UK-CAB 19 – Meeting Report

BHIVA standards project

24 November 2006
Programme for the meeting
Background Reading
Members attending
Introductions
Feedback session and round-up of recent events
BHIVA Standards project – Hilary Curtis
Other reports back
Any other business

Post meeting report word doc [53 Kb]

PowerPoint Slides

Glasgow feedback: Gus Cairns [152 Kb]
BHIVA Standards project – Hilary Curtis [260 Kb]

Post Meeting Report

Members attending:

Elijah Amooti African Eye Magazine
Edwin Bernard NAM
Gus Cairns UKC
Ben Cromarty North Yorkshire AIDS Action
Simon Collins i-Base
Rena Greifinger Body & Soul
Robert James CAB Steering group
Jim Jewers Positive East
Mary Lima THT
Badru Male Brent PCT
Tuli Matheus Thames Valley University (NIAS)
Melba Nyambe Mangolwa ACIA / African Eye Magazine
Michael Marr Waverley Care
Beatrice Nabulya RestorEgo Consultancy
Liz Nyawade The Grace Project NIAS
Roger Pebody THT
Margareth Rungarara Naz Project
Jax Shapter Independent

Presenters:
Hilary Curtis Regordane / BHIVA audit

Introduction:

The chair (Robert James) welcomed participants.

1. Introductions

Link to top of page

2. Feedback session and round-up of recent events

Glasgow feedback: Gus Cairns

PowerPoint presentation online:

i) Gemini – a study comparing saquinavir/r to lopinavir/r (Kaletra®)
48 week open label study – people knew which drugs they got.

There were similar responses in both arms – BUT this was a very early analysis of about half the patients at 24 week.

There was a difference in lipids in favour of the saquinavir arm, but also a potential for the small differences in efficacy, that are not statistically significant in the smaller numbers for this analysis, to become significant in the full study, and over the planned 48 weeks of the study.

ii) TMC-125 study – this is a new NNRTI – designed to work against viral strains resistant to nevirapine or efavirenz.

It randomised people on current failing NNRTI-based regimen to either the new NNRTI or lopinavir/r plus best working nucleosides.

However, the trial was stopped very early because of really poor response rates.

Analysis showed that people were kept on failing first-line treatment far longer in these countries than is standard of care in the UK, and that they accumulated both NNRTI and RTI mutations. The poor response in the TMC-125 arm was largely related to people having no new nucleosides to use with the new drug.

iii) Is drug resistance in decline?

3 studies

Portuguese study – database in 3093 samples – MDR decline

Italian Study (see slides)

Spanish study (see slides)

A new report on people infected with drug-resistance HIV (from 2002 to 2004)

Gus suggested that perhaps treatment is working better and common sense hopes that resistance goes down.

iv) Tipranavir fails in treatment naïve – balance of toxicity and efficacy means this isn’t being developed as a first line drug

v) D:A:D study and diabetes

Large international cohort – ie ongoing database of >33,000 patients
952 had diabetes on study entry – excluded in analysis
745 new cases – 6% incidence
d4T increased diabetes risk by 19% a year
AZT and ddI by 6%
Nevirapine reduced the risk by 11%
Ritonavir reduced risk by 6% but probably linked just to low doses now used.
No PI association was seen.

This was a new finding and has important implications for any country where d4T continues to be used.

vi) Pregnancies in East London

Results from a single clinic- Greenway clinic in Newham

95 pregnancies in 84 HIV+ women
41% didn’t know they had HIV
10% diagnosed in last 3 months
50% had viral load >50 at delivery 34/73 = 47%
14% had VL over 1000

Why? – late diagnosis – worry about paying for treatment? Or HIV diagnosis?

Many are asylum seekers. HAART was used rather than AZT, there was a slightly higher rate of premature births, but this has already been reported, and it is unclear whether this has any negative clinical impact. Also, the use of C-section didn’t go down.

vii) Tenofovir and kidney toxicity

This is an area of concern for both patients and doctors – what is the risk?

At Glasgow, there were 11 posters and 2 oral presentations. Interpreting the different results was complicated, because of multiple definitions of toxicity, more associated with TDF than abacavir.

Generally, serious kidney toxicity was fairly rare: at rates of 0.5-4.0% clinically relevant. It was usually reversible. 2 kidney related deaths.

Other risk factors included older age, other renally toxic drugs, female gender,
Possibly less common in Africans, but other studies didn’t support this.
Effects not predictable yet.

Gilead’s posters reported bone mineral loss in their long-term (5-year) study. It is not clear if this is clinically relevant

viii) PRESCO – higher success rate from using higher doses of ribavirin – not linked to higher toxicity due to lower use of AZT

ix) Darunavir resistance patterns

11 characteristic mutations – having one or two not linked to clinical resistance (phenotypic)

Generally different from other PIs

Only in 1.5% with 3 or more mutations – but if fail darunavir other PIs may work.

x) General comment:

Roche badges distributed at the conference focussed on getting viral load <50 copies/ml (i.e. using T-20 with other newly available drugs) – but perhaps this was a theme to conference.

  • TMC-125 study showed risks of continuing to treat with detectable levels
  • UK children’s study showed very late switching
  • Trials should focus on <50 — not on VL drop
  • Issue important worldwide — no viral load testing generally

Link to top of page

3. BHIVA Standards project – Hilary Curtis

PowerPoint presentation on line:

Context within NHS

The NHS is in continual state of flux – new ideas for structure and treatment of long-term illnesses, how doctors are trained, etc.

