DarunavirDARUNAVIR JUNO
Treatment of HIV infection in combination with other antiretroviral agents and co-administered with 100 mg ritonavir once daily, in protease inhibitor naïve patients with evidence of HIV replication (viral load >10,000 copies/mL) and/or CD4 cell counts <500 per cubic millimetre.
Decisions on record
- Meeting Nov 2019 Recommended Human immunodeficiency virus (HIV) infection
- Meeting Mar 2016 Recommended HIV infection
- Meeting Nov 2015 Not recommended HIV infection
- Meeting Jul 2013 Recommended Human immunodeficiency virus (HIV) infection no PSD
- Meeting Jul 2011 Recommended HIV infection no PSD
- Meeting Jul 2010 Not recommended HIV-infection
- Meeting Nov 2009 Recommended Anti-HIV drug
Access path
- TGA registered · DARUNAVIR JUNO
- Jul 2007Recommended · restricted
Comparator changed: tipranavir → standard care (i.e. one or more of a group of preferred…
- Jul 2007Recommended
Comparator changed: tipranavir → standard care (i.e. one or more of a group of preferred…
- Nov 2009Recommended · restricted
Comparator changed: standard care (i.e. one or more of a group of preferred or…
- Jul 2010Not recommended
Inappropriate choice of comparator (lopinavir instead of atazanavir); absence of clinical and cost-effectiveness data…
- Jul 2010Not recommended
inappropriate choice of comparator (submission nominated lopinavir but PBAC determined atazanavir was more…
Cost-effectiveness
Cost-minimisation analysis was presented but PBAC rejected the submission before conducting a formal ICER evaluation due to inappropriate comparator choice and lack of efficacy/safety data against the appropriate comparator (atazanavir).
The PBAC concluded that for effectiveness darunavir/ritonavir was non-inferior to lopinavir/ritonavir, and that, while the toxicity profiles were different, the overall impact in terms of cost of management would be similar. PBAC · 2009
Decision context
PopulationProtease inhibitor naïve patients with HIV-1 infection with evidence of HIV replication (viral load >10,000 copies/mL) and/or CD4 cell counts <500 per cubic millimetre, receiving treatment in combination with other antiretroviral agents
Why it was knocked back
- inappropriate choice of comparator (submission nominated lopinavir but PBAC determined atazanavir was more appropriate), no clinical or cost-effectiveness data provided for comparison against atazanavir, absence of direct or indirect comparison data between darunavir and atazanavir
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2010 | Not recommended | ritonavir boosted atazanavir (300/100 mg daily) | — | RCT · virologic response (plasma viral load <50 copies/mL) |
| Jul 2010 | Not recommended | ritonavir boosted atazanavir | — | RCT · VL |
| Nov 2009 | Recommended · restricted | lopinavir with ritonavir | — | RCT · Virological response |
| Jul 2007 | Recommended · restricted | tipranavir | $15k–45k | RCT · Virological response |
| Jul 2007 | Recommended | standard care (i.e. one or more of a group of preferred or alternative PIs) and tipranavir | — | RCT · Virological response |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| RESIST-2 | NA | 152 | Death | terminated |