Access to HCV treatment in Eastern Europe and Central Asia

Natalia Kravchenko(Alliance for Public Health)Liudmyla Maistat(Medicines Patent Pool)

Disclosure

Presenter: Natalia Kravchenko

FINANCIAL DISCLOSURE:

No relevant financial relationship exists

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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

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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

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Injecting drug use – a main driver of the epidemics

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

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Introduction of the SurveyHepatitis 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 www.aph.org.ua or direct link).

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Estimations for HIV, HCV and HBV prevalence

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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

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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%

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HCV prevalence among PWIDs

Availability of HCV Treatment GuidelinesInclusion of DAAs (June 2017)

Country Date Key treatment schemes Comments

Armenia

PEG-INF/RBV

According to the respondent, WHO guidelines on HCV are used

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,

SOF/DCV±RBV, SOF±RBV, SMV/PEG-INF/RBV

Recommendations will be updated

Georgia 2015 SOF/PEG-INF±RBV, SOF/LDV±RBV SOF-based regimen is indicated in the national program implemented since April 2015

Kazakhstan 2017 3D, 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 12.05.2017

Kyrgyzstan 2017 SOF/DCV, SOF/LED, SOF±RBV www.med.kg;

Moldova 2015 SOF/DCV±RBV, SOF/LDV±RBV, SOF/SMV±RBV; 3D±RBV; SOF/PEG-INF±RBV,

SOF/RBV, SMV/PEG-INF/RBV

Order no. 1035 dated 31.12.2015, published 2016

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

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,

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

Approved by Order of the MoH of Ukraine no. 729, dated 18.07.2016

Uzbekistan 2013 Alpha-interferon Will be revised in 2018 or upon availability of new evidence

Guidelines under development in TajikistanDAA included : Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia and UkraineNot included but used for treatment: Armenia, Tajikistan, Uzbekistan and Azerbaijan

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Registration of DAAs

Countrysofosbuvir sofosbuvir/ ledipasvir daclatasvir

elbasvir/grazoprevir

ombitasvir/ paritaprevir/

ritonavir/ dasabuvir

ombitasvir/ paritaprevir/

ritonavirdasabuvir simeprevir asunaprevir narlaprevir

originator generic originator generic originator generic

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%) countriesUzbekistan: SOF/LED, DAC not registered but generics available at commercial market (Gilead VLs and MPP/BMS VLs)

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Prices of HCV treatment (per pack)

Country

sofosbuvir sofosbuvir/ ledipasvir daclatasvir ombitasvir/ paritaprevir/

ritonavir/ dasabuvir

ombitasvir/ paritaprevir/

ritonavirdasabuvir simeprevir

Lowest available price for DAA-based, 12 weeks

treatment courseoriginator generic originator generic originator generic

Armenia 250 G 300 G

Azerbaijan 365 R5000 P

(112 tablets)2360,7

Belarus 2104620,6 P

(112 tablets)4705,9

Georgia free of chargesfree of charges

free of charges

Kazakhstan 6704 G 99,77 G (1 pack)

20 112

Kyrgyzstan 250 G 152 P 300 G 60 P 636

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 15 318

Tajikistan 250 G 145 300 G

Ukraine 250 G 300 G 512,9 P 2336,73

Uzbekistan 250 G 109 P 300 G 144 P 60 P 507

«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)

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Prices for HCV diagnostics

Full diagnostics in patients undergoing DAA treatment

• Georgia: 199.5 USD (average price, the state covering 70% for financially disadvantaged citizens and 30%

for other population groups)

• Ukraine: 55 USD (average price, FibroscanTM not included) or 98.2 USD (full price), the FibroscanTM

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

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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)

• 30-35 thousand people receive HCV treatment annually under treatment programs in EECA region

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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)

Comments Donor program Number of people

Armenia - PLHIV Absolute number unknown.Treatment provided due to the general health

policies+ 1 000

Azerbaijan + Without limitation Absolute number unknown.Quantity of people on treatment is not limited by

the state program- -

Belarus -Treatmen is free of charges for

children and post-transplantation patients

Absolute number unknown.Treatment provided due to the general health

policies+ 500

Georgia + Without limitation 20 000 people annually during 10 yearsUp to 20 000 000 GEL (about 8,3 mln USD from

local and regional budgets for support diagnostic and service)

+ > 200

Kazakhstan -All patients with HCV and

compensated liver diseasesAverage number of people who received hepatitis B

and C treatment is 1200/yearExpected to increase number of people treated

from HCV up to 10 000 / year + 20

Kyrgyzstan - PLHIV Up to 100 annuallyTreatment provided in the frames of National HIV

response program+ Up to 100

Moldova + n/a3000 people received HCV treatment in 2016. It’s

expected to increase number of people up to 5 000 0 in 2017

- - -

Russia - n/aNumber of patients who expected to receive 48-week course of PEG-IFN in 2017 is 540 and 290 treatment

courses of SMV.

Government announced HCV treatment procurement for total amount over 4,6 million

USD - -

Tajikistan - n/a n/a n/a - -

Ukraine -

Prioritized for treatment: people with >F2 fibrosis, PWID, woman

who planned pregnancy, HIV/HCV co-infected, people with extrahepatic syndroms,these who have freequent

contacts with infected people

n/aGovernment announced HCV treatment

procurement of DAAs (SOF, SOF/LED, 3D) which may cover up to 10 000 treatment courses

+Alliance program up to

2000

Uzbekistan - - - National treatment program is expected in 2017 + > 200

Currently less than 1% of people in need receive treatment

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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). Non-

anonymous 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 (co-

infection) 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 donor-

sponsored

program

Armenia, Moldova and Tajikistan: lack of anonymous testingArmenia, Belarus, Russia, Kyrgyzstan, Tajikistan and Uzbekistan (6/11 countries, 54,5%): limited or no access to treatment for key populations

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Inclusion of EECA countries in Voluntary Licenses

Countrysofosbuvir

sofosbuvir/ledipasvir

daclatasvirlicense status/patent status

ravidasvirDNDI /Presidio 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, UzbekistanMPP/BMS VL: Azerbaijan, Georgia, Uzbekistan.Uzbekistan benefits from both VL agreements (Gilead and MPP/BMS)DNDi/Presidio: Armenia, Kyrgyzstan, Moldova, TajikistanMPP/Pharco: Azerbaijan, Belarus, Kazakhstan, Russia, Ukraine

www.medspal.org

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Other approaches

• 2014-2017: 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

• 2015-2016: patent oppositions filed in Russia and Ukraine (pro-drug patent partially

revoked in Russia)

• 2015-2017: delivery of generics (sofosbuvir, sofosbuvir/ledipasvir, daclatasvir) through

“Buyers‘ clubs” in Belarus, Kazakhstan, Russia and Ukraine

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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:

developing national treatment programs and treatment guidelines

allocation of funds

price reductions

IP work

Testing and treatment programs:

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)

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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)

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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)

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Thank YouKravchenko Natalia

kravchenko@aph.org.ua

5 Dilova st., building 10A, 9th floor

03680 Kyiv, Ukraine

Tel.: (+380 44) 490-5485

Fax: (+380 44) 490-5489

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