Newer medicines for drug-resistant TB are desperately needed, but barriers to access, including high prices, keep them out of reach for most people around the world.
Hyderabad, 30 October 2019 – Médecins Sans Frontières (MSF) joined TB activists to disrupt the opening ceremony of the 50th Union World Conference on Lung Health (The Union Conference) in Hyderabad, India today, urging pharmaceutical corporations to make improved drug-resistant TB (DR-TB) treatment affordable and available for hundreds of thousands of people around the world who desperately need it. For the first time in over half a century, there are three new DR-TB drugs – bedaquiline, delamanid and, most recently, pretomanid – that can offer people a better chance to be cured, but barriers to access including high prices are preventing their scale-up by countries. Only 20% of people with DR-TB who need these newer drugs have been able to receive them.
According to the latest World Health Organization (WHO) Global TB Report, in 2018, an estimated half million people fell ill with DR-TB, yet only one in three started treatment. DR-TB cure rates remain unacceptably low: only 56% and 39% of people treated for multidrug-resistant tuberculosis (MDR-TB) and extensively drug-resistant TB (XDR-TB) were successfully cured, respectively.
“Bedaquiline, delamanid and pretomanid have shown the potential to cure more people of DR-TB with far fewer side effects than older toxic treatments that need to be injected and are still used in most countries,” said Sharonann Lynch, HIV & TB Policy Advisor for MSF’s Access Campaign. “It’s inexcusable that drug corporations continue to put profits over people’s lives, as if medicines were a luxury. It’s time to smash the status quo: all three newer TB drugs must be affordable to everyone who needs them so more lives can be saved.”
In July 2019, WHO Director-General Dr Tedros Adhanom Ghebreyesus called for countries to transition to all-oral regimens to treat DR-TB by World TB Day, 24 March 2020.
High prices and corporations’ unwillingness to license their drugs so generics can be produced are standing in the way of improved DR-TB treatment outcomes with these new drugs. Currently, the price of DR-TB regimens ranges from US$1,040 to $11,680, depending on the treatment length and combination of drugs needed. In order for more lives to be saved, MSF demands the following:
Getting to an affordable price for these new drugs is critical since treating DR-TB requires a combination of four or more medicines. MSF has called for treatment of DR-TB to be no higher than $500 per person for a complete regimen. As long as the new drugs are priced out of reach, this target will not be a reality.
“When I was on the standard DR-TB treatment that included drugs that needed to be injected, I suffered intense side-effects, including damage to my kidneys and some hearing loss,” said Nolduwe Mabandlela, who was diagnosed with MDR-TB in Khayelitsha, South Africa in 2017 and cured in 2019. “When MSF switched me from the old toxic treatment to a regimen that included the newer drugs bedaquiline and delamanid, which don’t have the same kind of harsh side-effects, my health improved much faster.”
“We’re protesting today because people with TB are tired of waiting for access to the newer and better drugs. It’s time for J&J, Otsuka, Mylan and TB Alliance to take action to allow people everywhere to access the medicines they need to stay alive,” said Lynch.
* Price estimates assume that at least 108,000 treatment courses are sold per year.
** Price includes charges for shipping, handling and insurance (15% approx.) but excludes Value Added Tax (VAT) (15%).
For more information about bedaquiline, delamanid and pretomanid:
DR-TB Drugs Under the Microscope, 6th Edition
Making the Switch
TB is an ancient disease and is the number one infectious disease killer worldwide, with 95% of deaths in developing countries. The TB epidemic is exacerbated by the rise of drug-resistant TB (DR-TB), which in 2014 was declared by the World Health Organization (WHO) as a global health emergency. An estimated half million people developed DR-TB in 2018. Highly resistant forms of the disease are particularly hard to treat: in 2018 only 39% of people with XDR-TB were successfully treated.
Currently, WHO recommends 18-20 months of treatment for DR-TB with four-drug regimens that combine bedaquiline and linezolid with older and repurposed TB drugs. Unfortunately, despite updated WHO recommendations, many countries have not implemented these new recommendations, and patients continue to receive old and toxic regimens, containing injectable agents that lead to severe side effects. BPaL (bedaquiline + pretomanid + high-dose linezolid), a shorter and simpler regimen, could therefore substantially improve the treatment of XDR-TB.
MSF and TB:
MSF is the largest non-governmental provider of TB treatment worldwide and has been involved in TB care for 30 years, often working alongside national health authorities to treat people in a wide variety of settings, including chronic conflict zones, urban slums, prisons, refugee camps, and rural areas. As of September 2019, across MSF projects in 14 countries, more than 2,000 people have been treated with the newer drugs, including 874 with delamanid, 1,946 with bedaquiline, and a subset of 429 people who were treated with a combination of both medicines.
MSF and BPaL:
In addition to providing DR-TB treatment in various settings, MSF is conducting research together with partner organisations to develop the evidence base for the therapeutic value of newer DR-TB treatments. In 2017, MSF launched the TB PRACTECAL trial (ClinicalTrials.gov Identifier: NCT02589782), a randomised, controlled, multicentre, Phase II/III adaptive trial to evaluate the safety and efficacy of six-month regimens that contain bedaquiline, pretomanid and linezolid (standard dose) with or without moxifloxacin or clofazimine, for the treatment of adolescents and adults with multidrug-resistant (MDR)-TB or XDR-TB. This trial should help inform which combinations of bedaquiline, linezolid and pretomanid-based regimens are effective and safe for the treatment of MDR-TB. The trial is sponsored by MSF and is being conducted in seven sites in Belarus, South Africa and Uzbekistan. Outcomes from this trial are expected in early 2022.
Source: Médecins Sans Frontières