US FDA approves dolutegravir/lamivudine (Dovato) as switch option

28 August 2020. Related: Antiretrovirals.

Simon Collins, HIV i-Base

On 6 August 2020, the US FDA extended the indication for the two-drug fixed dose combination of dolutegravir/lamivudine (DTG/3TC) to include use as a switch combination for people stable on other treatment.

DTG/3TC was initially only approved by the FDA in April 2019 as first-line antiretroviral treatment (ART).

The new use as a switch option is restricted to people who have an undetectable viral load on their current ART, and who do not have a history of treatment failure or resistance to either drug.

In Europe, DTG/3TC is already approved as both first-line ART and as a switch option so long as there is no resistance to either drug.

Dolutegravir/3TC is manufactured by ViiV Healthcare and is marketed with the tradename Dovato.

For full details see the full product characteristics. [2]

Reference

1. ViiV press release. ViiV Healthcare announces FDA approval of an expanded indication for Dovato (dolutegravir/lamivudine), a complete two-drug regimen for virologically suppressed adults with HIV-1. (6 August 2020).
   https://viivhealthcare.com/en-us/us-news/us-articles/2020/viiv-healthcare-announces-fda-approval-of-an-expanded-indication
2. ViiV Healthcare. US prescribing information for Dovato. (8 April 2019).
   https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Dovato/pdf/DOVATO-PI-PIL.PDF (pdf)

This article was originally posted on 7 August 2020.