NAPWA

A report from the Health and Treatments Portfolio presented to the NAPWA Special General Meeting held 29-30 April 2006.

Sculptra Special Access SchemeBefore a drug has been approved, manufacturers often provide the drug free of charge to people who cannot participate in a clinical trial and who meet certain criteria under a Special Access Scheme (SAS).

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 protocolA study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment 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 ASHMAustralasian Society for HIV Medicine. The peak Australasian organisation representing the medical and health sector in HIV/AIDS and related areas. through the MOC panel for HIV/AIDS and STI[Sexually Transmissible (or Transmitted) Infection] Infections spread by the transfer of organisms from person to person during sexual contact. Also called venereal disease (VD) (an older public health term) or sexually transmitted diseases (STDs). HASTI committee of the Ministerial Advisory Committee on AIDS, Sexual Health and Hepatitis (MACASHHMinisterial Advisory Committee on AIDS, Sexual Health and Hepatides. The Australian Government Department of Health and Ageing’s high level expert committee, providing advice on issues relevant to HIV/AIDS, sexually transmissible infections and hepatitis C. ). 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":http://www.ashm.org.au/moc. NAPWA will have input about a range of resources for the clinicalPertaining to or founded on observation and treatment of participants, as distinguished from theoretical or basic science. setting including information specifically for HIV-positive people on sexually transmitted infections.

Integrase Inhibitor Study

Merck have commenced phase 2A smaller clinical trial designed to establish whether a drug is effective. Phase II studies are conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks. If there is evidence that the drug is effective, a Phase III study is undertaken, with a larger number of participaants, to confirm this. studies of this new agent which is in a new drug classA group of anti-HIV drugs with the same target of action. Anti-HIV drug classes include nucleoside analogue reverse transcriptase inhibitors, protease inhibitors and non-nucleoside analogue reverse transcriptase inhibitors, as well as several others. Combining drugs from three or more classes is the basis of Highly Active Antiretroviral Therapy (HAART). (Integrase Inhibitors). This trial now is recruitingThe act of signing up participants into a study. Generally this process involves evaluating a participant with respect to the eligibility criteria of the study and going through the informed consent process..

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 EpidemiologyThe branch of medical science that deals with the study of incidence and distribution and control of a disease in a population. 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 AntiretroviralA medication or other substance which is active against retroviruses such as HIV. 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":/?q=node/415. 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/AFAOAustralian Federation of AIDS Organisations. AFAO is the peak non-government organisation representing Australia's community-based response to HIV/AIDS. AFAO's work includes education, policy, advocacy and international projects. 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 bioavailabilityThe extent to which an oral medication is absorbed in the digestive tract and reaches the bloodstream, thereby permitting access to the site of action.. 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 loadA measurement of the quantity of HIV RNA in the blood. Viral load blood test results are expressed as the number of copies (of HIV) per milliliter of blood plasma. 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 trialA clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Trials are in four phases: Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people; and Phase IV takes place after the drug or treatment has been licensed and marketed. 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 liverA large organ, located in the upper right abdomen, which assists in digestion by metabolising carbohydrates, fats and proteins, stores vitamins and minerals, produces amino acids, bile and cholesterol, and removes toxins from the blood. safety. The DSMBAn independent committee, composed of community representatives and clinical research experts, that reviews data while a clinical trial is in progress to ensure that participants are not exposed to undue risk. A DSMB may recommend that a trial be stopped if there are safety concerns or if the trial objectives have been achieved. decided that it was safe to continue with both the phase 3A large clinical trial designed to establish whether a drug is effective and safe enough for widespread use. Phase III studies include expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide and adequate basis for physician labeling. (efficacy(Of a drug or treatment). The maximum ability of a drug or treatment to produce a result regardless of dosage. A drug passes efficacy trials if it is effective at the dose tested and against the illness for which it is prescribed. In the standard procedure, Phase II clinical trials gauge efficacy, and Phase III trials confirm it.) 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[Therapeutic Goods Administration] The federal government body that approves drugs and treatments before they can be prescribed. (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 antiviralA medication or substance which is active against one or more viruses. May include anti-HIV drugs, but these are more accurately termed antiretrovirals. 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 resistantHIV which has mutated and is less susceptible to the effects of one or more anti-HIV drugs is said to be 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 NCHECRNational Centre in HIV Epidemiology and Clinical Research. Based at the University of NSW in Sydney, NCHECR is one of Australia's leading medical research centres and is recognised internationally as a leader in the field of research into HIV/AIDS and viral hepatitis. 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