Friday, May 13, 2016

Hepatitis C: global ambition, national realities

Volume 387, No. 10032, p1970, 14 May 2016


Hepatitis C: global ambition, national realities
The Lancet


Last week, new surveillance data released by the US Centers for Disease Control and Prevention (CDC), report that US hepatitis C virus (HCV)-associated deaths reached a record high—19 659 in 2014. Around 3·5 million people are currently living with HCV in the USA. The cost of direct-acting antivirals (DAAs), the curative drug class of choice in new WHO guidelines, is prohibitive, with some US insurers covering only severe cases. WHO has added most new DAAs to its model list of essential medicines. With an estimated 130–150 million people worldwide infected with HCV, the global treatment gap is urgent and reminiscent of the early AIDS crisis, with most countries lacking access to curative medicines.

One such example is China. Around 8 million people are estimated to be infected with HCV, which is double the US burden. HCV-related liver cancer deaths rose by 283% from 1990 to 2013. Around 100 000 Chinese HCV patients are on suboptimum interferon-based regimens annually because DAAs are not available. High costs for middle-income countries notwithstanding, DAAs are not yet registered nationally because the Chinese food and drug regulatory agency requires that all foreign medicines first undergo local clinical trials, a registration process that can take up to 5–8 years. Although HCV drugs qualify for (as yet undefined) accelerated registration, the situation is unacceptable for the 2·5 million Chinese HCV patients currently in need of treatment. According to WHO China, it is cheaper to treat than not to treat. Interferon-based regimens are estimated to be more than fourfold the cost of a standardised package using DAAs at an access price similar to Egypt. Solutions to consider would be a clinical trial waiver (granted for HIV antiretrovirals) or compulsory licensing for generic production.

The WHO global strategy on hepatitis will be deliberated at the World Health Assembly later this month. The goal to eliminate hepatitis as a major public health threat by 2030 is only achievable through planning urgent and affordable access to essential medicines—in all countries.

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