Re: Accelerated approval for Etravirine granted by FDA

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Dear Forum,

Re: /message/8329

I believe that Etravirine might be an essential addition to the

existing list of ARVs but its effectiveness is still questionable in the

backdrop of these studies and I would like to bring a few points forth to

bolster my opinion.

The background regimen was DRV/rtv and the addition of a placebo increased CD4

count by 64 cells/mm3 while the addition of etravirine increased it by 81

cells/mm3 at 24 weeks - a difference of a CD4 count of 17 cells/mm3 in 6 months

is not a huge difference considering that the comparison is with a placebo and

not an ARV.

Similarly, for the viral load - 59.8% of patients on Etravirine had undetectable

viral load at the end of 6 months and 40.2 % of patients on Placebo gave the

same report - a difference of less than 20% as compared to a placebo. But then

again, we have a background regimen of DRV/rtv which is responsible for the

increase in CD4 count by 64 cells/mm3 and decrease of viral load in 40.2%

patients speaking of the effectiveness of this drug.

As is apparent from this study, Etravirine has adverse effects very

similar to that of Nevirapine ( Rash, hepatitis, increase in cholesterol and LDL

level) but what needs to be seen is that whether it is a result of the drug

itself or a drug interaction. Although monotherapy studies have ethical issues

associated with it, some questions remain unanswered for Etravirine.

The only way out would be to have similar studies done in combination with other

drugs to understand the actual effectiveness of the drug and rule out any drug

interactions.

Considering its questionable effectiveness in children and pregnant

woman, universal use of this drug seems quite improbable but maybe newer studies

will be able to throw more light on the subject.

Fighting for an AIDS-free world in solidarity,

Sincerely,

Dr. Nochiketa Mohanty

Project Coordinator

AHF - India Cares

S 7 Panchsheel Park

New Delhi 110017 India

(+91) 11 417 45541[O]

(+91) 11 417 45542

(+91) 11 417 45543[Fax]

(+91) 9958262277[Cell]

<mailto:nochiketa.mohanty@...>

http://www.aidshealth.org/>