Interim results show affordable hepatitis C treatment to be safe

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An affordable hepatitis C treatment has been shown to be safe and effective, with very high cure rates for patients including hard-to-treat cases, in interim clinical trial results that offer hope to the 71m people living with the disease worldwide, reports The Guardian.

Treatment is expected to cost $300 for 12 weeks, or $3.50 per day, in Malaysia, where trials were conducted along with Thailand – a fraction of the cost of other hepatitis C medicines produced by major drug-makers, which often run to tens of thousands of dollars.

The Drugs for Neglected Diseases initiative (DNDi), a not-for-profit organisation, is working with the Egyptian drug-maker Pharco Pharmaceuticals to bring a combination treatment of two hepatitis C tablets, ravidasvir ¬(a new drug)¬ and sofosbuvir, to countries that cannot afford to pay the high prices charged by US companies Gilead and AbbVie.

The report says this is taking longer than expected but has moved a big step closer with the latest results.

The phase II/III trial of 301 people has been funded by Médecins Sans Frontières, one of DNDi’s founding partners which also include France’s Institut Pasteur. DNDi said 97% of patients were cured after being treated with the combination pill for 12 weeks. Even hard-to-treat cases such as people with HIV or liver cirrhosis showed very high cure rates, of 96% and 97% respectively.

The report says although highly effective Hepatitis C medicines have been available for several years, their high cost means that less than three million people are on treatment.

US drug-maker Gilead has lowered the price of its Harvoni tablet and other medicines in lower and middle-income countries, but it is still too high for governments to roll out mass hepatitis C treatment programmes. Harvoni now costs about $48,000 for a 12-week course in Malaysia and $12,000 in Chile. Gilead’s previous Sovaldi treatment cost $1,000 a pill, or $84,000 over 12 weeks.

Prices vary around the world and tend to be highest in the US. Also, the report says, Gilead has come under pressure from US rival AbbVie, which launched a new hepatitis C medicine, Mavyret, last year with a shorter, eight-week treatment course priced at $26,400.

Bernard Pécoul, executive director of DNDi, said: “The results indicate that the sofosbuvir/ravidasvir combination is comparable to the very best hepatitis C therapies available today but it is priced affordably and could allow an alternative option in countries excluded from pharmaceutical company access programmes.”

The treatment is expected to be available in Malaysia within one to two years. DNDi has also signed deals in Latin America to make it available for $500 for the 12-week course, with a provision to bring the price down to $300.

The report says the trial using medicines produced by Pharco was run by DNDi and co-sponsored by the Malaysian Ministry of Health. The medicine has also been tested on 300 patients in Egypt, who have different genetic characteristics, with a 100% cure rate. Further studies are being carried out in South Africa and Ukraine to cover all six genotypes of the disease.

DNDi has licensed rights for ravidasvir in low and middle-income countries from the Californian firm that developed it, Presidio Pharmaceuticals.

The Guardian report

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