Access to Hepatitis B and C

Medicines

Morgane Ahmar, International Treatment

Preparedness Coalition (ITPC), Morocco

Conference on Liver Disease in Africa (COLDA)

Cairo, September 8 2019

EPIDEMIOLOGICAL DATA AND

TREATMENT ACCESS GAPS

Africa is covered by 2 WHO Regional Offices

➢ EMRO (Morocco, Tun is ia,

L ibya, E gypt, S udan ,

S om alia)

➢AFRO

No consolidated data

▪ HBV:

- 10% of PLHBV aware of their status (27 of 257M)

- 1,8% are on treatment (4,5M)

- 1.1M people newly infected in 2017

▪ HCV:

- 19% of PLHCV aware of their status (13 of 70M)

- 2,5% on treatment (1,8 M)

- 1.75M people newly infected in 2015

Smith S. & al “Global progress on the elimination of viral hepatitis as a major public health threat: An

analysis of WHO Member State responses”, 2017

Large treatment gaps to fill globally

Africa lagging behind

WHAT MEDICINES DO WE NEED

DAAs: A revolution and a cure for

HCV

Afdhal et al; NEJM 2014; Bansai et al; World J Hepatol

2015; Feld et al; NEJM 2014;Sulkowski et al; NEJM 2014

▪ WHO recommended pangenotypic medicines:

Sofosbuvir+ Daclatasvir/ Velpatasvir

▪ Oral, short duration, some are pangenotypic,

simplified diagnostics, monitoring and treatment, high

cure rates, safe and tolerable

HBV treatment: No cure but efficient

treatment

▪ WHO recommendations for preferred first-line:

tenofovir/entecavir

▪ High genetic barrier to resistance, high

efficacy, minor side-effects, once-daily oral,

potential for harmonizing treatment (HIV co-

infection, TB)

▪ Available and used in most countries for HIV

treatment

Slow uptake in Africa

▪ Only 26% of AFRO countries and 56% of

EMRO countries reported access to DAA

regimens as first line treatment for all

▪ Only 44% of AFRO countries and 63% EMRO

countries reported access to tenofovir or

entecavir to be the first-line treatment for

patients with chronic HBV

Tordrup D. & al. Additional resource needs for viral hepatitis elimination through universal

health coverage: projections in 67 low-income and middle-income countries, 2016–2030, 2019

DRIVERS AND BARRIERS TO

ACCESS IN AFRICA

1/ Affordability and access to generics

Affordability/Prices of medicines = linked

to Local Patents

Access to generics and price

decreases▪ HBV:

- Generic TDF and FTC widely available at low cost in LMICs as part of national ART programs (e.g. TDF = US$ 32 ppy without patent protection)

▪ HCV:

- Strong advocacy by CSOs for access to generic HCV drugs => drastic price reductions in very short time : 142.000$ to 78$ per cure, around 150 US$ in several LMICS

- Very few patents filed in the continent, rejection of patent applications in Morocco and Egypt

- Local production: Egypt, Morocco, Tunisia, Algeria, others?

- Inclusion in voluntary licenses granted by originators to Indian generic manufacturers, advocacy for inclusion of North African in the licences: “theoretical” access to generics

Andrieux-Meyer & al, Disparity in market prices for hepatitis C virus direct-

acting drugs, 2015

DRUG USA PRICE

GLOBAL

LOWEST

PRICE

ESTIMATED

COST

PATENT

EXPIRY

(US)

TDF/FTC

$17,258

(pppy) $67 $54Expired

Entecavir

$5,915

(pppy) $409 $36Expired

SOF+LDV

$91,207

(per cure) $307 $792028-2032

SOF+DCV

$142,710

(per cure) $78 $472028-2031

Prices and costs of drugs to treat HBV

and HCV (A. Hill)

DRIVERS AND BARRIERS TO

ACCESS IN AFRICA

2/ Transparency, regulatory and

procurement obstacles

From theoretical access to generics...

Towards effective access

Transparency and procurement

challenges

▪ TDF and FTC sometimes unavailable outside of

HIV programs and large price variance 50-

500 US$

▪ High price variances for DAAs and lack of

transparency for SOF costs US$500 in Côte

d’Ivoire vs. 150 in India (lack of transparency)

Andrieux-Meyer & al, Disparity in market prices for hepatitis C virus direct-

acting drugs, 2015

CHALLENGES AND

OPPORTUNITIES FOR SCALE-UP

Challenges for scale up

▪ National strategic planning and dedicated funding:

▪ Lack of epidemiological data to inform prevention, testing and

treatment strategies

Reported

having

hepatitis

national plan

Reported

having a

published

national plan.

Reported

inclusion of

impact targets in

national plan

Reported inclusion

of service

coverage targets

in national plan

Reported having

dedicated

funding for

national plan

AFRO 52% 19% 15% 30% 22%

EMRO 82% 38% 38% 63% 44%

Tordrup D. & al. Additional resource needs for viral hepatitis elimination through universal

health coverage: projections in 67 low-income and middle-income countries, 2016–2030, 2019

Challenges for scale up (2)

▪ Lack of involvement of civil society:

▪ Civil society played an important role in advocacy for treatment scale

up of HIV and demand creation for services

▪ Number of NGOs very limited

- Among the countries where MoH reported engagement with civil society, 84% with a

national viral hepatitis elimination plan (1)

- Only 48% of AFRO countries (56% for EMRO), reported engagement with civil

society (2)

▪ Lack of funding mechanisms nationally and globally

- US$ 6bn per year needed to reach hepatitis targets

- Current spending of US$ 0.5bn as of 2016

(1) Smith & al., JHEP Reports, August 2019

(2) Tordrup D. & al. Additional resource needs for viral hepatitis elimination through universal health

coverage: projections in 67 low-income and middle-income countries, 2016–2030, 2019

▪ Leadership and strong political will

▪ Ambitious planning and target setting:

- Decentralization

- More than 20 million people tested

- More than 2 million people treated

▪ Resource mobilization (National budget, fundraising through mobile technologies,

private sector…)

▪ Price reduction strategy:

- Negotiations with pharma

- Public health approach to patent examination (patents on SOF and DCV rejected)

- Local production of DAAs

▪ Involvement of media, community based organizations

What works: the example of Egypt

Conclusions

▪ Ambitious targets have been set globally, access to treatment is increasing but unequally and

remains low in Africa

▪ Limited portfolio of medicines (4 to 6) is needed to treat both HBV and HCV according to

WHO standards: generic versions are available on the global market at low price

▪ Price and affordability do not AND should not constitute an access barrier in Africa (limited

or expired patents, inclusion in voluntary licenses…)

▪ Lack of transparency in pricing, mark-ups and negotiation power, regulatory issues and

procurement procedures may constitute a barrier to price reductions

▪ High potential for local manufacturing: an opportunity for the continent to develop local

industries and create autonomy from Indian dependence (HIV)

▪ Leadership, National planning and ambitious target setting are key for successful scale up

▪ The role of civil society is key for advocacy and demand creation and needs to be promoted

and funded

▪ The funding GAP needs to be addressed globally and nationally (innovative funding

approaches? Integration in existing programs, role of the private sector to reconsider…)

Thank you.