Abacavir Sulfate With LamivudineAbacavir/Lamivudine Viatris
Recommended Infectious diseaseRestricted
Treatment of HIV infection in combination antiretroviral therapy in patients over 12 years of age weighing 40 kg or more with CD4 cell counts less than 500 per cubic millimetre or viral load greater than 10,000 copies per mL.
1
Submissions
2005–05
On the record
—
ICER range
Cost-min
Cost basis
Access path
- TGA registered · Abacavir/Lamivudine Viatris
TGA label narrower than the PBS population
- Jul 2005Recommended
vs abacavir co-administered with lamivudine as single agents
- PBS listing · Restricted
RecommendedDeferredNot recommended
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated
Consistent with its policy on fixed dose combination products, the PBAC recommended listing on a cost-minimisation basis compared to the corresponding strengths of the individual components as the data from the two prospectively designed non-inferiority trials indicate once daily Kivexa as requested has similar safety and efficacy compared to concomitant abacavir 600 mg and lamivudine 300 mg daily. PBAC · 2005
Cost-effectiveness accepted
Decision context
PopulationPatients over 12 years of age weighing 40 kg or more with CD4 cell counts less than 500 per cubic millimetre or viral load greater than 10,000 copies per mL
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2005 | Recommended | abacavir co-administered with lamivudine as single agents | — | RCT · Non-inferiority |
Similar precedents
Dolutegravir + Abacavir + Lamivudine78%Tenofovir Disoproxil Fumarate With Emtricitabine And Rilpivirine Hydrochloride72%Tenofovir Disoproxil Fumarate With Emtricitabine72%Tenofovir Alafenamide, Emtricitabine, And Rilpivirine72%Tenofovir Alafenamide / Emtricitabine / Rilpivirine71%Emtricitabine + Tenofovir Alafenamide69%Tipranavir70%Cabotegravir And Rilpivirine68%
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to CD4 <500 cells/mm³ or viral load >10,000 copies/mL; TGA label has no such virological thresholds.