[Ip-health] Times of India: Hepatitis C cure may cost as low as Rs 67k

Thiru Balasubramaniam thiru at keionline.org
Sat Nov 28 22:52:23 PST 2015

Hepatitis C cure may cost as low as Rs 67kReema Nagarajan,TNN | Nov 29,
2015, 05.33 AM IST

NEW DELHI: In a move that comes as a huge relief to patients of chronic
Hepatitis C, the apex committee of the Central Drugs Standard Control
Organisation (CDSCO) has granted a waiver of local trials for crucial new
direct-acting antiviral drugs treating the disease.

The waiver for sofosbuvir and ledipasvir co-formulation and for daclatasvir
is expected to bring the generic version of these drugs, which cost a
fraction of the branded versions, into the Indian market within weeks. Some
patients facing a threat to life currently import these drugs at a huge

According to the World Health Organisation, about 12 million people are
infected with Hepatitis C in India. India is now one of the few countries
where generics are available for interferon-free treatment. Pegylated
interferon is an old, expensive, injectable chemotherapy drug with serious
side effects used to treat Hep C in combination with sofosbuvir and

The interferon-free treatment, which costs over $90,000 in the US and over
50,000 euros in the EU will be available to Indian patients for about Rs
55,000 or about $1,000 or even less thanks to competition between generic

Indian generics are expected to revolutionise Hep C treatment in the region
and all across the world as they did in the case of HIV/AIDS. People from
countries where treatment is being rationed by the governments, such as in
Australia, many European countries, the US, and Canada, already come to
India to get treated and this trend is only likely to continue.

Several patient groups, including International Treatment Preparedness
Coalition - South Asia, the Delhi Network of Positive People, thalassemic
patients' groups and Medecins Sans Frontieres (MSF) or Doctors Without
Borders have been petitioning the health ministry and the Drug Controller
General of India (DCGI) seeking a clinical trial waiver for these drugs.
Over a dozen patient groups and access-to-medicine activists from
Indonesia, Thailand, Malaysia, Nepal and Vietnam too had sent similar
appeals. "The requirement for a local clinical trial in India will delay
the introduction of the new HCV drug daclatasvir in the country, and also
in other high-burden countries in the region," stated the appeals.

HCV Patients with advanced liver disease, thalassemics, those with HIV
co-infection or those with kidney disease undergoing dialysis who have
hepatitis C need daclatasvir in combination with sofosbuvir for effective
treatment. They cannot tolerate interferon and/or ribavirin and treatment
with sofosbuvir alone was not possible for them. Hence they were left with
no treatment option when the manufacturer of daclatasvir, Bristol Myers
Squibbs (BMS), was not willing to bring the drug to India or other
developing countries.

Sofosbuvir was registered in India in January 2015 and daclatasvir was
registered this month. The combo is seen as a very potent cure with about
90% cure rate and for no other disease has such a short-time cure become
available, that too in a generic version.

According to the recommendations of a high level committee, waiver of
clinical trials in India for approval of a new drug that has already been
approved outside India can be considered only in cases of national
emergency, extreme urgency, and epidemic and for orphan drugs for rare
diseases and drugs indicated for conditions/diseases for which there is no
therapy. This was hampering the waiver that millions of Hep C patients were
petitioning for.

However, the technical committee, after examining the case of sofosbuvir,
said that it was the only drug which could be safely used in several
categories of Hepatitis C patients. In the case of daclatasvir, the
committee said that the drug in combination with other medicinal products
became imperative to expedite the treatment of all types (genotypes) of
Hepatitis C and hence recommended the waiver.

"We welcome the availability of a pan-genotypic directly acting anti-viral
(DAA) combination in India, which is a big step towards interferon free
treatment for chronic HCV patients, many of whom urgently need treatment as
they have advanced liver disease," said Leena Menghaney, head of MSF's
South Asia Access Campaign.

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