Hepatitis C is one of a very few diseases which could be eliminated globally with the tools that exist today, provided there is a political will to do so. WHO has a goal to eliminate viral hepatitis as a major public health threat by 2030, yet, today, more people get infected by hepatitis C than get treated every year.

Although new safe and highly efficacious direct-acting antivirals (DAAs) have been available for several years, access to affordable hepatitis C treatment remains extremely limited in many developing countries. Securing wider access to DAAs will be necessary to develop a public health approach to the disease and put this growing epidemic into reverse.

Ravidasvir was developed by the US biopharmaceutical company Presidio Pharmaceuticals and identified by DNDi. In 2016, Presidio Pharmaceuticals, DNDi, and the Egyptian generic manufacturer Pharco Pharmaceuticals signed a licence agreement to secure supplies of ravidasvir and of sofosbuvir. In 2016, DNDi launched a Phase II/III study in Malaysia and Thailand to assess the efficacy, safety, tolerability, pharmacokinetics, and acceptability of 12- and 24-week regimens containing the drug candidate ravidasvir, in combination with sofosbuvir, for people living with hepatitis C.

DNDi and The Foundation for Innovative New Diagnostics (FIND) also partner on a project in collaboration with the Ministry of Health in Malaysia to generate evidence to support policy change and scale up of hepatitis C diagnosis and treatment.

Project updates

2019

With the aim of enrolling 300 patients infected with genotypes 1a, 1b, 2, 3, and 6 – both with and without cirrhosis – the second stage of the trial was launched in late 2018, with the first patients enrolled in Malaysia in January 2019 and in Thailand in May 2019. 

As of January 2020, 180 patients had been enrolled, of whom 46 were in Thailand and 134 in Malaysia. 

Plans to submit for the conditional registration of ravidasvir with the Malaysian National Pharmaceutical Regulatory Authority are underway and filing is expected in mid-2020.

2018

Interim results published in April 2018 showed that 12 weeks after the end of treatment, 97% of the 301 patients enrolled were cured (95% CI: 94.4-98.6). Cure rates were very high, even for the hardest-to-treat patients. Importantly, patients combining several risk factors were cured, and no unexpected safety signals were detected. 

To further establish the pan-genotypic profile of ravidasvir, the second stage of the trial was launched in December 2018 in Malaysia and in Thailand in May 2019. Other trials are envisioned in other parts of the world for vulnerable patient groups, such as people who inject drugs. 

Registration of ravidasvir will be pursued in Malaysia and other middle-income countries, including in Argentina, with DNDi’s pharmaceutical partners Pharmaniaga and Laboratorio ELEA PHOENIX, respectively. 

2017

All 301 patients in DNDi’s Phase II/III trial combining ravidasvir and sofosbuvir in Malaysia and Thailand have completed treatment. Top-line results are being analysed and will be published in April 2018.

DNDi signed a technology transfer agreement with Pharco Pharmaceuticals (Egypt) and Pharmaniaga in late 2017.

2016

At the end of 2016, six study sites in Malaysia had recruited 164 patients (out of a target of 300) and four sites in Thailand had been initiated, with the full cooperation of the Ministries of Health in these countries. Sites in additional countries including Vietnam should be initiated in the coming months.

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