INTERNATIONAL JOURNAL OF LEPROSY^

Volume 64, Number 2Printed in the U.S.A.

Absence of Relapse within 4 Years Among34 Multibacillary Patients with High Bls

Treated for 2 Years with MDT'Kumar Jesudasan, Palanisamy Vijayakumaran,Natarajan Manimozhi, Thirthuvaraj Jeyarajan,

and Pamidipani Samuel Simon Rao 2

The World Health Organization (WHO)in 1982 ( 10) recommended multidrug ther-apy (MDT) for multibacillary (MB) patientsto be given for a minimum period of 2 yearsbut, ideally, until skin smears became neg-ative. The WHO Study Group meeting in1993 reviewed these recommendations (").Since there was increasing evidence that 24months of MDT was adequate for MB cases,the proviso to continue MDT until skinsmears were negative was dropped. A studyfrom Bamako, Mali, ( 8 ) reported only onerelapse among 44 MB patients treated for 2years with fixed duration therapy (FDT).Studies done by Becx-Bleumink (') Gana-pati, et al. ( 2) Katoch, et a!. (6 ) Li, et a!. ( 7 )also show similar results. Due to operation-al constraints, many national programs arealready adopting the 2-year MB regimensince it is much easier to implement. Thegroup of 34 MB patients in the current studywere a group of newly detected, previouslyuntreated, MB patients who were given afixed duration of MDT for 2 years.

MATERIALS AND METHODSPatients have been treated with MDT at

SLR & TC, Karigiri, since 1981. The initialcohort of all MB patients available (1067)were given MDT, and they were all treateduntil smear negativity ( 4 ). There were 35

' Received for publication on I May 1995; acceptedfor publication in revised form on 30 November 1995.

K. Jesudasan, M.B.B.S., D.T.P.H., Ph.D., Head;P. Vijayakumaran, M.B.B.S., D.P.H., Associate Epi-demiologist; N. Manimozhi, M.B.B.S., D.H.E., Asso-ciate Epidemiologist; T. Jeyarajan, B.A., D.H.S., OfficeSupervisor, Branch of Epidemiology and Leprosy Con-trol; P. S. S. Rao, M.A., M.P.H., Dr.Ph., F.S.S.,F.S.M.S., Director, Schieffelin Leprosy Research andTraining Centre, Karigiri, N. A. A. District, Tamil Nadu632106, India.

patients in this group who had a bacterialindex (BI) of 3+ or above. After this intakewas completed (1 January 1984-31 Decem-ber 1994), all new, previously untreated MBcases detected in our leprosy control pro-gram ( 5 ) have been put on FDT. A total of261 patients have been included in this FDTtrial. (These results will be presented in asubsequent paper).

For purposes of this study, the 34 patientswith a BI of 3+ or more, with a minimumof 4 years of follow up after completion of2 years of MDT, were investigated and theresults are presented. The fall in BIs in thisgroup is compared with the fall in BIs of the35 MB patients with a BI of 3+ or more inthe original cohort of 1067 treated untilsmear negativity, for whom 8-13 years offollow up after stopping conventional MDTwas available.

RESULTSThe average BI of the 34 MB patients was

3.4+ at the start of treatment (The Figure).This fell to 1.7 after 2 years of MDT, anaverage BI fall of 0.85 per year for the first2 years of treatment. All of the patients werereleased from treatment after 2 years of FDT.During the subsequent 4 years of follow up,the BI continued to fall; after 4 years offollow up, the average BI was 0.1+.

The Table shows the number of cases andtheir BIs after the start of MDT. At releasefrom treatment, after 2 years of MDT, twopatients had already become negative. Atthe end of 4 years of follow up without anytreatment, 25 out of the 34 (73%) patientshad become negative.

The Figure shows the fall in BIs of the 34MB patients treated with FDT comparedwith the 35 patients treated with MDT untilskin smears became negative (conventional

133

1 -°- BI-FDT - I - BI-MOT

134^ International Journal of Leprosy^ 1996

AVERAGE 131

IN 1 2 3 4 5 6

BI-FDT 3.4 2.6 •^1.7 . 0.9 0.6 0.3 0. 1

BI-MDT 3.6 2.6 2 11^

0.5 O. 1 0.04IfAVE FALL 0.9 0.8 0.9 0.4 0.4 0.1

THE FIGURE.

up.

