Fewer than 5 Percent of People in Need are Treated with New TB Drugs, Nearly Four Years After Becoming Available

Only 4,800 people with drug-resistant tuberculosis (DR-TB) in 2016 were treated with the two newest and much more effective medicines, even though these have now been on the market for about four years, Doctors Without Borders/M�decins Sans Fronti�res (MSF) said.

Apart from patients enrolled in a small number of clinical trials and compassionate use programs, only 469 people received delamanid in 2016, while just over 4,300 received bedaquiline, meaning fewer than five percent of people who need these drugs have received them. Pharmaceutical corporations and governments must expand access to bedaquiline and delamanind to save the lives of people living with DR-TB.

Tuberculosis is one of the world's biggest infectious disease killers, with 1.8 million people dying each year. In 2015, the World Health Organization estimated that more than half a million people were infected with DR-TB, with just one quarter of those being diagnosed and receiving treatment. People with DR-TB who don't have access to the two new drugs continue to be treated with older, more toxic regimens that cure only 50 percent of people treated and cause severe side effects ranging from severe nausea to deafness to psychosis.

"It's downright disheartening that, with hundreds of thousands of people living with deadly drug-resistant tuberculosis, only 4,800 people last year received the two new drugs that could dramatically increase the number of lives saved," said Dr. Isaac Chikwanha, TB advisor for MSF's Access Campaign.

Delamanid and bedaquiline -- produced by pharmaceutical corporations Janssen/ Johnson & Johnson and Otsuka, respectively -- were brought to market in the past four years and have the power to dramatically improve treatment for DR-TB. The current standard treatment for DR-TB involves people taking nearly 15,000 pills over two years, which often have severe and debilitating side effects and only cure half the people who are treated.

"When we have access to the new drugs like bedaquiline and delamanid, we give people a real chance at surviving this deadly disease," said Dr. Jennifer Hughes, MSF TB doctor in Khayelitsha, South Africa. "For the 18 patients in our project we've initiated on a combination of bedaquiline and delamanid, nearly 90 percent had a negative culture following six months of treatment, which is an early sign that the treatment will ultimately be successful."

"Efforts to increase access to bedaquiline and delamanid have moved at a glacial pace -- only 1 percent of those who could benefit from delamanid are receiving it in South Africa today, mostly in the small confines of one site," Dr. Hughes added. "How much longer will people elsewhere have to wait?"

While bedaquiline and delamanid have been approved by WHO to be added to treatment regimens for people with severe forms of DR-TB, MSF and others have fought to gain access to these new drugs. Access to bedaquiline and delamanidis is currently limited for several reasons, including the fact that the corporations have not registered the drugs in many high-burden TB countries.

"Our first major problem is that pharmaceutical corporations are not even registering important new drugs in some of the countries hardest hit by TB; The next major problem is their high price," said Dr. Chikwanha. "Both Janssen and Otsuka-but especially Otsuka, for delamanid -- must urgently speed up registration of their drugs in high-TB-burden countries, and price these drugs affordably."

Countries also need to facilitate greater access to the new drugs by allowing them to be imported before their registration is complete.

"Governments must do everything they can to help save their people's lives," Dr. Chikwanha continued. "Countries have a responsibility to treat DR-TB with the recommended tools at their disposal, including bedaquiline and delamanid, especially people who have run out of treatment options."