HIV treatment advocates network
HIV treatment advocates network
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Friday 1 May 2009
At the MRC Clinical Trials Unit, 222 Euston Road, London, NW1
Alastair Hudson
iPPF - Stigma Index UK
Angeline Marang
HIV i-Base
Badru Male
CHAT
Ben Cromaty
North Yorkshire AIDS Alliance
Brian West
Waverley Care
Elijah Amooti
The African Eye Trust
Jeff Ukiri
Black Health Agency
Jo Murray
National AIDS Trust
Jo Robinson
Terence Higgins Trust
Joram Barigye
THT - Woking
Lucy Stockpool-Moore
IPPF - Stigma IndexUK
Memory Sachikonye
UK CAB
Pamela Mahaka
London
Richard Blackburn
The Brunswick Centre
Samuel Serunjogi
London
Sepo Young
NHS Dumfries and Galloway
Simon Collins
HIV i-Base
Svilen Konov
HIV i-Base
Toju Cline-Cole
Terence Higgins Trust
Walter Zonke
HIV i-Base
Zhana Books
London
Ken Legg,
MRC and St Mary's Hospital
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Why is there no effective HIV Vaccine?
This presentation covered reasons why is there still no effective HIV vaccine. This included a brief HIV vaccine history and explained why 25 years later there is still not effective vaccine that has been licensed and scientists cannot envisage one becoming available in the next 10 years.
Current situation
Questions:
Q: Everyone's HIV is different, does that affect the way the vaccine is developed? Do you have to develop individual vaccines?
A: The virus mutates so much that a patients' virus from 10 years ago, will be the same today. This is why researchers are trying to make the vaccine work on the parts that don't alter, the envelop on the outside. By the time your immune system has kicked in, it is too late, we need a general vaccine that will destroy anything that comes along.
Q: Therapeutic or preventative vaccine trials?
A: Therapeutic vaccines could be used to come off treatment; preventative ones are still a challenge, with no successful results from any trials.
Comment: Need an open access transparent site of all trials in the UK on VaccNet.
Q: What is the timeline for this site to be set up?
A: Around September 2010.
Q: Any prospect from bone marrow transplant in Germany - vaccine ideas?
A: Don't know much about that. This is the process where the doctors replaced the patient's stem cells that now generate new immune cells with cells that HIV can't affect. It's not an easy process; there is a 30% chance of dying.
The full list of ongoing work on vaccines in the UK is available on the slides.
HIV Vaccine Advisory Board Jo Robinson is the UKCAB HIV Vaccine Advisory Board member. The board is being set up in support of the future trials and to initiate a CAB specifically for HIV vaccines. Board will include members of the HIV community, VaccNet network and trial team members. Role of the board is to help in the development of the protocols and recruitment strategies for trials.
Need for advocate input It was agreed that it is important for UK CAB to be involved in anything that the MRC does, as this will inform the general public and volunteers better about ongoing trials. UK CAB was also urged to be involved in other trials such as rectal microbicides, there is need to develop a formal link.
Discussion:
Q: - Is there a need /role for such a board?
A: It is important for UKCAB to be involved in anything that the MRC does. Recruiting volunteers is difficult, needs commitment and an understanding of the risks and impacts on individual health care providers. Have the sense of the HIV sector and UKCAB being involved so as to be able to inform the general public. Public needs to understand that they are not going to be exposed to HIV. This would then stop onward transmission and no new infections.
Q: Would it be a good idea to be involved?
A: It is good to be involved early on in the development of study design and protocols rather than just be asked to review a final version.
Q: How many people should be on it?
A: Preferably at least two; one already recruited and would have one more to be mentored.
Q: With other general trials, I been told its confidential and cannot be discussed elsewhere, makes it difficult to discuss in a community environment.
A: UKCAB involvement can help map out what volunteers can talk about, develop trust, and work it out together with MRC. There is lots of ongoing other work in other trials such as rectal microbicides, etc. I would like the CAB to be linked into that kind of work. Need to develop formal link.
Simon Collins
Download presentation as a PDF file [2.2 MB]
Simon Collins led an interactive workshop on facts and questions related to resistance (Rx), a great chance for all members to participate.
The discussion involved each person contributing a fact or question relating to resistance.
Facts about Resistance (Rx):
Questions about Rx:
Q: How adherent do you need to be to prevent resistance?
A: 100% is best guide. Anything less is just luck. Everyone occasionally misses or is late with a dose, but if this happens regularly (every week) then the risk of resistance is much higher, There is usually a window period fo 1-2 hours for most drugs.
Q: How and when should one have Rx test?
A: i) On diagnosis (to check you don't have a resistant strain)
ii) Before starting treatment (if you have been at risk of reinfection)
iii) If viral lad doesn't drop by one log within one month of starting treatment
iv) Before making any treatment change if your viral load is detectable.
