UK-CAB 6 – Meeting report

IAS conference feedback – GlaxoSmithKline

8 August 2003


Members attending

Report from 2nd IAS conference, July 2003 Rosy Weston, Principle HIV Pharmacist, St Mary’s Hospital
Lipodystrophy Workshop, Paris, July 2003
Resistance Workshop, Mexico, June 2003

GlaxoSmithKline (GSK)

  • Access programmes
  • ACTG 5095 report (Trial with early termination of Trizivir arm)
  • Interaction between abacavir and tenofovir
  • Fosamprenavir
  • Pigment/nail changes with AZT
  • Pipeline drugs

Internal: Programme for next CAB

Presentations are all available to download from the website for the August 2003 meeting

Members and attendees

Steve Atkinson
HIV i-Base
Simon Collins
HIV i-Base
Ben Cromarty
North Yorkshire Aids Action
Richard Day
Yorkshire Mesmac
John Deakin
OUR/Yorkshire Mesmac
Marc Ennals
HIV i-Base
Paul Foster
HIV i-Base
Cathal Gallagher
Whipps Cross Hosp/Living Well
Richard Jackson
THT, Bristol
Jim Jewers
The Globe Center
Rupert Jones
West Yorkshire African Group
Mohamade Jowata
Brent PCT
Edith Kaggwa
UK Coalition
Emma Hudson
Martin Leigh
UK Networx HIV Network
Mary Makarau
Miggie Marumo
Badru Male
Brent and Harrow PCT
Rachel Nkama
Uganda AIDS Foundation
Tendai Ndanda
Rain Trust
Jo Robinson
Kapula Simonde
Waverley Care SOLAS
Cathriona Sullivan
Kings College Hospital
Carmen Tarrades
Intl Community of Women
Annie Temba
Uganda AIDS Foundation
Brian West
Waverley Care SOLAS
Kirsi Ahola
Lambeth PCT
William Babumba
African HIV Policy Network
Hope Byarugaba
Hillingdon AIDS Response Trust
Elia Phiri
Report by Simon Collins and Steve Atkinson, HIV i-Base

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1. Introduction

The sixth UK-CAB met on Friday 8th August in the middle of the summer heatwave.

Training for the morning sessions were feedback sessions from three recent conferences and workshops, and abstracts for all these meetings are now posted as pdf file to the internet:

XII Resistance Workshop, Mexico

5th Lipodystrophy Workshop, Paris

2nd IAS Conference, Paris

You may require Adobe Acrobat Reader (free software) from

The afternoon meeting was with GSK.

A small internal meeting at the end of the day discussed the programme for the next meeting.
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2. IAS Feedback

Rosy Weston, Principal Senior Pharmacist, St Marys Hospital, London

The first session began with a short introduction about the role of an HIV specific pharmacist.

Pharmacists have a wealth of information about individual drugs and drug interactions, and probably know more about this area of your healthcare than doctors who prescribing the treatment. A recent study for example showed that it is not unusual for pharmacists to pick up prescribing errors, some of them serious.

IAS Meeting

The feedback on the IAS conferences covered several studies with very important study results showing:

  • Trizivir to be much less effective than efavirenz-containing treatment
  • Significant problems with the triple nucleoside combination of abacavir/tenofovir/3TC
  • A new once-daily nucleoside called FTC (emtricitabine)
  • Nucleoside-sparing regimens
  • Use of atazanavir and boosted PI regimens
  • Further data on enfuvirtide (T-20)
  • New formulations of nelfinavir, saquinavir, both requiring fewer pills
  • Dramatic protection to breastmilk and reduction of post natal transmission using 3TC or nevirapine syrup to the baby

Details from each of these studies are provided in the set of 80 powerpoint slides posted to the i-Base website for this CAB, and a summary of each is included below.

Trizivir and 5095 Study

Triple nucleoside combinations are easy to take, have minimal drug interactions and potentially reserve other drug classes for future, but concerns include potency with higher baseline viral load (over 100,000cp/mL) and they are not recommended as first line in BHIVA, IAS or DHHS guidelines.

ACTG 5095 compared three PI-sparing regimens and closed the Trizivir arm following an early analysis when it perform significant less well to polled results of either efavirenz+AZT+3TC or efavirenz+Trizivir.

