March 2019 digital v1

TREATMENT
SUCCESS RATE
83%
54%
30%
TB MDR-TB XDR-TB
SOURCE: WHO
WHO REMOVES INJECTABLE DRUGS
FROM MDR REGIMENS
The WHO has revamped the treatment
guidelines for MDR and rifampicinresistant
(RR-TB) even as multi-drug
resistance poses a threat to the End TB
Strategy.
The guidance, based on a review of
the recent evidence on priority questions
in MDR/RR-TB treatment, was formulated
by the Guideline Development Group
(GDG).
“The new WHO recommendations,
based on the most recent available
evidence, signal an important departure
from previous approaches to treat
MDR/RR-TB. Injectable agents are no
longer among the priority medicines
when designing longer MDR-TB
regimens. Fully oral regimens should thus
become the preferred option for most
patients,” stated Dr Tereza
Kasaeva, Director of WHO’s Global TB
Programme.
The evidence included the recently
completed phase 3 trials of delamanid
(Otsuka’s Trial 213) and the standardised
9-12-month shorter MDR-TB regimen
(STREAM Stage 1), as well as individual
data for 13,100 patients treated with
longer MDR-TB regimens in 40 countries
and over 2,600 patients treated with
the shorter MDR-TB regimen from 15
countries. Additional trial data from
patients under 18 years of age allowed
a review of recommendations for the
use of bedaquiline and delamanid in
children.
Fluoroquinolones (levofloxacin or
moxifloxacin), bedaquiline and linezolid
are strongly recommended for use in
longer regimens, which are completed
with other medicines ranked by their
relative balance of effectiveness to
potential toxicity.
The shorter MDR-TB regimen may be
offered to eligible patients who agree to
a briefer treatment. Shorter regimens for
MDR may, however, be less effective than
an individualized longer regimen and
that requires a daily injectable agent for
at least four months. Regimens that vary
substantially from the recommended
composition and duration like the
FLUOROQUINOLONES
(LEVOFLOXACIN OR
MOXIFLOXACIN), BEDAQUILINE
AND LINEZOLID ARE
STRONGLY RECOMMENDED
FOR USE IN LONGER
REGIMENS
standardized 9-12-month shorter MDR-
TB regimen in which the injectable
agent is replaced by bedaquiline can
be explored under operational research
conditions.
The recommendations apply
generally to children and adults, to
people living with HIV (PLHIV) and to
MDR/RR-TB patients who have additional
resistance to fluoroquinolones or other
agents.
Bedaquiline may now be given to
children aged 6 years and more and
delamanid from 3 years of age.
Supportive measures to improve
diagnostics and other programmatic
components will be critical. Ahead
of enrolment on MDR-TB treatment,
all patients should be appropriately
counselled to enable participatory
decision-making. Patient-centred support
for medication adherence and active TB
drug safety monitoring and management
(aDSM) are essential for anyone starting
an MDR-TB regimen.
March 2019 / FUTURE MEDICINE / 27