tag@treatmentactiongroup.org
150 HIV Organizations Urge Continuation of D:A:D Study

To:           

Richard Gonzalez, Chairman of the Board, Chief Executive Officer. AbbVie Incorporated
George Hanna Vice President, Virology Development. Bristol-Myers Squibb
Gary Rose, Director Global Medical Advocacy, Virology. Bristol-Myers Squibb
Norbert W. Bischofberger, PhD, Executive Vice President. Gilead Sciences
Daria Hazuda, PhD, Vice President. Merck
Mike Miller. HIV Drug Discovery & Development, Merck
Paul Schaper, Executive Director, Global Health Policy. Merck Sharp & Dohme
David Anderson, MD, Senior Medical Director. Janssen Therapeutics
Frank Tomaka, Senior Director, Global Clinical Development. Johnson & Johnson
John Pottage, MD, Chief Scientific and Medical Officer, ViiV Healthcare

Cc:

Mondira Bhattacharya and Richard Rode, AbbVie Incorporated
Simon Portsmouth and John Coumbis, Bristol-Myers Squibb
Barbara Long and Geraldine Reilly, Gilead Sciences
Christiane Moecklinghoff and Marc Ceuppens, Janssen
Christopher Mast and Fabio Lievano, Merck
Neil Shortman and Robert Cuffe, ViiV Healthcare

February 20, 2015

The undersigned organizations strongly support the D:A:D study.

HIV drugs are used in combinations, so it is right that the companies who make and sell these drugs collaborate on this study on long-term safety.

We urge the following companies to continue funding this vital study: AbbVie, Bristol-Myers Squibb, Gilead Sciences, Janssen, Merck Sharpe Dohme and ViiV Healthcare.

The funding must also make it possible to add new patients to the D:A:D database for another five years, since many will be starting treatment with newer HIV drugs.

For over 15 years the D:A:D study has been a remarkable collaboration.

Since 1999, it has included:

  • The US and European drug safety bodies (the FDA and the EMA)
  • Drug companies that manufacture HIV drugs
  • Independent scientists and researchers
  • HIV community representatives

What has the D:A:D study shown so far?

D:A:D was originally set up to look at HIV drugs and the risk for liver and heart disease.

Since then, D:A:D  has answered many other long-term safety issues.

These include:

  • The risk of rare side effects from individual drugs
  • HIV drugs and body shape changes
  • HIV drugs and blood pressure
  • The long-term safety of HIV drugs and the liver
  • HIV and hepatitis coinfection
  • A new HIV-specific calculator for heart disease risk
  • Causes of, and risk for, death among HIV-positive people
  • Making sure that causes of HIV-related deaths are recorded accurately
  • HIV drugs and kidney disease
  • HIV and cancers, especially non-AIDS cancers
  • HIV drugs and diabetes
  • HIV drugs and stroke

D:A:D combines results from over 50,000 HIV-positive people from 11 research networks in Australia, Europe and the US.

Although the companies no longer have to fund this study, we think D:A:D is too important to let close.

Results from D:A:D have been used to change HIV treatment guidelines and the way people are treated by their health care providers.

D:A:D has developed practical tools for estimating risk of heart and kidney disease in HIV-positive people.

D:A:D has also reported new side effects that were not found when the drugs were first studied, including:

  • Heart disease with abacavir, ddI, saquinavir, lopinavir/ritonavir, and indinavir/ritonavir
  • The risk for diabetes with d4T
  • Kidney damage with tenofovir, atazanavir/ritonavir, and lopinavir/ritonavir

D:A:D has also showed that other drugs did not have these side effects.

D:A:D has also shown whether guidelines are being followed.

  • It reported on use of lipid lowering drugs among HIV-positive people
  • It provided evidence that stopping smoking has similar impact on heath for HIV positive people as the general population
  • It showed that people at high risk of suicide were not using efavirenz (and that efavirenz did not increase suicide rates in people who were not at high risk)

What is needed now?

We need this essential study to continue.

We need new patients to be included to answer the same questions for the newest drugs and combinations.

Why do we need D:A:D to continue?

