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Levinia Crooks CEO – ASHM

Update on the DHHS Guidelines for ARV treatment in Adults and Adolescents, Australian Commentary Process . Levinia Crooks CEO – ASHM. Historical perspective. Australian ARV Guidelines developed by CTARC, published by ANCARD, 1996, 1997 and for pregnant women in 1999

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Levinia Crooks CEO – ASHM

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  1. Update on the DHHS Guidelines for ARV treatment in Adults and Adolescents, Australian Commentary Process Levinia Crooks CEO – ASHM

  2. Historical perspective • Australian ARV Guidelines developed by CTARC, published by ANCARD, 1996, 1997 and for pregnant women in 1999 • 2001 Guidelines reviewed but not finalised by CTARC • 2003 CTARC abolished • 2004 ASHM proposed re-development of guidelines or adaptation of others Guideline, stakeholder meeting, selected DHHS ARVG

  3. ARV Guidelines Panel • Endorsed by MACASHH and BBVSS • ASHM to administer, support and manage an ARV Guidelines panel which would produce a commentary on DHHS ARV Guidelines for Management of HIV in Adults and Adolescents • Three basic types of adaptation: • Routine relating to info, contacts, services etc • Basic, relating to differences in availability of drug , epidemiology difference • Issues relating to management, based on interpretation of evidence

  4. Relationship with DHHS Panel • Commentary travels in both directions • Intermittent engagement with DHHS panel • Sharing of technology to produce and update guidelines and incorporate comments

  5. Relationship with other Guidelines • Panel decided not to run public comparative reviews of other Guidelines • Wanted simplified and evidence based Guidelines • Has considered producing own Guidelines but has been concerned by duplication and cost • Able to produce commentary in timely manner

  6. Functioning of the Panel • Confidential, and confidentiality agreements • Considerable focus on potential for conflict of interest • Declaration of conflicts of members • Clinical and community representatives • ASHM board approves nominees • Consensus is aimed for • When not reached indicated in commentary

  7. In practice • DHHS Guidelines published in full on website • Commentary imbedded into Guideline • Reader is able to submit feedback which goes back to Panel

  8. March Iteration of DHHS Antiretroviral therapy (ART) is recommended for all HIV-infected individuals. The strength of this recommendation varies on the basis of pretreatment CD4 cell count: • CD4 count <350 cells/mm3 (AI) • CD4 count 350 to 500 cells/mm3 (AII) • CD4 count >500 cells/mm3 (BIII) Regardless of CD4 count, initiation of ART is strongly recommended for individuals with the following conditions: • Pregnancy (AI) (see perinatal guidelines for more detailed discussion) • History of an AIDS-defining illness (AI) • HIV-associated nephropathy (HIVAN) (AII) • HIV/hepatitis B virus (HBV) coinfection(AII) Effective ART also has been shown to prevent transmission of HIV from an infected individual to a sexual partner; therefore, ART should be offered to patients who are at risk of transmitting HIV to sexual partners (AI [heterosexuals] or AIII [other transmission risk groups]; see text for discussion). Patients starting ART should be willing and able to commit to treatment and should understand the benefits and risks of therapy and the importance of adherence (AIII). Patients may choose to postpone therapy, and providers, on a case-by-case basis, may elect to defer therapy on the basis of clinical and/or psychosocial factors. Rating of Recommendations: A = Strong; B = Moderate; C = Optional Rating of Evidence: I = data from randomized controlled trials; II = data from well-designed nonrandomized trials or observational cohort studies with long-term clinical outcomes; III = expert opinion

  9. When to start • Panel did not reach consensus • section 100 indications for funding of antiretroviral treatment of HIV infection are a CD4 cell count less than 500 cells/μL or symptomatic HIV. • Highlights the reader to consideration of individual issues on starting 350 – 500 • Indicates paucity of evidence for >500 and urges great reading to assist in decision making

  10. Treatment as prevention • The panel did not reach consensus • Cautions on transferability of HTPN 052 heterosexuals in developing countries to a predominantly MSM transmission setting • Observes that transmission occurred in couples in HTPN052 at <350 cells/μL where MSM in Australia likely to be on treatment • Indicates 2 trials specific to MSM to be watched for more information

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