Pharma-backed initiative delivers low-cost hep C drugs

Print 20 April 2016
Ben Adams / FierceBiotech

A new program run by charities and academia with the support of pharma is looking to cure 25,000 hep C patients in Africa and Southeast Asia by allowing better access to new drugs.

The ministries of Health in Ethiopia, Indonesia, Myanmar, Nigeria, Rwanda, and Vietnam have all signed up to accelerating access to hepatitis C (HCV) testing and treatment with help from the Quick-Start program--which aims to cure 25,000 people of HCV in the next two years.

The Quick-Start program is a partnership of the U.S. charity Clinton Health Access Initiative (CHAI) and the academic group Duke Health, and works closely with Amsterdam’s PharmAccess Foundation--which is establishing HCV treatment projects in several sub-Saharan African countries.

Just this month the program got a boost from Bristol-Myers Squibb ($BMY) when the U.S. Big Pharma said it would donate its new HCV treatment Daklinza to Quick-Start, building on similar access deals signed with Hetero, Mylan, and Roche ($RHHBY).

Daklinza has a number of U.S. licenses, including for the difficult-to-treat genotype 3 form of the disease and for those who already have HIV-1 infection.

As some of these meds do not have a full license in these countries, under the remit of Quick-Start all suppliers have undergone--or are currently undergoing--review by a strict regulatory authority WHO Prequalification Program, or an Expert Review Panel, for their respective HCV products.

These deals mark the first step toward making treatment more affordable in low- and middle-income countries, according to a statement released by CHAI.

The aim is to drastically cut the cost of diagnosing and treating patients living with HCV in these countries to between $488 and 737 per patient from between $1,370 and $1,570 per patient--a 45-70% reduction in cost.

The cornerstone of the initiative, according to CHAI, is a simplified screening and treatment algorithm, developed with Duke Health, combined with new direct-acting antiviral medicines (such as Daklinza) that will “improve and enhance clinical impact while reducing costs and allowing for treatment to be prescribed by general clinicians.”

Global HCV antibody prevalence is estimated at 115 million people, with around 80% of cases occurring in low- and middle-income countries. An estimated 700,000 people die each year from HCV-related complications.

The countries where this initiative is being launched: Ethiopia, Indonesia, Myanmar, Nigeria, Rwanda, and Vietnam, have as many as 24 million people who are antibody-positive for hepatitis C.

Gilead ($GILD) has not been named in the deal despite marketing Harvoni and Sovaldi, two drugs which can cure nearly all HCV patients of the liver-destroying disease. Gilead has however selected certain countries to help with the cost of its drugs, and recently struck a deal in India allow 9 generics makers to market Sovaldi at $900 per course. The drug costs $84,000 for a full course of treatment in the U.S.

“Today, we are with hepatitis C where we were at the beginning of the HIV crisis,” said Ira Magaziner, CEO of CHAI.

“With these pricing agreements, we can begin to stimulate the development of a low-cost, sustainable market for HCV medicines and diagnostics that will drive increased access to treatment across low- and middle-income countries," Magaziner continued. "I commend these governments for their commitment to tackling their epidemics today, before increasing rates of cirrhosis and mortality resulting from HCV overwhelm health systems.”

Dr. H. M. Subuh, director general of the Directorate General of Disease Control & Prevention, Ministry of Health in Indonesia, added: “Hepatitis C is a major concern in our country and we have taken significant strides to start our comprehensive hepatitis control program, from prevention to treatment. These reduced prices make it affordable for the Government of Indonesia to begin covering the cost of treatment for those most in need.”

The products covered in the agreements include HCV screening tests, viral load tests, and direct-acting antiviral agents. The details of individual pricing and supply agreements are being kept confidential.

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