A drug that has been recommended by the WHO to treat cryptococcal meningitis has become inaccessible for patients suffering from the disease. Cryptococcal meningitis is an infection of the brain, which if left untreated, results in death for people living with HIV.
According to Medecins Sans Frontières (MSF), about a year ago, the United State pharmaceutical company Gilead Sciences had announced its “access initiative” under which it had promised lower prices for liposomal amphotericin B (L-AmB) in 116 developing countries, including India.
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.
About a year ago, this drug was recommended by the WHO as the preferred treatment for the disease, as opposed to a “suboptimal, more toxic treatment (AmB deoxycholate)”, keeping in mind the safety benefits and fewer side effects, MSF said in a statement. Use of this drug could improve treatment outcomes and management in low-resource settings where most cases of cryptococcal meningitis occur.
“The WHO, however, recognised that the high prices and a lack of registration of L-AmB created major barriers to people accessing this drug in developing countries,” MSF said in the statement. Although Gilead publicised their pledge to reduce the price of the drug to a ‘no-profit’ price of $16.25 per vial in September 2018, L-AmB continues to be priced out of reach in many developing countries. In South Africa, for instance, the drug is priced at $200 per vial (at least $4,200 per full treatment course).
In India, the drug, an anti-fungal is already available in the private market, and used to treat drug resistant fungal infections. “The cost of the drug, when purchased from the private market for the HIV patients, comes to $45 per vial, nearly $1,000 for the full treatment course. From a public health program perspective, that is a very high cost,” said Leena Menghaney, head, south asia, MSF.
In countries such as India, the pharmaceutical company was already providing the same drug for kala azar treatment at a lower cost, and they ought to do it for cryptococcal meningitis as well, she said.
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 (kala azar) and cryptococcal meningitis in people living with HIV.
Menghaney said that Gilead has a monopoly on the drug, and though the medicine was no longer under patent, the corporation had 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.”
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, MSF spokespersons said. 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.
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.
