Opinion paper. Resistance to new anti-HIV agents: problems in the pathway of drug registration.
Resistance data are now requested by the regulatory agencies as an integral part of the approval process of new antiretroviral drugs. We examined the means by which resistance data was gathered during pre-clinical and clinical Phases I, II and III of drug development, and how the public and academic experts access these proprietary data. The analysis identified various opportunities for improvement of the current process, in particular the need for standards in generating and reporting resistance data on new antiretroviral drugs, and the need to enforce warnings in the product labelling on the drug combinations that can potentially lead to resistance and treatment failure.
Dalmau
David
D
Institute of Microbiology, University Hospital, Lausanne, Switzerland.
Klimkait
Thomas
T
Telenti
Amalio
A
D019380:Anti-HIV Agents / Q000494:pharmacology* / Q000627:therapeutic use; D002986:Clinical Trials as Topic; D003625:Data Collection / Q000379:methods*; D017277:Drug Approval / Q000379:methods*; D024921:Drug Resistance, Multiple, Viral; D005062:European Union; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology*; D015497:HIV-1 / Q000187:drug effects; D006801:Humans; D011795:Surveys and Questionnaires; D014481:United States; D014486:United States Food and Drug Administration
D019380:Anti-HIV Agents