UK-CAB 23 – Meeting Report

Access to treatment for migrants and people facing deportation — Roche

2 November 2007

Summary

Firstly, there was useful input from Roche on a number of topics. The Gemini study has shown that the protease inhibitor saquinavir is as effective as what many regard as the “gold standard” for PIs, Kaletra (lopinavir). Roche also updated the meeting on the findings of the investigations into what caused the high levels of an impurity in some batches of nelfinavir, leading to the recall of nelfinavir and concerns about increased cancer risk for those who had taken contaminated tablets. Roche expanded on their decision to halt work on the Biojector as a means of needle-free delivery for T-20.

Secondly, there was a lively discussion about the treatment issues for people who may face imminent deportation. This was followed by an input on some work done by NAT on the standard of HIV treatment in immigration removal centres.

Finally, there was an update on some of the key things to come out of the most recent major HIV conference, EACS.

Contents

1. Presentation by Roche on Gemini data, nelfinavir recall and Biojector
2. Access to treatment for migrants and people facing deportation: the clinician’s perspective.
3. HIV treatment in immigration removal centres.
4. Feedback from European AIDS Clinical Society Conference (EACS), Madrid 2007
5. AOB

1. Presentation by Roche

GEMINI data

Philippa Gately, the HIV Business Leader with Roche, gave a presentation on the recently announced results of the GEMINI study. These were presented at the 11th European AIDS Conference in Madrid. The results showed that saquinavir boosted by ritonavir (SQV/r – Invirase) is essentially equivalent in terms of potency to boosted lopinavir (LPV/r – Kaletra) in patients new to HIV therapy.

After nearly a year on therapy, the proportion of patients with an undetectable viral load (below 50copies/ml) was 64.7% on SQV/r and 63.5% on LPV/r. Viral load suppression by the two drugs was also almost identical. Since we didn’t have a copy of Roche’s presentation, the details below are summarised from Aidsmap.

All patients who started the study had CD4 counts below 350 cells/mm3 and viral loads over 10,000 copies/ml. Four out of five were men, with a median age of 38 years. They were in advanced HIV infection: the median viral load at the start of the study was high, at 160,000 copies/ml and the median CD4 count low, at 138 cells/mm3. Sixty-three per cent had viral loads above 100,000 copies/ml and 40% had CD4 counts below 100 cells/mm3.

One hundred and sixty-seven patients started the study on SQV/r and 170 on LPV/r but the 48-week analysis was of 263 patients, 128 on SQV/r and 135 on LPV/r. About 20 patients in each arm were excluded from the final results because of protocol violations (i.e. they should never have been in the study in the first place) and 30 either changed treatment due to failure or toxicity or were lost to follow-up.

The increase in CD4 count was 127 at week 24 and 178 at week 48 for patients on SQV/r; it was 134 at weeks 24 and 204 at week 48 for patients on LPV/r. The differences between the two drugs were not statistically significant.

There were eleven failures due to incomplete viral suppression on SQV/r and five on LPV/r. Five of the eleven SQV failures had at least one HIV protease inhibitor resistance mutation at baseline compared with none of the three LPV failures; five of the patients on SQV and four of those on LPV developed the M184V FTC resistance mutation; and one patient in each arm failed virologically with apparently wild-type, non-resistant HIV.

Only one patient, taking saquinavir, developed a new protease inhibitor resistance mutation (in addition to M184V) while on failing therapy, and they were one of the ones with primary PI resistance. Six patients on SQV/r had ‘documented poor adherence’, versus two on LPV/r.

In terms of side effects, the study tended to favour SQV/r. Seventeen per cent of patients on SQV/r complained of diarrhoea versus 27% on LPV/r. In terms of lipids, the percentage of patients with total cholesterol above the upper limit of normal went up in both groups, from 14% to 31% on SQV/r and 10% to 39% in patients on LPV/r. However at week 48 34% of patients on SQV/r versus 24% on LPV/r had raised levels of ‘bad’ LDL-cholesterol. For triglycerides, the proportion with abnormal levels (two times the upper limit of normal) went down in patients on SQV/r from 1.9% to 1.4% but up from 2.4% to 9% in patients on LPV/r.

Roche were first to market with a PI (saquinavir, licensed in 1996); the results above are for a new formulation of Saquinavir, which reduces the pill burden from 5 to 2 (plus one capsule of Ritonavir). The results above suggest that saquinavir may become more used in future: it should be cheaper than Kaletra, and seems to have fewer side effects. However, Ritonavir needs to be taken separately, which requires refrigeration, unlike Kaletra, where the Ritonavir is co-formulated, and refrigeration is no longer needed.

