26/07/2013
THE FRENCH NATIONAL
AGENCY FOR RESEARCH ON
AIDS & VIRAL HEPATITIS
Titre document / Le 15 - 09 - 2013
1
Dr Didier Laureillard, ANRS, HCMC
didier.laureillard@anrs.fr
Introduction
 Public agency, created in 1992, aimed at funding and
coordinating research in all areas relevant to HIV/AIDS and viral
hepatitis
 As of 1/01/2012, an autonomous agency within INSERM
(Institut National de la Santé et de la Recherche Médicale) in
2013
 Annual budget of research: 48 Millions € (total equivalent
to 125 millions €)
 Supported by:
• Ministry of Research (39M€)
• Ministry of Health
• Ministry of Foreign Affairs
• Institutional partners : INSERM, CNRS, Pasteur Institute,
IRD, Esther
 Scientific Advisory Board:
• 50% of whose members are from outside France
• President: Pr Françoise Barré-Sinoussi
ANRS
ANRS Scientific Advisory Board
Pr Barré Sinoussi Françoise – Chair
Pr Vella Stefano – Co-Chair
ANRS
Alcami José
Barin Francis
M’Boup Souleymane
Moradpour Darius
Ball Andrew
Davril Juliette
Douek Daniel
Negro Francesco
Persiaux Renaud
Reiss Peter
Fischer Hugues
Lerderman Michael
Lert France
Schechter Mauro
Trepo Christian
Weller Ian
Levrero Massimo
Commitment to all areas of research
 Basic research
 Vaccine research
 Clinical, therapeutic and epidemiologic research
 Research in public health and the human & social
sciences
 Research in resource limited countries
ANRS
Who are the researchers ?
 Researchers are :



clinicians,
biologists,
social science specialists
 They are based in the laboratories of INSERM,
CNRS, Pasteur Institute, IRD, and universities and
hospitals
 Some of them are not working in France but are
based in other countries
ANRS
ANRS « Scientific performance »
• 550 publications/year
• Approximately 50% of publications have IF > 5.
• 1% of ANRS publications are in the 10 top international
journals
• 6,2% of ANRS publications (HIV/AIDS and hepatitis) are in
the 1% group of excellence (number of citations), higher than
the national average in the field of biology/health
• France is ranked 2nd or 3rd international position in the field of
HIV and 2nd in the field of hepatitis
ANRS
ANRS Funding Mechanisms
• 2 main calls for proposals/year
• Top-down vaccine research programme
• Clinical Trials: AC5/AC24 committees for approval and
funding
• ANRS: essentially only funder for HIV and viral hepatitis
research in France
• ANRS: funds research, but not institutions, nor salaries
ANRS
% Distribution of funds according
to research area 2012 (44 M €)
• Basic Science HIV
14 %
• Vaccine HIV-HCV
12 %
• Clinical trials and cohorts (HIV)
26 %
• Epidemiology/socio-behavioral science
7%
• Resources limited countries (HIV-Hepatitis)
22 %
• Hepatitis B and C
19 %
ANRS
GLOBAL HEPATITIS 24% (11 M €)
GLOBAL BASIC SCIENCE : 39% (17 M €)
4 main ANRS priorities HIV
• Study reservoirs with the objective of eradication or
functional cure
• Testing: Novel methods; Early and better treatment
• Prevention of new infection with a biomedical
approach
• Develop new vaccine strategies
With a NORTH   SOUTH vision
Integrating economic aspects
ANRS
5 main ANRS priorities Hepatitis
•
•
•
•
•
Molecular mechanisms involved in cell-virus
interactions
Relationships between fibrosis, inflammation and
viral replication
Strategic evaluation of new molecules anti HVC
(Cohorte, co-infections...)
New tools for prevention
HBV Cure
+ research priorities in Social and Health Science:
- Hepatitis B and C among drug users and inmates
- Screening strategies of HCV and HBV chronic infection,
including rapid tests,
- Modeling of HCV transmission among drug users
ANRS
Research in resource-limited
countries
ANRS
Developping countries department
By 1994, the ANRS started to fund research
projects in many resources-limited countries, and
has set up sites in Africa, Asia and South America
A specific department and a specific scientific and
review board (CSS6) were set up
2 calls for grant/year: 15 of March & 15 of September
In 2012: ¼ of its budget (ie, ≈12 millions €) to research on
HIV/AIDS and viral hepatitis in these countries
≈ 70 ongoing projects
ANRS
ANRS in resource limited countries
ANRS
Ongoing projects in resource limited
countries in 2013
ANRS
ANRS in Viet Nam
ANRS
Introduction
 Collaborations between French and Vietnamese researchers
began in 1988.