D:A:D is critical for many reasons:

  • D:A:D results gives people the confidence to start HIV treatment. It is an independent study that produces real-life data (including people who are not well-represented in studies, including women).
  • Because HIV treatment is now being used earlier and at higher CD4 counts.
  • Because D:A:D can detect new safety concerns that we might not yet know about.
  • D:A:D can look at risks in specific groups of people living with HIV. For example, by age at infection, gender, ethnicity, race, sexual orientation, illicit drug use, and in younger and older people.
  • ART is lifelong. We therefore need longer-term information about drug- and drug class-specific safety and tolerability, including additional data on reversibility of toxicities when drugs are switched.
  • D:A:D can identify safety concerns or rule out concerns with new drugs or drug classes. This includes the newest integrase inhibitors (raltegravir, elvitegravir, dolutegravir). It can look at new drugs like etravirine, cobicistat and the new version of tenofovir (TAF).
  • D:A:D can look at long-term outcomes after treatment with new hepatitis C drugs. More than 4,000 people in D:A:D are infected with both HIV and hepatitis C.
  • We need to know more about generics and co-formulated drugs.
  • We need to know more about drug-drug interactions and long-term safety. This is particularly true as we get older. By 2016, more than 5,000 people in D:A:D will be over 60. Half of the people in D:A:D will have been using HIV meds for more than 10 years.

If D:A:D is allowed to end, it will be lost forever.

If there is a new safety issue, we will not be able to rebuild D:A:D—16 years of results will be lost.

For these reasons, we urge the above companies to support the D:A:D study for another five years.

Continuing to fund D:A:D makes a powerful statement about your company’s commitment to people living with HIV/AIDS.

Your support sends a clear message about supporting our communities and health care providers.

This research is invaluable to millions of people living with HIV/AIDS. It has a direct effect on our lives.

We hope to hear that you are willing to continue supporting D:A:D.

 

Signed:

4HIVHelp, USA

ABD – Asociación Bienestar y Desarrollo, Spain

Abounding Prosperity Inc, USA

ABPLUS, UK

acavih, Spain

ACRIA, USA

ACT UP New York, USA

Adhara, Spain

African American Health Program, USA

AID FOR AIDS, USA

AIDS Action Baltimore, USA

AIDS Foundation of Chicago, USA

AIDS Research Alliance-Los Angeles, USA

AIDS Resource, USA

AIDS Treatment Activists Coalition – ATAC, USA

American Run to End AIDS (AREA), USA

APOHA (Association for support people living with HIV), Bosnia and Herzegovina

APOYO POSITIVO, Spain

ARRIVE, USA

AS – Center for the Empowerment Youth of people who are living with HIV and AIDS, Serbia

Asociación COMIT… CIUDADANO ANTISIDA DE PALENCIA, Spain

Asociación T4 DE LUCHA CONTRA EL SIDA, Spain

Asociación Caracol, Spain

Asociación Itxarobide, Spain

Association Lux Vitae, Croatia

Association of HIV affected women and their families, Demetra, Lithuania

Association PROI, Bosnia and Herzegovina

Association SKUC, Slovenia

Australian Federation of AIDS Organisations AFAO, Australia

Austrian HIV Cohort Study, Austria

AVERT, UK

BASELINE Magazine, UK

Best foot first, UK

CALCSICOVA-Coordinadora de Asociaciones de VIH y sida de la Comunidad Valenciana, Spain

