Safe and effective $300 hepatitis C treatment a global game-changer
Interim clinical trial results offer hope to people living with hepatitis C who stand to benefit from reduced price treatment, including the 2.3 million people who have HIV co-infection.
An estimated 71 million people have hepatitis C worldwide, but less than three million are on treatment. This huge imbalance is set to change with interim results showing a new, affordable, hepatitis C treatment is safe and effective, with very high cure rates for patients (97%) including hard-to-treat cases such as people living with HIV or liver cirrhosis (96% and 97% respectively).
The treatment, which uses the investigational drug ravidasvir with sofosbuvir, was developed by the Egyptian drugmaker Pharco Pharmaceuticals and The Drugs for Neglected Diseases initiative (DNDi), a not-for-profit organisation. It is expected to cost $300 for 12 weeks, or $3.50 per day, in Malaysia, where trials were conducted, and Thailand. This is a fraction of the cost of other hepatitis C medicines produced by major pharmaceuticals, which often run to tens of thousands of dollars per treatment.
Although US drugmaker Gilead has lowered the price of its Harvoni (sofosbuvir/ledipasvir) tablet and other medicines in lower and middle-income countries, the costs are still too high for governments to roll out mass treatment programmes. High costs mean even health systems in the highest-income countries currently restrict provision.
Some countries have used legal tools such as compulsory licenses and patent oppositions allowing for generic versions of hepatitis C drugs to be procured. This has enabled some, including Egypt and India, to scale up treatment. However legal manoeuvring by pharmaceutical companies and a lack of political will continue to limit access in most countries.
There is considerable overlap between hepatitis C and HIV, as both blood-borne viruses can be transmitted in similar ways and affect some of the same groups – particularly people who inject drugs. So the prospect of affordable access to hepatitis C treatment is also good news for the 2.3 million people living with HIV and hepatitis C co-infection.
The phase II/III trial of this new sofosbuvir/ravidasvir combination in a group of 301 people in Malaysia has been funded by Médecins Sans Frontières, one of DNDi’s founding partners which also include France’s Institut Pasteur.
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 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.
The generic drugs are 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.
Bringing down financial barriers to treatment access is a major ‘win’ for those with hepatitis C and those co-infected with HIV who have so far been denied medicine. For healthcare professionals and policy-makers, one of the key issues that remains however, is the potential for drug-drug interactions between medications for HIV and hepatitis C. When these may occur, the regimens for either infection may need to be altered and carefully managed.
In addition, as currently practiced, the clinical management of hepatitis C requires sophisticated laboratory capacity to diagnose infection, identify the genotype, assess fibrosis and monitor response to treatment. In many countries, the costs of these tests is prohibitive or there are few laboratories that can perform them.
As people living with HIV live longer, liver disease in people with HIV and hepatitis C co-infection is becoming a major cause of morbidity and mortality.