PBAC's latest decision on Dolutegravir + abacavir + lamivudine: Recommended with restriction (2014). Considered for Treatment of HIV infection in antiretroviral treatment naïve patients aged 12 years or older weighing 40 kg or more, as well as in patients who have previously received PBS-subsidised therapy for HIV infection.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2014
Submissions
1
2014 → 2014
Eligible population
HIV-infected antiretroviral treatment naïve patients aged 12 years or older weighing 40 kg or more, or patients who have previously received PBS-subsidised HIV therapy, excluding those with integrase inhibitor resistance.
Therapy area
Infectious disease
Line of therapy
Any
Evidence base
RCT
Primary endpoint
Bioequivalence
Pivotal trial size
66 patients
Key trials
ING114580, SPRING-2, SINGLE, FLAMINGO
Comparator
dolutegravir + Kivexa (abacavir + lamivudine FDC)
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated by design. Costs in the economic model table are redacted (shown as asterisks).