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The efficacy of a four-week, ofloxacin-containing regimen compared with standard WHO-MDT in PB leprosy
Marivic F. Balagon
  Marivic F. Balagon
Affiliation
Leonard Wood Memorial Center for Leprosy Research, Cebu, Philippines
Correspondence to: Marivic F. Balagon, LWM Center for Leprosy Research, Cebu, Philippines, PO Box 727, Cebu City, Philippines (Tel/fax: +63 32 2311601; e-mail: csc˙epi@yahoo.com)
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a,*
Roland V. Cellona
  Roland V. Cellona
Affiliation
Leonard Wood Memorial Center for Leprosy Research, Cebu, Philippines
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a
Rodolfo M. Abalos
  Rodolfo M. Abalos
Affiliation
Leonard Wood Memorial Center for Leprosy Research, Cebu, Philippines
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a
Robert H. Gelber
  Robert H. Gelber
Affiliation
University of California, San Francisco, USA
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b
Paul R. Saunderson
  Paul R. Saunderson
Affiliation
Leonard Wood Memorial Center for Leprosy Research, Cebu, Philippines
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a
Objectives:

To compare the efficacy of a 4-week ofloxacin-containing regimen and the standard WHO-MDT regimen for PB leprosy, in terms of the rate and timing of relapse after treatment completion.

 Design:

124 PB patients were enrolled in a randomised, double-blind trial. Of these, 66 received the standard 6-month WHO-MDT regimen, whereas 58 received 28 daily supervised doses of rifampicin 600 mg + ofloxacin 400 mg, plus 5 months of placebo. Patients were regularly monitored for clinical response and for signs of relapse after treatment completion.

 Results:

Patients enrolled in the ofloxacin group had a mean follow-up of 10.8 years (628 patient-years) with 1 early relapse at 3 years after treatment completion. On relapse, this patient remained smear negative but was reclassified by current WHO criteria (≥6 skin lesions) as multibacillary (MB). Patients on the WHO-MDT regimen had a mean follow-up of 11.3 years (749 patient-years) with two late relapses at 8 and 12 years, both still classified as PB on relapse.

 Conclusion:

In conclusion, both regimens appeared generally efficacious, and, in particular, resulted in few relapses.
Cite this article
Marivic F. Balagon, Roland V. Cellona, Rodolfo M. Abalos, Robert H. Gelber, Paul R. Saunderson;
The efficacy of a four-week, ofloxacin-containing regimen compared with standard WHO-MDT in PB leprosy; Leprosy Review; 2010; 81; 1; 27-33; DOI: 10.47276/lr.81.1.27
home.article_information

DOI: 10.47276/lr.81.1.27

articleview.journal_title: Leprosy Review
articleview.publisher: British Leprosy Relief Association
articleview.publisher_location: Colchester, UK
articleview.article_date_pre accepted on 24 November 2009 and articleview.pub_on 01 March 2010
© Lepra 2010
LEPROSY
Leprosy Review
0305-7518
British Leprosy Relief Association
Colchester, UK
02-7033
0305-7518/10/064053+07
10.47276/lr.81.1.27
Original Papers
The efficacy of a four-week, ofloxacin-containing regimen compared with standard WHO-MDT in PB leprosy
BalagonMarivic F.
a
CellonaRoland V.
a
AbalosRodolfo M.
a
GelberRobert H.
b
SaundersonPaul R.
a
a
Leonard Wood Memorial Center for Leprosy Research, Cebu, Philippines
b
University of California, San Francisco, USA
Correspondence to: Marivic F. Balagon, LWM Center for Leprosy Research, Cebu, Philippines, PO Box 727, Cebu City, Philippines (Tel/fax: +63 32 2311601; e-mail: )
01032010
81
1
27
33
24112009
© Lepra
2010
Objectives:
To compare the efficacy of a 4-week ofloxacin-containing regimen and the standard WHO-MDT regimen for PB leprosy, in terms of the rate and timing of relapse after treatment completion.
Design:
124 PB patients were enrolled in a randomised, double-blind trial. Of these, 66 received the standard 6-month WHO-MDT regimen, whereas 58 received 28 daily supervised doses of rifampicin 600 mg + ofloxacin 400 mg, plus 5 months of placebo. Patients were regularly monitored for clinical response and for signs of relapse after treatment completion.
Results:
Patients enrolled in the ofloxacin group had a mean follow-up of 10.8 years (628 patient-years) with 1 early relapse at 3 years after treatment completion. On relapse, this patient remained smear negative but was reclassified by current WHO criteria (≥6 skin lesions) as multibacillary (MB). Patients on the WHO-MDT regimen had a mean follow-up of 11.3 years (749 patient-years) with two late relapses at 8 and 12 years, both still classified as PB on relapse.
Conclusion:
In conclusion, both regimens appeared generally efficacious, and, in particular, resulted in few relapses.