CAB 1: Friday 31 May 2002

Notes for meeting

Introduction
Reading Material
Background information on Gilead
Agenda for Gilead meeting
Programme for day
Venue Details

PDF files of PowerPoint slides from May meeting:

GILEAD [328k]
Norbert Tamm [112k]
Timn Peto [152k]

PowerPoint slides from May meeting:

GILEAD [2.2MB]
Norbert Tamm [52k]
Timn Peto [332k]

Report from May meeting

as a PDF file:

1. Introduction Community Advisory Boards

Currently there is no forum in the UK where patient/community groups can formally meet with either research groups or the pharmaceutical industry. Where organisations do have contact with a company it is more likely to be related to funding and/or marketing.

What is a CAB and what does it do?

An independent CAB can have many roles. It can be a forum for:

  • General discussion about any treatment issue
  • Ideas about trial design
  • Focus for community groups

Community Advisory Boards or CABs are a way that ordinary, non-professional people can have some input into their healthcare at many levels. This can include planning effective trials that have better standards of care and safety than would otherwise be the case. It can also involve making sure that patient information is clear. CAB groups can also become involved in getting early access to new drugs.

Meetings with companies can also focus on the reality of taking treatments and result in better research ad monitoring of side effects. It can also increase interactions between patients and patient groups and scientists at the companies that are producing the drugs that we use.

In the US CABs have been established for many years with the major government research centres and hospitals. Individual companies also set up CABs. More recently the ATAC group (American Treatment Activists Coalition, http://www.atac-usa.org/) has been formed so that one group of people across the US can meet with each of the companies.

A European CAB (ECAB) has been running for about four years and includes community activists from 18 countries who meet for three days every two months. Following the ECAB model, national CABs have been set up in Italy, Spain and Germany.

In France, TRT-5 is an umbrella organisation which includes people from the seven largest treatment-focussed HIV organisations, and which meets with industry, government and researchers.

We think that it would be very useful to develop a UK-CAB along similar lines. As with the ECAB, this can provide training on specific subjects and strengthen links between community groups as well as meeting with companies.

This group could meet 4-6 times a year. The programme for these meetings should be developed with group members, perhaps with an organising group.

2. Reading Material

An Assay is a Test Or How to Talk to Real People
By Julie Davids and Karen L. Lyons

A Guide for HIV/AIDS Community Advocates
collected by Julie Davids for Project TEACH, with help from Charles Nelson, Kiyoshi Kuromiya, and Jane Shull

Thinking it Over: Is a Clinical Trial Right for Me?
From NIH: AIDS clinical trials: Talking it Over

MRC HIV Trials

Reading Is Believing? A Guide to Clinical Trial Reports

3. Background information on Gilead

Gilead Sciences research and market drugs that work against HIV, hepatitis B, fungal Infections, influenza and Kaposi’s Sarcoma (KS). Many of the drugs they have developed have broad anti-vial activity. Most ot the UK-CAB meeting will focus on tenofovir for HIV. Gilead is a US-based company whose main subsidiaries are in France, Spain, Germany, UK and Italy. The UK site in Cambridge deals with international safety and regulatory support. Although there is an office in Greece this is only a distribution point for the rest of the world.

Corporate headquarters is in Foster City, California. Oncology and Research and Development (R&D) are in Boulder, Colerado, and the plant manufacturing liposomes is in San Diego. [1] European distribution is from Ireland

Around 80% of just over 800 staff are based in the US. Staff outside the US are mainly involved in sales and marketing many of who are new to HIV.

Powerpoint Slide
click on slide for a larger view

HIV drugs developed by Gilead

Gilead have developed several antiviral drugs that are active against HIV and other viral infections:

Tenofovir

Tenofovir is a nucleotide analogue that is the most recently approved HIV drug (in the US in October 2001 and in Europe in February 2002). Tenofovir produces approximately –0.6 log drop in viral load in people who are treatment experienced and –1 log drop in people who are treatment naïve. Most importantly it is active against HIV that is resistant to AZT and 3TC.

