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
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.
- 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.
ABD – Asociación Bienestar y Desarrollo, Spain
Abounding Prosperity Inc, USA
ACT UP New York, USA
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
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
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
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
Czech AIDS Help Association, Czech Republic
Drive for Universal Healthcare (DUH), USA
End AIDS Now, France
End AIDS Now, USA
Estonian Network of PLWH, Estonia
European AIDS Treatment Group – EATG
European Community Advisory Board – ECAB
Family Equality Council, USA
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
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’m Still Josh, 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
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
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
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
Redribbon o.s., Czech republic
Reliable Diagnostic Supplies (Pty) Ltd, South Africa
Sai Heart hospital, India
Salamander Trust, UK
San Francisco AIDS Foundation, USA
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
UCL and UNSW, UK and Australia
Union C, Nepal
Unity Fellowship Church, USA
Universal Light Ministries, Inc., USA
University Hospital for Infectious Diseases, Croatia
VIVIR EN POSITIVO, Spain
WHO India, Inda
World Foundation for Medical Research and Prevention, USA
World Health Organization, Switzerland
Yale Internal Medicine and Pediatrics Residency Program, USA