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European Pharmaceutical Contractor

The Path to Prevention

If you have read, watched or listened to the UK’s news in recent weeks, you may believe that the Ebola crisis in West Africa is at an end; the Nepalese disaster and General Election have driven the disease off the front page.

It is certainly true that the number of Ebola cases has plateaued, but the WHO warns that much is still to be done to finally contain the outbreak, and for authorities to be able to declare the epidemic over; the encouraging reduction in infection in Liberia is yet to be replicated in Gambia and Sierra Leone, where new cases are reported regularly. In all, over 26,000 people have carried the disease, with an excess of 10,000 deaths in the year since the initial outbreak.

Among numerous therapies proposed, experts convened by the WHO have identified antivirals as potential treatments for the virus. While they have not been tested specifically for Ebola, some of these medicines – in particular, brincidofovir and favipiravir – show promise, and clinical trials of these products will begin shortly in West Africa.

When tested in Phase 1 studies in the US and UK in 2014, an investigational Ebola vaccine – by GlaxoSmithKline (GSK) and the National Institute of Allergy and Infectious Diseases – proved to be safe and induced an immune response. This candidate is now being tested as part of the Partnership for Research on Ebola Vaccines in Liberia (PREVAIL) in a Phase 2/3 trial. In late March 2015, initial results from the Phase 2 portion of the PREVAIL study, involving more than 600 volunteers, indicated that the vaccine is safe. A consortium of partners have plans under way to begin Phase 3 testing, via blood transfusion services within the affected countries.

There is more good news from GSK: the world’s first malaria vaccine could be approved by international regulators for use in Africa from October, after final trial results showed it offered partial protection for up to four years. Designed for children, RTS,S would be the first licensed human vaccine against a parasitic disease and could help prevent millions of cases of malaria, which currently kills more than 600,000 people a year. Although the candidate has been under development for some 30 years, GSK does not expect to sell the product at a profit, and is thus willing to have no return on its lengthy investment. The same philosophy is likely to pertain to any Ebola treatment.

Bill Gates has expressed the view that an HIV vaccine (and cure) will become a reality within 15 years. In the past year, Uganda has achieved some progress and reduced new infections by 13% to 140,000, compared to 160,000 in 2011. But new HIV cases still remain unacceptably high: over 380 Ugandans are infected daily. Despite the signs of progress in both prevention and treatment, the AIDS Treatment Action Group believes that existing hurdles – such as funding and regulatory pathways – cannot be underestimated. The world is spending billions of dollars on HIV/ AIDS support and research – the US alone spent over $20 billion in 2014. Unfortunately, expenditure this great to treat and prevent such an intractable disease is beyond the altruism of the pharma industry.

Certainly, it is sad to say that medicinal breakthroughs can sometimes have the opposite of their desired effect; the success of antiviral therapy has led to a certain blasé attitude and, thus, increased levels of infection. Maybe the key to prevention in all countries is a focus on education, rather than cure.

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