Gilead Sciences fails on promise to expand access to lifesaving drug for people living with HIV

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, the medical humanitarian organisation Doctors Without Borders (MSF) said today. Nearly one year ago, Gilead announced its 'access initiative' promising lower 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. 

MSF, Doctors Without Borders, Access to HIV medicines
An MSF nurse performs a Cryptococcal Antigen (CrAg) screening test to test for Cryptococcal Meningitis in an AIDS patient. Photo: Albert Masias/MSF

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.

Just over a year ago, the drug was recommended by the World Health Organization (WHO) as the preferred treatment over a sub-optimal, 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.

MSF, Doctors Without Borders, Access to HIV medicines
An MSF laboratory technician Gentil Lusamba, examines centrifuged blood samples of HIV patients at the Kabinda Hospital in Kinshasa, Democratic Republic of Congo

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.”

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 "expand access to [L-AmB] for cryptococcal meningitis in high burden countries, including expanding registration," the drug only is currently in a mere six of the 116  low- or middle-income countries where it should be able to be produced at Gilead's 'non-profit' price, only two of which are in sub-Saharan Africa. 

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Vials of Amphotericin B which is used to treat Cryptococcal Meningitis. Photographer: Albert Masais

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.”

Cryptococcal meningitis kills more than 180,000 people every year, 75% 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.

In MSF-run and MSF-supported hospitals providing specialised care for people living with HIV in many countries including in the Democratic Republic of Congo, Guinea, India, Kenya, Malawi and Mozambique, cryptococcal meningitis is the second biggest AIDS-related killer, after tuberculosis (TB).

In Bihar, India, MSF, together with state authorities, is providing comprehensive inpatient hospital care to reduce the number of deaths for people living with advanced HIV, including by diagnosing and treating life-threatening infections such as TB and cryptococcal meningitis. 

Liposomal drugs:

Liposomes are the first nano drug delivery systems, and a number of liposome-based drugs are now available, including for cancer and fungal infections. The drug liposomal amphotericin B (L-AmB) is indicated for the treatment of some serious, life-threatening infections including leishmaniasis and cryptococcal meningitis in people living with HIV.

Cryptococcal meningitis:

Cryptococcal meningitis is a severe fungal infection of the brain and surrounding membranes that causes about 15% of AIDS-related deaths worldwide, three quarters of which occur in sub-Saharan Africa. Despite major progress over the last decade in expanding access to antiretroviral therapy and reducing HIV-related deaths, up to half of people living with HIV present to care with advanced forms of the disease, and many continue to die from HIV-related opportunistic infections such as cryptococcal meningitis.