A recent study published in the Lancet shows inferiority of
moxidectin and albendazole to ivermectin and albendazole against T trichiura.
Control efforts against soil-transmitted helminths focus on
preventive chemotherapy with albendazole and mebendazole, however these drugs
yield unsatisfactory results against Trichuris trichiura infections. We aimed
to assess the efficacy and safety of moxidectin and albendazole compared with
ivermectin and albendazole against T trichiura in adolescents living on Pemba
Island, Tanzania.
This open-label, non-inferiority, randomised, controlled,
phase 2/3 trial was done in four secondary schools (Kilindi, Kwale, Ndagoni
[Chake Chake District], and Kiuyu [Wete District]) on Pemba Island, Tanzania.
Adolescents aged 12–19 years who tested positive for T trichiura in at least
two of four Kato-Katz slides with a mean infection intensity of 48 eggs per
gram (EPG) of stool or higher were considered for inclusion. Participants were
randomly assigned (21:21:2:2:8) to five treatment groups (8 mg moxidectin and
400 mg albendazole [group 1], 200 μg/kg ivermectin and 400 mg albendazole
[group 2], 400 mg albendazole [group 3], 200 μg/kg ivermectin [group 4], or 8
mg moxidectin [group 5]) using a computer-generated randomisation code,
stratified by baseline T trichiura infection intensity. Study site
investigators and participants were not masked to study treatment; however,
allocation was concealed to participants. The primary outcome was egg reduction
rate (ERR) of T trichiura 14–21 days after treatment in the available case
population. Moxidectin and albendazole was considered non-inferior to
ivermectin and albendazole (control group) when the lower limit of the
two-sided 95% CI of the difference was higher than the non-inferiority margin
of –2 percentage points. This study is registered with ClinicalTrials.gov,
NCT04700423.
Findings:
- Between March 1 and April 30, 2021, 771
participants were assessed for eligibility. 221 (29%) of 771 participants were
ineligible and a further 14 (2%) were excluded. 207 (39%) of 536 participants
were randomly assigned to moxidectin and albendazole, 211 (39%) to ivermectin
and albendazole, 19 (4%) to albendazole, 19 (4%) to ivermectin, and 80 (15%) to
moxidectin. - Primary outcome data were available for all 536
participants. - The geometric mean ERR of T trichiura after
14–21 days was 96·8% with moxidectin and albendazole and 99·0% with ivermectin
and albendazole - No serious adverse events were reported during
the study. - The most reported adverse events were headache
(160 [34%] of 465), abdominal pain (78 [17%]), itching (44 [9%]), and dizziness
(26 [6%]).
The findings show inferiority of moxidectin and albendazole
to ivermectin and albendazole against T trichiura. However, given the high
efficacy, moxidectin coadministration might complement treatment progammes,
particularly in areas in which ivermectin is not available
Reference:
Efficacy and safety of moxidectin and albendazole compared
with ivermectin and albendazole coadministration in adolescents infected with
Trichuris trichiura in Tanzania: an open-label, non-inferiority, randomised,
controlled, phase 2/3 trial