ACTG A5409 (RAD-TB): Study protocol for a phase 2 randomized, adaptive, dose-ranging, open-label trial of novel regimens for the treatment of pulmonary tuberculosis

In the first fifteen years following BPaL’s approval, more than 2 million people treated for drug-resistant TB will be treated with BPaL/M. This means millions of people will benefit from improved treatment outcomes and experiences.

When TB doesn’t kill, it often leaves people with long periods of disability. By curing drug-resistant TB faster and more effectively, BPaL/M helps people not only survive, but recover faster, and avoid long term disabilities. That means fewer years lost to illness and more people living fully again, faster. In its first 15 years of approval, BPaL/M will result in people experiencing more than 5 million more healthy years of life.

BPaL/M has higher treatment success rates than previous therapies and use of these regimens is rapidly scaling up globally. In its first 15 years of approval, BPaL/M will save an additional 190,000 lives by replacing older treatments with lower success rates.

BPaL/M drastically reduces the cost of fighting drug-resistant TB for individuals, families, and governments. Hospital visits are fewer, and medicines are more affordable. As a result, in the first 15 years of approval, BPaL/M will save health systems nearly $1.3B globally. Shorter treatments also mean reduced out of pocket costs and time out of work for people receiving treatment.

The BPaL/M treatment costs less than $2 per day, however the vast majority of cost savings from implementing these new regimens is achieved through shorter and simpler treatment, reducing human and financial burden on health systems. This allows for the expansion of DR-TB care where costs and human resources have previously limited health systems’ capacities to treat DR-TB.

Traditionally, many people receiving treatment for drug-resistant TB did not complete therapy. This was often due to the length and side effects of treatments. Those who don’t complete treatment may remain contagious and infect others, as well as suffer increased disability or death. In its first 15 years of approval, BPaL/M will lead to nearly 180,000 additional people completing treatment.

People who do not complete treatment and/or follow-up are not considered to have successful treatment outcomes. Thus, additional treatment successes are about more than just “lives saved.” In its first 15 years of approval, BPaL/M will lead to more than 330,000 additional people with drug-resistant TB being successfully treated.