Pathology test to determine if a patient has been infected with CCR5 tropic HIV-1 for access to maraviroc

Medical Services Advisory Committee
Record ID 32015000421
English
Authors' recommendations: After considering the strength of the available evidence in relation to the safety, clinical effectiveness and cost-effectiveness of genotypic testing for HIV tropism to help determine eligibility for existing PBS-subsidised fourth-line maraviroc or for proposed PBS-subsidised earlier-line maraviroc, MSAC does not support public funding on the basis of insufficient evidence that genotypic tropism testing as proposed adequately distinguishes between HIVinfected individuals who should and should not receive maraviroc. This is important because the effectiveness of HIV treatment regimens not involving maraviroc is not predicted to vary by HIV tropism status, whereas a HIV tropism test that can be relied upon should accurately distinguish between individuals with R5-tropic virus (who will respond to HIV treatment regimens involving maraviroc to the same extent as to these alternative regimens) and individuals with X4-tropic virus (who will have a less effective response to regimens involving maraviroc). Where there are existing anti-retroviral therapy options (that is, the proposed PBS listing of maraviroc), a high level of test accuracy is required because any false positive R5-tropism results will mean that the maraviroc-containing therapy will be less effective overall. Where there are no existing anti-retroviral therapy options (that is, the existing PBS listing of maraviroc as part of a fourth-line option), a high level of test accuracy is still important because any false positive R5-tropism results will mean that the effectiveness of maraviroc-containing therapy will be reduced. MSAC also advised that the PASC process would not need to be re-visited before lodging any resubmission addressing the matters outlined above.
Details
Project Status: Completed
Year Published: 2012
URL for published report: http://www.msac.gov.au/internet/msac/publishing.nsf/Content/1174-public
English language abstract: An English language summary is available
Publication Type: Not Assigned
Country: Australia
MeSH Terms
  • Humans
  • HIV-1
  • Triazoles
Contact
Organisation Name: Medical Services Advisory Committee
Contact Address: MSAC (MDP 107), GPO Box 9848, Canberra, ACT 2601, Australia. Tel: +61 2 6289 6811; Fax: +61 2 6289 8799.
Contact Name: msac.secretariat@health.gov.au
Contact Email: msac.secretariat@health.gov.au
Copyright: Medical Services Advisory Committee (MSAC)
This is a bibliographic record of a published health technology assessment from a member of INAHTA or other HTA producer. No evaluation of the quality of this assessment has been made for the HTA database.