Update amp Scenario Planning for FACTS001 Trial Manju Chatani Gada amp Kay Marshall February 2015 FACTS 001 UPDATE Thanks to FACTS001 team for the update slides CAPRISA 004 results in 2010 ID: 921154
Download Presentation The PPT/PDF document "Getting the FACTS Right!" is the property of its rightful owner. Permission is granted to download and print the materials on this web site for personal, non-commercial use only, and to display it on your personal computer provided you do not modify the materials and that you retain all copyright notices contained in the materials. By downloading content from our website, you accept the terms of this agreement.
Slide1
Getting the FACTS Right!
Update & Scenario Planning for FACTS001 Trial
Manju Chatani-Gada & Kay Marshall
February 2015
Slide2FACTS 001 UPDATE
(Thanks to FACTS001 team for the update slides)
Slide3CAPRISA
004 results in 2010
Ground-breaking South African study was first to show microbicide could work to prevent HIV
Study showed tenofovir
gel reduced the risk of vaginally transmitted HIV by 39% when used before and after sex (BAT24)
Also demonstrated a reduction in the risk
of
Herpes Simplex Virus 2 (HSV2) by 51%.
Slide4Why do a confirmatory study?
4
Slide5FACTS 001 Overview & Timelines
Large-scale, double-blinded placebo-controlled
Aimed at confirming and expanding the CAPRISA 004 findings
for licensure
Enrolment started
Oct 2011
2,059
healthy, HIV-negative women,18 to 30 years, enrolled at 9 sites Participant follow-up concludedin August 2014Results expected at CROI 2015
5
(Slide Adapted by AVAC – Feb 2015)
Positive
results could lead to licensure of first vaginal microbicide and expand women’s
options for HIV prevention methods
Slide6Purpose of the study
Is 1% tenofovir gel
:safe for women, effective for preventing HIV infection,
effective
for
preventing genital herpes
WHEN USED BEFORE AND AFTER
SEX.
6
Slide7Who could participate in FACTS 001?
HIV-uninfected
womenSexually-active
A
ged
18 to 30 years
Agreed to be on hormonal contraceptive
Women WERE still allowed
to enroll if they:had genital herpeshad Hepatitis Bwere breastfeeding
7
Slide88
Slide9How the study worked
After recruitment, all
participants were randomly placed in 1 of 2 groups
9
“
Active
”
gel with tenofovir
Placebo gel without tenofovir
OR
Slide10They were instructed to use study gel before and after sex…
12 hours
asap
12 hours
FACTS 001: Community Presentation V3.0 13 June 2012
Slide11They had monthly follow up visits
Monthly follow up visit procedures included:Clinical
HIV counselling and testing STI testing and treatmentPregnancy testingPhysical examination
Participant support
Risk reduction counselling and provision of condoms
Motivational interviews to support participants to use gel
FACTS Clubs (social and support groups)
11
Slide12What happens between now and when the results are announced?
Participants have finished their study visits as required by the protocol.
The study team is now preparing the
data to be analysed (
by checking that everything was filled in correctly and completely) that has been collected over the past 3 years.
Once the data is analysed, final results will be released (planned for early 2015).
Each
participant has made valuable contributions to this
study.12
(*AVAC Note: This is what they said in August 2014 at community dialogues)
Slide13And now?
FACTS001 results will be announced at the
2015 Conference for Retroviruses and Opportunistic Infections (CROI) on 24 February in SeattleTrial participants, other stakeholders, media will also hear the results around that time
But the first set of results will only be top-level, still more analysis to do…
(won’t have all the answers)
Slide14And then - if it works?
The study team, sponsor and other stakeholders are planning for possible positive results of FACTS
001Open-Label Extension study –will invite all eligible
former FACTS participants to
join
OLE and receive active tenofovir gelAdditional research to facilitate product licensure
(e.g. Adolescent safety study)
Licensure preparations
Social marketing researchManufacturing, packaging, costing and distributionDemonstration projects and roll-out plans14
And if it works – what about other countries?
Slide15Consider…
If you were to asked to speak to an audience of
other advocates about FACTS study, what are the three most important messages you would want to convey?And what would you say to your aunty – about why this South African study is important for you to follow?
Slide16FACTS001 is
meant to confirm previous positive
results
about
tenofovir gel
Even if the results show it works – the gel will not be available immediately: there are several different processes from research to rollout
Even
if
the results do not show it works (well) – there is other ongoing microbicide research; the research will still teach us many important things
(That’s how scientific enquiry goes!)
3 Key Points to remember:
Slide17Considering the results…
What will the results be?What will be their implications?
What could they mean for the HIV field?Let’s consider the possible scenarios… but before that….
Slide18Final study results published
Feb 5
Bottom line remains the same:
3 products tested
were safe
but overall
not
effective
in preventing HIVAdditional analysis (blood drug levels) shows 3 months into the trial, majority of participants not using any product But among women who did use tfv gel (had drug in blood at 3 mo. visit) – a 66% reduction in HIV risk (statistically significant, BUT small group; not primary analysis)Encouraging, but we
cannot infer from this that FACTS will workNews: Final VOICE study data
Slide19Consider and plan
How will you respond?What will the media say?
What would you like the media to say?How do you want policy-makers to act?
How can you advocate or influence messages and follow-up?
Slide20FACTS 001 Possible scenarios
It works (e.g
., 50% effective)It doesn’t work (e.g. “flat
”
results)
It’s complicated (e.g
., low efficacy, low adherence,
not
immediately clear how/if it will move forward)
Slide21Back to the task at hand:
Why we need to anticipate results & messages?
Slide22Top line messages -- It works
Amazing
results – exciting moment for women in fight
to end
HIV
Shows us
women will use products
Confirms CAPRISA004
Cannot delay –donors, researchers, advocates, others must work to move forward for licensure and accessNeed more research for more, even better optionsGrateful for women in trial, researchers, communities
Slide23Top line messages -- It doesn’t work
Disappointed not to have gotten the result we all hoped
for… …but need to find
additional
HIV
prevention options
for women
as
important as everMust continue to support other options being tested and additional researchGrateful for women in trial, researchers, communities
Slide24Top line messages -- It’s complicated
Could be additional proof for new option for women, but need more information to illuminate way forward
Must be stringently reviewed by regulators to determine way forwardResearchers, advocates, others must engage with regulators and policymakers as decisions being made
At same time, must continue to support other options being tested and additional research
Grateful for women in trial, researchers, communities
Slide25Consider and plan
How will you respond?What will the media say?
What would you like the media to say?How do you want policy-makers to act?
How can you advocate or influence messages and follow-up?
Slide26“After climbing a great hill, one only finds that there are many more hills to climb.”
Nelson Mandela