 6 January 2000: official agreement between Vietnam Ministry
of Health and ANRS for collaboration and creation of an ANRS
site in Viet Nam
 Most ANRS-funded studies were conducted in Ho Chi Minh
City, with support from Pasteur Institute and the city’s hospitals,
in the framework of national (VAAC) and provincial (PAC)
programs in the fight against HIV/AIDS.
 The studies now extend to the north of the country, notably in
Hài Phòng.
 13th of March 2014: Official agreement for collaboration with
Hanoi Medical University
ANRS
ANRS Site Coordinators
French Coordinator
Vietnamese Coordinator
Pr Françoise Barré-Sinoussi Pr Truong Xuan Lien
Pasteur Institute
Pasteur Institute
Paris, France
Hô Chi Minh City, Viet Nam
ANRS
More than 10 years of collaboration
Training &
technology transfer
Basic research
Social sciences
Biological characterizations of HIV-1 - Sexual behaviors & HIV/AIDS
- Social determinants of access to
Immune & genetic determinants of
protection
care for children living with HIV
2 projects
7 projects
Clinical research
Improving diagnostic & treatment of
patients infected by HIV & associated
diseases (TB, Hepatitis…)
ANRS
14 projects (5 ongoing)
18
A lot of partnerships
ANRS
France
Ministry of health
Vietnam
Co-ordination
Truong Xuan Lien & F.Barre-Sinoussi
-Pasteur Institute HCMC
-Health service HCM & Hải phòng
-PAC HCMC & Hai phong
-Pham Ngoc Thach Hospital
-Pediatric Hospital n°1 & 2
-National Pediatric Hospital
-OPC HCMC & Hải phong
-Việt Tiệp Hospital Hai phòng
-Medical University Hải phòng
-Southern Institute of Social Sciences
- Vietnamese academy of social
sciences
-Institute for Population and Social
ANRS
-Studies,
National Economics
University
-Institut Pasteur Paris
-Université d’Aix Marseille III
-Université Victor Segalen, Bordeaux
-Kremlin Bicêtre hospital, Paris
-European G.Pompidou hospital, Paris
-Necker hospital, Paris
-Pitié-Salpétrière hospital, Paris
-Saint Antoine hospital, Paris
-INSERM
-Montpellier medical University
-IRD, Marseille et Montpellier
-ESTHER
19
ANRS funded ongoing projects
in Viet Nam
ANRS
ANRS 12150 – RAP
Pharmacokinetics of rifabutin with antiretroviral
therapy in the treatment of tuberculosis patients with
HIV infection in in Ho Chi Minh City
 33 TB-HIV co-infected patients enrolled
 End of clinical activities: october 2012
 Presentation of results :
• Ethic paper published to « Public Health Action » –
June 2013
• Poster at IAS conference – July 2013
• Oral presentation at World TB Union conference –
Paris, October 2013
• Princeps paper published in « PLoS One » – January
2014
 PK-genomics analysis still on-going
ANRS
PAANTHER 01 – ANRS 12229
Pediatric Asian African Network for Tuberculosis and HIV Research
Improving diagnosis of Tuberculosis in HIV-infected
children in Asia & Africa with alternative specimen
collection methods (string test, nasopharyngeal
aspirate) and Xpert MTB/RIF assay
 420 HIV-infected children with suspicion of TB
 4 countries: Burkina Faso, Cambodia, Cameroun, Vietnam
 Principal objective: Develop a diagnostic algorithm to
improve the diagnosis of TB in HIV-infected children
 In Vietnam, HCMC:




ANRS
3 hospitals : Pham Ngoc Thach hospital, Nhi Dong 1, Nhi Dong 2
Enrolment started in September 2012
108 children enrolled
End of enrolment: June 2014End of the study: December 2014
ANRS 12290 – STATIS
Systematic empirical vs. Test-guided Anti-TB
Treatment Impact in Severely immunosuppressed HIVinfected adults initiating ART with CD4 <100/mm3
 Multi-countries, two-arm, unblinded, randomized,
superiority trial: Ivory Coast, Cambodia, Cameroun, Uganda,
Vietnam
 Principal objective: To compare the 24-week risk of death
and occurrence of invasive bacterial infection between 2
experimental strategies :
 continuous extensive TB screening (chest X-ray, Xpert, urine
LAM) during follow-up when the patient present symptoms
 systematic empirical TB treatment (2ERHZ/4RH) started 2 weeks
before ART initiation
 Specific objectives: Mortality, bacterial infections, loss-tofollow-up, morbidity, tolerance of TB treatment, efficacy of ART,
care consumption, cost-effectiveness of the strategies.
