Ukraine to receive innovative anti-tuberculosis drug bedaquiline through USAID program


Ukraine will receive a new anti-tuberculosis drug bedaquiline to treat the most critical cases of drug resistant tuberculosis (TB) within the USAID project “Challenge TB”, providing free supply of drugs to countries with the highest drug-resistant TB rates, announced project partners and representatives of the Ministry of Health during a press-briefing at Ukraine Crisis Media Center. The project is implemented by the international organization РАТН in partnership with the Yanovksy National Institute of Phthisiology and Pulmonology. “According to our plan, the medicines will be shipped in early April this year, we have almost finalized this process,” noted Kateryna Hamazina, head of PATH Office in Ukraine.

At present bedaquiline is considered to be the most efficient drug to treat drug-resistant TB. It has been developed during the last 40 years. “This new medicine brings hope for healing to the patients with multi-drug resistant TB. The research has shown that bedaquiline make it possible to overcome tuberculosis in six month only, instead of 20,” noted George Kent, Deputy Chief of US Mission in Kyiv. As of the end of 2016, bedaquiline was used in already 70 countries. One course of treatment costs nearly USD 2 thousand.

“On behalf of the Ministry of Health and all our patients I would like to thank our partners, the international organizations which provided this medicine. This is a real hope for 1,500 Ukrainian patients with drug-resistant TB,” noted Oksana Syvak, Deputy Minister of Health of Ukraine on European integration issues. According to WHO data, each fourth Ukrainian with tuberculosis has drug-resistant TB.

200 critically ill patients to be treated within a pilot project

The first patients to be treated with the use of bedaquiline are 200 patients with critical forms of multidrug-resistant TB. They will undergo treatment in the hospital of the Institute of Phthisiology and Pulmonology. Treatment guidelines have been developed by USAID professionals according to the international recommendations of the WHO. Bedaquiline is always used together with 5-7 other drugs. “Critically ill patients need 20-month treatment, but bedaquiline is used only during the first six month. It is accumulated in the organism, so the therapeutic effect is long-lasting. During these six moth these patients will be treated in the hospital, later they can continue treatment in the regions where they live,” said Kateryna Hamazina. “In fact, outpatient care is a better option, but in the given situation we have to consider such factors as critically ill patients and the fact that the drug is used for the first time in Ukraine. It is very important to ensure that patients are treated in the necessary conditions and regularly examined by doctors, that they do not interrupt treatment. Otherwise they risk to develop resistance to this drug,” she explained.

Bedaquiline to be included into the National anti-TB Action Plan and protocols

According to Natalia Nizova, general director of Public Health Center at the Ministry of Health, now the key tasks are to make the procedure of drug registration quicker and to update the national protocols. The National anti-TB Action Plan already prescribes larger use of this medicine. In addition, the Ministry of Health negotiates with drug producing company to put Ukraine on the list of the countries which have preferences for procurement of this drug. “We believe that we have a real chance to ensure this treatment for all patients with multidrug-resistant TB within the next National anti-TB Action Plan for 2017 – 2021,” she stated.

Situation in Ukraine and Europe: statistics and tendencies
In 2016, TB rates in Ukraine decreased by 2,2 per cent, to 54,7 persons per 100 thousand, except for the occupied territories of Donbas and Crimea. However, despite overall decrease, the rates went up in 13 regions. In total, 23 thousand new cases were registered, including 779 cases among children and teenagers. The rates of death from all types of TB decreased by 13,9 per cent. Nowadays the main challenges are to ensure efficient care without interruptions and to reveal the disease as early as possible. “According to our data, the number of unregistered people with TB who do not know that they are ill is almost equal to the number of registered patients with TB,” says Vasyl Melnyk, deputy director of Yanovsky Institute of Phthisiology and Pulmonology.

Globally, TB remains in the top-10 causes of death. Nearly 10 million people got TB over the last year, two million died. In the European region tendencies are rather positive as the TB rate decreases by 4,3 per year, which is the fastest decline among all regions. However, drug-resistant TB remains a major challenge, only 51 per cent of patients get cured, says Doctor Masoud Dara, Coordinator for Contagious Diseases, Program Manager for TB, HIV/AIDS & Hepatitis of the WHO Regional Office for Europe. “Among the countries of former Soviet Union there are countries, for example, Latvia and Estonia, which managed to decrease their TB rate not only in absolute numbers, but also in terms of rates. So hard work pays off, but that needs a lot of work, sustainable financing, people-centered care and access to quality care,” he emphasized.