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[e-drug] BMJ on access to hepatitis treatment

E-DRUG: BMJ on access to hepatitis treatment
--------------------------------------------------------------
[Although written with the perspective of the UK, this has relevance to 
other countries. Many low- and middle-income countries have access to 
hepatitis C treatments at lower costs than in high income countries, but 
issues of affordability and reaching affected patients remain. Copied as 
Fair Use. DB]

Slashed cost of hepatitis C drugs spurs drive to eliminate the disease

BMJ 2018; 361 doi: https://doi.org/10.1136/bmj.k1679 (Published 16 April 
2018) Cite this as: BMJ 2018;361:k1679
https://www.bmj.com/content/361/bmj.k1679
Richard Hurley

Access to hepatitis C virus testing and treatment should be expanded now 
that effective, curative drugs are so affordable, the World Health 
Organization said on 13 April. The advice comes two years after the 
agency made a global commitment to eliminate all types of viral 
hepatitis by 2030.1

Until recently, such a promise felt like pie in the sky. Eye watering launch 
prices of drugs such as sofosbuvir of around $90 000 (�63 000; 
�73 000) per patient in the US and almost �35 000 in England meant 
that even rich countries were restricting access to direct acting antiviral 
combinations when they launched, some five years ago.

In the UK, NHS England took action in 2015 to ensure that only the 
sickest patients had access to the drugs, although they were recommended 
by the National Institute for Health and Care Excellence.2 But in 
January this year the agency promised that England would be the 'first 
in the world' to eliminate hepatitis C by 2025, beating WHO's deadline 
by “at least five years.”3

The change of policy seems to have come after NHS England secured deals 
with manufacturers, reducing the cost of a course of treatment to about 
£5000 a patient, says Charles Gore, chief executive of the UK advocacy 
group the Hepatitis C Trust.

Worldwide, everyone over 12 should now receive treatment regardless of 
the disease's severity, say imminent WHO guidelines announced on 13 
April at the International Liver Congress in Paris, France.4 Prevention, 
testing, and treating should be embedded in countries' broader service 
delivery, they say.

Gottfried Hirnschall, director of WHO's HIV and AIDS Department and the 
Global Hepatitis Programme, told The BMJ, 'We need an aggressive 
stepping-up of the pace. The treatment is simple, can be given in 
primary care, and is curative.'

Oral, fixed dose combinations of direct acting antiviral drugs taken 
once a day for 8-12 weeks can cure six common genetic variants of the 
hepatitis C virus, making expensive genotyping redundant. Elimination 
rates exceed 90%, and the life saving treatment is now cost saving 
because of the substantial reduction in liver cirrhosis or cancer, as 
well as diseases such as depression and diabetes.

Last month the UK All Party Parliamentary Group on Liver Health outlined 
'a vision for a national elimination strategy,' recommending how the 
government should fund prevention, case finding, testing, and treatment.5

Gore said, “The NHS was worried about initial prices, but it’s 
completely turned around, and now they’re worried about finding people 
to treat.” The bloodborne infection carries a stigma because it is often 
transmitted by sharing needles when injecting drugs, which was probably 
more common before dangers such as HIV transmission were known about.

At least 80.000 symptomless people in England do not know that they have 
the infection, he explained, and 50,000 others have tested positive but 
have been lost to follow-up.

'We need to make it easy for anonymous testing, in pharmacies, for 
example. And we need a public awareness campaign,'  said Gore. Another 
challenge, he added, is getting different healthcare commissioners to 
prioritise the issue in drug services, community nursing, and prison care.

Hirnschall said that 'champion countries' such as Egypt and Pakistan, 
which have some of the heaviest burdens of hepatitis C virus infection, 
show what can be achieved with government action. Currently, they 
account for half of the total number of people receiving treatment.

In other countries, such as Malaysia and India, compulsory and voluntary 
licensing has led to generic production and lower treatment costs.

Unpublished interim trial results presented at the Paris conference 
showed that generic drugs costing just $300 have shown over 95% 
effectiveness in Malaysia and Thailand.6

'A cure for hepatitis C cure has sparked momentum. Patients are 
demanding it. Now politicians need to step up,'  said Hirnschall, calling 
for a response similar to that seen with HIV: political leadership, 
international solidarity, and considerable funding, as well as civil 
society commitment.
'The alternative is more costly and will cost more lives,'  he said. 'We 
cannot wait.'

Hepatitis globally
-� Viral hepatitis of all types kills 1.3 million people a year worldwide - 
more than HIV, malaria, or tuberculosis.
-� Last year 1.7 million people became infected with hepatitis C, and 1.5 
million were cured.
-� Only three million of the 71 million people infected with hepatitis C virus 
in 2017 had access to direct acting antiviral drugs, and only 20% of people 
know their status.

References
World Health Organization. Global health sector strategy on viral hepatitis, 
2016-2021. June 2016. 
www.who.int/hepatitis/strategy2016-2021/portal/en/. 

Gornall J, Hoey A, Ozieranski P. A pill too hard to swallow: how the NHS is 
limiting access to high priced drugs. BMJ2016;354:i4117. 
doi:10.1136/bmj.i4117 pmid:27469086

NHS England. NHS England sets out plans to be first in the world to eliminate 
hepatitis C. 29 Jan 2018. 
https://www.england.nhs.uk/2018/01/hepatitis-c-2/.

World Health Organization. Hepatitis C: simplified curative treatments can 
drive global scale-up. 13 April 2018. 
www.who.int/hepatitis/news-events/hep-c-scale-up/en/.

All-Party Parliamentary Group on Liver Health. Inquiry report: eliminating 
hepatitis C in England. March 2018. 
www.appghep.org.uk/download/reports/Eliminating%20Hep%20C%20APPG.pdf.

Drugs for Neglected Diseases Initiative. New affordable hepatitis C combination 
treatment shows 97% cure rate. 12 April 2018. 
https://www.dndi.org/2018/media-centre/press-releases/new-affordable-hepatitis-c-combination-treatment-shows-97-cure-rate/.

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