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Today is World Hepatitis Day. This year sees the first ever World Health Organization’s Global Strategy for Viral Hepatitis, which sets a goal of eliminating viral hepatitis as a public health threat by 2030. In light of this, we spoke to Leena Menghaney and Jessica Burry of the MSF Access Campaign about the barriers to treatment access and how to overcome them.

With an estimated 150 million people worldwide being infected with hepatitis C, the most important goal is to guarantee access to treatment. One third of the world’s population currently lacks access to essential medicines and in the poorest parts of Africa and Asia this rises to around half of the population. In these areas, the medicines that could save their lives cost around a hundred times what these people earn in a year.

Médecins Sans Frontières (MSF) is a humanitarian organisation that runs medical programmes in over 60 countries and exists to save lives by providing medical aid in areas that call for a rapid response with specialised medical and logistical help.

Two of the main barriers faced by MSF while treating patients are that the medicines are too expensive, or that they are no longer produced. They believe it is fundamentally unacceptable that access to essential medicines is increasingly difficult, particularly for the most common global infectious diseases. Medicines should not be a luxury.

In response, the MSF Access Campaign was launched in 1999 with the prize money from the Nobel Peace Prize awarded to the MSF in the same year. This campaign pushes for access to, and the development of, life-saving and life prolonging medicines, diagnostic tests and vaccines for patients.

Leena Menghaney, head of South Asian MSF Access Campaign

We spoke to Leena Menghaney, lawyer and head of the South Asian MSF Access Campaign, about current barriers to access to Hepatitis C treatment and asked her to outline strategies and responses to face these barriers.

“Today MSF’s medical response to Hepatitis C (HCV) is on the cusp of change. Our medical projects in several countries including Pakistan, India, Myanmar and Cambodia are rolling out HCV testing and oral treatment for vulnerable communities in high burden settings. This is attributable to the partnership between medical field projects and Access Campaign – who have pushed for access and started receiving supplies of direct acting antivirals (DAAs) – in less than two years from the time when the first DAA sofosbuvir received USFDA approval.

Earlier in the decade, frustrated with the prohibitively expensive treatment option of pegylated interferon and ribavirin, which included an injectable with poor treatment outcomes often causing severe side effects in patients, MSF started to explore the pipeline of new oral drugs that promised to provide a pan-genotypic cure for HCV.

The struggle to procure two new oral HCV medicines (sofosbuvir and daclatasvir) for MSF patients reflects the continued challenges of access to affordable lifesaving medicines in different developing countries.

Photo: Zen Lefort

From 2012 to 2015 the MSF Access team – consisting of a medical advisor, pharmacist and lawyers – pursued compassionate use access in negotiations with originator pharmaceutical companies for HCV patients with advanced liver disease; made submissions to encourage WHO to include pan-genotypic DAAs in the Essential Medicines List; pushed generic companies in India to develop low cost generic versions; supported challenges to patent barriers; questioned restrictive licensing deals, lobbied to remove restrictive anti-diversion clauses from procurement agreements and highlighted the critical need for accelerated registration of sofosbuvir and daclatasvir before developing country Drug Regulatory Authorities (DRAs). Many of these objectives were met by the Access Campaign working closely with civil society organisations.

In parallel medical projects started screening vulnerable communities including people living with HIV and injecting drug users to assess the burden of chronic HCV, scaled up diagnostic capacity; prioritised patients who needed HCV treatment urgently and started developing models of care appropriate to resource poor settings.

Even as low cost generic versions of sofosbuvir and daclatasvir from Egypt and India are becoming available at affordable prices (less than 500 USD per treatment), and are in the process of quality-assurance validation, intellectual property barriers will prevent projects in several middle-income countries from accessing them for patients. The continued need for close collaboration between MSF’s field projects and Access Campaign to overcome and challenge such barriers cannot be over emphasised.”

The urgent need to reduce the burden of viral hepatitis on communities across all global regions prompted policy makers and major changes are underway. With the Elimination Strategy for Viral Hepatitis, national governments sign up and commit for the first time to the goal of eliminating viral hepatitis. In it, they vouch to ensure that “everyone living with viral hepatitis has access to safe, affordable and effective care and treatment.” A global elimination movement, NOhep has also been launched to bring people together and provide a platform for people to speak out, be engaged and take action to ensure global commitments are met and viral hepatitis is eliminated by 2030.

MSF has urged Member States to endorse the strategy and to provide resources for its implementation on a large scale.

For more information, watch Leena’s talk at the MSF Scientific Day South Asia meeting in New Delhi in June.

(Source)

Slides are available to download here:
https://f1000research.com/slides/5-1027