Treatment shortening would be welcomed as a primary goal for future TB drug regimens, according to a new study from the Global Alliance for TB Drug Development.
The recently published study, "New TB Regimens: What Countries Want," is one of the TB Alliance's recent initiatives to increase market understanding. The report is an analysis of interviews with 211 key stakeholders in Brazil, China, India, Kenya and South Africa - five countries with high TB burdens - and with 11 global stakeholders. These 222 individuals influence global and country-level decisions to recommend and adopt new TB treatment regimens.
The TB Alliance is committed to developing new, faster-acting drugs to treat tuberculosis, and also to ensuring that these new drugs are widely available and affordable. The TB Alliance has the largest TB drug portfolio in history and is scaling up efforts to map and understand the markets where these new drugs are most needed.
The interviews and resulting report explore, for the first time, a wide range of issues relevant to both the development and use of new TB drug regimens, and offer new insight into how decision makers prioritize various attributes when considering adoption of new TB regimens. The results indicate that stakeholders desire a new regimen based on: oral delivery, dosing consistent with current local practices, availability as fixed-dose combinations (FDCs) in most countries, a high degree of safety, without lasting or serious side effects, or significant interactions with antiretroviral (ARVs) or other essential medicines, and efficacy equal to or greater than the current regimen. Concerns about potential resistance to new TB drugs underscored the need to better understand existing drug resistance and the options for treating multidrug-resistant TB (MDR-TB).
In addition, some general themes emerged from the study:
- A vast majority of interviewees said drugs that shorten treatment duration would be of high value, with a reduction of two months from the current treatment regimen for drug-sensitive disease representing a significant improvement
- Stakeholders said they would be willing to pay more for faster-acting TB drugs because drugs represent a relatively small portion of current TB program costs. In addition, a shorter therapy could help to increase adherence, thus increasing effectiveness and reducing the development of drug-resistant TB, which is considerably more expensive to treat.
- Recommendation of a new regimen by the World Health Organization was seen as necessary but not sufficient to drive adoption in most high-burden countries.
- Stakeholders in four of the five countries studied would require or prefer data from trials in their own countries, suggesting the need to conduct pivotal trials in multiple regions. Data on real-world effectiveness may also be necessary.
- The primary concerns about changing regimens vary widely among countries, suggesting that future efforts will be a mixture of meeting and tempering expectations.
Many of the study's findings have reinforced and helped to refine the TB Alliance's project selection criteria and clinical development strategies. This alignment will be maintained by ongoing dialogue between TB drug developers and local and global stakeholders - those who will ultimately make the decisions regarding adoption of new treatments. The TB Alliance is committed to fostering and learning from such dialogue and has additional studies underway, including an analysis of regimen change in all 22 of the TB high-burden countries. Study results and other ongoing engagement of stakeholders and patients in high-burden countries are expected to further increase the understanding of needs in the field and clarify the pathway from TB drug development to a maximal impact on saving lives.