PBAC's latest decision on Darunavir + cobicistat: Recommended with restriction (2016). Considered for Treatment of HIV-1 infection in combination with other antiretroviral agents in antiretroviral treatment-naïve patients and in treatment-experienced patients with no darunavir resistance-associated mutations.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2016
Submissions
1
2016 → 2016
Eligible population
Adults with HIV-1 infection who are antiretroviral treatment-naïve or treatment-experienced with no darunavir resistance-associated mutations
Therapy area
Infectious disease
Line of therapy
First-line
Evidence base
Single-arm
Primary endpoint
Surrogate
Key trials
Study 1001, Study 1003, Study 0130, ARTEMIS, ODIN, FLAMINGO, 2LADY, ACTG 5257
Comparator
For treatment-experienced: darunavir 800 mg + ritonavir 100 mg. For treatment-naïve: atazanavir 300 mg + ritonavir 100 mg
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis conducted; no ICER calculated