Country Regulatory Filing Status Actions in Progress Notes

Australia Filed April 2015

Discussions indicate a possible approval in mid-2016

BrazilFiled September 2014

PrEP is being evaluated by the Brazilian drug regulatory authority. No timeline has been published

Canada Filed summer 2015

Québec has developed guidelines for health care providers

Europe No filingGilead is in discussions with the European Medicines Agency re: regulatory filing for PrEP

Gilead has provided data for assessment in France for PrEP that could result in temporary access or expanded access programs

TAG: Truvada as PrEP: Select Global Regulatory Filings

Country Regulatory Filing Status Actions in Progress Notes

Kenya Pending

The Kenya National AIDS Control Council has included PrEP in its HIV Prevention Revolution Road Map

This is only a recognition that PrEP is needed, not a step toward regulatory approval

South Africa

Filed November 2013; queries issued Q1 2015 (addressed by Gilead)

Both originator and generic manufacturers have submitted to the MCC and updated their submissions to include data from the IPERGAY and PROUD studies; however, the MCC has not indicated any specific timeline for review or approval

Updates to the existing guidelines are in process; expansion to populations beyond men who have sex with men expected

TAG: Truvada as PrEP: Select Global Regulatory Filings

Country Regulatory Filing Status Actions in Progress Notes

Thailand

Filed May 2014; queries issued Q3 2015 (addressed by Gilead)

United States

Approved July 2012 N/A

Approved in July 2012 for prevention indication

TAG: Truvada as PrEP: Select Global Regulatory Filings

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 - AdvocacyMA in Communication and Cultural Studies