UK-CAB 2: Friday 2 Aug 2002

Notes for meeting

Introduction to meeting and speakers
Background Information – BMS Pharma
Agenda for BMS Meeting (2-4pm)
Programme for the day
Venue Details

Transcripts from the meeting

Summary Report from the meeting
Genetics, Resistance and HIV Prof. Clive Loveday
PDF of PowerPoint slides of the above as a PDF file [2.5MB]
Approaches to Salvage Therapy Dr Mike Youle
PDF of PowerPoint slides of the above [1.1MB]

PowerPoint Slides from the meeting

BMS atazanavir[834KB]
BMS
d4t=ER [166KB]
BMS
DuPont083 [914KB]

1. Introduction to meeting and speakers

This is the second UK CAB meeting and we have a full and interesting programme. The reading material sent out before the meeting will help you on the day. As with the first meeting, we are fortunate to have two experienced (and very friendly) experts to provide the training:

Prof Clive Loveday

Developed the first viral load tests long before they became part of routine HIV management. These test completely changed the understanding of how HIV progressed. Previously doctors thought that after you were infected with HIV, there was a latent or dormant period, and that HIV then was triggered by something to become active again after several years.

Viral load tests showed that what actually happens, is that after the initial burst of very high levels just after infection, levels of HIV virus do drop down again, but are then progressively increasing over the next few years.

Since the arrival of combination therapy (and both advances came almost at the same time) viral load tests have become the only effective way to monitor how well HIV treatment is working. In most instances, they are the only way to judge when to change treatment. Most importantly, the viral load test that measures to <50 copies, is used to know whether you will be able to use your treatment for many years. Simply put, if you get <50 your chance of developing resistance is very low and the drugs should work for years – if you only get <400 then low level resistance is much more likely to develop and the combination will only have limited benefit.

For at least the last 15 years Clive has run the virology laboratories at the Royal Free Hospital. He is an international expert on resistance testing and has instituted and advised many expert committees and international guidelines groups.

It would be helpful if anyone who has had a resistance test can bring a print-out of their results for interpretation as part of this session.

Dr Mike Youle

Is Director of Research at the Royal Free Centre for HIV Medicine. He has been an HIV consultant for over 15 years and been at the forefront of research for all aspects of HIV. He was one of the first doctors to recommend use of multiple drug therapy in salvage therapy, and is a principle investigator for many of the currently available treatments as well as for new drugs in development. He runs a specialist research clinic using L-Acetyl Carnitine for peripheral neuropathy and is working for greater access to New-Fill for facial lipoatrophy.

Mike will talk about the approaches that are available for salvage therapy including how to use your first treatment properly so that you can avoid salvage treatment in the future. Options in salvage therapy that can be discussed include mega-HAART (more than 5 drugs) compared to regular treatment, treatment interruptions, drug level monitoring, use of new drugs within a study, use of drug in expanded access programmes, which new drugs will be available in studies in the UK.

Both training session will have plenty of time for open discussion – so please come with questions (and resistance test print-outs if you have one) and be ready to talk!

2. Background Information – BMS Pharma

Bristol Myers Squibb (BMS) is one of the largest pharmaceutical involved in HIV drug development. The company expanded further recently when they bought Du Pont Pharmaceuticals and changed their name accordingly to BMS Pharma.

Original BMS drugs include ddI (didanosine, Videx), d4T (Zerit) and a new protease inhibitor called atazanavir. With the acquisition of Du Pont they acquired efavirenz (Sustiva) and a collection of pipeline drugs (protease inhibitors and second generation NNRTIs), some of which they has since resold.

Although atazanavir (TAZ) has an overlapping resistance profile with existing protease inhibitors, it works in a different way, and appears to have a much smaller effect on lipid metabolism – and therefore may reduce the risks of lipodystrophy. This is now one of the indications for accessing TAZ in the expanded access programme.

About half the meeting with be focussed on information about atazanavir – how it works, who will it work for, interactions etc – and any other questions you have. Other ongoing issues include ddI interactions, d4T/XR, efavirenz, and new pipeline drugs. If you have specific questions for the agenda, please send me an email and I’ll forward it to the company.

Dr Andrew Clark is the Medical Director for HIV drugs at BMS, and will lead most of the treatment-related discussion. He is a very experienced HIV consultant, previously working in South Africa, only recently went into the pharmaceutical industry when he joined BMS a couple of years ago, notably after presenting several well published studies about a beneficial effect on facial lipoatrophy by switching from d4T!

Because of his history as a treating physician, he is also ideally placed to answer questions relating to the management of side effects associated with any of the BMS drugs.

3. Agenda for BMS Meeting (2-4pm)

Company overview (15 mins)
Overview of atazanavir
Current licensing status and ongoing studies
Resistance profile
Lipid profile
Side effects
Food interaction data
Interactions with other HIV medications
Indications for use
Future development studies
Paediatric formulation
Use in pregnancy
Availability to developing countries(60 mins)
Other issues (45 mins)
ddI interaction with tenofovir and foodOnce-daily formulation of d4T (d4T/XR)
Questions about efavirenz
Overview of pipeline drugs (BMS-806 – new entry inhibitor; DPC 081/083 – NNRTI, DPC protease inhibitor).

4. Programme for the day

8.45 – 9.00
Registration
9.00 – 9.30
Introductions and aims of day.
9.30 – 11.00
Prof Clive Loveday (tbc)
Primer on resistance:
Basic mechanisms of resistance, how to avoid resistance, when to change treatment, how to interpret different resistance tests
11.00 -11.20
Break
11.20 -1.00
Dr Mike Youle, Director of Research, Royal Free Hospital
Strategies for salvage therapy:
avoiding initial failure, mega-HAART including Optima Study, treatment interruptions, use of new drugs in expanded access and in studies, pipeline drugs with UK studies.
1.00-2.00
Lunch
2.00 – 4.00
Andrew Clark Bristol Myers Squib Pharma
Overview of atazanavir:
Resistance profile. Side effects and safety Lipid profile Expanded access programmeOther: (ddI, d4T, efavirenz, pipeline)ddI interaction with tenofovir and food Once-daily formulation of d4T Brief overview of pipeline drugs
4.00 – 5.00
Feedback Seesion
Follow-up from BMS meeting
Feedback from Barcelona conference
Programme for next UK CAB (October)
Ongoing training programme

 

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: August 2, 2002
Last edited: August 15, 2013