The Roche presentation (or one similar to it) is on the UK-CAB website. There were a number of questions:

Q: Why were 25% patients not available by 48 weeks? This seems like a large dropout rate.
A: This is due to enrolment criteria violations and lost to follow-ups: there was a whole range of issues, but no single, simple reason.

Q: Interesting that baseline lipids are good and yet there were some with advanced AIDS
A: These are the figures.

Q: Why were Kaletra (LPV/r) formulations different?
A: When study started, only Kaletra capsules were available, so with the old formulation; when the Kaletra tablets came out in 2004, patients were able to switch.

Q: Were there significant differences between the countries?
A: Not sure if we can analyse this

Q: What are Confidence intervals – how good or bad could results be?
A: Intention to Treat analysis (ITT)-1.14% difference – even with approx 0-15% 95% CI – essentially curves are superimposed.
There is no statistical significance in the differences in CD4 responses between arms.

Q: Will trial continue?
A: No, all finished at week 48, SQV has been around 10 years

Q: Why not fund this – if the study is so good – 48 weeks is not enough – KLEAN just presented 96-week data?
A: Maybe lack or foresight by Roche, maybe budget

Q: Was anyone using LPV/r once-daily
A: No, all twice daily.

Q: Can we see resistance data on all patients with baseline resistance – not just failures
A: Not sure this is planned – we only analysed virological failures

Q: Patients involved will need these results themselves
A: I suppose so, and they should be able to get them

Q: How do you see the market for SQV developing over 5 years?
A: LPV/r is a fantastic drug that every company is comparing against. We hope that people will see SQV as equally efficacious. Cost pressure in trusts may be a factor.

Q: What is the cost difference?
A: Varies by trust – can be as different as £1000 a year – with large patient groups this may be important in some trusts. Taking separate Ritonavir (RTV) may be an issue because of pill burden. But because of diarrhoea with LPV/r, SQV/r may be better.

Q: When will we see analysis, results >100,000, results geographically – Thailand, BMI etc. Is there any difference in lipodystrophy DEXA?
A: We can suggest all these.

Nelfinavir recall

Phiippa described the background to the recall of Nelfinavir, and updated us on the investigations to date.

Viracept (nelfinavir mesylate) is a member of the protease inhibitor (PI) class of antiretroviral agents, which was approved by the U.S. Food and Drug Administration for the treatment of HIV infection in 1997 and in the European Union in 1998. PIs block the activity of a key enzyme, HIV-1 protease, which is an important target for antiretroviral therapy. Protease is essential for the final stages of viral assembly and for the infectivity of newly produced virions. When the enzyme is blocked, HIV makes copies of itself that cannot mature and infect new cells. Viracept is one of several currently available protease inhibitors used to limit viral replication and improve immune function in HIV-infected individuals. It is administered in combination with other antiretroviral agents. Nelfinavir has been evaluated with nucleoside reverse transcriptase inhibitors (NRTIs) in treatment-naïve patients, or as an additional antiretroviral agent in protease inhibitor -naïve patients already receiving NRTIs. These studies have shown good efficacy in terms of HIV viral load reduction and increased CD4+ cell counts.

In the summer of 2007, Roche, in agreement and cooperation with Health Authorities (EMEA and Swissmedic), issued a recall in Europe and some other world regions of all batches of Viracept powder and tablets. The US, Canada and Japan were not affected by this recall. Roche had received several reports that some batches of Viracept 250 mg tablets had a strange odour. A detailed chemical analysis of the affected tablets showed they contained higher than normal levels of methane sulfonic acid ethylester, also known as ethyl mesylate. This is a by-product of manufacture, which is usually present in extremely low quantities (less than three parts per million). It was thought that human error during standard maintenance of the production line at the end of 2006 led to some contamination occurring. A Roche investigation found variations in the levels of contaminant in different batches, which in the worse case reached 2,300 parts per million. The normal specification should be <1ppm.

In terms of assessing the risk to patients, Roche has calculated that someone who ingested nelfinavir containing the highest amount of contaminant would have been exposed to 0.1mg per kilogram per day. Although there have been no human studies regarding the cancer risk of ethyl mesylate ingestion, studies have been done in the test tube and in rats. These found that approximately 100 times greater amounts of the genotoxin were required to be ingested over three months (10mg per kilogram per day) for cancer to develop in rats.

Roche was initially unable to say exactly how many UK patients are currently taking nelfinavir. It is no longer recommended as a first-line regimen by the British HIV Association (BHIVA), although a 2006 BHIVA audit of first-line regimens reported at the recent BHIVA/BIS Spring Conference found that a small percentage of patients did receive nelfinavir as a first-line therapy. Roche believes many of the estimated 550 patients affected will have taken it for only 30 days as part of Post-exposure Prophylaxis (PEP).

