Dolutegravir-based single-tablet regimen set for EU approval

1 August 2014. Related: Antiretrovirals.

Simon Collins, HIV i-Base

On 27 June 2014, ViiV Healthcare issues a press statement noting a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for approval of a single tablet regimen (STR) of dolutegravir/lamivudine/abacavir. [1]

A positive opinion from this European Medicines Agency (EMA) advisory committee, usually predicts successful approval in Europe within two months.

The indication is for the treatment of HIV infection in adults and adolescents aged 12 years and older and weighing at least 40kg.

Comment

The EU approved dolutegravir in January 2014 but broad UK access is still dependent on the final outcome of the Medicines Optimisation Clinical Reference Group (CRG) recommendations. [2]

This has been put out for a three month comment period that will delay UK access to dolutegravir until at least mid October. Public engagement in this process may be essential to minimise further bureaucratic delays by the NHS – and this may become increasingly important for future drugs.

Comments on the proposed commissioning policy should be made online by 17th September 2014. [3]

Hopefully the same process with not need to be repeated for the STR, although access will also be connected to the price set by ViiV.

References:

1. ViiV press statement. Triumeq (dolutegravir/abacavir/lamivudine) single-tablet regimen receives positive CHMP opinion in Europe for the treatment of HIV. (27 June 2014).
   http://www.viivhealthcare.com/media
   http://www.viivhealthcare.com/media/press-releases/2014/june/triumeq®-dolutegravirabacavirlamivudine-single-tablet-regimen-receives-positive-chmp-opinion-in-europe-for-the-treatment-of-hiv.aspx
2. Clinical Commissioning Policy: Dolutegravir for treatment of HIV-1 in adults and adolescents. Draft for public consultation, 2014. Ref: NHS ENGLAND B06/P/b.
   https://www.engage.england.nhs.uk/consultation/5900b767/user_uploads/dolutegravir.pdf
3. To give feedback on the dolutegravir report you have to click the “Online survey” button, under the give us your views headline on this page:
   https://www.engage.england.nhs.uk/consultation/5900b767 (survey page)
   https://www.engage.england.nhs.uk/consultation/5900b767/consultation/intro/view (direct URL)