Q: Can you request Rx test if you have been on the same medication for a while with an undetectable viral load and have no problems?
A: There is no point You, need a VL of at least 500 copies/mL for the test to work. If VL is undetectable, by definition, you do not have Rx.
Q: Treatment interruptions/break - any hope?
A: This is a research area. The largest interruption study (SMART) showed that generally being on treatment protects you form many serious illnesses, including heart disease, liver failure etc.
Q: Co-infection: can treatment for one virus impact on the drugs use to treat other viruses?
A: Only if the same drugs works on both viruses. Some hepatitis B drugs also treat HIV (tenofovir, 3TC, FTC). 3TC resistance to hepB is different to HIV because it involves different chances in the structure of each virus. This is a specialist area. Everyone should have a Hep B test yearly.
Q: What specific drugs can use if you need to take an STI?
A: Switching to a boosted PI for a month when you stop an NNRTI-based combination is probably safest...
Q: Is it possible to have caught HIV 10 years ago, get diagnosed today and have Rx?
A: This is much less likely, Resistance could only be to drugs that were available 10 years ago, and would be difficult to detect. You could have been reinfected within that time though.
Q: What happens to Rx over time?
A: Resistant virus is not as fit as non-resistant virus (called 'wild-type) If you are not taking treatment, or you stop taking the treatment you are resistant to, then wild-type virus takes over and becomes the main virus. However, even though you may not be able to test it, resis itant virus remains in small quantities (called 'archived' virus).
Q: If you have been on 4 failed regimes, are there chances that you are resistant to 3 regimes?
A: Yes, this is very likely...
Q:What is the risk then if you pass this to someone else or are reinfected with resistant virus.
A: The importance of the risk of reinfection is much more serious with greater Rx. Transmission risk is relative to VL; if low less risk but is worse if you have a sexual transmitted infection. The SWISS statement recognized that VL may always not be undetectable, and maybe detectable in genital fluids.
Q: What is Genotype and phenotype testing?
There are 2 types of Rx tests:
Q: l. Do HIV drugs treat both HIV-1 and HIV-2?
A: Most do, but some drugs (notably NNRTIs) do not HIV-2.
The question about swine flu was raised and it was explained that it is different from the seasonal flu. It's a new strain and the vaccine is yet to be produced. The UK-CAB forum has a link to resources to information about dealing with swine flu.
It was a time to briefly review the drugs manufactured by GSK: AZT, abacavir, amprenavir, 3TC and the combined formulations of Combivir, Kivexa and Trizivir. Members could relate to this and be able to ask the pharma the issue of abacavir and heart disease still remains topical. It was necessary to raise issues to GSK about the DAD study results. It is important for UK CAB to meet with the companies that manufacture the drugs we take.
Dr Michelle Moorhouse
GSK
As with all CAB meetings with companies, this started with one minute silence to remember those who had not lived long enough to benefit form today's treatment and for those people who currently have no access to treatment.
GSK merger with Pfizer is to create a company that is more sustainable and broader in scope that either company's individual business with equity split of GSK- 85% and Pfizer - 15%. Discussions are still ongoing about the details so this information is preliminary.
The main meeting focussed on the GSK response to abacavir and cardiovascular (CV) (heart disease) data.
GSK have been transparent with the DAD results of 2008 with more data presented at CROI 2009. Patient safety is paramount, CV risk should be evaluated and managed as part of the assessment for each patient, consistent with the BHIVA guidelines.
Relative risk and absolute risk should also be taken into account. GSK is working with scientists to further understand the data and its implications, and is also undertaking further investigations to seek greater clarity on the CV risk signal reported for abacavir. They also ensure that health professionals are fully aware of the data.
GSK said they had stopped marketing abacavir for new sales, but based on the latest EMEA statement this may now change.
Discussion:
Q: Is it just abacavir or all drugs that contain abacavir component.
A: Both abacavir and the formulations that contain abacavir (Kivexa and Trizivr).
Q: Does 1.9 relative risk result mean you take all your risks and double it?
A: You need to take an individual's total risks into account. This is then doubled, but it your absolute (actual risk) is very low, doubling this is also very low.
Q: Would you advise anyone to switch from abacavir?
A: This is an individual situation that you need to ask for assessment from your doctor.
Q: Does taking abacavir and other things like coffee change the rhythm of heartbeat , do these have an interaction?
A: No evidence has been found of changing heart rhythm.
Q: What are heart attack symptoms?
A: Very severe pain in the chest on the left side sometimes goes up to the jaw of arm and feeling you are going to die.
Q: Why do I get breathless when I run a short distance, I do not smoke?
A: We can't engage in personal issues; recommend you raise issue with your doctor.
