In Pakistan, the launch of generic versions of sofosbuvir in
early 2016 led to an enormous increase in the number of people starting
treatment. Professor Saeed Hamid, President of the Pakistan Society for the
Study of Liver Disease told a symposium organised by the World Health
Organization (WHO) that nearly 10,000 people started hepatitis C treatment in two
weeks during February 2016 alone. Pakistan treated around 257,000 people for
hepatitis C between 2011 and 2015 using pegylated interferon or interferon and
ribavirin, and was able to achieve relatively high cure rates in its
predominantly genotype 3-infected population, with cure rates as high as 80% in
under-30s. The arrival of sofosbuvir supplied by Chinese generic manufacturers
is set to drive down the cost of treatment from approximately US$300 per month of
treatment to $252 per treatment course. The cost could fall further – Prof.
Hamid revealed that the government of the state of Punjab has just finalised a
tender for 2016-2017 that will permit people to be treated with sofosbuvir and
ribavirin for $80 per treatment course – less than the estimated cost of the
active pharmaceutical ingredients.
The arrival of generic products has thrown up problems too.
Counterfeit products and poor quality products have already been detected,
including pills that fail to dissolve when tested. Unregulated prescribing also
risks misuse of direct-acting antivirals. “I’ve had patients come in whose
cardiologist has prescribed sofosbuvir,” said Professor Hamid.
In India, the availability of generic direct-acting
antivirals produced by more than 15 companies at a cost of between $177 and $300
for a three-month course of treatment – has permitted around 42,000 people to
be treated with products manufactured by one company alone. A comprehensive
national picture of how many people are being treated is lacking and, outside a
few states, treatment is dependent on private means. India lacks a national
strategy for hepatitis C treatment and prevention. To eliminate hepatitis C as
a public health problem in India by 2030, the country would need to treat 10
million people by 2020.
“To treat 10 million
people by 2020 we need to treat over 5500 patients a day,” said Professor Shiv
Sarin, Director of New Delhi’s Institute of Liver and Biliary Science. This
implies that at least 10,000 doctors will each need to treat at least 180
patients with hepatitis C a year, he went on. India currently has around 2500
liver specialists, so the only way to achieve this big increase in capacity is
to train primary care physicians to manage hepatitis C treatment.
Another barrier to treatment in India is the high cost of
viral monitoring tests. At the very least, viral load (HCV RNA) should be
measured four weeks after starting treatment to check response, again at the end of
treatment and 12 weeks after completion of treatment, but with each test
costing around $30, the cost of testing is equivalent to the cost of one month
of treatment in India, Prof. Sarin said. Furthermore, testing needs to be
carried out in laboratories equipped to conduct PCR testing. “We need a global
strategy for affordable, point-of-care diagnostic and monitoring tests for
hepatitis B and C,” said Prof. Sarin.
A potential short-term solution for many countries in Asia
and sub-Saharan Africa may lie in partnering with national tuberculosis (TB) programmes.
Recent investment in the GeneXpert molecular diagnostic platform has provided
access to fast-throughput diagnostic testing for TB and
drug-resistant TB. Manufacturer Cepheid recently launched an HCV
Xpert test that can be used on the platform to provide an HCV RNA test result
within 2 hours, on a machine that can be located in a primary health clinic or
a small hospital rather than a large central laboratory.
In the longer term, FIND is working with the WHO Global Hepatitis
Programme to catalyse the development an array of diagnostic and monitoring
its strategy document here), in particular affordable point-of-care
molecular diagnostics and a core antigen assay for monitoring hepatitis C treatment,
as well as improved tests for diagnosing hepatitis C infection and staging of