Kirsty Machon and John Daye met with Victoria Elegant (Sanofi-Aventis representative for Sculptra, formerly known as New-Fill) to look at developing a Special Access Scheme. NAPWA were requested by Sanofi-Aventis to develop a protocol for people who need access to the procedure but cannot afford it because of financial hardship. Kirsty, in collaboration with JD, BW and the TPG, has drafted a proposal for Aventis to consider, and will be meeting with them to discuss how such a scheme might work in practice.
ATPA
A new Fact Sheet on management options for facial lipoatrophy has been prepared by Kirsty Machon in consultation with ATPA and the TPG and will be circulated soon.
Models of Care Panel
The Models of Care (MOC) for HIV infection project has been undertaken by ASHM through the MOC panel for HIV/AIDS and STI HASTI committee of the Ministerial Advisory Committee on AIDS, Sexual Health and Hepatitis (MACASHH). The project is progressing and non-Australian guidelines are being modified to suit local needs. A database of relevant resources is being compiled electronically firstly to provide a resource for clinicians and secondly to provide the foundation for a needs assessment for further MOC work. The MOC database will be continually updated to remain a useful resource. The database on MOC has been set up from the ASHM homepage. NAPWA will have input about a range of resources for the clinical setting including information specifically for HIV-positive people on sexually transmitted infections.
Integrase Inhibitor Study
Merck have commenced phase 2 studies of this new agent which is in a new HAART).”>drug class (Integrase Inhibitors). This trial now is recruiting.
Non Occupational Post-exposure Prophylaxis Reference Group.
This reference group is reviewing the guidelines for the management and post exposure prophylaxis of individuals who sustain non-occupational exposure to HIV (Pep Guidelines). The reference group is reviewing guidelines for HASTI and approval by the Commonwealth Department of Health and Aging to reflect and support best practice in Australia. An electronic version of the guidelines is being developed on the ASHM website. NAPWA’s involvement in the reference group is particularly important because it will assist in identifying barriers to accessing this service.
MSAC Genotyping (Resistance) Testing
After the Medical Services Advisory Committee’s (MSAC) handing down its finding that it would not list genotyping as a rebatable Medicare item NAPWA has been working with the National Centre of Epidemiology and Research to investigate how this decision can be reversed pending a resubmission to MSAC with new supporting data. A health economist will be recruited to bring together the necessary information required for a further application to MSAC. The issue of the importance of recognising genotyping as a diagnostic tool has been raised in MACASHH.
SMART Study
The SMART trial (Strategies for Management of Antiretroviral Therapy) has been terminated after it was found that people on treatment interruptions guided by CD4 counts rather than continuous treatment put HIV-positive people at an increased risk of disease progression, AIDS and death. Those taking CD-4-guided treatment interruptions had a risk of progression calculated at 3.8 times greater than those on continuous therapy. TON has been briefed on this, and NAPWA is working on a briefing paper.
Ton met in March. The Treatment Officers/Care & Support Officers report high levels of activity in a wide range areas from HIV-positive people who are seeking advice. At the last TON meeting a presentation from the co-ordinator of the mental health H2M project was well received particularly because it covered in depth material on depression, recreational drug use and anxiety (issues that Treatment Officers deal with in their roles).
Complexity Paper
IGCHARD are pursuing the issues detailed in the complexity paper. A planning meeting is scheduled to explore the strategic directions identified in the paper and to develop a series of recommendations. Overlapping areas will be developed within the Models of Care Panel as they are being drafted. A draft model of care will be presented to the Treatments Policy Group for input. Planning meetings will be scheduled within the NAPWA/AFAO Joint Care & Support Task Force to progress the complexity paper.
Kaletra New Formulation
Abbott is launching their new formulation of Kaletra in July 2006. The new formulation is reported to reduce the number of pills, have no requirement for refrigeration and lower gastrointestinal side effects. The new formulation will simplify this drug and improve tolerability. The new formulation was presented at the AIDS Conference on HIV Pathogenesis and Treatment which examined its bioavailability. Adverse event rates for diarrhoea appeared lower with the tablet compared with the soft gel capsules.