Tenofovir is also active against hepatitis B, although the development programme for hepB is only just entering larger studies.

Adefovir

DaunoXome (daunorubicin citrate liposome injection), a liposomal form of the anticancer agent daunorubicin, is the only oncology product to receive clearance as a first-line chemotherapy agent for advanced AIDS-related Kaposi’s sarcoma (KS).

It may also be active against Non-Hodgkins Lymphoma.

Cidofovir

Cidofovir (Vistide) (cidofovir injection) is an antiviral medication for the treatment of cytomegalovirus (CMV) retinitis. Approved in the US in June 1996 and in May 1997 in Europe. As with other anti-CMV IV drugs cidofovir is a toxic and difficult to tolerate drug that requires careful monitoring.

Cidofovir is active against other viruses including HPV (warts), JC virus (PML), herpes, HHV-8 (KS) although early studies have not always proved clear benefits and cidofovir is not licensed for any of these indications.

It has also produced successful results when used as a gel to treat HIV-related molluscum.

AmBisome

AmBisome (amphotericin B) liposome for injection is a liposomal formulation of the antifungal drug amphotericin B for the treatment of confirmed infections caused by various fungal species or visceral leishmaniasis, a parasitic infection. Additionally, AmBisome is used to treat patients who are refractory to or intolerant of conventional amphotericin B therapy. These infections can be life threatening, particularly in patients who have depressed immune systems as a result of aggressive chemotherapy regimens or HIV infection.

  1. Liposomes are closed lipid spheres (1/1000th the width of a human hair) comprised of the basic components of natural human cell walls. By enclosing a drug in a liposome, you get improvements in the way a drug is released throughout the body and the amount of time it remains within the body.

4. Agenda for Gilead Meeting

2.00 – 4.00
Gilead
(15 mins)
Company overview
(60 mins)
Overview of tenofovir

Registrational study results
Resistance profile
Side effects
Food interaction data
Indications for use
Future development studies
Paediatric formulation
Use in pregnancy
Availability to developing countries
Tenofovir for hepatitis B and coinfection

(30 mins)
Adefovir for hepatitis B:

Adefor Efficacy and safety results and development timeline
Expanded access programme
Availability to developing countries

(15 mins)
Other questions: Cidofovir etc

5. Programme for day

Draft Progamme revised 28/5/02

8.30 – 9.00
Registration
9.00 – 9.30
Introduction – i-Base
Why we need a network for advocates in the UK.
Aims of day.
9.30 – 11.00
DouglasNewberry
and tbc Medical Research Council (MRC)
Clinical trials:
Introduction to structure of trials, timelines and trial design.
Basic statistics and study power
MRC and current studies
11.00 -11.20
Break
11.20 -1.00
Speaker to be confirmed
Informed consent and patient involvement in trials
1.00-2.00
Lunch
2.00 – 4.00
Gilead
Overview of tenofovir for HIV
Resistance profile. Side effects and safety
How to use TNF in clinical practice
Indication in US vs EuropeAdefovir for HBV
4.00 – 5.00
Feedback Seesion
Role of advocates. Coordinated input into studies, EAP programmes and pharmaceutical companies etc.
UK Forum. European and US Community Advisory Boards.Programme for next two meetings

 

Financial support

The UK-CAB receives unrestricted funding from some pharmaceutical companies towards the direct costs of holding four meetings each year. This funding supports the travel and accommodation costs for members to attend from outside London, plus the cost of catering.

The content, programme and agenda for meetings is decided by the UK-CAB steering group in consultation with the wider membership. Funding is unconnected to meeting content.

We believe that manufacturers who currently develop and market medicines have a responsibility to actively engage with advocacy organisations and that HIV positive people and their advocates should be able to directly question manufacturers about the safety and efficacy of their products and proposals for future research.

For a list of companies that support the UK-CAB please see the “about us” page.

Edit
Published: May 31, 2002
Last edited: August 15, 2013