With the availability of oral drugs promising to simplify and improve hepatitis C (HCV) treatment in India, the Delhi Network of Positive People (DNP+) wants the ministry of health to start rolling out treatment with the same, for the millions of patients waiting. This demand comes in the wake of lacklustre attitude adopted by the government to include the oral drug treatment options in their programme against the other treatment available i.e. painful injections which has some side effects.

The complexities and costs associated with the current injectable treatment, have acted as a deterrent for treatment providers and governments to invest in a Hepatitis C testing and treatment programme. However, it is understood that treatment options are now improving with the invention of potent oral medications, called direct-acting antivirals (DAAs), which are dramatically increasing the cure rates.

New DAAs including sofosbuvir approved by the US FDA in December 2013 and many others in late stage development - can be produced generically in India and marketed at very affordable prices, just like antiretrovirals (ARVs) used in the treatment of HIV. For example, a twelve-week course of sofosbuvir, produced generically, is estimated to cost between US$ 130-US$ 270; daclatasvir, a highly effective drug from a different class, produced by BMS, may cost just US$ 10- $30 per treatment course.

In a protest held outside the premises of the ministry, Umesh Sharma, from the Indian Drug Users Forum (IDUF) stressed, “I have already endured HCV treatment, with painful injections and side effects, but I am still sick with the infection. Like many people who are chronically infected with HCV, I am also anxiously waiting for the government to start treatment with oral drugs. I do not want to die from a disease when effective oral treatment could be made available.”

It is understood that, Gilead Sciences, a US pharmaceutical company is expected to apply for Drug Controller General of India's (DCGIs) approval for sofosbuvir in the coming months. Although Gilead has applied for multiple patents on sofosbuvir in India, the country’s intellectual property laws are strict about what does and what does not deserve a patent.

“Now is the time to fight for affordable DAAs so that everyone who needs it has access to life-saving HCV treatment,” pointed out Vikas Ahuja, president of DNP+. This week, DNP+ and Initiative for Medicines Access and Knowledge (I-MAK) together filed a patent opposition before the Delhi Patent office to prevent Gilead from gaining a patent in India.

Tahir Amin, director of intellectual property at I-MAK pointed out that to get a patent under the law, one needs to prove that their drug is scientifically new. “We believe that Gilead does not meet this lawful requirement. Opposing the patent at the examination stage is a way of ensuring patients have access to this drug at affordable prices without unnecessary patent barriers standing in the way.”

In the last decade, availability of affordable generics drugs dramatically expanded access to HIV treatment to millions across the world. As HIV becomes an increasingly manageable chronic infection in developing countries, more people are now dying of complications from the co-infection with hepatitis C virus, undermining the success of the HIV treatment scale-up.

“The Indian government is providing TB and HIV treatment to millions of patients. It has the same responsibility to treat HCV and save millions of people who are chronically infected with HCV in India. We learnt with HIV that we have to fight for a national treatment programme to start with and for drugs to be affordable, and we are now applying these lessons to hepatitis C,” said Loon Gangte, of International Treatmemt Preparedness Coalition (ITPC), South Asia.

The World Health Organisation (WHO) estimates that more than 12 million people in India may be chronically infected with the hepatitis virus, with most of them even unaware about their infection. The number of people who are going to get sick or die due to HCV infection are expected to keep rising in India as infections incurred years ago increasingly take their toll.