When the waiting proves fatal

[Guest guest]

Dear FORUM,

Here is an article published in The Hindu on 16/06/05 which I would like to

share with all the frieds of the forum who are concerned with HIV/AIDS related

issues.

Dhananjay Kumar Sinha

E-mail: dhananjay_kumarsinha@...

___________________

When the waiting proves fatal

A clinical trial is slated to study the possibility of treating HIV patients

with TB and use DOTS for better compliance to HIV medication.

THE FREE Anti Retroviral Therapy (ART) given by the Indian Government to some

infected with HIV is a step in the right direction, to reduce the number of

people succumbing to the disease every year.

The free treatment comes with some riders though; only those people with CD4

counts less than 200 are eligible for free medicines and those suffering from

tuberculosis need to first get it treated before becoming eligible for free ART

medicines. This latter condition applies even if the patient has a CD4 count; an

indicator used to understand the condition of a person's immune system; less

than 200.

High mortality

Ironically, many HIV infected persons who also have tuberculosis die before TB

can be treated. " The mortality rate is high among HIV patients with TB, " said

Dr. Soumya Swaminathan, Deputy Director (Division of HIV/AIDS), Tuberculosis

Research Centre, Chennai. " Nearly 20 per cent of them die in the first year and

another 20 per cent in the subsequent year in the absence of ART. "

Hence the need of the hour is to offer ART at the earliest to those suffering

from TB. " With a median survival rate of 18 months, it is a serious problem for

those with HIV and TB, " said Dr. Swaminathan.

If the implications of delaying treatment to those suffering from HIV and TB are

indeed so serious, what was the compulsion for the Government to impose such

guidelines in the first place? " The TB symptoms flare up when someone with TB is

put on ART, " she explained. " This is because the ART boosts the immune system

and this in turn aggravates the symptoms of any infection. "

Drug interaction

There is one more reason why patients are required to get treated for TB before

starting on ART. Nevirapine; one of the drugs given as part of ART; and

Rifamycin given for treating TB, get metabolised by the same enzyme in the

liver. This leads to Rifamycin increasing the metabolism of Nevirapine and in

turn reducing Nevirapine level in the blood. " So there is a risk of patients

developing drug resistance to Nevirapine, " she said.

Combining the two

But the high mortality rate amongst those with TB and infected with HIV is a

cause for concern. This is particularly true in the case of patients in an

advanced stage of TB. " So we want to give ART along with TB drugs, " noted Dr.

Swaminathan.

Experience had shown that those with CD4 counts of 450 and above can get the TB

cleared before starting on ART. Such cases are not common though. Many patients

who present with HIV and TB have CD4 counts less than 200; most of them have it

below 350 and are heading towards a stage of immune suppression.

" So there is a move to make TB as `AIDS defining illness for HIV,' " she said.

AIDS defining illnesses are defined as the conditions that occur only in HIV

patients. So anybody with HIV and TB will be considered as an AIDS patient.

" This labeling is from the treatment point of view only, " she pointed out. " Our

study has shown that 7-8 per cent of HIV patients will develop TB every year.

And 70 per cent of HIV positive persons who have TB will fall under this

category requiring ART. "

Checking the CD4 counts before starting on ART is the ideal way of tackling this

category of patients. But many clinics in rural areas and semi-urban areas do

not have the facilities required to do this. " Even if CD4 counts are not

checked, nearly 80 per cent of the patients may stand to benefit when put on

ART, " she stressed. " That is the way it should be. " No policy decision has yet

been taken by NACO (National AIDS Control Organisation) on this issue.

Dr. Swaminathan and her team are interested in starting a three-year clinical

trial in August on 250 volunteers in Chennai and Madurai (in Tamil Nadu) to look

at the possibility of changing the HIV treatment schedule from twice a day to

once a day and assess the feasibility of using Directly Observed Treatment

Short-course (DOTS) to achieve better compliance to medication.

" Now a month's supply (of medicines for HIV) is given to the patients. If they

don't take the drugs regularly, it will lead to drug resistance, " she

highlighted. " There must be 95 per cent compliance to medication, else there

will be problems. " With the Government having no second line of treatment (as it

is ten times more expensive), there is a compelling need to ensure very good

compliance.

DOTS for HIV

This is where DOTS is seen as an effective strategy. With the TB cure rate

increasing from 33 per cent to 85 per cent once DOTS was introduced for treating

TB, the reasons for trying the same strategy on HIV patients are more than

compelling.

But DOTS has been successful in the case of TB, as the duration of treatment is

six months; HIV needs lifelong treatment. So can DOTS for HIV be feasible?

She is also exploring the possibility of a companion (such as spouse or a

parent) who will ensure regular intake of medicines by the patients. Such a

`partners in health' programme is underway in Haiti to ensure better drug intake

compliance.

Another issue that she intends to validate is the safety of using Nevirapine

along with Rifamycin. Clinical observation studies have shown that it is indeed

safe to use the two drugs simultaneously; pharmokinetic studies show that

Rifamycin reduces Nevirapine levels in the blood.

" So one group of volunteers will be given Nevirapine and the other Efavirenz

along with Rifamycin to see the drug interaction, " she explained. The clinical

trial is a first of its kind for several reasons. Only time can tell if it will

yield the desired results.

R. PRASADin Chennai

http://www.hinduonnet.com/seta/2005/06/16/stories/2005061600181600.htm