The World Health Organization has issued global
treatment guidelines for hepatitis C, strongly recommending the use of the
new direct-acting antivirals sofosbuvir (Sovaldi)
with ribavirin for genotypes 1, 2, 3 and 4 or simeprevir (Olysio) with pegylated interferon and ribavirin for genotype 1
The guidelines also make a strong recommendation that everyone in a
population with a high prevalence of hepatitis C should be offered an antibody
test for hepatitis C, as should people with a previous risk of exposure to
Approximately 150 million to 180 million people are estimated to be infected
with hepatitis C worldwide. The majority live in Asia and Africa, where access
to new drugs for treatment of hepatitis C, and diagnostic and monitoring tests,
remains extremely limited due to cost.
The new guidelines, developed after review of the evidence from clinical
trials and observational studies, recommend that sofosbuvir or simeprevir
should be used, in combination with pegylated interferon and ribavirin where
necessary, in preference to pegylated interferon and ribavirin alone.
The guidelines recommend that simeprevir should be used in genotype 1a
infection in patients without the Q80K polymorphism. This viral variation
reduces the antiviral efficacy of simeprevir. There is no restriction on the
use of simeprevir in genotype 1b infection.
The guidelines state that treatment with the first generation of direct-acting
antivirals, telaprevir (Incivo) and
boceprevir (Victrelis) is 'suggested'
in preference to pegylated interferon and ribavirin alone, but the guidelines
note that these antivirals are only active against genotype 1, and that there
is an increased risk of serious side-effects when they are used.
WHO finalised its recommendations before price information became
available for countries outside the United States. Although a 12-week course of
sofosbuvir costs $84,000 in the United States, manufacturer Gilead Sciences has
recently negotiated a price of approximately $1200 for a 12-week treatment
course with the Egyptian government.
Sciences is seeking to negotiate voluntary licences that will allow Indian pharmaceutical
companies to manufacture sofosbuvir and sell the drug in around 60
lower-income countries in Africa and Asia for approximately $2000 for a 12-week
course of treatment.
Stefan Wiktor, head of the WHO hepatitis programme, told Reuters: “I
hope these guidelines will help to promote a reduction in price and thereby an
increase in access.”
However, modelling by Dr Andrew Hill of Liverpool University suggests that a
combination of licensing to Indian manufacturers and bulk purchasing could
drive down the cost of some forms of hepatitis C treatment to $200 per
treatment course within a few years.
Treatment at this price would enable large-scale treatment of hepatitis C
in many countries if governments are prepared to commit resources. The
alternative will be a growing burden of liver cancer and other forms of liver
disease, as well as high levels of ongoing transmission of hepatitis C.
WHO will update its treatment recommendations regularly as new drugs are
WHO strongly recommends that everyone diagnosed with hepatitis C should
undergo an assessment of alcohol intake, and all patients with a moderate to
high intake of alcohol should be offered a behavioural alcohol reduction
intervention, with the aim of minimising accelerated liver damage caused by
alcohol in people with hepatitis C.
The guidelines make no recommendation about who should be prioritised for
hepatitis C treatment. But, in order to assess liver damage, the guidelines
recommend that in resource-limited settings the aminotransferase/platelet ratio
index (APRI) or FIB4 tests be used for the assessment of hepatic fibrosis
rather than other non-invasive tests that require more resources such as
elastography or Fibrotest.