[Ip-health] I-MAK Roadmap Special Edition Report: TAF

[Priti Krishtel]

*Dear all,I-MAK is excited to share our recent publication, the Roadmap
Special Edition Report on Tenofovir Alafenamide Fumerate (TAF) available
here: http://www.i-mak.org/roadmap/ <http://www.i-mak.org/roadmap/>. This
is our third report in the Roadmap series. We created The Roadmap: The HIV
Drug Pipeline and its Patents in August 2013, which summarized the key
clinical, cost, and patent information on important ARVs in the pipeline.
Since The Roadmap 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 is now
releasing this special edition on TAF. This report expands on the
information provided in the original Roadmap, and most importantly, aims to
provide the international community with critical analysis well in advance
of when policy-makers will have 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.
- We recommend that 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, we  also recommend
that additional questions should be answered prior to defining a strategy,
including: (i) whether TAF has any additional therapeutic benefit compared
to unboosted TDF, (ii) the patent status of TAF, (iii) the geographic scope
of voluntary licenses for TAF, and (iv) 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. We sincerely hope that it
is useful to you. If you have any feedback you have on what you found
helpful, what additional information you would like included, or any
questions, please contact Rohit Malpani at rohit at i-mak.org
<rohit at i-mak.org>. Best,Martine Hughey and the I-MAK team*


-- 
*Priti Radha Krishtel*
Co-Founder and Co-Executive Director
Initiative for Medicines, Access & Knowledge (I-MAK)
Website: www.i-mak.org
Email: priti at i-mak.org <martine at i-mak.org>
Skype: pritiwho
Tel: +1 9177032876