Roche’s investigations have revealed that between 1999 and 2003, there were batches of nelfinavir where the specification level for ethyl mesylate of <1ppm was exceeded, with the highest level seen being 25ppm; between 2004 and 2007, the highest level in a batch seen was 132ppm. No details of ranges or averages were given, however, making it difficult to interpret the significance of these numbers, though Roche stated that the majority of batches were in fact in spec for ethyl mesylate.

Roche told the meeting that 32 packs of 1 month’s supply out of a total of 1956 packs shipped to the UK were contaminated.

There was some lively discussion:

Q: Not enough information about range of levels across batches – averages are not enough to go on.

During final manufacturing steps, EMS decreased by 60%
Highest concentration found in tablets 920ppm (March 2007)
(Original safety concerns calculated at 2,300ppm)

Estimated 45,000 patients taking Viracept at time of recall worldwide. Global rough estimate that 20-25,000 patients are from countries that received supply with levels >1000ppm.

Q: This was picked 6 yrs later due to smell of drug, why was it not monitored before?
A: Changed policies-Quality Assurance (QA) and Quality Control (QC) on every batch now.

Q: Does EMS degrade with time, since products manufactured in 1999 are being checked in 2007?
A: Not known.

Q: How many people would have been exposed to EMS in UK?
A: Great Britain has approx 700 people on Viracept. Difficult to determine how many are on Post-Exposure Prophylaxis (PEP) or PMTCT in UK.

Q: But how many of the 700 patients were exposed to contaminated Viracept?
A: Not known at patient level.

Total number of packs shipped was 1956.However 32 packs have not been retrieved, and so may have been used.

(1 pack means a months supply).

Q: Do you have access to the registry of patients receiving Viracept?
A: Working to get this data from the EMEA. The risk is low, though there are still 32 people who need to be contacted.

Comment: It should be easy for Roche to get the data of the 32 people since the delivery services keeps this data.

Comment: Would contacting these people cause them unnecessary concern? This would need to be eliminated.

Comment: There is a duty to inform the people who received those batches. Distributors and clinicians need to advise patients on Viracept.

Q: Was there follow-up on clinicians on whether they had advised the patients?
A: Not done. Healthcare at home (agency) distributes the drug to patients home, clinicians might not be aware which patient is on Viracept. Safety registries are being formed – when finalised, patients exposed can be told, as they will have the option to be followed more carefully. These Registries are being designed and will be based on current toxicity knowledge. There will be 2 registries:

  1. patients who were potentially exposed to EMS at >1000ppm. Restricted to countries that received these batches from March 2007.
  2. all pregnant women and exposed children and PEP use since approved in 1998. This is a huge undertaking – working with existing paediatric and pregnancy registries

Biojector Update

Biojector is a needle-free method of delivering T-20. T-20 (enfuvirtide, Fuzeon) is the first of a new class of drugs called fusion inhibitors, so-called because they stop HIV from binding to and entering the human cell.

T-20 binds to a protein on the surface of HIV called gp41, which is the ‘key’ used by HIV to bind onto and enter cells. By blocking gp41, T-20 blocks the infection of cells by HIV. T-20 was developed by Trimeris Pharmaceuticals and Roche. Formerly known by the generic name pentafuside, it is now called enfuvirtide, and is marketed under the trade name Fuzeon.

European and United States drug regulatory authorities granted accelerated approval for T-20 in March 2003. It has been approved for use in individuals who have experienced failure of at least one drug from each existing class of antiretrovirals, or who have intolerance to previous antiretroviral regimens.

Two large-scale studies of T-20 (enfuvirtide, Fuzeon) in treatment-experienced people have indicated that the addition of T-20 to antiretroviral salvage regimens enhances reductions in HIV-1 viral load. It is not active against HIV-2. TORO 1 (conducted in the United States, Canada and Brazil) and TORO 2 (conducted in Europe and Australia) were similar studies involving about 1000 people in total. The participants had experienced failure of drugs in each of the existing classes and underwent resistance testing to select an ‘optimised background therapy’. In addition, two-thirds of the participants were randomised to receive T-20. In both studies, intent-to-treat analysis showed significantly greater reductions in viral load among those taking T-20.

