2. Impact of Using Fixed Dose Combinations (FDCs) versus
Single Dose Combination Among New Pulmonary Smear Positive Patients in Bangladesh
Author:Dr. Md. Khurshid Alam Hyder, Jr. Consultant
National TB Control Programme,Directorate General of Health Services
Ministry of Health & Family Welfare,Dhaka, Bangladesh
Co-Author:Dr. Moinul Haque, Coordinator TB & LCC
NSDP, Dhaka, Bangladesh

3. Population: 132 million (2003)
Density: 981 per-sq-km
GNP per capita: 370 US $
DOTS Geographical Coverage:99 %
Estimated sm +ve TB incidence 105/100,000 popul. (2002)
No. of sputum microscopy centre functioning 559
TB case detection Rates: (2003) 38% (ranging from 10% to 80%)
Over 52,000 smear positive cases detected in 2003 compared to base line smear positive cases of
38,500 in 2000
Treatment success rate : 84%

4. Year implementation of DOTS started: 1993 Total population : 132 million (2003)
Estimated population
2000
2001
2002
2003
DOTS coverage (Geographical)
95%
98%
99%
Estimated all new cases
290,000
302,000
307,000
310,000
Total cases notified
73,977
74,252
81,833
86,000
Estimated new smear positive cases
130,000
136,000
138,000
140,000
New Smear positive cases notified
38,484
(29.9%)
40,771
(31.4%)
46,771
(33.8%)
52,500
(38%)
New Smear positive cases treated successfully under DOTS
83%
84%
84% (upto 3rd quarter 2002)

5. Data for 2000-2003 Total population: 132 million (2003) Year implementation of DOTS: 1993

6. DOTS Coverage and Treatment Outcomes 2000-2003

7. Background on the involvement of NGOs
The NGOs under the banner of Leprosy Coordination Committee were working for leprosy control since The Damien Foundation has been treating TB cases since 1991
BRAC has been working for TB control in a limited area since 1984
Bangladesh introduced DOTS in 1993, however the formal collaboration with NGOs was 1st initiated in 1994 through two separate MOUs
MOUs have been signed between NSDP, UPHCP and Public-Private Pilot Project for Urban TB Programme

8. Principles of Collaboration
Mutual respect and trust
Commitment to follow NTP guidelines
Pulling of resources to maximize the use of expertise of partners to make the programme cost effective
Periodic review of programme performance

9. NTPs initiatives to involve other stake holder
National TB Control Programme has recently revised the national guidelines
Introduced Fixed Dosed Combination from 1st quarter 2004
Availability of FDC’s from Global Drug Facility ensured

10. Global Drug Facility - Services
Grants of first line drugs, to support DOTS expansion
A direct procurement mechanism for countries and NGOs, to buy drugs for use in DOTS programmes
A web-based tool for placing orders and tracking shipments
A white list of ‘pre-qualified’ manufacturers of quality TB drugs
Received 1st year assignment of 4FDCs and 2FDCs, separate Isoniazid, Ethambutol in 2003
Request sent for 2nd year 4FDCs and 2FDCs which is under process

11. Global Drug Facility - Bangladesh
Applied - March 02
Approved for 3 years
1st year (55,700 patients; $700,000)
Received 1st year assignment of 4FDCs and 2FDCs, separate Isoniazid, Ethambutol in 2003
Technical assistance - GDF country visit (May 02), GDF monitoring visit (Sept 03)
2nd year request (97,000 patients; $1.2 million)
Request for 2nd year is for 4FDCs and 2FDCs which is under process
Bought additional drugs through GDF Direct Procurement mechanism in 2003

12. Background Information of the Study
NTP Bangladesh recently introduced FDCs in treatment regimen to rationalize the use of fewer tablets compared to a larger number of tablets in a single drug combination to increase compliance
The objectives of the study are to assess the impact of FDCs on efficacy, sputum conversion and side effects among new pulmonary smear positive patients compared to those on single drug combinations under DOT
Prospective study with comparison series
Two Public Urban Chest Disease Clinics, and Centers of NSDP at Dhaka were selected

13. Methodology Two phases of intervention
BCC among service providers at the study centers during last two quarters of 2003
Development of questionnaire for collection of information
Implementation among two groups of new pulmonary smear positive patients – FDCs and Single Drug Combination started from first quarter of 2004

14. Treatment Regimens SDC regimen Intensive phase FDC regimen Drug
No. of tablets per day
3 tablets per day
Isoniazid 300 mg
Rifampicin 450 mg
Pyrazinamide 500 mg
Ethambutol 400 mg 1 3
Isoniazid 75 mg
Rifampicin 150 mg
Pyrazinamide 400 mg
Ethambutol 275 mg
Continuation phase
3 times per week Isoniazid 300 mg 2
3 tab 3 times per week
Isoniazid 150 mg

15. Preliminary Results
Total patients enrolled for the study (Jan-Feb, 2004): 32
SDCs: 14
FDCs: 18
Sex of 32 new smear positive patients by regimen
Regimen
Males
Females
Total
SDCs
9 (64%)
5 (36%)
14 (44%)
FDCs
12 (67%)
6 (33%)
18 (56%)
21 (65.5%)
11 (34.5%) 32

16. Preliminary Results (Cont..)
Frequency of all complaints during the first month of intensive phase of treatment by regimen
Regimen
Gastro-intestinal
Skin reaction/ Itching
Joint Pain
SDCs
2 (14 %) -
3 (21 %)
FDCs
2 (11 %)
1 (6 %)

17. Inference
Too early to comment as implementation started in 1st qr. 2004, however, preliminary results shows that more patients on SDCs have joint pains as compared to patients on FDCs

18. Expected Outcome from the Study
Efficacy of FDCs in the treatment regimen of NTP in Bangladesh
Sputum conversion rates comparison among new pulmonary smear positive patients using SDCs and FDCs
Knowledge of Adverse/Side effect using SDCs and FDCs
Provide information to the policy makers and program management on use of FDCs in NTP of Bangladesh

19. Thank You