tajikistan and Uzbekistan (6/11 countries, 54,5%): limited or no access to treatment for key populations

17 Inclusion of EECA countries in Voluntary Licenses Country sofosbuvir sofosbuvir/ledipasvir daclatasvir license status/patent status DNDI /Presidio ravidasvir MPP/Pharco Armenia no no/no yes Azerbaijan no yes/no yes Belarus yes no/no yes Georgia no yes/no Kazakhstan no no/no yes Kyrgyzstan yes no/no yes Moldova no no/no yes Tajikistan yes no/no yes Russia no no/yes yes Ukraine yes no/no yes Uzbekistan yes yes/no Gilead VL: Belarus, Ukriane, Kyrgyzstan, Tajikistan, Uzbekistan MPP/BMS VL: Azerbaijan, Georgia, Uzbekistan. Uzbekistan benefits from both VL agreements (Gilead and MPP/BMS) DNDi/Presidio: Armenia, Kyrgyzstan, Moldova, Tajikistan MPP/Pharco: Azerbaijan, Belarus, Kazakhstan, Russia, Ukraine

18 Other approaches : direct price negotiation. The Alliance price for sofosbuvir (300 USD) and sofosbuvir/ledipasvir (300 USD) became the benchmark for state procurements: 250 and 300 USD, respectively : patent oppositions filed in Russia and Ukraine (pro-drug patent partially revoked in Russia) : delivery of generics (sofosbuvir, sofosbuvir/ledipasvir, daclatasvir) through Buyers clubs in Belarus, Kazakhstan, Russia and Ukraine

19 Civil society s role in scaling up access to HCV diagnostics and treatment Awareness raising and mobilization: awareness campaigns educational and training programs (patients, care providers, social workers, police officers) establishing networks of advocates, patients, lawyers Advocacy campaigns aimed at: Testing and treatment programs: developing national treatment programs and treatment guidelines allocation of funds price reductions IP work testing campaigns to identify anti-hcv+ for generating data, fostering evidence based advocacy, increasing demand and referral to clinics treatment programs (integration in harm reduction programs, developing community oriented treatment models)

20 Remaining challenges Access to diagnostics and treatment remains limited Lack of national strategies Limited funding for treatment programs Limited or no access to treatment for PWIDs (criminal and/or administrative responsibility for personal use of drugs without intent to sell is applied in 11/11 (100%) of the surveyed countries, with programs for PWIDs in Ukraine and Georgia only)

21 Acknowledgements: Liudmila Maistat (MPP, Switzerland) Sergey Golovin (ITPCru, Russia) Tetiana Nikelsen (Institute for Social development, Ukraine) Olga Golubovskaya (Ministry of Health, Ukraine) Akmal Aliyev (Community of People Living with HIV, Uzbekistan) Anahit Harantyunyan (NGO Positive People Armenian Network, Armenia) Sergey Biryukov (NGO AGEP C, Kazakhstan) Pascal Boulet (Medicines Patent Pool, Switzerland) Kiromiddin Gulov (Equal Opportunities CSO, Tajikistan) Ehtiram Pashaev (NGO To Fight AIDS Azerbaijan) Liudmyla Untura (league of People Living with HIV, Moldova) Mari Chokheli (Open Society Foundation, Georgia) Aibar Sultangaziev (Partner Network, Kyrgyzstan) Anatoly Leshenok ( NGO Belarusian community of PLHIV, Belarus)

22 Thank You Kravchenko Natalia 5 Dilova st., building 10A, 9th floor Kyiv, Ukraine Tel.: ( ) Fax: ( )