High-Dose Rifapentine

with Moxifloxacin for

Pulmonary Tuberculosis

Indana Zulfa 2011730042

Preceptor:
Dr. Hj. Ihsanil Husna, Sp.PD
 Background

Tuberculosis regimens that are shorter
and simpler than the current 6-month daily
regimen are needed.
Methods

Study oversight
Patients
Study design
Efficacy and safety
Statistical Analysis
 Study oversight

RCT carried out within the framework of the
INTERTB. Sponsored and implemented by St.
Georges University of London + MRC CTU at UCL
and 6 institutions in southern Africa.
The study protocol was reviewed and
approved by the ethics review committee at St.
Georges by medical ethics and regulatory
committees representing each of the
participating countries.
 Patients

Written informed consent
>18 yo
Weigh 35 kg
Provide two sputum samples that were
positive for Tb bacilli on direct smear
microscopy
To have had <1month of prev anti-TB
chemotherapy
A firm home adress
 Study Design
Patient randomly

assigned in a ratio
1:1:1
A control 4 month 6 month
regimen regimen regimen

2 E, moxifloxacin (400mg),
2 E, M400mg, RZ
6 month of 2RHZE+4RH RZ
administered daily
2 M+R (900mg)
4M+R(1200mg)
administred twice weekly

All drugs were administered at standard doses unless otherwise

stated
Efficacy and Safety
Sputum

Sample
s

Culture
Smears
s

- Average follow up 18 months

- Adverse events were graded for severity with the use of
criteria from the National Institute of Allergy and
Infectious Diseases, Division of AIDS, after minor
modification.
 Result

Study population
Efficacy
Safety
 Study Population

August 15, 2008

August 1, 2011

Worcester (209)
Johannesburg (255)
827 patients South Africa (203)
enrolled Marondera (89)
Zimbabwe, in Francistown, Bostwana
(56)
Macha, Zambia (15)



 Efficacy

The proportion of patients with unfavorable
outcomes among those receiving the control
regimen, the 4-month and the 6-month regimen
was 4.9%, 18.2% and 3.2%, respectively in the
per protocol analysis, and 14.4%, 26.9% and
13.7%, respectively in the modified intention-to-
threat analysis.




 Safety

827 patients
25 died:
6 control group
12 In the 4 MR
13 7 in 6 MR

4 probably
8 ascertained 6 HIV related
related to TB

*MR = Month
Regimen
 Discussion

The substitution of moxifloxacin for isoniazid
was proposed after a report of an acceleration in
bacillary elimination after such an substitution
was made in a study mice.
 Conclusions

The 6-month regimen that included weekly
administration of high-dose rifapentine and
moxifloxacin was as effective as the control
regimen. The 4 month regimen was not
noninferior to the control regimen.