Transcript Bridging the gap between research, MCC

Bridging the gap between
research, MCC approval and
public access to tenofovir gel
Quarraisha Abdool Karim
on behalf of the CAPRISA 008 & CAPRISA 009 teams
Parliamentary Portfolio Committee on Science & Technology
5 June 2013, Cape Town
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Tenofovir Gel since CAPRISA 004:
Next Steps
• Confirmatory Trial – FACTS 001
 For MCC & FDA approval and licensure
• Manufacture – ProPreven
• Normative Guidelines (WHO/UNAIDS draft)
• Implementation
 CAPRISA 008 – integration into family planning services
 CAPRISA 009 – treatment outcomes in women with HIV
• Preparing for Public Access
 Toolkit development for providers and users
 Community Advocacy Efforts
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Why does HIV continue to spread in
South Africa?
Seroprevalence of HIV infection in rural South Africa
AIDS 1992, 6:1535-1539
Quarraisha Abdool Karim, Salim S. Abdool Karim,
Bipraj Singh*, Richard Short† and Sipho Ngxongo‡
Prevalence (%)
10
Male
1990
Female
8
6
4
2
0
3
<9
10-14
15-19
20-24
25-29
30-39
40-49
>49
High rates of
HIV among
key
populations:
young
women in
Africa
HIV in 15–24
year men and
women
(2008–2011)
Young women have
up to 8 times more
HIV than men
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Source: Adapted from
UNAIDS 2012
Zimbabwe
HIV prevalence in
young pregnant women
in rural Vulindlela,
South Africa (2009-2012)
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Age Group
(Years)
HIV Prevalence
(N=1029)
≤16
8.4
17-18
18.6
19-20
25.4
21-22
32.8
23-24
44.8
Grassroots Advocacy Efforts
Siyafuna
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Key Goals of CAPRISA 008
1. Provide post-trial access to tenofovir gel for HIV
uninfected CAPRISA 004 study participants and
community volunteers (UNAIDS Guidance point 19)
2. Develop and assess an implementation model for
tenofovir gel provision through family planning
services
- Quality Improvement Model
- Comprehensive SRH services
3.
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Collect additional safety data on tenofovir gel
CAPRISA 008: Implementing tenofovir
gel in family planning clinics
• Tenofovir gel provided by Family
Planning service nurses with
◦ DMPA, oral contraceptive and other
method users – tenofovir gel provided
every 3 months
◦ For Nur-isterate users – tenofovir gel
provided every 2 months
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Components of the Toolkit
• Providers, Users, Marketing & Demand Creation
• Providers
 “How to” Training Manual – SRH service provision to
include tenofovir gel
 Clinic procedures and systems to:
◦ Monitor safety, pregnancy and HIV
◦ Drug accountability & AE reporting
 Counseling and support aids
 Key information for M&E
 Management of post-PrEP infection
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Current status of CAPRISA 008
• First participant enrolled on November 5, 2012
• 425 participants screened; 359 enrolled and in
follow-up
• 43% of women enrolled are CAPRISA 004 high
adherers
• 54/516 women from CAPRISA 004 became
infected prior to initiation of CAPRISA 008
 10.5% seroconversion rate
 Incidence rate of 3.8/100wy
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Goal of CAPRISA 009
• Follow-up of HIV infected participants from
CAPRISA 004 (control & intervention arm) to
compare:
 Disease progression
 Therapeutic outcomes using a tenofovir
containing treatment regimen
 Monitor drug resistance
• Target population:
 119 seroconvertors at end of CAPRISA 004
 54 post-004 seroconvertors
 Seroconvertors in CAPRISA 008
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Current status of CAPRISA 009
• All seroconvertors who agree are in followup and care in CAPRISA 002/ Acute Infection
Study until ARV treatment eligible
• First patient initiated on ARV treatment in
CAPRISA 009 in June 2011;
 34 initiated on ARV treatment
 15 from the tenofovir gel arm
• 6 month treatment success rate – 88.9%
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Summary
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CAPRISA 008 provides an opportunity to generate
evidence for implementation that will be required when
a licensed product is available

Inclusion of research naïve volunteers from community
completes ethical obligations and adds value to experience
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CAPRISA 009 will provide additional safety data postinfection following exposure to tenofovir and provide
data on concerns about drug resistance and
therapeutic options for post-PrEP seroconvertors
•
Toolkit based on experiences and outcomes from 008
and 009 will enable rapid introduction and scale-up of
a licensed product
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Conclusions
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•
Tenofovir gel potentially adds a new approach to
empower women to take control of their own risk
of HIV infection
•
CAPRISA 004 is the first step – it is likely that
with time other products and formulations will
surpass tenofovir gel
•
Post-trial access of tenofovir gel through
CAPRISA 008 provides an opportunity to
generate evidence for implementation that will
fast track the timelag between potential licensure
and public access
Acknowledgements
•
Financial support:
 USAID through CONRAD
 The South African Government’s Department of Science & Technology (DST)
through the Technology Innovations Agency (TIA)
 M-A-C AIDS fund through the Tides Foundation
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Trial Oversight Committee:
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
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CAPRISA: Q Abdool Karim, SS Abdool Karim, LE Mansoor
USAID (US): D Stanton, L Claypool
USAID (Pretoria): R Fertziger
CONRAD: H Gabelnick, G Doncel
DST/TIA: S Gumbi, G Loots
M-A-C AIDS/Tides: N Mahon, A Flynn
Gilead Sciences: J Rooney
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Tenofovir & placebo gel: Provided by CONRAD & Gilead Sciences
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FHI Statistical: M Chen
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CONRAD regulatory support: J Schwartz, J Schafer
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Research infrastructure & training: US NIH’s CIPRA Program & the Columbia
University - Southern African Fogarty Training Program
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