PBAC's latest decision on Dolutegravir with lamivudine: Recommended with restriction (2020). Considered for Extension of listing for DTG/3TC fixed-dose combination to include treatment-experienced (switch) patients with HIV-1 infection who are virologically suppressed on a stable antiretroviral regimen, in addition to the existing treatment-naïve population.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
2
first 2019
Submissions
2
2019 → 2020
Eligible population
Treatment-experienced adult and adolescent patients (≥12 years, ≥40 kg) with HIV-1 infection who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable tenofovir alafenamide-based regimen for at least 6 months with no history of treatment failure and no known or suspected resistance to the integrase inhibitor class or lamivudine.
Therapy area
Infectious disease
Line of therapy
Any
Evidence base
RCT
Primary endpoint
Virologic failure (HIV-1 RNA ≥50 c/mL at week 48)
Pivotal trial size
743 patients
Key trials
TANGO (Study 204862)
Comparator
dolutegravir 50 mg and lamivudine 300 mg taken concomitantly; basket of three-drug FDCs (Biktarvy, Genvoya, Odefsey, Triumeq) and two-drug FDC (Juluca)
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated
Submission history
Jul 2019: Deferred · Restricted
Jul 2020: Recommended with restriction · Authority Required