Virologic failure was defined as viral load > 200 copies/ml at 16 weeks, or previous undetectable viral load that had since rebounded. Only 61% of the Trizivir arm compared to 83% of the efavirenz containing arms had undetectable viral load less than 50 copies/ml after one year. The Trizivir group also had a shorter time to first failure and the study concluded that in treatment naïve patients Trizivir is inferior to EFV containing combinations for both rates and time to virological failure.

Triple-nuke combination of abacavir/tenofovir and 3TC

One pilot study presented at the meeting – and a larger study that released results during the same week – showed that this triple nucleoside combination performed very poorly. And produced some of the worst results presented from any combination presented in the last few years.

After both 8 and 12 weeks almost 50% of people using the triple-nuke combination had met the definition of failure compared to only 5% using efavirenz/3TC/abacavir.

The EMEA have issued a public statement not recommending the combination of abacavir/tenofovir/3TC and to increase monitoring and consider modification of treatment for people currently using this combination:

The interaction has not been explained and possible mechanisms included:

  • Interaction that caused poor absorption?
  • An intracellular interaction? – ie similar to why AZT and d4T can’t be used together
  • Resistance development?
  • Abacavir was used once daily, which is not within the official license – and it may not be an appropriate once-daily drug?

ESS40013 is another US study using tenofovir with Trizivir (AZT+3TC+abacavir) and additional data on the interaction may become available. In this study people are failing with similar resistance mutations to the other abacavir/tenofovir/3TYC studies which may be a warning sign (ie mutations M184V+K65R).

Q-Why did it take so long for 3TC to be licensed as a once daily drug?

A-Original data support twice daily, it took time to look into and produce data to satisfy licensing for once daily. Pharmacokinetics are complicated, they look at the metabolism of drug, at drugs levels and active form – difficult to do studies and produce data.

Q-Is once daily 3TC exactly the same?

A-Yes, the data have been well scrutinised by the regulatory agencies.

Q-Have patients at St Mary’s been on abacavir once daily?

A-No, we don’t use it at St Mary’s – and it is not yet licensed for once daily dosing.

New once-daily nucleoside – FTC (emtricitabine)

The US have just approved a new once-daily nucleoside, taken as a capsule with or without food, and European approval is expected in a couple of months.

FTC is manufactured by Gilead and is similar to 3TC and that also has activity against Hepatitis B.Two studies were presented to the IAS conference with FTC performing better that d4T as a background nucleoside in the 301 study.

In the FTC301 study the combination of ddI/efavirenz/FTC, all taken once daily, achieved viral load <50 copies/ml (ITT) in 74% patients at 48 weeks. The ANRS99 Study showed that people switching to this combination from their current combination had slightly better results one year after the switch (with 95% vs 87% with <50 copies/ml).

The very long half-life both in plasma and inside cells makes once-daily dosing very reliable and may also give protection in the event of occasional missed doses.

Q-Will FTC be combined with 3TC?

A-Yes, it is hoped so, and this may help in hepatitis B coinfection. Timeline is probably 2005,and it could easily come up against Combivir as starting option. It will be interesting to see pricing of FTC – if priced at same as 3TC 300mg, then could be a problem – 3TC 300mg once-daily formulation is expensive.

Nucleoside-sparing regimens

The link between lipoatrophy (fat loss) and nucleoside has prompted some researchers to look at combinations that do not include this family at all.

One study reported using only lopinavir/r plus efavirenz (BIKS Study) – preliminary results showed reasonable efficacy (64% patients <50 copies (ITT) at week 48, but not an advance group of patients to start with. (note: this study did not report on benefits from lipodystrophy, specifically fat loss, which would be a reason not to use nucleosides, and used two drugs that have greater potential for other side effects – ie Kaletra with lipids and efavirenz with CNS).

Boosted PIs

BHIVA only recommends using a PI in first line therapy if it is boosted by ritonavir – because this give a much greater protection in terms of higher drugs levels with and smooths out the differences in absorption that can be a problem with PIs.

Earlier atazanavir studies this drug performed with similar efficacy to efavirenz but that levels of people who became undetectable in the 034 study in treatment naïve patients (using unboosted 400mg atazanavir once daily) were very low (only 2 and 37% respectively <50copies after one year).

