PHARMACOGENOMICS- RELEVANCE AND APPLICABILITY IN POST-GENOMIC ERA (HIV-THERAPY)

Author(s)

Abhineet Chawla, MPharm, Associate, Rajeev Kumar, MPharm, Associate, Gavneet Aneja, MPharm, Associate, Mayank Bhanderi, MPharm, Senior Associate, Manu Sehgal, MPharm, Assistant Vice PresidentHeron Health Private Ltd, Chandigarh, India

OBJECTIVES: The study aims to explore the evidence of pharmacogenomic testing in clinical trials of anti-HIV drugs. This study reviews the challenges and barriers to pharmacogenomic research, highlights opportunities, reveals gaps, and aids in identifying specific, achievable goals that will advance the field. METHODS: HIV drugs with a confirmed linkage between the drug and genomic variations exhibited by individuals were identified from database (hiv-pharmacogenomics.org). We searched a clinical trials registry (clinicaltrials.gov) for the prevalence of pharmacogenomic parameter as outcome measure in studies of HIV drugs with confirmed linkage. RESULTS: Clinically significant and confirmed pharmacogenomic relationships were identified for seven HIV drugs. Out of the 980 potential studies, 326 (33.3%) met the inclusion criteria. Of the included studies only 28 (8.6%) assessed pharmacogenomic variation as one of the evaluable parameter (3 as primary, 9 as secondary and 16 as one of the determinants in study). Use of pharmacogenomic testing in the included studies was frequently observed in Indinavir (22.2%) followed by Efavirenz (15.4%), Saquinavir (15.0%), Abacavir (13.3%), Atazanavir (10.4%), Nevirapine (9.3%) and Ritonavir (4.0%). The included studies reported were interventional (24) and observational (4), which included 9 randomised controlled trials. Approximately 57% of the studies were phase IV post-marketing clinical trial. Out of 28 studies assessing pharmacogenomic parameter, 11 (39.3%) were sponsored by the industry, 11 (39.3%) by government agencies, 4 (14.3%) by universities and 2 (7.1%) by other sources. CONCLUSIONS: There are several, well-established pharmacogenomic relationships relevant to HIV and its treatments. However, collection of outcomes data that would support targeting treatments to patient groups defined through pharmacogenomics is not widely carried out, without which there is a possibility of ignorance of outcomes in groups of patients where the treatment effects may be most clinically significant.

Conference/Value in Health Info

2008-11, ISPOR Europe 2008, Athens, Greece

Value in Health, Vol. 11, No. 6 (November 2008)

Code

PIN7

Disease

Infectious Disease (non-vaccine)

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