NHS England has launched a 30-day consultation on a proposal to make available a new triple therapy based on the integrase inhibitor (INI) bictegravir. Bictegravir is only available as a 3 in 1 tablet combined with the nucleo(s)tide reverse transcriptase inhibitors (NRTI) emtricitabine and tenofovir alafenamide. The new treatment is therefore known as bictegravir / emtricitabine / tenofovir alafenamide (B/F/TAF).
NHS England proposes that B/F/TAF will be routinely commissioned for HIV-1 infected adults in line with cost-based, regional prescribing guidelines if:
- Patients meet the commissioning criteria set out in NHS England Commissioning Policy 16043/P on tenofovir alafenamide; OR
- If they require an unboosted integrase inhibitor-containing regimen but neither raltegravir nor dolutegravir can be taken due to drug-drug interactions or poor tolerability/toxicity.
Potential patients will have to be considered in an HIV specialist treatment multidisciplinary meeting before the new therapy is prescribed, the proposition states.
Interested parties can take part in the consultation via an online survey at https://www.engage.england.nhs.uk/consultation/bictegravir-emtricitabine-tenofovir-alafenamide/ until 27 March.
B/F/TAF has a positive opinion from the EMA for the treatment of adults with HIV-1 who are without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir.
An evidence review by NHS England found that B/F/TAF has comparable safety and efficacy in first line with two other triple drug combinations, both based on one INI + two NRTI: dolutegravir, abacavir and lamivudine (DTG/ABC/3TC), and dolutegravir, emtricitabine and tenofovir alafenamide (DTG/F/TAF).
The review also assessed the safety and efficacy of B/F/TAF when switching from 3-drug regimens based on boosted protease inhibitors and DTG/ABC/3TC. B/F/TAF was found to be comparable in terms of maintaining HIV control and other important outcomes.