Adding T-20 to an effective background regimen produces the strongest and most enduring virological response. A recent analysis has shown that even adding T-20 to a background regimen consisting of drugs to which the patient is resistant reduced viral loads in the first four weeks of the study. However, it is clear that a background regimen including drugs to which the patient’s virus is susceptible is required for the best chances of virological success. The results of TORO 1 showed that phenotypic resistance testing has an important role to play in the optimisation of T-20 salvage regimens. This raises questions about whether it is appropriate to delay use of T-20 until patients have failed a number of different antiretroviral drugs.

T-20 cannot be taken by mouth because it is broken down by the digestive system. However, when administered by injection under the skin, T-20 achieves sufficient levels in the blood to have anti-HIV activity. The recommended adult dosage is 90mg injected twice daily. T-20 is not an easy option because injections have to be prepared each day. Patients are provided with a carton containing phials of T-20 powder, phials of water used to dissolve the powder, as well as syringes and alcohol swabs. Detailed,

Despite concerns that the process of preparation and self-injection may be too difficult for many people, a survey of 638 people who were taking T-20 provides evidence that most people can manage the process: 67% found self-injection easy or very easy and only 11% found it difficult or very difficult. Around 13% found dissolving medication difficult or very difficult but only 1% reported difficulty disposing of needles and phials. Another assessment of patient satisfaction with self-injected therapy was encouraging, with only 13% of participants reporting difficulties.

A needle-free method of delivering T-20 is available to some patients in the United States, but not in Europe. The Biojector 2000 system is a carbon dioxide-powered system that delivers drugs through the skin. It results in improved dispersion of T-20, with more consistent depth of delivery and a wider choice of injection sites, resulting in improved patient satisfaction over injection. One study has shown that the needle-free method results in similar drug levels to injection but with less severe injection site reactions. However, three cases of transient nerve pain have been reported in patients using this system. This is believed to be due to low fat levels under the skin in these patients, and injection near the joints, where the nerves are closer to the surface of the skin.

The Biojector B2000 is placed against the skin and delivers T-20 without the need for needles and syringes with T-20 being pushed under the skin using high pressure. The manufacturers of this product designed a prospective, open label, twelve-month study designed to evaluate the Biojector B2000 against insulin syringes and standard syringes currently used for T-20 dosing. The results demonstrated high levels of persistency, tolerability and patient satisfaction and represent a (preferred?) alternative to standard needle/syringe administration of T-20

In October 2007, Roche has withdrawn its application to US regulatory authorities for approval of this needle-free way of administering T-20. Although the Biojector B2000 reduced the incidence of injection site reactions in T-20-treated patients, earlier in 2007 the Food and Drug Administration, which regulates medicines in the US, revised the labeling and required more testing to be done.

Roche have now announced that they will not be pursuing their application for US approval for the B2000 for T-20 administration. In a press release they cite: “significant delay in achieving US regulatory approval due to the time required to generate additional data.”

Patients in the US who are currently using the B2000 to administer T-20, either because of their inclusion in a clinical trial or other programme, will be allowed to continue to use the B2000 to take the drug. Patients in Europe will now not get a chance to use the Biojector.

There is a feeling that Roche have done this because they see that there is a declining market for T-20, as newer, more easily tolerated drugs are coming on-line, and they cannot justify the cost of continuing this work. The decision to stop work in this area has disappointed many T-20 users, who had hoped for an easier delivery system. There had been no prior discussion with the community about this withdrawal by Roche.

It was felt that this decision would also increase the rate of decline of T020 use. Roche, however, was adamant that there was no discussion within Roche about withdrawing from the T-20 market. They also suggested that they were working on using smaller needle gauge, to make the injections easier.

There was some discussion:

Q: This is difficult to hear especially from the French community (there are more T-20 users in France than the UK).
A: There has been some benefit from the Biojector for some patients but overall there are many drawbacks with the Biojector – adverse events like nerve damage. The decision was based on many studies; it is recognised by Roche that it is not an ideal product.

Q: More detail of its adverse events.
A: Nerve pain, parasthesias, arthralgia, haematomas (clinical trials in USA).

Q: How does community feel:

A: Huge disappointment from the people we know on T-20 – Think this will speed up transfer of patients away from T-20 – – In previous meetings with the CAB, Roche was very excited and positive about the Biojector – Unclear about balance between cost issues and efficacy

Q: As business leader, will Roche still produce T20 in 3 years time?
A. The level of manufacture may diminish but Roche will still produce and market it. Yes, it will still be used but the numbers of patients will be fewer.

Q: Below what level of use will Roche stop producing T20?
A: From the medical perspective there will always be clinical need and T20 will be available for resistant patients. However, there remains discussion relating to volumes of production and other business aspects.

Q: Any data on Lipodystrophy with T20?
A: Not specifically; we will request an electronic search.

