NIH/NIAID study of generic drugs shows results consistent with stringent manufacturing standards
1 April 2003. Related: Conference reports, Antiretrovirals, Treatment access, PK and drug interactions, CROI 10 (Retrovirus) 2003.
Polly Clayden, HIV i-Base
This conference had a strong emphasis on international issues and treatment in resource limited settings.
Production of generic antiretrovirals by generic manufacturers has reduced the cost of HAART to as little as $1 a day. Several sessions included reports of programmes using these affordable drugs in their treatment strategies, including data from Malawi using Triomune  and India and Mozambique using nevirapine (NVP)-containing generic HAART regimens [2, 3].
However concerns have been raised (with varying agendas) that generic medications may contain little or no active ingredient or may not be bioequivalent to originator products. A poster from Dr Penzak and colleagues from the NIH and NIAID compared the NVP content of several generic and originator formulations as part of a pilot, quality control investigation .
The authors explain that “There are currently no publicly available data describing the integrity (drug content vs. label claim) of these preparations.” These data are essential to enable governments and healthcare providers to make decisions as to which antiretroviral formulations will provide the greatest benefit to the 90% of HIV positive people who currently have no access to these medications.
Tablets containing NVP (alone or in combination with other ARVs) were obtained from six international sources and the NVP content of the six products was determined by HPLC. In total, six chromatographic analyses were performed for each individual tablet. The NVP content and demographic data for the individual products are listed in the table below.
All products in this study were labeled as containing 200 mg of NVP drug. The average NVP content among the tested preparations was 197.9 mg. Average accuracy of nevirapine content in the tested preparations versus labeled amounts was 99.0%.
The investigators concluded that: “The results are encouraging and consistent with stringent manufacturing standards (± 3% of labeled drug amount); these data are particularly reassuring given the widespread use of nevirapine-containing products in the developing world.”
Studies are currently in progress to analyse all currently available generic antiretroviral products at the NIH and UAB.
Unless stated otherwise, all references are to the Programme and Abstracts of the 10th Conference on Retroviruses and Opportunisitc Infections (CROI), 10–14 February 2003, Boston.
- Hosseinipour M, Namarika D, Magomero K et al The Malawian antiretroviral Program: the first year experience with triomune. Abstract 172
- Kumarasamy N, Chaguturu S, Mahajan A et al. Safety, tolerability, and effectiveness of generic HAART regimens in South India. Abstract 174
- Emberti Gialloreti L, De Luca A, Perno CF et al Increase in survival in HIV-1 infected subjects in Matola, Mozambique, after the introduction of combination therapy with generic-manufactured antiretrovirals: preliminary results from the DREAM cohort. Abstract 175
- Penzak S, Tavel J Acosta EP Quality-control analysis of generic nevirapine formulations in the developing world: an initial report. Abstract 549a