Dolutegravir/3TC dual FDC (Dovato) approved in the US and given positive opinion in the EU

Simon Collins, HIV i-Base

On 8 April 2019, the US FDA approved a new single-pill two-drug fixed dose combination (FDC) of dolutegravir (DTG) plus lamivudine (3TC). [1]

A few weeks later, positive opinion for dolutegravir/lamivudine was also given by the European Medicines Agency, indicating likely approval in the EU. [2]

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. [5]


  1. FDA announcement listserve. FDA approves first two-drug complete regimen for HIV-infected patients who have never received antiretroviral treatment. (8 April 2019).
  2. 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).
  3. 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. (abstract) (webcast)
  4. Collins S. DTG/3TC dual therapy is non-inferior to triple-ART in GEMINI study. HTB August 2018.
  5. ViiV Healthcare. US prescribing information for Dovato. (8 April 2019). (pdf)

Links to other websites are current at date of posting but not maintained.