Q: Since we have patients in UK who still use T20, could you provide this choice through a community trial using Biojector?
A: I can look into this, but it is difficult since Biojector not licensed in Europe.

2. Access to treatment for migrants and people facing deportation: the clinician’s perspective.

This was a brief presentation, but mostly a discussion, led by Dr Mike Youle, Royal Free Hospital, London.

Mike said that from a doctor’s perspective, there was not much he could do once the leave to remain has been denied. Writing a support letter would only be useful when the country in question has issues with access to antiretroviral therapy. But you cannot argue that ARVs are not available in Uganda or India because there is to a large extent, wide availability of these drugs. As clinicians, we cannot comment on other reasons like political or social issues.

Some patients could get drugs from friends who would anonymously register at clinics. Asylum seekers are legitimately able to access HIV treatment in the UK; however, people who have been denied leave to remain in the UK are not legally under NHS responsibility.

There are just not legal implications (for which we campaign) but also ethical issues of access to medical care by this group of people.

So what would be the options?

  • Boxes of returned drugs should not be destroyed (especially when returned to pharmacies). Expiry dates reflect that the drug will be less active but could still be used 1 or 2 years after the expiry date and not be harmful. HIV i-Base could collect these drugs for redistribution to people being deported or other countries;
  • Another way would be to put them on clinical trials or use drugs not available in their home country;
  • Work with doctors that want to treat – and see patients out of hours – when interview officers are not working;
  • Pick most important patients to fight for – those at most risk of deportations;
  • Very clinic dependent. Attending high African clinic may increase risk of being deported;
  • Marriage and civil partnerships;
  • Develop an agenda for change.

Issues of deportation must be viewed and dealt with at different levels such as individual, medical, advocacy and political level.

Some countries still have a lot of stigma towards HIV patients; for example, Singapore where HIV patients have to go to Bangkok for treatment; also many Arab countries.

Q: I’m from Zimbabwe and know most drugs are not available.
A: Zimbabwe is very specific case. Responsibility is shared by medical, social and political climate.

Q: I am from Uganda and work in the main hospital in Mulago. Many patients (deportees) arrived on second-line drugs that we can’t provide.
A: These are political problems. Uganda gets global fund money but chooses not to buy second-line drugs.

Q: When prescribing for a deportee, do you recommend newest drugs, or those only available in Africa?
A: No reason not to switch between treatments. Can use the best treatment in the UK, and switch, for example to Combivir, if you are returned to a country where, for example, tenofovir is not available. Some old drugs are still good for lots of patients,

Q: Does the availability of treatment in these different countries mean that there is good standard of laboratory monitoring (CD4, Viral loads etc)? Doesn’t this affect deportation?
A: CD4s and Viral loads might not be readily available. However, if the patient is adherent and VL<50 copies, the most important labs to monitor are liver function tests and renal function tests. Most centres are moving to doing viral loads once a year.

Q: What about patients on 2nd line who are facing deportation?
A: Give a 6 months supply of Kaletra and try and contact a local clinician in that country to take over patients care. Or advocate against deportation on medical grounds.

Q: There are doctors outside of London (north) who might not be linked with doctors in other countries.
A: It is essential that HIV-I Base or UK CAB create a database of key clinicians in every country on the web to whom patients could be referred in case of deportation. This should be a policy organisation priority.

3. HIV treatment in immigration removal centres.

This presentation was given by Joe Murray, of the National AIDS Trust (NAT). A copy is available on the UK-CAB website.

Research suggests that HIV prevalence from certain migrant communities may be higher than in the general population of the UK, although there is no accurate way of knowing, although there have been large increases in the number of individuals diagnosed with HIV and many of these were in black and minority ethnic communities. It is estimated that 3.6 per cent of black Africans and 0.3 per cent of black Caribbeans are living with HIV in the UK, which is respectively 46 and 3.7 times the estimated prevalence in white heterosexuals (0.08 per cent).

NAT conducted a survey of healthcare managers in the ten Immigration Removal Centres (IRCs) in the UK regarding the management of HIV and AIDS there. On average, between 1300-1400 asylum seekers are detained in IRCs per quarter of year.

Most common nationalities in 2007 were Nigeria, China, Sri-Lanka and Jamaica. IRCs are holding centres for asylum seeking people or foreign nationals who are detained pending immigration decision or deportation. Not all refused asylum seekers go to the IRCs; it is dependent on whether they are likely to disappear or voluntarily leave the UK.

