Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p57
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 57/476)
Character Range: 1107375–1123101

be in combination with other antiretroviral agents; AND
                                                                                                                                            The treatment must not be in combination with ritonavir; AND
                                                                                                                                            Patient must have experienced virological failure or clinical failure or genotypic resistance after at least one antiretroviral regimen.
                                                                                                                                            Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment‑limiting toxicity.
                                                                       C6413                                                                Human immunodeficiency virus (HIV) infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures ‑ Streamlined Authority Code 6413
                                                                                                                                            Initial treatment
                                                                                                                                            Patient must be antiretroviral treatment naive; AND
                                                                                                                                            The treatment must be in combination with other antiretroviral agents; AND
                                                                                                                                            The treatment must not be in combination with ritonavir.
                                                                       C6428                                                                Human immunodeficiency virus (HIV) infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures ‑ Streamlined Authority Code 6428
                                                                                                                                            Continuing treatment
                                                                                                                                            Patient must have previously received PBS‑subsidised therapy for HIV infection; AND
                                                                                                                                            The treatment must be in combination with other antiretroviral agents; AND
                                                                                                                                            The treatment must not be in combination with ritonavir.
Darunavir with cobicistat, emtricitabine and tenofovir alafenamide     C10317                                                               HIV infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 10317
                                                                                                                                            Continuing treatment
                                                                                                                                            Must be treated by a medical practitioner or an authorised nurse practitioner in consultation with a medical practitioner.
                                                                                                                                            Patient must have previously received PBS‑subsidised therapy for HIV infection; AND
                                                                                                                                            The treatment must not be in combination with ritonavir.
                                                                       C10324                                                               HIV infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 10324
                                                                                                                                            Initial treatment
                                                                                                                                            Must be treated by a medical practitioner or an authorised nurse practitioner in consultation with a medical practitioner.
                                                                                                                                            Patient must be antiretroviral treatment naive; OR
                                                                                                                                            Patient must have experienced virological failure or clinical failure or genotypic resistance after at least one antiretroviral regimen; AND
                                                                                                                                            The treatment must not be in combination with ritonavir.
                                                                                                                                            Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment‑limiting toxicity.
Deferasirox                                                            C7374               P7374                                            Chronic iron overload                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures
                                                                                                                                            Initial treatment
                                                                                                                                            Patient must not be transfusion dependent; AND
                                                                                                                                            The condition must be thalassaemia.
                                                                       C7375               P7375                                            Chronic iron overload                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures
                                                                                                                                            Initial treatment
                                                                                                                                            Patient must be transfusion dependent; AND
                                                                                                                                            Patient must not have a malignant disorder of erythropoiesis.
                                                                       C7385               P7385                                            Chronic iron overload                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures
                                                                                                                                            Initial treatment
                                                                                                                                            Patient must be red blood cell transfusion dependent; AND
                                                                                                                                            Patient must have a serum ferritin level of greater than 1000 microgram/L; AND
                                                                                                                                            Patient must have a malignant disorder of haemopoiesis; AND
                                                                                                                                            Patient must have a median life expectancy exceeding five years.
                                                                       C8326               P8326                                            Chronic iron overload                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures ‑ Streamlined Authority Code 8326
                                                                                                                                            Continuing treatment