When the sample were retested using a more standard way of collecting samples (this had been changed in the first analysis) then the results were much more in line with what would be expected – ie up to 86% (ATZ) and 93% (efavirenz), which provides some reassurance for the potency of atazanavir.

In treatment experienced patients atazanavir is expected to only be used when boosted by ritonavir (300mg dose ATZ boosted by 100mg ritonavir, once daily) and in one treatment experienced study showed similar rates of response to lopinavir/r (Kaletra). Atazanavir+saquinavir together did not perform as well.

In the MaxCin2 study, lopinavir/r (Kaletra) was compared to saquinavir+ritonavir (1000mgFortovase/100mgritonavir, twice daily) in a mixed group of treatment naïve and experienced patients. This study was sponsored by Roche who manufacture saquinavir to compare it to the current standard of care, but the Kaletra arm produced better responses with more patients will undetectable viral load and less discontinuations for side effects. (Note: Fortovase was used in this study rather than Invirase formulation of saquinavir which would normally be recommended, and this may have driven the higher side effects and discontinuations using Saquinavir).

Q-What about using boosted Atazanavir?

A-Atazanavir can only be used unboosted currently (boosted dose = 300mg, requiring 150mg capsules which aren’t available yet under protocol for expanded access – only 200mg capsules are available).

Q-With boosted PI’s – all studies have used 100mg ritonavir – could you use less?

A-Yes, you could possibly get away with less but Abbott want more rather than less! Other agents could probably be used to boost drugs (studies need to come from independents research because no drug company just wants to use drug as a booster).

T-20 (enfuvirtide, Fuzeon)

The conference presented pooled data form previously presented T-20 studies showing that benefits reported at 24 weeks continue out to 48 weeks. Detailed reports on t-20 results were included in the previous CAB report (May 2003).

Q-With T-20, how long does it take for hard lumps to disappear and are they related to formulation?

A-It can take several weeks, sometimes they are quite large. You can try gentle massage, some people give the injection after a bath, some change the injection site. Some people are fine but still experience a sting.

Q-Does T-20 patient information help?

A-Yes, the information is really good, we are very impressed, and the video is good as well. The majority of clinics train both patients and ward staff.

Q-How should T20 be used?

A- It shouldn’t be used just as salvage therapy (this is a horrible name anyway!) – It needs to be used with other drugs and other classes. If you haven’t had Kaletra then is a better outcome. Many Trusts may raise financial implications when they become aware of the cost, but Roche have supplied good data for PCT’s on cost effectiveness and quality of life issues.

Q- Any other issues with T-20 and difficulties around use?

A-Trials were more closely monitored, real life may be more difficult but I have seen dramatic results in viral load reductions (it helps people but is not easy).

Q-How are people managing syringes – are there any ulcerated sites?

A- I have no data on ulcerated sites. People use retractable needles – different to hospital needles – Roche give 60 syringes in starter pack – we asked for 10 more to play around with (some ran out initially but we are now getting more. Generally there are no particular problems. There has been thought about using other but technology but nothing will change in the short term. Nursing staff have done well training people.

Q-What about asylum seekers being dispersed and support around T-20?

A-Use of T-20 is not just focused in London – a lot of smaller centres have 1 or 2 patients on it. I know of one case of T-20 being accessed via a GP in the week before it was launched. Training packages are good and Roche are willing to support. If someone is going to an area they don’t know, then they should contact Roche. If a person is transferred, pharmacy has an obligation to maintain supply.

New formulations of saquinavir and nelfinavir

Two PIs are being developed into reduced pill formulations.

A new saquinavir 500mg capsule that is slightly smaller than the current 200mg Invirase capsule, and about half the size of the Fortovase capsule.

A new nelfinavir 625mg tablet (slightly larger than current 250mg formulation) has been developed (with reduction in incidence of diarrhoea).

Both these formulations will reduce number of pills needed in combinations using these drugs.

SIMBA study – reducing risk of transmission from breastfeeding

Finally, in what was perhaps the most significantly important results at the IAS meeting, a study showed that giving either 3TC syrup or nevirapine syrup to the baby for an average (median) of three months after birth (IQR 87-approx 150 days) (mothers were given AZT+ddI from week 36 to one week after delivery) almost eliminated transmission – even though these mothers were breast-feeding.