Canadian HIV/AIDS Legal Network, Canada

Cara Trust, UK

CHOW Project, USA

Clinical Hospital of Infectious and Tropical Diseases Dr. Victor Babes, Romania

COCQ-SIDA, Canada

comision anti-sida de la rioja, Spain

COMITE CIUDADANO ANTI-SIDA DE ASTURIAS, Spain

COMITE CIUDADANO ANTISIDA DE BURGOS, Spain

COMMUNITY AND FAMILY AID FOUNDATION, Ghana

Coordinadora Estatal de VIH y sida, Spain

Coordinadora Vivo Positivo, Chile

CREDUM, Czech Republic

CWRU, USA

Czech AIDS Help Association, Czech Republic

DCAB, Germany

Drive for Universal Healthcare (DUH), USA

End AIDS Now, France

End AIDS Now, USA

Estonian Network of PLWH, Estonia

Ethno-Medizinisches-Zentrum, Germany

European AIDS Treatment Group – EATG

European Community Advisory Board – ECAB

Family Equality Council, USA

FEAT, Spain

FreeLance Medical Consultants, USA

Friends of Treatment Action Campaign – UK  (FoTAC), UK

Fulton County Jurisdictional Planning Group, USA

FUNDACION 26 DE DICIEMBRE, Spain

Fundación Tri·ngulo, Spain

GAT – Grupo de Ativistas em Tratamentos, Portugal

Gay Health Advocacy Project – Columbia U, USA

GCAB/ACTG, USA

GHAP at Columbia, USA

Glide Foundation, USA

Greater Love HIV Services, USA

Grupo de Trabajo sobre Tratamientos del VIH (gTt), Spain

H.O.P.E. Alliance, USA

HCMSG-The Hepatitis C Mentor and Support Group, Inc., USA

He Intends Victory, USA

Health Education Network, USA

HIV Dental Alliance, USA

HIV i-Base, UK

HIV Justice Network, UK

HIV Prevention Justice Alliance and AIDS Foundation Chicago, USA

Hope Against AIDS Foundation, Bulgaria

Hwupenyu Health and Wellbeing Project, UK

i-Foundation, Bulgaria

I’m Still Josh, USA

IFARA, USA

Indian Walk in center, USA

Institute for public health Belgrade, Serbia

International HIV Partnerships, UK

Kirby Institute UNSW, Australia

Let’s Kick ASS – AIDS Survivor Syndrome, USA

Lila Italian league for fighting aids, Italy

MAS Marketing, USA

MEDFASH (Medical Foundation for HIV & Sexual Health), UK

Methodist Church Ghana, Ghana

Mind, UK

MSF, India

Nadir Onlus, Italy

NAM / aidsmap.com, UK

National Coalition for LGBT Health, USA

National Coalition of People Living With HIV in India, India

National Long Term Survivors Group, UK

National Minority AIDS Council – NMAC, USA

NEPHAK, Kenya

Network of Low HIV Prevalence Countries of Cenrtal and South East Europe – NeLP, Regional – Central and South East Europe

NGO Action Against AIDS, Bosnia and Herzegovina

NHS Lothian, UK

Nightsweats & T-cells, Co., USA

NLTSG, UK

NPS Italia, Italy

Open Arms support group, program of Michigan AIDS Coalition (MAC), USA

PeterCares House, USA

Philadelphia FIGHT, USA

Plus Onlus, Italy

Positive Life Series – Palm Springs, USA

Positive Living Association, Turkey

Positive People Armenian Network NGO, Armenia

Positively UK, UK

POSSITIVE VOICE, Greece

Project Inform, USA

Projecte dels NOMS-Hispanosida, Spain

Projekt Information e.V., Germany

PSPS, Puerto Rico

Q-Club, Serbia

Redribbon o.s., Czech republic

Reliable Diagnostic Supplies (Pty) Ltd, South Africa

Sai Heart hospital, India

Salamander Trust, UK

San Francisco AIDS Foundation, USA

SCOTFREEHIV, UK

solidarmed, UK

Stronger Together, Association for Support of People Living with HIV, Macedonia

Treatment Action Group, USA

TAPWA, Tennessee Asso. of People With AIDS, USA

Test Positive Aware Network, USA

Thai AIDS Treatment Action Group, Thailand

The Ihangane Project, USA

Thru with HIV, USA

Treatment Education Network, USA

TRT-5, France

UCL and UNSW, UK and Australia

UK-CAB, UK

Union C, Nepal

Unity Fellowship Church, USA

Universal Light Ministries, Inc., USA

University Hospital for Infectious Diseases, Croatia

VIVIR EN POSITIVO, Spain

VOCAL-NY, USA

WECARe+, Germany/UK

WHO India, Inda

World Foundation for Medical Research and Prevention, USA

World Health Organization, Switzerland

Yale Internal Medicine and Pediatrics Residency Program, USA

 

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