The aims of the study were to:

  • Collate information about the measures currently undertaken in each IRC to prevent and treat HIV;
  • Gather examples of good practice in the prevention, testing and treatment of HIV and to identify gaps and barriers in these areas;
  • Promote improvements in healthcare for people living with HIV in these centres.

Some of the findings are given below:

Average Length of Stay

  • Approximately 18 days (range from 3 to 30 days);
  • Shortest and longest period of stay for an individual detainee was 30 minutes to 18 months.

Known HIV Cases

  • 159 detainees were known to healthcare managers as HIV positive;
  • 140 of those were diagnosed before entering the IRC;
  • 28 were pregnant women;
  • 91 received ARVs while detained;
  • Not every one in the detention centre discloses their serostatus. HIV is not a mandatory test except if clinically indicated or a detainee requests test.

HIV Testing

  • 9 of 10 IRCs offered testing if requested by the detainee and 4 offered this where it was clinically indicated (none offered routine testing);
  • Mainly carried out in the IRC, either by clinical staff or by visiting clinical staff;
  • 3 IRCs arranged for detainees to visit external medical services for testing;
  • Majority of IRCs reported detainees would have to wait a week or less for an HIV test result (longest was two weeks);
  • All IRCs provided access to pre- and post-test discussion.

HIV Treatment

  • Local PCTs funded ARV treatment;
  • In almost all IRCs, ARVs were provided where clinically indicated;
  • In one case, ARVs were only provided where the detainee was already taking medication prior to detention;
  • Initial health assessment was reported as a fundamental tool for determining the need for continuing medication.

Access to Community Services

  • All provided access to NHS services;
  • All provided access to voluntary services such as local HIV support organisations (e.g. Body Positive, Terrence Higgins Trust)

HIV Education and Advice

  • In most cases, GPs or nurses were the primary access point for individual support;
  • Two IRCs described having mental health professionals available via referral.

Preparation for Repatriation

  • 2 IRCs reported that no arrangements were made to enable a detainee living with HIV to prepare for repatriation;
  • Most reported they tried to enable some continuity of treatment by providing additional supplies of medication, ranging from 1 to 6 months supply;
  • IRCs commonly identified finding ways to link detainees to support services in the destination country as a key concern.

Harmondsworth can be used as a specific example; there are currently 3 detainees who are living with HIV and all are on ARV treatment:

  • 1 has been in the IRC since 30 Sept (although in detention since 30 June), is to be removed to Cameroon and has been given a 3 month supply of medication;
  • 1 has been in the IRC since 6 Sept, is to be removed to Uganda and has been given a 6 month supply of medication;
  • 1 has been in the IRC since 7 July (although in detention since 24 May), is to be removed to Liberia and has been given a 3 month supply of medication;
  • All have regular follow up with the local clinic;
  • Currently 1 detainee is being tested for HIV (it was requested by the detainee);
  • Pre- and post-test counselling is provided externally by the local clinic;
  • ARV treatment is available to all detainees who are clinically indicated to require it;
  • Detainees are allowed to have medication in possession (if newly diagnosed, gradually the detainee will be allowed to have medication in possession)

From this survey and subsequent work, it appears that Healthcare managers are striving to provide the best care possible for their HIV positive patients within the limitations of significant detainee turnover and available resources. However, the survey highlighted suboptimal care in detention and in preparation for repatriation. NAT and BHIVA, in coordination with other stakeholders, are working to develop advice to support best practice related to the needs of asylum seekers living with HIV during detention and the removal process. NAT will continue to work with the IRC healthcare managers working group and participate in a specific ‘work stream’ on HIV.

NAT wants to work with other organisations like BHIVA etc for providing advice to healthcare workers (best practise booklets/guidelines) on needs of asylum seekers. NAT is also pushing to get HIV on the agenda of IRCs health care management.

Key issues highlighted were:

  • New asylum model (designed in 2005 and implemented by 2007)
  • focussed on rapid and fast track integration or deportation at IRCs;
  • HIV prevention and testing;
  • Access to treatment and continuity of care could be improved;
  • Preparation for repatriation is key concern;
  • Access to community services
  • it is said that this is accessible but no idea about actual take-up or use;
  • Establish clear guidelines on clinical advice on delay of removal – on health grounds;
  • Others -HIV training for IRC workers.

There were several questions:

Q: All this information is from the IRC, and I am not convinced about its accuracy. GPs usually don’t educate about HIV outside IRCs, so why should this be different in the IRCs.
A: This is what is reported.

Q: What level of interaction do we actually know takes place between IRCs and community organisations?
A: It is not well known. THT links to an Oxford centre, but it is not well organised.

