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THE FRENCH NATIONAL AGENCY FOR RESEARCH ON AIDS & VIRAL HEPATITIS. 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

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the french national agency for research on aids viral hepatitis

THE FRENCH NATIONAL AGENCY FOR RESEARCH ON AIDS & VIRAL HEPATITIS

Dr Didier Laureillard, ANRS, HCMCdidier.laureillard@anrs.fr

Titre document / Le 15 - 09 - 2013

introduction
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

commitment to all areas of research
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

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

Who are the researchers ?
anrs scientific performance
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 funding mechanisms
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

distribution of funds according to research area 2012 44 m
% 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 %

GLOBAL HEPATITIS 24% (11 M €)

GLOBAL BASIC SCIENCE : 39% (17 M €)

4 main anrs priorities hiv
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

slide10
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

5 main ANRS priorities Hepatitis

  • + 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
developping countries department
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
introduction1
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

slide18

More than 10 years of collaboration

Training &

technology transfer

Social sciences

- Sexual behaviors & HIV/AIDS

- Social determinants of access to

care for children living with HIV

2 projects

Basic research

Biological characterizations of HIV-1

Immune & genetic determinants of protection

7 projects

Clinical research

Improving diagnostic & treatment of patients infected by HIV & associated diseases (TB, Hepatitis…)

14 projects (5 ongoing)

18

slide19

ANRS France

Ministry of health Vietnam

A lot of partnerships

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
  • 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 12150 rap
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
slide22

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

PAANTHER 01 – ANRS 12229

Pediatric Asian African Network for Tuberculosis and HIV Research

  • 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:
    • 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
slide23

ANRS 12290 –STATIS

Systematic empirical vs. Test-guided Anti-TB Treatment Impact in Severely immunosuppressed HIV-infected 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-to-follow-up, morbidity, tolerance of TB treatment, efficacy of ART, care consumption, cost-effectiveness of the strategies.
slide24

ANRS 12290 –STATIS

Systematic empirical vs. Test-guided Anti-TB Treatment Impact in Severely immunosuppressed HIV-infected 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
slide25

ANRS 12300 –REFLATE TB 2

Non-inferiority of TDF/3TC & Raltegravir 400 mg BID compared to TDF/3TC/Efavirenz in ART naïve HIV-infected 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

W 24

W0

W48

Phase 3 randomized trial in Brazil, France, Ivory Coast, Mozambic, Vietnam

Primary endpoint

HIV RNA<250 copies/mL

slide26

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
slide27

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

  • Approved by ANRS in July 2013
  • Primary Objective: To assess the efficacy of a combined preventative intervention targeting PWID on the reduction of HIV incidence.
  • Secondary objectives: To estimate the impact of the intervention on HCV incidence, To estimate the overall HIV and drug-related morbidity and mortality, To identify the determinants of risk and harm reduction seeking behaviours,...)
  • 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-to-reach 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:
    • Submission to IRB HPMU next week
    • First patient enrolled September 2014
    • Inclusion time: 6 months
    • End of follow-up: May 2015
slide28

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
slide29

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, …)