Click on slide for a larger view

This study is most important because in addition to the protective effect, it opens a new option that is not reliant on formula feed and the associated difficulties of preparation and sterile water etc. Breastmilk contains many important nutrients for the baby and is associated with many socially and culturally important issues (whereas this treatment can be given privately at home).

Infection through breastfeeding may account for over 40% of all mother to baby infections, and if adopted this strategy has the potential to prevent many 100,000’s paediatric infections every year.

Q-In the Simba study – what were the grade3/4 side effects in 15-20% of the babies?

A-Probably rash due to nevirapine, I’m not sure for 3TC. It is difficult to pick up more common side effects in babies eg. Nausea, vomiting. This is significant advance in developing world but doesn’t make it entirely safe. Breast-feeding not recommended in UK but in developing world there is risk of malnutrition. Even if formula feeds were given, clean water is issue. Alternating breast and formula feed is also strongly not recommended – stopping and starting may alter virus and immune responses.
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3. Feedback from Resistance meeting

Simon Collins, HIV i-Base

A feedback reports from two other meetings were given by Simon Collins. Please see the powerpoint slides posted to the i-Base website for study details.

The Resistance meeting is one of the most important scientific meetings, but unfortunately still only allows very few community places, and this reports is from a review of the abstract book..

Studies will clinical importance included:

Transmission of drug resistance

Levels of transmitted resistance are up to around 10% in one or more classes across Europe and up to 17% in the UK. This is now very high and BHIVA guidelines now recommend resistance testing prior to starting treatment, and on HIV diagnosis.

Q-Something concerning is key mutations – when you consider at least half of new infections are “imported” and therefore presumably would not show resistance. This suggests transmission in UK must show higher mutations.

A- Yes, it would be interesting to contact Deenan Pillay to ask if he has looked at this and it would be interesting to pull this out of the data.

Q-What happens if clinic reluctant to do resistance testing?

A-It depends on urgency for treatment. While sorting out the problem you can take a guess on using newer drugs. Definitely have a blood sample stored for testing before starting. If the clinic won’t do a test then perhaps change clinic.

Q-But how urgent is it really?

A-Most people could wait 2-3 weeks before starting, but one third of new diagnoses have CD4’s lower than 200, and some people are much lower or diagnosed when hospitalized for an AIDS-related illness. Treatment should not be delayed if it is indicated just to wait for resistance results. In the first few weeks it may not make too much difference if only two drugs working, and you modify treatment when the resistance results are back.

Q-Isn’ tresistance with HIV like TB – if you are resistant to one drug you can be resistant to others?

A-Yes, it is very similar, however if only two drugs are working in combo they would still give some protection (wouldn’t be recommended though). If three drugs are started and a resistance test is taken after four weeks, resistance would show then. A large percentage of people failing in the UK resistance study are NNRTI resistance – backbone of most people starting treatment.

Resistance tests should be taken on diagnosis with other tests as the earlier it is taken the earlier it will show resistance. Results can be stored. If don’t have resistance test and then start treatment in 5 years this information will be lost but the resistance will still return (this is why it is important to have it stored).

Co-infection, reinfection, superinfection

Several studies documented clear cases of individuals who had more than one distinct HIV virus. This included people original infected with two different strains, or who were infected with one virus and then reinfected with a different strain later.

Researchers can confirm this by looking at the structure of each virus, and the degree of diversity for each virus can indicate a recent infection.

Some people were reinfected with resistant virus and some with wild-type, and a separate study showed that people infected with resistant virus progress at the same rate as those with wild type.

Q-What are implications of superinfection?

A-Many people hate this data on superinfection – they don’t want to have to think about it – but we need to recognize that this occurs, but has until now bee difficult to pick up in individuals. But we can’t say this doesn’t happen though we are not clear about the frequency that is occurs.

HIV-positive people need to know about this when sleeping with other HIV-positive partners, and again there will be a range of different situations. Two HIV-positive partners likely to have the same virus and same treatment history this should not present any additional problems. At the other extreme, if one person has multi-drug resistance with a high viral load, then unprotected sex with an HIV-positive partner who is treatment naïve, or currently on stable treatment becomes a greater concern…

Single dose nevirapine led to resistance in 75% mothers

Reanalysis for the resistance data from the HIVNET012 study, showed, as previously feared, that resistance rates were even higher than the 30% found at 8 weeks and that this could prevent these mothers from benefiting form NNRTI therapy in the future.