Q: Most members in this meeting have not been offered a CV risk by their doctors. Are GSK doing anything to prompt doctors to do this?
A: Sales people are going out since DAD data to encourage doctors to do CV risk.
Q: Why hasn't this got through to clinics, even a year later?
A: GSK is trying their best to encourage doctors to do CV risk assessments.
Q: Other people do not understand the CV risk, its adding more distress to the HIV they have already. What about the long-term risks?
A: GSK ran long-term clinical trials, data has been reviewed and nothing came through showing heart attack risk.
Comment: Clinical trials - 48 week in a young population is unlikely to see any risk, even if there is one, should look at long-term effects.
A: Drug development takes about 10years before it goes for clinical trials. Clinical trials set up to compare drug efficacy. Other indicators will come out the trial. There are specific reasons. Any side effects should be submitted to doctor and should be sent to GSK.
Q: what are about absolute risk - vs relative risk being - on abacavir ?
Comment: From a satellite session at BHIVA, there was a study on someone who had had a heart attack and still on abacavir. This is surely the highest predictor of a future heart attack and isn't included in Framingham, It was disturbing to see GSK include the recommendation that an individual patient with a history of heart disease should still continue on abacavir. For people with high CV risk, D:A:D showed this risk is doubled with abacavir. Generally speaking people enrolling in clinical trials are generally at low risk and should be excluded from trials. A: Will take this on board to GSK.
Q: How do you advise your patients in your clinic?
A: I offer a 6-monthly risk assessment, but because of demographics (South Africa) it has not been necessary. If a patient doesn't have any other treatment option, then I would explain available options and risks. Some patients say they do not want to switch.
Q: How long before an assessment whether to withdraw the drug?
A: DAD cohort had 517 heart attacks and 192 of these were on abacavir. We have no plans to take it off the market. Too many people rely on abacavir, provided they are informed of risk. Everyone must have a CV risk assessment. Some doctors may just want an easy option to switch.
Comment: Should restrict abacavir to older patients, look at age factor.
Comment: BHIVA satellite symposium would have been a perfect opportunity to inform doctors of CV risk, but the session wasn't centered on this. Instead it includes one case study that was probably inappropriate.
A: GSK not marketing abacavir for new sales, based on EMEA advice, still ongoing dialogue with customers.
Q: Do you have any studies to look at the DAD results?
A: A study in health volunteers is being developed to look at pure drug effect.
Q: Any other studies on HIV being a CV risk factor itself, what's your feeling?
A: Don't know how to factor it, as I cannot put a number on it. Risk is higher when not on HIV treatment.
Q: How many people have confidence to challenge their doctors?
Q: Will doctors honor up to putting you on the wrong treatment?
Summary:
There was not enough time to discuss the rest of the issues, Pipeline Drugs and Pfizer merger. The slides will be uploaded on the UK CAB website.
Simon Collins
Download presentation as a PDF file [72 Kb]
Members urged to watch the presentations online.
Q: What is my risk from using or not using treatment?
The meeting looked the charts on the "When to start" from the BHIVA guidelines treatment booklet showing comparative 6 month risk, delayed vs immediate. These let you look at the risk of becoming ill based on your latest CD4 and viral load results, and importantly, by age (i.e. 25, 35, 45 and 55). They show the risk when on treatment compared to not being on treatment and being on treatment reduces the risk at every point Risk increase with age, meaning it is more important to start treatment as you get older.
HIV risk in pregnancy
Studies from South Africa have shown women being HIV negative at beginning of pregnancy and testing positive later. Other studies shoed importance of earlier treatment during pregnancy.
New boosters
3 new formulations coming through, Gilead 4-in-1 pill, Abbott formulation that doesn't need refrigeration and an early compound from Sequoia.
Swine flu and HIV
Treatment of flu can improve symptoms. General good hygiene is recommended.
Q: Any interactions with ARVs?
A: None with Tamiflu or Relenza but the Liverpool drug interaction site has a new detailed interaction chart.
More information available from:
www.hiv-druginteractions.org
i-Base answered an online Q&A on this:
http://www.i-base.info/qa/?p=814
Information from the US Centre for Disease Control:
HIV/AIDS Update - Interim Guidance--HIV-Infected Adults and Adolescents: Considerations for Clinicians Regarding Swine-Origin Influenza A (H1N1) Virus
http://www.cdc.gov/swineflu/guidance_HIV.htm
An online PowerPoint update on the current swine flu outbreak.
This is a good source of information - what it is, how many people have gotten sick, how to protect yourself (pay particular attention to clean hands), etc. It is updated daily:
http://www.pitt.edu/%7Esuper1/lecture/lec34601/index.htm
BHIVA feedback - no time for feedback, slides to go on website.
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