The design and adoption of new tuberculosis (TB) regimens requires a
close understanding of the opinions of those who approve, prescribe and
receive TB treatments: what they like and dislike about current regimens
and what they would value, tolerate or reject with regard to a new,
shorter regimen. To assess these opinions regarding first-line regimens
for drug-susceptible TB, interviews were conducted with 211 stakeholders
in Brazil, China, India, Kenya and South Africa - five countries with
high TB burdens - and with 11 global stakeholders.
Based on these interviews, efficacy, safety and side effects of current
regimens were generally judged to be acceptable. A treatment frequency
of five to seven days a week was common for current regimens and
preferred for new regimens, with some exceptions in China and India.
Avoiding interaction with antiretroviral drugs (ARVs) was a significant
priority for African and global stakeholders, as was the availability of
fixed-dose combinations (FDCs) in all but China and the Indian public
Two international Phase III trials are currently testing whether the
substitution of a fluoroquinolone into first-line TB regimens will allow
these treatments to be shortened to four months. In the current study,
with the exception of some stakeholders in China, the potential for a
shorter (four- or two-month) regimen was positively received. Many
stakeholders noted that a shorter regimen would increase the likelihood
of adherence and listed several acceptable trade-offs, including
increased drug costs. Shorter regimens including moxifloxacin would be
welcomed for the same reasons, although there are concerns about whether
primary fluoroquinolone resistance already exists and whether
fluoroquinolone use for first-line treatment would lead to the loss of
the fluoroquinolones as a viable option for second-line treatment.
Before adopting a new regimen to replace an existing one, stakeholders
said they would require or prefer data including results from trials in
their own countries (for Brazil, China, India and South Africa), cost
and real-world effectiveness data, and efficacy data for various
subgroups, including patients co-infected with HIV and TB.
The findings of this study are consistent with the target product
profile used by the TB Alliance and with the organization's clinical
trials strategy as currently implemented. Stakeholder feedback can guide
the development of new TB drugs, but the diversity of opinions
underlines the challenges ahead and the need for continued exchange of
data and information.
TB Alliance, New York, USA, 20 pp.
New TB regimens: What Countries Want. The Value Proposition of Existing and New First-Line Regimens for Drug-Susceptible Tuberculosis.