Q-If you become resistant to NVP, are other NNRTIs ruled out?

A-Yes, you then can’t use other drugs in that class. NVP will be the basis of most combo’s in Africa and Asia (generic triple combo of NVP/d4T/3TC). If people are resistant they won’t be able to use it – they would be on 2 drug combo – this is an important issue.

Effectiveness of resistance tests

Several studies showed limitations with current resistance tests – only detecting majority populations.

Cross resistance between NNRTIs

Although it is not recommend to use an NNRTI after failing treatment using another, sometimes lack of resistance mutations has been used to justify this. Several studies showed that mutations have often developed but at a level that is too low to be detected with regular tests. Also that whether of not mutations are found, use of an NNRTI in a failing regimen, you will stand little chance of benefiting for using another current NNRTI in the next regimen.

Residual activity of drugs

Some studies were presented showing that NNRTIs have no residual effect on viral load once mutations have developed. Nuceosides continue to show and effect, and removing d4T or 3TC in two studies showed viral load increases. These studies did not address residual viral activity in different body compartments, and as resistance can be different in compartments, withdrawing treatment may still be having a benefit there.

Tenofovir resistance

Several studies looked at tenofovir resistance – especially the K65R mutation, but the limited numbers in the studies mean that together with recent approval to use tenofovir in first line therapy, requires more research for the relatively low numbers of people who do fail using tenofovir.
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4. Feedback from 5th Lipodystrophy Workshop

Simon Collins, HIV i-Base

This annual workshop, which also focusing on side effects in general, was held this year in Paris just before the IAS meeting.

Over 350 researchers and doctors attending including many community advocates, and community and press registration are welcomed by the organizers, who provide 10 or so full community scholarships.

About half the meeting deal with basic science – ie test-tube, animal and non-clinical studies trying to identify the root causes of different lipodytrophy symptoms. This year there were many studies looking at the chemical signal used in the body in the metabolism of fat – called adipocytokines.

Please see slides for study details.

This also included looking and comparing differences in fat biopsies from HIV-negative and HIV-positive who were treatment naïve or using different nucleosides. Both fat cells (called adipocytes) and mitochondria were damaged and reduced in HIV-positive compared to HIV-negative, and then reduced again in people on treatment compared to treatment naïve. d4T caused more damage than AZT.

This probably had the most clinically important relevance as it also related to studies where AZT or d4T was switched to abacavir and previously lost leg-fat was show to slowly return (ie MITOX study). The benefit was reported previously at a low level at 24 weeks (approx increase of +0.4kg), was shown at the meeting to continue to increase out to 2 years (approx increase of +1.26kg).

One study showed modest increases in Intima Media Thickness (a blood vessel in the neck, which if the wall gets thicker if a measure for risk of heart disease), but this is also the subject of debate as several different studies have reported different results – and much of the increased risk can be due to traditional risk factors such as smoking, low exercise and diet etc.

An important study showed that HIV-positive women are at higher risk of reduced bone mineral density – and have higher rates of osteopenia and osteoporosis – indicating that increased monitoring it likely to be important.

Rosiglitazone improved lipoatrophy in HIV-positive patients with insulin resistance.

Also, in a strange and upsetting report, people who had had fat taken from their Buffalo Hump injected into their cheeks to help with lipoatrophy, found that in 50% of cases, when the fat across their shoulders started to return, their cheeks became similarly swollen.

A study from Londons Kings College reported approx 2-3% referral to a specialist psychiatric centre or 6/200 patients started on an efavirenz-containing regimen with ‘severe psychiatric’ side effects including suicide attempts, and feelings of suicide and in one case homicide. Awareness that a few people may suffer these extreme side effects is very important, especially as efavirenz-based combinations are the ost widely recommended and prescribed first line therapy in the UK.

Further reading

Two reports by Mark Mascolini (each approx 30 pages) are highly recommended for further reading, and can be downloaded as pdf files. Even reading just a couple of pages of either report would leave you very well informed on any particular topic.

They contain a lot of solid data/research but are also written in less technical language.

XII Resistance Workshop, Mexico

2nd IAS Meeting
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5. Meeting with GSK

The afternoon meeting with GSK began with a minutes silence in memory of people were unable to benefit from currently available treatment, followed by introductions to the group.

