E-DRUG: 4-drug fixed dose combinations for TB
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Dear E-druggers,
Richard Laing asked last week for the pro's and con's of fixed dose
combinations (FDC) in tuberculosis (TB) treatment during the intensive
phase. During the Southern African Tuberculosis Control Initiative meeting
(SATCI) the following arguments were mentioned:
"PRO FDC"
- simpler dosage schedule improves compliance (patient takes 4-5 similar
tablets once a day, compared to 8-12 different tablets when separate
tablets are taken); researchers claims this improves treatment outcomes
- prevents resistance (rifampicin is never alone in the blood)
- simplifies drug storage and handling, and thus lowers risk of "out of
stock"
- only 1 expiry date (single products may have different expiry dates)
- lower packing and shipping costs
"AGAINST FDC"
- FDCs are more expensive than separate tablets (in SA one day of 4-drug
FDC costs USD 0.41 versus USD 0.23 for separate tablets; assuming a daily
need of 600mg rifampicin, 300mg isoniazide, 1500mg pyrazinamide and 800 mg
ethambutol).
- potential quality problems, especially with the pyrazinamide if it is
added to rifampicin and isoniazid. This requires expensive bio-availability
testing (USD 25,000+ per test).
- if a patient is allergic or has a side-effect to 1 component, the FDC
must be stopped and replaced by separate tablets.
- the 4-drug FDC is a 'heavy' tablet: nearly 1 gram of active ingredient;
hard to swallow.
Up to now only South Africa has introduced a 4-drug FDC in Southern Africa.
2 other countries are also contemplating its introduction.
Botswana uses the separate tablets, and has good treatment results.
Maybe the crucial variable remains how the drugs are taken (DOTS yes or
no?) rather than whether they are FDCs or loose tablets?
kind regards
Wilbert Bannenberg
SADAP coordinator
Email: WilbertBannenberg@compuserve.com
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