Dolutegravir With LamivudineDovato
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.
Decisions on record
- Meeting Aug 2019 Recommended Human immunodeficiency virus (HIV) infection no PSD
- Meeting Jul 2019 Deferred Human immunodeficiency virus (HIV) infection
Access path
- TGA registered · Dovato
TGA label narrower than the PBS population
- Jul 2019Deferred
Comparator changed: Individual components (dolutegravir 50 mg and lamivudine 300 mg taken…
- Jul 2019Deferred
Comparator changed: Individual components (dolutegravir 50 mg and lamivudine 300 mg taken…
- Jul 2020Recommended · restricted
Comparator changed: dolutegravir + tenofovir disoproxil fumarate/emtricitabine (DTG +…
- PBS listing · Authority Required
From the public summary
The PBAC recommended the Section 100, Highly Specialised Drugs Program (Community Access), Authority Required (STREAMLINED) listing of combination dolutegravir with lamivudine (DTG/3TC) be extended to allow use in patients with HIV infection who have previously been treated with an alternative anti-retroviral therapy (ART) regimen.PSD · Jul 2020
The PBAC’s recommendation for listing was based on, among other matters, itsPSD · Jul 2020
The submission presented a cost-minimisation analysis (CMA) for DTG/3TC based on the lowest cost methodology according to the individual components (Part 1) or the nominated comparators (Part 2). The CMA, other than nominated comparators, was unchanged from the previous submission. Table 9 presents the key components of the CMA. 12PSD · Jul 2020
A difference in MBS costs for monitoring requirements was expected between DTG/3TC and the alternative FDC triple therapies containing abacavir (ABC) and tenofovir (Biktarvy, Triumeq, Genvoya, Odefsey): Abacavir (ABC): human leukocyte antigen (HLA)-B*5701 testing prior to the commencement (MBS Item 71203/73323; $34.50) Tenofovir: urinary protein and glucose at baseline and every 6 months (MBS Item: 66503; $9.95 at baseline, 6 months, and 12 months) …PSD · Jul 2020
The submission described DTG/3TC as non-inferior in terms of effectiveness compared to the TBRs Biktarvy, Genvoya, Odefsey and non-TBRs Triumeq and Juluca. This claim was adequately supported if PBAC accept that the TBRs in the TANGO trial could act as a proxy for the other two or three-drug regimens. Biktarvy and Juluca were not used by patients in the TBR arm in the TANGO trial.PSD · Jul 2020
The submission described DTG/3TC as non-inferior in terms of safety compared to Biktarvy®, Genvoya®, Odefsey®, Triumeq®, and Juluca®. This claim was adequately supported. At its July 2019 consideration of DTG/3TC for treatment-naïve patients, the PBAC considered the data supported a conclusion of non-inferior comparative safety versus a regimen of DTG + Truvada, and by extension other similar 3DR regimens in treatment-naïve patients (paragraph 7.4, …PSD · Jul 2020
6.2 The PBAC noted the advice from Positive Life NSW, which supported the listing of a two-drug regimen as it may improve medication management and adherence for some people living with HIV, especially those who are managing multiple health conditions.PSD · Jul 2019
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated
The PBAC considered the evidence presented supported the claims of bioequivalence with concomitantly administered DTG + 3TC. PBAC · 2019
Decision context
PopulationTreatment-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.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2020 | Recommended · restricted | dolutegravir 50 mg and lamivudine 300 mg taken concomitantly; basket of three-drug FDCs (Biktarvy, Genvoya, Odefsey, Tri | — | RCT · Virologic failure (HIV-1 RNA ≥50 c/mL at week 48) |
| Jul 2019 | Deferred | Individual components (dolutegravir 50 mg and lamivudine 300 mg taken concomitantly); also considered therapies prescrib | — | RCT · Other |
| Jul 2019 | Deferred | dolutegravir + tenofovir disoproxil fumarate/emtricitabine (DTG + TDF/FTC, Truvada®) for treatment-naïve patients; indiv | — | RCT · HIV-1 RNA <50 copies |
Clinical evidence
Consumer voice
No consumer comments were received for this item.
The PBAC noted that no consumer comments were received for this item. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts treatment-experienced patients to those on tenofovir alafenamide-based regimens for ≥6 months; TGA label permits any stable regimen.