Single-pill dolutegravir/abacavir/3TC (Triumeq) approved in EU and US
1 October 2014. Related: Antiretrovirals.
Simon Collins, HIV i-Base
The fixed dose combination (FDC) of dolutegravir (50 mg) plus abacavir (600 mg) plus 3TC (300 mg) was approved on 22 August 2014 in the US and on 3rd September 2014 in the EU. [1, 2]
This integrase inhibitor-based combination – brand name Triumeq – is not recommended for anyone with documented or suspected integrase inhibitor associated mutations, as this would require a higher dose of dolutegravir.
As with any combination including abacavir, Triumeq is contraindicated in people with HLA-B*5701 and should never be restarted in anyone with a suspected hypersensitivity reaction, irrespective of HLA-B*5701 status.
EU approval is based primarily upon data from the phase III SINGLE study in treatment-naive adults (using dolutegravir and abacavir/3TC as separate pills), plus a bioequivalence study of the FDC single pill compared to dolutegravir and abacavir/lamivudine as separate pills. A pharmacovigilance plan for Triumeq will be implemented as part of the EU marketing authorisation.
The recommended adult dose is one tablet once daily orally with or without food. For further details, see the product information. [3, 4]
Comment
NHS England is still finalising recommendations for dolutegravir as a single medication, even though EU approval for this was in January 2014. This decision is expected in October 2014.
It is unclear whether access to the FDC will require a separate set of commissioned guidelines. Presumably, as long as the price for the FDC is comparable to that of the separate components, another 9-month evaluation should not be needed.
In Scotland, dolutegravir has been available since May 2014, with advice on Triumeq from the Scottish Medicines Consortium due on 8th December. [5]
References:
- ViiV Healthcare press statement. ViiV Healthcare receives FDA approval for Triumeq. (22 August 2014).
http://www.viivhealthcare.com/media.aspx - ViiV Healthcare press statement. ViiV Healthcare receives EU marketing authorisation for Triumeq. (03 September 2014).
http://www.viivhealthcare.com/media.aspx - Triumeq European public assessment report (EPAR).
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002754/human_med_001796.jsp&mid=WC0b01ac058001d124
- Triumeq. Highlights of prescribing information.
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205551s000lbl.pdf (PDF) - Scottish Medicines Consortium
http://www.scottishmedicines.org.uk/SMC_Advice