[Ip-health] Another Study Finds Generic AIDS Drug Effective

[James Love]

-------- Original Message --------
Subject: RE: [Ip-health] NYT: Study Finds Generic AIDS Drug Effective
Date: Fri, 2 Jul 2004 13:52:57 +0200

  Jamie,

I wonder if you could mention that a far larger study was reported in
December from India. The report was presented at the December WHO FDC
meeting. The document is available at
http://www.who.int/medicines/organization/par/FDC/Pujari.doc It reports
  on 1253 patients treated with two different generic FDCs. Here is the
abstract:

Abstract
Efforts should be directed at developing fixed dose combinations (FDCs)
of antiretroviral drugs for treatment of HIV infection. FDCs improve
adherence to therapy because of their convenience.  Generic companies in
the developing world have developed certain FDC formulations for drugs
used as highly active antiretroviral therapy (HAART), some of which are
not available through international companies.  Bioequivalence studies
have shown equivalence between some of these formulations and the
patented products.  It is essential to document the long-term
effectiveness of these generic formulations in clinical settings.

We report here the safety and long-term clinical and immunological
effectiveness of generic FDC formulations (AZT/3TC/NVP and d4T/3TC/NVP)
amongst antiretroviral na=EFve HIV-1 infected patients in India.  Carried
out at two private tertiary referral centres, this observational study
recruited 1253 patients with minimum three months of follow up, thus
making it the largest study from India.  Safety was assessed clinically
  and by laboratory markers and immunologic effectiveness was assessed
by serial CD4 counts. Clinical events were documented during follow up.

There was a significant improvement in the mean CD4 counts over time.
Most improvement occurred within 3-6 months of initiation of HAART and
was sustained for up to 2 years.  Rash and hepatitis were documented in
6.9% (95% CI 5.5-8.3) and 3.2% (CI 2.3-4.8) respectively of patients
initiating therapy.  Only female gender was associated with higher risk
of development of any adverse event.  All adverse events occurred within
1-12 weeks of initiating therapy.

The incidence of mortality and morbidity on HAART was 5.2 and 28.1 per
100 person years of follow up respectively.  Tuberculosis was the
commonest cause of death and overall clinical events in the cohort.
Only baseline CD4 counts were significantly associated with increased
risk of development of clinical events.

Thus HAART delivered as FDCs has shown potent and durable effect amongst
HIV-infected patients in this clinical study.  Programmes intending to
scale up antiretroviral therapy in the developing world should consider
FDCs containing nevirapine-based HAART as a first line regimen.