Trevor Skelton, responsible for community liaison in the UK, briefly outlined GSK community programme to support community-based organization in the UK and internationally together with a commitment to improve access and reduce cost of treatment in countries that currently have either limited access and who cannot afford Western priced drugs.

The scientific presentation was from Dr Claudio Avila, who works as a medical advisor to GSK, and who still runs an HIV clinic in London, and who was involved in HIV voluntary organizations prior to training as a doctor. He originally trained as a scientist and later as a doctor and came to the UK seven years ago from Australia.

Contact email addresses for Trevor and Claudio are:

Trevor Skelton

Dr Claudio Avila

This session focused on three main issues:

  1. Triple nucleoside studies shown at IAS (ie Trizivir and 5095, and the tenofovir/abacavir/3TC combination)
  2. Fosamprenavir (also know as 908)
  3. Pipeline drugs

Detailed information in included in the slides accompanying the talk. A reduced slide set is posted to the i-Base website, but CAB members can also email me for the full slides.

Triple nucleosides

Details from the 5095 study were presented together and GSK suggested reasons why Trizivir performed so poorly. This included a higher pill count in a placebo study (up to seven a day) compared the one-pill twice daily that is one of the benefits of Trizivir. It was also suggested that any poor adherence – is any missed doses – would carry a higher risk of reduced potency in the Trizivir arm compared to the others. Adherence was reported as 100% in the study, but fewer people failed with resistance patterns seen in other Trizivir studies.

Nevertheless, the efavirenz-containing arms continue blinded and the caution against using this treatment has not been included as a first line recommendation in UK or US treatment guidelines.

Q-Is there any indication that adherence worse in TZV arm?

A-No, cant say this because we don’t have the data, but 7 pills a day is more that 2 pills.

Q-Why research on people with high viral load?

A-This was outside our recommendations – it was not a GSK study – but it was passed those review panels

Q-Where do GSK see TZV

A-BHIVA say this is not a choice for all naïve patients – only in niche groups where adherence is an issue, or where there are issues of drug interactions (ie TB coinfection). Previous studies have shown a role for mintenance therapy for any patients who have viral load <50 copies/ml for over 6 months and who have never previously failed and never received mono/dual therapy.

GSK also have no explanation for the poor results the abacavir/tenofovir/3TC study, although they said that they have not seen comparable results in other studies using once-daily abacavir with 3TC, so think that a previously undescribed interaction between abacavir and tenofovir looks more likely to them. GSK issued a Dear Doctor letter to US doctors following these study results.

Fosamprenavir (908)

Fosamprenavir in a new formulation to improve (a pro-drug) of the protease inhibitor amprenavir. The new formulation is currently available on an expanded access programme in the UK, and this includes free drug level monitoring (TDM) sponsored by GSK. Fosamprenavir dosing is two pills plus ritonavir-boosting, both twice daily.

Q-Do you have interaction on recreational/street drugs like ecstasy?

A-There are no interactions including with methadone for licensed nucleosides (3TC, AZT or abacavir). Most interaction with HIV drugs are due to liver interaction with RTV mainly – so this may include amprenavir. 3TC is contraindicated with ddC. Generally there is very little data on many drugs. Viagra etc has potential interactions.

Q-Why is there a pigmentation change with AZT in some African people?

A-We still don’t have an answer for this. It doesn’t appear to affect people from the Mediterranean with dark skin – only Africans. Further research would involve looking at sample taken from underneath the nail which is invasive and difficult so we may never know.

Q-Are you doing lipodystrophy research?

A-Yes, we are supporting many groups – including the Australian groups looking at lipoatrophy and mitochondrial toxicity with AZT.

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6. Internal meeting: Programme for next CAB

The next meeting will either be the first or second Friday in November – date to be confirmed asap. We will also try to arrange a programme of dates in advance for 2004.

Subjects that the group discussed for the next meeting included:

  • immunology and immune-based treatment,
  • Access to treatment and test when included in guidelines but not provided in your clinic – ie general advocacy
  • The afternoon session will also included a section for feedback from other groups (ie the new Treatment Action Campaign support group in the UK)

We should include training on paediatric care in the subsequent meeting.

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7. AOB

The meeting finished at 5.00pm.

Report: Simon Collins and Steve Atkinson, HIV i-Base
August 2003

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