ANRS
ANRS 12290 – STATIS
Systematic empirical vs. Test-guided Anti-TB
Treatment Impact in Severely immunosuppressed HIVinfected adults initiating ART with CD4 <100/mm3
 1050 HIV-infected adults (CD4<100/mm3), naïve of ART
 In Vietnam, Pham Ngoc Thach hospital, HCMC:
 300 patients
 Process of submission to ERB MOH
 First patient enrolled September 2014
 Inclusion time: 24 months
 End of follow-up: August 2017
 First results: December 2017
ANRS
ANRS 12300 – REFLATE TB 2
Non-inferiority of TDF/3TC & Raltegravir 400 mg BID
compared to TDF/3TC/Efavirenz in ART naïve HIVinfected patients receiving Rifampicin
TDF245mg qd + 3TC 300mg qd + EFV 600 mg qd
1:1
460 patients
• VIH-1
• ART naïve
• Tuberculosis
• RIF containing
regimen
TDF245mg qd + 3TC 300mg qd + RAL 400 mg bid
RHZE 2mo followed by RH 4mo
W0
Phase 3 randomized trial in Brazil,
France, Ivory Coast, Mozambic, Vietnam
ANRS
W 24
W48
Primary endpoint
HIV RNA<250 copies/mL
ANRS 12262 – FIBRHIVIET Study
Pilot Study on clinical and virological
characteristics of HIV-HCV co-infected patients in
Hai Phong
 Main objective: To describe clinical and virological
characteristics of HCV/HIV co-infected patients followed in Viet
Tiep Hospital and potentially eligible for a HCV treatment
 Specific objectives:
 To determine the proportion of patients with active HCV
infection
 To determine the genotype distribution of HCV infection
 To assess the severity of liver fibrosis
 To study factors associated with severity of liver fibrosis
 Cross-sectional study in 111 HIV/HCV co-infected patients
 Just finished clinical & biological activities  Analysis ongoing
ANRS
ANRS 12299 – DRIVE-IN Study
Feasibility phase of an interventional project to
reduce HIV incidence among people who inject
Drugs in Hai Phong, Viet Nam
 Primary objective: to evaluate the feasibility of implementing
an interventional cohort of PWID in Hai Phong by
demonstrating that enrolment and follow-up of various hard-toreach subgroups of PWID is feasible in the local context.
 Sponsored by ANRS, funded by ANRS & NIDA
 600 participants to the RDS study, then 250 participants
followed 6 months

Agenda:
Approved
by ANRS in July 2013
Primary
Objective: To
the efficacy
a combined preventative intervention
 Submission
toassess
IRB HPMU
nextofweek
targeting PWID on the reduction of HIV incidence.
 First objectives:
patient enrolled
September
Secondary
To estimate
the impact2014
of the intervention on HCV
To estimate
overall HIV and drug-related morbidity and mortality,
incidence,
Inclusion
time: 6the
months
ANRS
determinants
of 2015
risk and harm reduction seeking behaviours,...)
To identify
End ofthe
follow-up:
May
Research priorities in Vietnam
 Related to the National HIV/AIDS Research Agenda
 Basic sciences, epidemiology, clinical trials, social
science, …
At this moment:
Interventions in most at risk populations, notably
PWUDs (ex: “Test and Treat strategy”)
Co-infection with Tuberculosis (ex: “Phase III with
rifabutin”)
Viral hepatitis C (ex: “Pilot project on HCV
treatment in HIV-coinfected patients”)
 But others topics possible
ANRS
Process to obtain ANRS funds for
research project
 2 call for grants/year:
 Deadline 15th of March & 15th of September
 Specific forms for submission (available on ANRS website,
in French)
 Submission in English OK
 2 Principal Investigators: 1 from Vietnam and 1 from France
 Max: 36 months project
 Review by an independent scientific Committee (CSS6):
 Meetings in June & December
 Answer 1 month later (positive in 25-30%)
 If needed: Help from ANRS site coordinators (finding
French partners, writing protocol, submission, …)
ANRS
ANRS
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