Scotland approves dual therapy with dolutegravir/lamivudine (Dovato)

30 September 2019. Related: Antiretrovirals, Treatment access.

Simon Collins, HIV i-Base

On 9 September 2019 the Scottish Medicines Consortium (SMC) issued positive advice for dolutegravir/lamivudine (Dovato), making this option immediately available in Scotland.

The indication is for adults and adolescents above 12 years of age weighing at least 40 kg, with no known or suspected resistance to integrase inhibitors, or lamivudine.

It is a two-drug fixed-dose combination (FDC) manufactured by ViiV Healthcare with the trade name Dovato.

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The rapid evaluation of new medicines by the SMC is a model that should be just as easy to adopt across the UK – especially when the price ensures there are no new cost pressures on the NHS.

Dovato was approved in the US in April 2019 and in the EU in July 2019 as initial ART based on GEMINI 1 and 2 studies.

At IAS 2019, the phase 3 TANGO study reported dolutegravir/lamivudine was non-inferior as a switch option compared to people remaining on TAF-based triple ART. [2]

Reference

1. ViiV press release. Positive SMC decision enables the first UK patients to access Dovato(dolutegravir/lamivudine), a 2-drug regimen, once-daily, single-pill for the treatment of HIV. (9 September 2019).
   https://www.scottishmedicines.org.uk/medicines-advice/dolutegravir-lamivudine-dovato-abbreviated-smc2205/
2. Switching to dolutegravir/lamivudine dual therapy is non-inferior to TAF-based triple therapy at week-48 in TANGO study. HTB July 2019.
   https://i-base.info/htb/36450