Dolutegravir/3TC dual FDC (Dovato) approved in the US and given positive opinion in the EU
On 8 April 2019, the US FDA approved a new single-pill two-drug fixed dose combination (FDC) of dolutegravir (DTG) plus lamivudine (3TC). 
A few weeks later, positive opinion for dolutegravir/lamivudine was also given by the European Medicines Agency, indicating likely approval in the EU. 
DTG/3TC is a once-daily combination that can be taken with or without food.
The indication is for treatment-naive adults who do not have drug resistance to either of these two drugs and approval is based on results of the phase 3 GEMINI 1 and 2 studies that were presented at the IAS conference last year. [3, 4]
The approval includes a boxed warning for management of patients coinfected with hepatitis B (HBV). All patients should be tested for HBV before starting DTG/3TC and additional treatment for HBV should be used.
There is also a caution for women to avoid dolutegravir during conception and in early pregnancy due to a risk of neural tube defects.
Dolutegravir/3TC is manufactured by ViiV Healthcare and is marketed with the tradename Dovato.
For full details see the full product characteristics. 
- FDA announcement listserve. FDA approves first two-drug complete regimen for HIV-infected patients who have never received antiretroviral treatment. (8 April 2019).
- ViiV press statement. ViiV Healthcare announces CHMP Positive Opinion for Dovato® (dolutegravir/lamivudine) as a once-daily, single-pill, two-drug regimen for the treatment of HIV infection. (26 April 2019).
- Cahn P et al. Non-inferior efficacy of dolutegravir (DTG) plus lamivudine (3TC) versus DTG plus tenofovir/emtricitabine (TDF/FTC) fixed-dose combination in antiretroviral treatment-naïve adults with HIV-1 infection – 48-week results from the GEMINI studies. AIDS 2018, 23-27 July 2018, Amsterdam. Late breaker oral abstract TUAB0106LB.
- Collins S. DTG/3TC dual therapy is non-inferior to triple-ART in GEMINI study. HTB August 2018.
- ViiV Healthcare. US prescribing information for Dovato. (8 April 2019).