Table 3. Barriers to Developing a Combination ARV With Dolutegravir and TAFa
Need for a company to manage the development and introduction of a new product with good collaboration from the other companiesIf Gilead and/or ViiV are not willing to take leadership, generic companies or other partners might take the lead.
Access to data on each individual agentGaining regulatory permission to test agents together may require ability to reference the master file for each agent.
Financing of new product developmentThe cost of developing and introducing a new product would be substantial. Neither innovator nor generic manufacturers may have motivation to invest unless they have proprietary rights.
Formulation developmentCombining the 2 agents into a single pill would require reformulation and expertise in this area.
Clinical testing of new combinationsBeyond showing bioequivalence of a combination to each agent given separately, further tests may be needed.
Manufacturing scale-upA new, quality-assured process would need to be developed to manufacture the new product at large scale.
Registration of the products in many countriesA market authorization holder of the new product(s) would be needed, responsible for regulatory filing, marketing, and pharmacovigilance of the new product.
Introduction of the product in country programsCountry guidelines, policies, and plans would need to be adapted, and providers would need to be trained in how to use the new product.
  • Abbreviations: ARV, antiretroviral; MPP, Medicines Patent Pool; TAF, tenofovir alafenamide fumarate.

  • ↵a Plus a third agent—either emtricitabine or lamivudine.