Q: When talking to the staff, did you get the general feeling of confidentiality?
A: Yes. Most were aware of sensitivities of HIV, confidentiality, diet restrictions for food etc. At least survey responses indicated they were trying to provide good care, but some care was sub-optimal, and little communication between centres.

Comment-People never know when they are going to be detained. They go to sign on, and are taken away. They may not have meds and so a gap in access to medication can arise. In practice, this gap occurs now. We also know that HIV care is not taken seriously. People have their mobile phones taken away, and when we hear from them they are pleading to get access to their doctors.

Comment-we would need to compare the NAT report with shadow report from human rights organisations since this report is at best likely to be biased and at worst unreliable. You should review this survey further.

Q: We had a client deported 3 years ago, leaving messages, but when we tried to contact them, no-one at the centre answered the phone. She was deported with no medication. Can NAT not work with people who are frontline voluntary centre work?
A: Yes, we think this survey is not so good, we know we were reliant on information given by the IRCs.

Q: Why not do personal in-depth interviews with detainees? We need information on whether people access care after they are deported – this should be possible by email.

Q: Why did you choose not to work directly with detainees and volunteers who have worked in these centres to get a more reliable picture?
A: Personally I was not in post when the survey was done. There is need to do a follow-up survey.

Comment: The relationship you are developing with healthcare managers to get them to engage is probably crucial to any change; it needs to be maintained and nurtured. Alienating them would probably be counter-productive.

Q: Is an IRC like prison? If so, how believable is it that people get drugs to take?
A: Yes, it is physically like a prison – gated, barbed wire, and two security doors. Once inside, though, it is more like an open dorm. People have access to facilities such as library, gym, TV room etc – so more comfortable than a prison. Some IRCs allow you to keep ARVs, other make you go every day to the pharmacy,

Q: Are condoms available?
A: They are provided upon request

Q: Are there storage facilities for ARVs – e.g., fridges?
A: Yes, in Handsworth (1 of the IRCs).

Comment: Do we want to do something as UK-CAB
A-Reserve space and continue further discussion with NAT.

4. Feedback from European AIDS Clinical Society Conference (EACS), Madrid 2007

Simon Collins, HIV i-Base, gave some feedback.

1. Up to 60 percent of HIV infections in Europe have not been diagnosed, experts said at EACS. Europeans talked about AIDS in Africa, but much remained to be done in Europe itself, Danish expert Jens Lundgren said. The number of diagnosed HIV infections has doubled to about one million over the past decade in Western and Eastern Europe, according to figures given by Lundgren. At least one million Europeans also have HIV without knowing it. Infections are increasing most rapidly in Eastern Europe, where around 70 percent of infected people carry the HIV virus unawares, whereas most Western European cases have been diagnosed, Lundgren explained. Many new Western European cases are found among immigrants, while in the east, the HIV virus is spreading among people born in the region. Late diagnoses pose a problem both for treatment and for prevention. Testing should be increased among people belonging to risk groups or showing symptoms of diseases that could have been caused by AIDS, it was suggested.

2. Results from the ARTEMIS trial have shown that ritonavir-boosted darunavir is virologically non-inferior to boosted lopinavir (Kaletra) in treatment-naïve patients after 48 weeks of treatment, and that patients with viral loads greater than 100,000 copies/ml were more likely to achieve undetectable viral loads with darunavir than with lopinavir. Darunavir was better tolerated with less diarrhoea and less impact on the lipids. A switch from Kaletra to Darunavir may be an alternative to lowering cholesterol instead of using lipid-lowering agents such as statins. However Darunavir is likely to be expensive.

3. HIV-positive patients with lipodystrophy can be treated safely and effectively with tesamorelin (TH9507) for at least 52 weeks. The results presented reflect the second half of a one-year study in which patients stopped, started, or remained on tesamorelin therapy to evaluate the long-term effects of the drug.

To date, no treatments have been approved for the management of visceral adipose tissue (VAT) increases – a buildup of fat around the gut, deep within the body – seen in many HIV-positive people. However, studies have shown that administration of Serostim (recombinant human growth hormone) reduces VAT – an average 20% drop in VAT after 12 weeks was seen in one recent study – and may also have a therapeutic effect on lipid levels. Unfortunately, Serostim therapy is associated with some notable side effects, including fluid retention and an increased risk of blood glucose elevations. In fact, Serostim has been turned down for approval by the U.S. Food and Drug Administration for the treatment of lipodystrophy, though an appeal is pending.

