Generic antiretrovirals for the treatment of HIV: a novel challenge for Western countries?

Int J Clin Pharmacol Ther. 2017 May;55(5):381-393. doi: 10.5414/CP202775.

Abstract

The introduction of generic antiretroviral medications in developing countries has resulted in significant CD4 cell restoration, HIV viral decline, and a noteworthy reduction in the time to initiation of therapy. Projection models have also predicted significant cost saving associated with the extensive diffusion of generic antiretrovirals in developed countries. However, some uncertainties on generics have recently been raised. These concerns mainly relate to the adequacy of the study design for bioequivalence testing, the potential for uncontrolled switching from one generic to another, and the loss of adherence if patients switched from fixed-dose coformulations to single components in order to incorporate the new generic drugs. In the present review, we deal with current evidence and potential controversial issues regarding generic antiretrovirals and their underlying economic implications and provide some proposals on how to favor the widespread diffusion of generics in HIV medicine. This may be particularly relevant considering that the safe, systematic switch from patented to generic antiretrovirals could potentially guarantee access to therapies for HIV-infected patients worldwide and lead to money savings that would compensate the expenditure increase resulting from new, innovative HIV drugs. .

Publication types

  • Review

MeSH terms

  • Anti-HIV Agents / adverse effects
  • Anti-HIV Agents / economics
  • Anti-HIV Agents / pharmacokinetics
  • Anti-HIV Agents / therapeutic use*
  • Cost Savings
  • Cost-Benefit Analysis
  • Developing Countries* / economics
  • Drug Combinations
  • Drug Costs
  • Drug Substitution
  • Drugs, Generic / adverse effects
  • Drugs, Generic / economics
  • Drugs, Generic / pharmacokinetics
  • Drugs, Generic / therapeutic use*
  • HIV Infections / drug therapy*
  • HIV Infections / economics
  • HIV Infections / immunology
  • HIV Infections / virology
  • Health Services Accessibility* / economics
  • Humans
  • Medication Adherence
  • Therapeutic Equivalency
  • Treatment Outcome

Substances

  • Anti-HIV Agents
  • Drug Combinations
  • Drugs, Generic