Philippine participates in new TB drug tests

HYDERABAD, India ­– The Philippines is one of 12 countries that will be participating in the Phase-3 clinical trial of a new drug that will prevent the spread of multi-drug resistant tuberculosis (MDR-TB) within a household, an official of the United States government’s National Institute of Health (NIH) announced here the other day.

According to Peter Kim, director of the Division of AIDS Therapeutic Research Program, National Institute of Allergy and Infectious Diseases at NIH, they have invested $70 million for the trial to assess treatments for preventing “household contacts” of people infected with MDR-TB using “Delamanid” drugs developed by Japanese Otzuka Pharmaceuticals.   

“We are here to announce a new Phase 3 global trial will be rolled out in 12 countries. It will look at how we can prevent MDR-TB among those who have been exposed to MDR-TB cases,” he said at a press conference in line with the 50th Union World Conference on Lung Health being held here.

Called PHOENIx MDR-TB or Protecting Households on Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients, the trial will enroll 5,610 participants, including 2,158 adults aged 18 years old and older, who are being treated for confirmed active MDR-TB, and 3,452 members of their households.

The study will take place in more than 27 sites in the Philippines, Botswana, Brazil, Haiti, India, Kenya, Peru, South Africa, Tanzania, Thailand, Uganda and Zimbabwe. The trial has started in some countries while it will commence very soon in others. 

MDR-TB is a condition wherein a TB patient develops resistance to the first-line for not completing the six-month treatment recommended by the World Health Organization (WHO). Treating MDR-TB cases is more complicated. 

In the Philippines, the treatment cost for TB was pegged at around P6,000 for six months. In 2017, the cost for treating MDR-TB could reach P250,000 for 18 months.

Kim noted the Philippines was included in the program because “there is an issue on MDR-TB” in the country.  

Aside from this, it has “really good research infrastructure that is already there so we can go in and do the trial without having to overly invest in developing a new couple of research site.”

“We need to have a trial that is globally represented so Philippines, being a major area of TB in Asia, is important to be represented,” he added.

Data from the WHO show the Philippines is one of the 22 countries high-burdened for TB. Worldwide, the agency estimates that 460,000 people have developed MDR-TB in 2017.

The Department of Health believes that the country’s cases of TB are under-reported. It has embarked on a program to “find and treat” some 2.5 million “missing cases” by 2022.

Kim said the trial is a collaboration between the US government and Otzuka to test whether Delamanid will be effective in preventing MDR-TB among household contacts.

“Though we have significant advancement, as you can see in the prevention of TB, one critical gap that still remains is how do we prevent MDR-TB to those who have been exposed … Rifampicin does not treat MDR-TB that is resistant to Rifampicin,” he claimed, referring to one of the drugs being used to treat TB.