YEARS, OF FOLLOW UP

Fall in BI of patients on FDT or regular MDT with an initial BI of 3+ or more; a 6-year follow

4

3

2

1

O

MDT). The fall in BIs in both groups weresimilar. During the first 3 years, the averagefall was 0.8-0.9 per year; in subsequentyears, the rate of fall was smaller.

No relapses have been detected in eithergroup. For those patients on conventionalMDT, an average follow up of 10 years wasavailable after release from treatment; forthe 34 patients on FDT, a follow up of 4years after the initial 2 years of FDT wasavailable.

THE TABLE. Six-year follow up of 34 MBpatients with a BI of 3+ or more.a

BIYear

1 2 3 4 5 6

0 0 2 7 11 21 250.1-1.0 1 7 16 15 9 81.1-2.0 7 13 9 8 4 12.1-3.0 18 10 2 0 0 0

:̂3.1 8 2 0 0 0 0

Patients treated with 2 years of fixed duration MDT.

DISCUSSIONThe report of the Marchoux Chemother-

apy Group ( 10) reported an overall relapserate of 20% or 3.3 per 100 patient-years.The WHO report (") gives the results ofseveral studies on the chemotherapy of MBpatients with MDT, either with conven-tional MDT (until skin-smear negativity) orfor a fixed duration of 2 years. The risk ofrelapse was less than 1/1000 person-years,regardless of whether the patients weretreated for 2 years or until smear negativity.However, fears have been expressed that the2 years of FDT may be inadequate in pa-tients with a high BI. The Marchoux studyshows a high relapse rate, with an averageincubation period of relapse of 62.7 ± 18.7months. This study shows that even in pa-tients with a BI of 3+ or more, the fall inthe BI was similar to patients who weretreated until their skin smears became neg-ative. Further, a follow up of 4 years afterrelease from treatment showed no relapses.Thus, the results are better than that ob-

64, 2^Jesudasan, et al.: No Relapses After 2 Years MDT^135

tained in the Marchoux study where tworelapses were reported within 5 years of fol-low up. The current study showed no re-lapses up to the fifth year of follow up (Oc-tober 1995) although results in this paperare for 4 years of follow up. This study re-quires further follow up to sustain its op-timism.

SUMMARYThirty-four multibacillary patients with a

bacterial index (BI) of 3+ or more weretreated with 2 years of WHO multidrugtherapy (WHO/MDT). Treatment was thenstopped and the patients followed for a min-imum of 4 years. The rate of fall in the BIin this group without further treatment wassimilar to the rate of fall in the BI in anearlier group of similar patients treated withMDT until skin-smear negativity. No re-lapses have been seen.

RESUMENTreinta y cuatro pacientes con lepra multibacilar (in-

dice bacteriolOgico, BI, de 3+ o mãs) se trataron du-rante 2 aims con la poliquimioterapia (PQT) de la OMS.Despues de terminar el tratamiento los pacientes sesiguieron durante un minimo de 4 afios. La tasa decaida en el 131 en este grupo sin tratamiento posteriorfue similar a la tasa de caida en el 131 observada an-teriormente en un grupo similar de pacientes tratadoscon PQT hasta que se tornaron BAAR negativos (linfacutanea). A la fecha no se han observado recaidas.

RESUME

Trente-quatre patients multibacillaires avec un in-dice bactêrien (113) de 3+ ou davantage ont etc vanespar deux ans de polychimiotherapie de I'OMS. Letraitement fut alors arre. te et les patients suivis pourun minimum de 4 ans. La vitesse de diminution del'IB dans ce groupe sans traitement ulterieur fut sem-blable a celle observee anterieurement dans un groupesemblable de patients traites par PCT jusqu'd negati-vation des frottis cutanês. Aucune récidive n'a etc ob-servee.

Acknowledgment. The authors wish to thank Mr.P. Samuel, who maintains patient records; Mr. RajaSamuel Bushanam, for the statistical help; Mr. C. LewisKumar, the departmental secretary, and the leprosycontrol staff involved in this study. This trial received

financial support from the UNDP/World Bank/WHOSpecial Programme for Research and Training in Trop-ical Diseases (TDR).

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