Government policy drives many pressures on the NHS – i.e. to have diversity of providers – pressure to use new service providers:

  • GUM — easy to out source — i.e. could buy from somewhere other than local hospital.
  • Move to community provision
  • Acute sector redevelopment — always a problem — always under discussion — new chief executive is much firmer — saying services will close and change — likely to lead to smaller number of specialist services
  • Payment by results — better to think of this as payment by activity — results are not really measured – but unbundling services possible. May become more sophisticated — i.e. where payment for HIV care decided for a year, but shared between providers of different services.
  • Role of Foundation Trust — who can manage and buy in other services.
  • Primary Care Trusts are commissioning groups. Foundation Trust are the providers (i.e. hospitals, etc.)

Commissioning of specialised services – i.e. HIV – but also includes bone marrow transplant, transplant, haemophilia– every PCT must be a member of the regional group. No PCT can go off on it’s own.

Model of care for case management for chronic disease:

  • Pressure to reduce admissions
  • Mainly elderly people
  • GP and matron roles
  • Multidisciplinary
  • Self-management and expert patients

The HIV sphere could learn from this – but some things not appropriate – i.e. GPs and community matrons do not have the expertise for this.

  • Medical education — changing the way doctors are trained — HIV still not recognised as a speciality. There is a pressure for shorter training of doctors, competency based, possibility that re-certification may be developed (at least every 5 years, and not only in their speciality).
  • Advocates often know more about HIV than a general doctor.
  • Difficult to be precise about expertise and experience in guidelines.
  • Accountability — patient’s choice, partnership and accountability not easy to include.

There is a lot of concern, often anecdotal; about general in-patient care – the setting where most deaths occur, often covered by non-HIV specialists – aim of BHIVA Standards document is to raise priority of doctors with expertise of HIV to be required.

If GUM is outsourced – how will standards be met?

  • Too few GPs have any HIV experience
  • Historical baggage — record-keeping and communication (i.e. confidentiality)
  • Most serious crisis is late diagnosis — mainly because GPs don’t test for HIV, because of concern of counselling, etc. Feel strongly that this has to change.

Final document to be published in early 2007.

Q- document is interesting – building on MedFASH standards – what is the gap between standards and implementation? Will these standards be paid for?

A-Some things were left out because of cost – i.e. risk that everything would be thrown out. In themselves these standards shouldn’t be expensive – in-patient care is expensive. Getting it right is cheaper in the long run. NHS will continue to provide HIV drugs.

Q –what about pressure of new diagnosis? – perhaps 70,000 people are positive…

A- Still peanuts compared to major disease areas like cardiovascular care

Q- to reduce unplanned hospital admissions – need to strengthen community services?

A- BHIVA mainly medical association – but appropriate to say that community support is also essential.

Q-no mention of HIV-related brain impairment? Psychology needs to be stronger too.

A-standards are from doctors’ perspective

Q- HIV testing? Advocate for more testing? Role of rapid tests?

A- two different aspects – provision of testing in routine settings, which should be available much more widely; and also much greater uptake by GPs. For instance, someone with shingles can be easily recognised and treated – but should be a prompt for HIV testing.

Debate about access to testing and availability as routine service in recognition of stigma levels that are related to late diagnosis.

Denial of treatment is a big issue in African care.

NAT and THT are lobbying over inequality of charging

Can change treatment centre though and can find loopholes

GUM is becoming very different to services 20 years ago – broadening into general health, wider chlamydia screening, contact tracing etc

Next steps:

  • Building on existing networks and get commissioner buy-in
  • Accept rationalisation of in-patient care
  • Keep HIV as a specialist services

Q- how will you ensure implementation?

A-BHIVA is a doctors association – I am a consultant for the group but my commission end with the publication of the standards. As a specialist society it is recognised as having a certain standing – but has no legal power to enforce this. They are likely to be audited though, and may run a mapping exercise to see how different groups work together. Under freedom of information act a hospital could be obliged to publish individual hospital results. BHIVA don’t publish individual hospital analysis. Very rare – as the person who sees blinded data- to pick up very bad clinics – but can see that getting individual reports back to clinics is important.

Other audits only report after a new plan has been implemented.

Link to top of page

4. Other reports back

i) BHIVA sexual health guidelines – Edwin
ii) CPS – looking at hate crimes and HIV
iii) INSIGHT trial network – Simon

INSIGHT is a proposed trial network (based on the investigators and trial sites from the SMART, ESPRIT and SILCAAT studies). The MRC in the UK is one of 4 regional coordinating centres (with Copenhagen, Sydney, and CPCRA in the US). The UK site includes ~ 6 European countries, plus Morocco.

Three main studies have gone forward, outlines of which were provided as training in the CAB meeting.

  • A ïwhen to start’ trial (CD4 350 or higher etc)
  • Strategies for treatment experienced patients
  • Reduced drug options using MK-0518

The discussion focussed on different practical and ethical questions raised in each of these areas, so that community feedback could be taken to the trial planning committees.

Link to top of page

5. Any other business

Next meeting will be on Friday 26 January 2007.

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Published: November 24, 2006
Last edited: January 10, 2011