Delhi/Geneva — Pharmaceutical corporation Gilead Sciences has failed to deliver on promises to make an important drug available to people suffering from a life-threatening HIV-related infection, said Médecins Sans Frontières (MSF).

Nearly one year ago, Gilead announced its ‘access initiative’ promising lower prices for liposomal amphotericin B (L-AmB) in 116 developing countries, but to date, the drug largely remains inaccessible. Gilead has registered the drug in only six of the 116 countries, and even where it is registered, the drug is unavailable at an affordable price, for MSF and others.

L AmB is highly effective when used in combination with other medicines to treat cryptococcal meningitis, which is the second biggest killer of people living with HIV, after tuberculosis. Cryptococcal meningitis is an infection of the brain, which if left untreated, results in an agonising death for people living with HIV.

No registration and priced out of reach

Just over a year ago, the drug was recommended by the World Health Organization (WHO) as the preferred treatment over a suboptimal, more toxic treatment (AmB deoxycholate), as the safety benefits and fewer side effects associated with L-AmB could improve treatment outcomes and management in low-resource settings where most cases of cryptococcal meningitis occur. WHO, however, recognised that high prices and a lack of registration of L-AmB created major barriers to people accessing this drug in developing countries.

Although Gilead publicised their pledge to reduce the price of the drug to a ‘no-profit’ price of US$16.25 per vial in September 2018, L-AmB continues to be priced out of reach in many developing countries. For example, in South Africa, the drug is priced as high as $200 per vial (at least $4,200 per full treatment course). In India, it is priced at $45 per vial (nearly $1,000 per full treatment course).

National programmes and treatment providers are still unable to purchase the drug at the corporation’s promised price. Meanwhile, Gilead continues to earn billions of dollars each year from global HIV drug sales – the corporation reported $14.6 billion in sales from global HIV drugs in 2018 alone.

“We are outraged that Gilead’s announcement to provide this lifesaving drug at a supposed ‘no profit’ price and expedite its registration appears to have been nothing more than a public relations stunt,” said Jessica Burry, MSF Access Campaign Pharmacist. “The corporation has failed to make good on their promise to do more to help ensure the survival of people living with HIV affected by this deadly disease – it’s deplorable that they keep dragging their feet at the expense of people’s lives.”

“Gilead must urgently honour their commitment to make L-AmB available for everyone who needs it, and quickly register the drug in high HIV-burden countries,” Ms Burry said.

Gilead has registered L-AmB in numerous high-income countries, where they can charge higher prices for the drug – including the US, where it has been approved for use for more than 20 years. However, contrary to Gilead’s 2018 announcement that it was working to “expand access to [L-AmB] for cryptococcal meningitis in high-burden countries, including expediting registration,” the drug is currently registered in a mere six of the 116 low- or middle-income countries where it should be able to be procured at Gilead’s ‘no-profit’ price, only two of which are in sub-Saharan Africa.

Monopoly on drug prevents access to those who need it most

Gilead has a monopoly on L-AmB. Although this medicine is no longer under patent, the corporation has refused to license its technology and manufacturing methods to potential generic manufacturers, thereby delaying the availability of less expensive products.

“We are alarmed to see that people living with HIV in India today continue to suffer from cryptococcal meningitis just as they did during the height of the global AIDS epidemic nearly two decades ago, even though effective prevention and treatment for the infection exists,” said Dr Amit Harshana, MSF Medical Coordinator in India. “It’s unacceptable that people are still dying because the tools to prevent, treat and cure cryptococcal meningitis are not available where people who have this infection live.”

“Due to Gilead’s inaction to make this drug widely accessible, we are forced to buy the drug on the private market and will have to continue to do so, at nearly three times the price the corporation announced last year,” Dr Harshana said.

Cryptococcal meningitis kills more than 180,000 people every year, 75 per cent of whom live in sub-Saharan Africa. It especially affects people living with HIV whose immune systems are severely suppressed, leaving them vulnerable to such deadly opportunistic infections. MSF treats the infection in all its HIV programmes, including in the Democratic Republic of Congo, India, Malawi, Myanmar and South Africa.