Theratechnologies, a company based in Montreal, has been experimenting with the use of a synthetic growth hormone release factor (GRF) dubbed tesamorelin. It acts on pituitary cells in the brain, triggering growth hormone production and secretion. This more natural release of growth hormone by the pituitary gland, researchers associated with the development of tesamorelin suggest, may result in treatment benefits similar to those seen in Serostim lipodystrophy studies, but with fewer side effects.

The data reported at EACS come from one of two Phase III clinical trials being conducted by the company. The study originally enrolled 412 U.S. and Canadian HIV-positive patients with evidence of lipodystrophy-associated VAT increases. For the first 26 weeks, patients were randomized to receive either daily subcutaneous injections of 2 mg tesamorelin (273 patients) or placebo (137 patients). Upon completing 26 weeks, patients receiving tesamorelin were re-randomized to switch to placebo (50 patients) or continue taking the drug (154 patients). All patients originally randomized to receive placebo were given tesamorelin for the second 26 weeks of the study. During the first 26 weeks of the study, patients treated with tesamorelin saw their VAT decrease by 15 percent, compared with pre-treatment measurements. In the placebo group, there was an average 5 percent increase in VAT after 26 weeks. This 20 percent difference between the two groups was statistically significant.

In the second half of the study, patients treated with tesamorelin for a total of 52 weeks had lost 18 percent of their VAT; most of the fat loss occurred during the first 26 weeks of treatment. Patients treated with tesamorelin and subsequently given placebo experienced a VAT loss of 18 percent by week 26. Upon switching, VAT concentration were only 2 percent below pre-study levels. Among patients who switched from placebo to tesamorelin, the 5 percent gain in VAT seen after the first 26 weeks in the study became a 12.5 percent decrease—compared with pre-study levels—during weeks 26 to 52.

Approximately 50 percent of patients treated with tesamorelin developed antibodies to the drug during the trial. However, this did not appear to affect patients’ responses to treatment. Tesamorelin was generally well-tolerated by patients during the first 26 weeks of treatment. The safety profile observed during the 26- to 52-week treatment period is in line with the previously reported 26-week data, but with a lower incidence of side effects. The four most commonly reported side effects were: upper respiratory tract infections (6.5 percent), colds (5.8 percent), stuffed sinuses (5.2 percent) and joint pain (3.9 percent). During the first 26 weeks of the study, the four most common side effects were headache (16 percent), joint pain (13 percent), injection site bruising (9 percent) and diarrhea, fluid retention and muscle pain (all reported at 8 percent). It appears, though, that continuous treatment with the drug will likely be required to maintain fat loss.

4 .A report, presented by Marta Boffito of the St. Stephen’s Centre in London, looked at drug levels in the blood of people taking Kaletra once daily or twice daily, or Norvir-boosted Reyataz (atazanavir). Dr. Boffito’s team enrolled 16 HIV-negative participants who received either 300 mg of Reyataz plus 100 mg of Norvir once a day, once daily Kaletra (800 mg lopinavir plus 200 mg ritonavir) or twice daily Kaletra (400mg lopinavir plus 100mg ritonavir) for 10 days. Blood concentrations of the protease inhibitors were measured regularly for 72 hours following day 10. They found that 24 hours after the last dose, none of the participants taking boosted Reyataz had blood levels below the minimum effective concentration (MEC) required to keep virus suppressed. However, 44 percent of those taking Kaletra once daily had drug concentrations below the necessary MEC—suggesting that once-daily Kaletra may not be suitable for some HIV-positive people. While further studies are needed to verify the results of these two trials, they do suggest that once-daily Kaletra may not be an ideal dosing option, especially for HIV-positive people with high pre-treatment viral loads.

5. There was a good overview session on resistance, with key slides on the importance of keeping the CD4 count <50 copies/ml. Resistance is just as important now as ever – we are talking about lifelong treatment, and are unlikely to see another block of new drugs for years. There seem to be now good models for how resistance develops; the key, though, seems to be keeping the CD4 count below 50.

5. AOB

Dates for UK-CAB meetings for next year, and provisional topics are:

  • Jan 25th – BHIVA audit, microbicides and PEP/PrEP – Pfizer
  • April 11th – TB co-infection – Tibotec
  • July 25th – Transition of care from paediatric to adult care – GSK
  • Oct 24th – Cardiovascular disease – BMS

Toju Cline-Cole was elected to the post of Community Representative on the hydroxychloroquine study Trial Steering Committee.

A vacancy for a community representative on the BHIVA treatment guidelines writing group was announced.

Views expressed in this report are personal and do not represent the views of any organisation involved in the meeting. Reasonable steps have been taken to ensure this report is accurate but it is for information only and not a substitue for professional advice.

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Published: November 2, 2007
Last edited: December 19, 2010