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

30 April 2019. Related: Antiretrovirals.

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]

References

1. FDA announcement listserve. FDA approves first two-drug complete regimen for HIV-infected patients who have never received antiretroviral treatment. (8 April 2019).
   https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm635526.htm
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).
   https://www.viivhealthcare.com/en-gb/media/
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.
   http://programme.aids2018.org/Abstract/Abstract/13210 (abstract)
   https://youtu.be/pgmb1Fi63Fo?t=3642 (webcast)
4. Collins S. DTG/3TC dual therapy is non-inferior to triple-ART in GEMINI study. HTB August 2018.
   https://i-base.info/htb/34647
5. 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)