Transcript Presentation PRAKSIS - ILGA

TAG: Truvada as PrEP: Select Global Regulatory Filings
Country
Regulatory
Filing Status
Australia
Filed April
2015
Brazil
Canada
Europe
Actions in Progress
Notes
Discussions indicate a
possible approval in mid2016
PrEP is being evaluated by
Filed
the Brazilian drug
September
regulatory authority. No
2014
timeline has been
published
Québec has developed
Filed summer
guidelines for health care
2015
providers
No filing
Gilead has provided
data for assessment in
Gilead is in discussions
France for PrEP that
with the European
could result in
Medicines Agency re:
temporary access or
regulatory filing for PrEP
expanded access
programs
TAG: Truvada as PrEP: Select Global Regulatory Filings
Country
Regulatory
Filing Status
Actions in Progress
Notes
The Kenya National AIDS This is only a
Control Council has
recognition that PrEP is
Kenya
Pending
included PrEP in its HIV needed, not a step
Prevention Revolution
toward regulatory
Road Map
approval
Both originator and
generic manufacturers
Filed
have submitted to the
Updates to the existing
November
MCC and updated their
guidelines are in
2013; queries submissions to include
process; expansion to
South Africa issued Q1
data from the IPERGAY
populations beyond
2015
and PROUD studies;
men who have sex with
(addressed by however, the MCC has not
men expected
Gilead)
indicated any specific
timeline for review or
approval
TAG: Truvada as PrEP: Select Global Regulatory Filings
Country
Thailand
United
States
Regulatory
Actions in Progress
Filing Status
Filed May
2014; queries
issued Q3
2015
(addressed by
Gilead)
Approved July
N/A
2012
Notes
Approved in July 2012
for prevention
indication
Popular (Greek) narratives about PrEP
‘After chems comes condomless sex’
‘An observational study was enough to
make gay men throw away condoms’
Pharma tries to sell more medicines’
‘
‘Pharma companies are happy with these
campaigns. In the meantime, resistant
gonorrhea is stronger than ever’
‘With all these a new mutation of
the virus will come up’
‘It’s a new fad, saying “I am on
PrEP”. I say “fuck off”’
Challenges for PrEP in Europe?
Community acceptability surveys (e.g. in Pride events)
Demonstration/Implementation studies (e.g. Amsterdam)
A prevention indication is needed after a pediatric
investigation plan (PIP) is carried out
Generics
Patent expiration and new formulation on the way (F/TDF
 F/TAF)
Challenges for PrEP in Europe?
Public budget (but until then…)
Out of pocket (e.g. London) {will the right people get
PrEP?}
Buying from internet or pharma tourism {no prescription /
no follow-up}
PEP for PrEP
Apostolos Kalogiannis - Advocacy
MA in Communication and Cultural Studies