Geneva — The international medical humanitarian organisation Doctors Without Borders/Médecins Sans Frontières (MSF) today welcomed the new World Health Organization (WHO) recommendations for improved treatment for people with drug-resistant tuberculosis (DR-TB), prioritising the use of several oral drugs, including the newer drug bedaquiline, and minimising the use of drugs that must be injected.
The newly recommended 18- to 20-month treatment regimen can help improve cure rates, decrease mortality and have far fewer side effects. For these recommendations to be put in place and for many more people with DR-TB to receive treatment, MSF today called on the US pharmaceutical corporation Johnson and Johnson (J&J), which produces bedaquiline, to take immediate steps to make the drug affordable for all who need it, in particular in low- and middle-income and high DR-TB burden countries.
Today, only 20% of people with DR-TB globally receive the treatment they need. People on standard DR-TB treatment currently have to endure an agonizing regimen of medicines for up to two years, involving as many as 20 pills per day, which can cause side effects as severe as psychosis, along with painful daily injections for up to eight months that can lead to hearing loss and deafness. The current standard DR-TB therapy typically only achieves cure rates of around 55%. In the past six years, two new drugs have been approved for DR-TB, but their uptake to improve TB treatment has been lagging.
“It’s well beyond overdue for people living with TB to have a better chance of getting cured of this killer disease with more effective treatments that are easier for them to tolerate,” said Dr Mercedes Tatay, MSF’s International Medical Secretary, currently in MSF’s DR-TB project in Mumbai, India. “Governments and treatment providers should not waste another minute and should urgently make sure people can access optimal treatments including bedaquiline, and this means Johnson & Johnson needs to lower the price of the drug and ensure it is available for every person who needs it.”
J&J recently announced a price reduction for bedaquiline in some countries, but it falls short in terms of making the drug affordable in countries that are hardest hit by DR-TB. The reduced price of US$400 for six months of treatment that certain countries are promised, remains excessive. Bedaquiline is just one drug in an otherwise costly regimen of multiple drugs, and effective treatment very often require more than six months of bedaquiline. In countries excluded from J&J’s price reduction, the corporation currently charges between $3,000 and $30,000 for six months of treatment.
In order to facilitate treatment scale-up, MSF has been calling for a full DR-TB treatment regimen to be priced no higher than $500. MSF supports the call from HIV and TB activists asking J&J to cut the price of bedaquiline to $32 per month — or $192 for six months — across all low- and middle-income and high DR-TB burden countries.
To ensure the long-term affordability and sustainable supply of bedaquiline — which is patented quite widely until 2023 — MSF called on J&J to also issue a license to the Medicines Patent Pool, which would enable access to affordable generic versions of the drug. High TB burden countries wishing to scale up TB treatment to more people, like India (which is also a major supplier of TB drugs globally), should also consider issuing a ‘government use’ license for bedaquiline to encourage price-lowering competition among generic producers, before the patent expires.
MSF additionally urged J&J and its Russian partner Pharmstandard — responsible for supply in Eastern Europe and Central Asia — to work swiftly to register the drug, particularly in the 10 of 30 high DR TB burden countries where it remains unregistered.
Global leaders gathering at the world’s first United Nations TB Summit in New York in September are expected to prioritise accessibility and affordability of all TB drugs needed to provide optimal treatment regimens to people.
“We are finally seeing the long-awaited and desperately needed political momentum required to curb this global health emergency that affects the most vulnerable everywhere,” said Els Torreele, Executive Director of MSF’s Access Campaign. “We have better tools to diagnose and treat this epidemic now. It’s high time for governments to rise to the challenge and close the deadly diagnostic and treatment gaps and put an end to the high number of senseless deaths caused by this ancient disease.”
MSF has been involved in TB care for 30 years, often working alongside national health authorities to treat patients in a wide variety of settings, including chronic conflict zones, urban slums, prisons, refugee camps and rural areas.
Recent interim findings from MSF and partners’ endTB* observational study of 1,200 DR-TB patients on treatment, revealed that newer oral drugs, bedaquiline and delamanid, appear safer than commonly-used drugs that must be injected. Read here for detailed study findings: http://www.endtb.org/resources/endtb-interim-analysis-july2018
* EndTB Consortium (Expand New Drug Markets for TB, endTB.org) is a research partnership, funded by UNITAID, treating MDR tuberculosis and conducting operational research into the safety and efficacy of bedaquiline and delamanid in 17 low-resource countries (Armenia, Bangladesh, Belarus, North Korea, Ethiopia, Georgia, Haiti, Indonesia, Kazakhstan, Kyrgyzstan, Kenya, Lesotho, Myanmar, Pakistan, Peru, Vietnam and South Africa).