Re: On the EMTRI-Side effects. A personal testimony

[Guest guest]

Dear FORUM,

Ref: Personal testimony from Padmaja of Positive women Network on

EMTRI Side effects.

I think it is important that this sort of testimony is taken

seriously. The lipodystrophy syndrome was first recognised as a

widespread problem as a result of discussion amongst people with HIV

on a mailing list like this one, not because a drug company

volunteered the information.

There is a plausible explanation for why different generic

formulations of the same triple drug combination may have different

levels of side effects.

When generic drugs are approved, manufacturers need to show

`bioequivalence` - that is to say, the drugs needs to reach similar

levels in the blood to the branded products. However, demonstrating

bioequivalence requires a company to show that its product reaches

blood levels between 85% and 120% of the levels reported by the

manufacturer of the branded product. There may also be variations

between individuals, and it is also plausible that people with lower

body weight will achieve higher blood levels of a drug.

At least one study of generic formulations of the same drug has

shown variations between products in the drug levels achieved (this

was a study of antiretroviral formulations for children).

http://www.aidsmap.com/en/news/A9A0B5E6-CF15-4CCB-AA15-

29E7A7B97BBF.asp

Some of the side effects described in the post from Positive Women

Network are a result of high blood levels of nucleoside analogue

drugs such as stavudine and zidovudine, and Emcure should report

whether its bioequivalence studies showed that the blood levels that

result from taking the nucleoside analogue drugs in Emtri are higher

on average than those of competitor products.

Alcorn

Senior Editor

http://www.aidsmap.com

NAM Publications

Lincoln House, 1 Brixton Road

London, SW9 6DE

Tel +44 20 7840 0056

E-mail: <KEITH@...>

[Guest guest]

Dear FORUM,

It is important that we know the facts about the bioequivalence data as well as

the post marketing drug survey done by EMCURE on its drug Emtri which is being

distributed through the Government ARV Programme.

The side effects of EMTRI is a serious issue and we need to respond to this

positively.

EMCURE co would be doing all of us a great service if it makes public the

bioequivalence report as well as the post marketing drug survey report of Emtri.

Sunil

Peoples Health Movement

E-mail: <sunilcssr@...>