A critical analysis of TAF, as part of a Roadmap series, aims to help the international community assess the best route to safe, effective, tolerable, and affordable HIV treatment.
Make Medicines Affordable partner, the Initiative for Medicines, Access and Knowledge (I-MAK), has produced the Roadmap Special Edition Report on Tenofovir Alafenamide Fumarate (TAF). It aims to provide the international community with critical analysis for policy-makers to determine how TAF may be used in HIV treatment programs.
Key findings of this report are:
- All pending and granted patents for TAF are weak and should be rejected by patent offices.
- Since additional safety and efficacy data is required to determine whether TAF can be used in low and middle income countries, it is advisable to to wait for such additional safety data before defining an access strategy for TAF. In the meantime TDF should continue to be used for first-line treatment for HIV.
- If and when TAF is deemed safe and effective for use in low and middle income countries, additional questions should be answered prior to defining a strategy, including whether TAF has any additional therapeutic benefit compared to unboosted TDF, the patent status of TAF, the geographic scope of voluntary licenses for TAF, and whether increasing production of TAF will have a negative impact upon the production of low-cost generic TDF that may continue to be needed in middle-income countries that are excluded from Gilead’s voluntary license and which may have approved a secondary patent that blocks generic competition.
See pages 3-4 for a summary covering clinical importance, cost and access, patents, and strategies for access.
This is I-MAK’s third report in the Roadmap series. The Roadmap: The HIV Drug Pipeline and its Patents (2013) summarized the key clinical, cost, and patent information on important ARVs in the pipeline. Since it was published, the need to provide safe, effective, tolerable, and affordable HIV treatment has grown more important than ever. In order to provide key information updates for prioritized ARVs, I-MAK created a special edition report on dolutegravir last June and has now released this special edition on TAF.
- Download: The Roadmap: The HIV Drug Pipeline and its Patents
- Download: The Roadmap: Special Edition Report on Dolutegravir.