Ukraine’s Experience:Implementing the BPaL Regimen
TB Alliance is the world’s leading developer of new TB drugs and is the first non-profit organization to develop a new TB drug. TB Alliance’s pretomanid and the BPaL (bee-pal) regimen is a therapy for people with drug-resistant tuberculosis (DR-TB), consisting of bedaquiline (B), pretomanid (Pa), and linezolid (L).
Pictured: A participant of Ukraine’s BPaL operational research program in Kyiv after the start of the war.
Photo credit: Brendan Hoffman / Getty Images for TB AllianceBPaL Enables Cure Amid Crisis
Ukraine was the first high-burden country to adopt the BPaL regimen. A shortened, simplified treatment for DR-TB has been an especially welcome advance for patients who needed treatment amid wartime conditions. As the war began, Ukrainian patients were given the remainder of their full treatment course so the remaining duration of their treatment could be completed remotely. According to preliminary data from Ukraine’s National TB Institute, 47 of 50 such patients successfully completed treatment. Overall, more than 90% of Ukrainian patients who completed DR-TB with BPaL 6+ months ago remain TB-free. These outcomes would have been extraordinarily difficult using the longer, more toxic, and less effective treatments that were in place prior to BPaL. Ukraine’s National TB Program is now moving quickly to scale up access to BPaL on a nationwide basis.
Despite the ongoing war with Russia, patients on BPaL in Ukraine have been able to continue their treatment even when TB hospitals were under assault.
“Nataliia Lytvynenko, who has overseen BPaL treatments in Ukraine, said the more manageable amount of pills meant it was easier for patients to continue treatment after being displaced by the war in her country.”
  (31 August 2022)
Photo credit: Brendan Hoffman / Getty Images for TB AlliancePhoto credit: Dennis Matsko“At the time the Russian invasion of Ukraine began, 50 patients were receiving BPaL. Some were forced to flee their homes but could continue their treatment as they were able to carry the drugs—a small set of pills—with them and did not need to access healthcare facilities for injections or supervision.”
About Drug-Resistant TB
TB is one of the world’s oldest and deadliest poverty-related neglected diseases. TB is now killing more than twice as many people every day as COVID-19 – 1.6 million per year. Though present in every country in the world, TB preys disproportionately on the poorest of the poor. TB is also a significant driver of the increasing threat of antimicrobial resistance (AMR)—there are roughly half a million cases of DR-TB each year, and is responsible for about 1 in 3 deaths from AMR infections.
About the BPaL Regimen
BPaL was first studied in TB Alliance’s Nix-TB trial, which enrolled people with highly drug-resistant TB. Nix-TB data have demonstrated a favorable outcome in 90 percent of patients after six months of treatment with BPaL and six months of post-treatment follow-up. Pretomanid has been clinically studied in more than 1,100 participants in 19 clinical trials evaluating the drug’s safety and efficacy. Pretomanid has been clinically studied in 14 countries.
Prior to the introduction of BPaL, treatment of highly DR-TB was lengthy, intolerable, and complex. Most patients with highly drug resistant- TB took a combination of up to eight antibiotics, some involving daily injections, for 18 months or longer. Success rates were lower than 6 in 10.
“[Ukraine’s BPaL implementation team] has been offering patients with drug-resistant TB a shorter treatment regime that also involves taking fewer pills every day. And rather than asking patients to show up at a clinic to collect their medication, the doctors pop it in the post. Patients are then checked on through messaging apps such as Viber, Whatsapp and Telegram. It proves that TB treatment can innovate to fit the needs of patients in new circumstances.”
Mariia’s Story of #TBCourage
Mariia had gotten sick while she worked at a factory making doors. By the time she went to the doctor, she found out that she had been infected with drug-resistant TB for over a year. She began her treatment journey in Lviv, Ukraine, but her doctors recommended she go to Kyiv to join a research program that would give her access to “a better treatment.” Mariia then went to Kyiv where she was enrolled in an operational research program to help expand access to BPaL in the country. “I am happy because I got better fast,” Mariia said of her experience on BPaL. “I do not have weakness anymore.”