Low-priced challenger to Gilead hep C drug emerges

Egyptian drugmaker Pharco Pharmaceuticals has teamed up with the Drugs for Neglected Diseases initiative (DNDi) to create a hepatitis C treatment costing less than $300. This low-priced alternative has been created for countries that cannot afford hepatitis C treatment from major drugmakers such as Gilead, AbbVie and Merck whose prices start at $80k. Latin America and parts of the Middle East stand to benefit most from the new medication, with prices expected to fall to $100 in the coming years.

A hepatitis C treatment that costs less than $300 (£210) – a tiny fraction of the $80,000-plus price charged by major drugmakers – has been successfully tested in Egypt and is expected to be available within two years.

The Drugs for Neglected Diseases initiative (DNDi), a not-for-profit organisation, has teamed up with the Egyptian drugmaker Pharco Pharmaceuticals to bring a combination treatment of two hepatitis C tablets, ravidasvir and sofosbuvir, to countries that cannot afford to pay the high prices charged by US drugmakers Gilead, AbbVie and Merck.

Hepatitis C is a blood-borne viral infection that can lead to liver cirrhosis, cancer and death.

Announcing the collaboration at the international liver congress in Barcelona, DNDi said it would conduct clinical studies of the combination treatment, which has already been tested on 300 patients in Egypt with a 100% cure rate, in Malaysia and Thailand, which have different genetic characteristics. It is expected to be available in Egypt within the next 12 months, and elsewhere within 18-24 months.

Malaysia’s health minister, YB Datuk Seri Dr S Subramaniam, said: “Because of the high prices of new hepatitis C medicines, it has been almost impossible for governments to provide access to treatment at the necessary scale. We hope data from these studies will support our efforts to introduce this combination as soon as possible and scale up to reach all patients in need.”

Pharco has agreed to produce the combination treatment for $300 or less, or $3.50 per day. This compares with the $1,000 a day initial price tag for Gilead’s Sovaldi, or $84,000 for a 12-week treatment. Its Harvoni combination pill now costs $80,000 for 12 weeks. The list price of AbbVie’s Viekira Pak is $83,000 while the recently approved Zepatier, made by Merck, is priced at $54,600.

However, Bernard Pécoul, DNDi’s executive director, said the active ingredient of sofosbuvir costs far less to make (an estimated $68 to $136 for a 12- to 24-week course) and reckons that the commercial price of the combination treatment could drop to around $100 in a few years’ time.

DNDi, whose founding partners include Médecins Sans Frontières and France’s Institut Pasteur, has licensed rights for ravidasvir in low and middle income countries from the Californian firm that developed it, Presidio Pharmaceuticals. The treatment is expected to become available in Europe, the US and Japan after March 2018. The UK has an estimated 1.6m hepatitis C cases, while the US has 3.4m.

Pécoul held out the prospect of eradicating hepatitis C, which affects up to 150 million people globally. At the moment, due to the prohibitive cost only the most severe cases are treated in many poorer countries. But if the cost drops, enabling all affected patients to be treated and cured, the disease would stop spreading.

Pécoul said: “I don’t think we have many public health situations where we have such a tool.”

Three-quarters of people with hepatitis C live in middle-income countries such as Malaysia and Thailand, which are excluded from the voluntary licensing agreements that Gilead and Bristol-Myers Squibb have struck with generic drugmakers, for example in India, to lower the cost of their treatments. Latin America stands to benefit from DNDi’s and Pharco’s move, along with Malaysia, Thailand, Saudi Arabia and Iran.

Egypt is the worst affected country in the world, where 10% to 12% of the population has hepatitis C, but the government expects to treat 1 million patients this year.