Technical Comments on Tuberculosis in Malawi, Cathy Hewison

1. Since we are not doing a study I suggest to have a TB protocol for Malawi. What we
have now is a proposal for a feasibility study. By this I mean a working document
that can be used day to day for training and working purposes. I can give you some
examples of TB protocols and help you to write it. ( for example Akuem, Galaha).
They include the diagnostic, adherence, data collection and technical details etc. I
think it is worth to work on this together. Let me know when you are ready. Please
send these. I think we can start the discussion to complete when you are here.
2. Addition technical comments that I think should be added.
a. I suggest that patients already treated with 5 months of Ethambutol during their
category one treatment who now need category 2 treatment should have RHZE
in continuation phase instead of RHE. See TB guide MSF page 52 and 160 .
You choosen not to do this. I still recommend it . ( you can also look in the
IUTLD TB guidelines where it is also recommended) Maybe we can rediscuss
this when you are here. My main concern is that Pyrizinamide is notorious for
its hepatotoxicity which is the main side effect we are worried about when
combining ARVs and TB treatment. Are there studies strongly supporting its
use in this case? Just trying to weigh the benefits against the risks.
b. Active contact tracing for family members ( ask the patient to bring his family
in during the time they are in hospital). Isoniazid prophylaxis for children who
do not have TB . Treatment for those children with suspected TB. Especially
under 5 years old. See page 76 TB guide MSF. Definitely. We have discussed
this a bit. Where I think we need input the most is how far we should go to rule
out TB. Mantoux? (All children get BCG in Malawi, low sensitivity in the
immunosuppressed) CXR? History and exam only?
c. Pregnant women under rifmapicin. See page 45 of TB guide. They need vit K (
the mother and the child.)Sure
d. There are some people who give 7 months of therapy in continuation phase for
milary TB, Spinal TB or TB meningitis. There is no scientific proof and WHO
and MSF do not recommend this. I would take this out of your protocol. ( it
could be used on a case by case way). We noted this and made a change as
you may have seen in the drugs order.
e. The role of the Pandy and Rivalta tests should be included as well as the
possibility of cultures to confirm failure cases ( if there is not a local one there
is possibility to use European ones). This is because there is a lot of evidence
that positive slide at the 4/5th month is often due to dead bacillus and it is not
confirmed on culture. We are discussing this with Laurence we will copy you
everytime.
f. When to order an Xray, algorithm for diagnosis of sputum negative patients I
think would be useful to include as well as the crofton score ( or an adapted
one) for children. We have a vague one in NTP guidelines but we can improve
this. We are working on the children one we will send to Myrto and a copy to
you.
g. Contraception for women on Efavirenz. I know you have already discussed
this with Liza, so I think it is good to put something clear in the protocol for
malawi. We should do a pregnancy test on women before starting them on EFV
and also warn them of potential teratogenicity. I know you already use this but
maybe it is good to put something specific in the protocol for malwai sure
3. Other points to note
 a. In MSF we use only 2 categories now. See page 52 of MSF guide. In the guide
WHO page 31 and bottom of page 35 you will also see that WHO
recommends the use of standard category 1 treatment for all patients except
Smear negative known HIV negative
In reality the treatment is the same 6 months therapy but it will be much clearer
and easier if you use only cat 1 and 2 and not try to make a distinction for
Category 3. If the MoH insists on still using category 3 then its not such a big deal
as long as everyone understand that the treatment is the same. I think the latter
might be more acceptable as we will work closely with NTP

b. Treatment of adenitis cases. Generally non severe cases of TB adenitis who are
systemically well are not treated for TB but left to heal themselves. This avoids
overloading your program with unnecessary treatments. We should treat
fistulising adnenitis and children who are systemically unwell in any way.

4. I dont where you are it in terms of analysis of the points of weakness and action
but I am sure you are working on different levels ( diagnosis, integration TB/HIV,
laboratory , clinic, hospital treatment, patient follow-up, adherence, data collection,
analysis, etc ) . I know you are working in the ward and working on the lab, If you
have any questions Please let me know.