Boosted Atazanavir as Potent as Kaletra
BMS published data shows that ritonavir boosted atazanavir is as potent at reducing viral load and increasing CD4 counts as Kaletra at 96 weeks of treatment.
Pfizer CCR5 Inhibitor (Maraviroc)
This drug is under investigation UK-427,857, blocks HIV from using the CCR5 receptor and thereby prevents HIV from entry into cells. The trial of this new drug in another new class is underway. There are three arms trials looking at the drug in different populations. Some issues with other CCR5 inhibitors were raised several months ago and at that time Pfizer reviewed its clinical trial design in the light of those issues, the Pfizer Advisory Committee of which Jo Watson is a member determined to proceed with this trial. The independent Data Safety & Monitoring Board reviewed concerns including maraviroc’s liver safety. The DSMB decided that it was safe to continue with both the phase 3 (efficacy) and phase 2B (safety) clinical trials in treatment-experienced and treatment naive people.
Truvada
Gilead Sciences launched their new formulation of Tenofovir and FTC in February this year. Truvada (one combined pill of tenofovir and FTC taken once daily) has been approved by the TGA (Australian Government licensing body for new drugs)
Second-line Regimes for Indonesia
After consultation with Australian clinicians and researchers considerations for the use of second-line antiretroviral regimes were documented by John Daye for Chris Green, a treatments access advocate in Indonesia. Of particular concern was a proposal by Indonesia to use ddI and tenofovir in the same regimen.
Avexa
Discussions within the treatments portfolio have commenced around the trial of Avexa’s new nucleoside analogue AVX754. The study is to evaluate the drug in people who have confirmed M184V mutation (the main drug mutation of 3TC). AVX754 has a very similar chemical structure to 3TC but in tests so far in the laboratory it has shown potent antiviral activity in the presence of 3TC resistance.
MSD Forum
Merck, sharp & Dohme ran the HIV Postgraduate Forum in Melbourne in February. The content of the workshops was particularly good, many of the presenters overlapped with the same presenters for the ATPA and ASHM Short Course in HIV Medicine. The theme of the meeting was “New Frontiers – Addressing Challenges in HIV from a Different Point of View”. Workshop areas included mental health, the management of highly treatment experienced patients, HIV associated metabolic and cardiovascular problems.
TMC-114 (Darunavir) & TMC-125
After consultation with NAPWA Janssen Cilag of Johnson & Johnson have commenced a Special Access Scheme for TMC -114 branded as Darunavir. This new protease inhibitor is highly active against HIV with protease inhibitor resistant mutations and particularly significant for those who have reduced treatment options because of drug resistance. Clinical trials of this company’s other new drug in the Non-Nucleoside Reverse Transcriptase Inhibitor class TMC – 125 are planned for early next year, these trials will see the duel use of two new agents under investigation together TMC -114 & TMC -125.
Uridine
At the 7th International Workshop on Adverse Reactions & Lipodystrophy a report on the use of Nucleomaxx, a uridine food supplement to block some of the harmful effects of nucleoside analogue drugs and stop fat loss looked promising. To properly explore this agent that could potentially prevent the onset of mitochondrial damage causing lipoatrophy it has been placed on the agenda of the next NCHECR Toxicology & Pharmacology Working Group. The Treatments Policy Group has been working on getting research and access initiated here in Australia. A proposal for a pilot study is currently being worked on.
Changes within the Treatments Portfolio
There has been a lot of movement of key people involved in the treatments portfolio and their contribution will be missed. Alan Strum has been appointed to a HIV management position within Merck, Sharp & Dohme. ACON Treatments Officer Stephen Gallagher has retired for health reasons, Tony Maynard has taken up a position within Janssen Cilag. On behalf of the treatments portfolio we wish to thank them for their hard work over the years.
Bill Whittaker & John Daye
Co-convenors