Generic Name: dolutegravir + lamivudine
Abbreviation: DTG + 3TC
Drug Class: Single-Tablet Regimens
Company: ViiV Healthcare
Approval Status: Approved
Generic Version Available: No
Dovato is approved for adults who have not previously received treatment for HIV. It has not yet been reviewed for inclusion in the DHHS list of recommended HIV treatments.
Dovato (dolutegravir + lamivudine) is single-tablet regimen for HIV. It contains two different types of antiretoviral drugs: one integrase inhibitor and one nucleoside reverse transcriptase inhibitor (NRTI). The combination pill contains two currently approved HIV medications: dolutegravir (sold separately as Tivicay) + lamivudine (sold separately as Epivir). It was approved by U.S. Food and Drug Administration in April 2019.
Approval of Dovato was based on findings from the Phase III GEMINI-1 and GEMINI-2 trials. Together, the trials included 1,433 first-timers to HIV treatment. They were randomized to receive either the components of Dovato or a three-drug regimen of dolutegravir plus tenofovir disoproxil fumarate/emtricitabine (the drugs in Truvada). The two regimens suppressed HIV at a comparably high rate after 48 weeks.
One tablet once a day. Each tablet contains 50mg dolutegravir + 300mg lamivudine.
Dosing Info: This is a complete one-pill, once-daily drug regimen. It can be taken with or without food.
The most common side effects of Dovato are headache, diarrhea, nausea, insomnia and fatigue.
If you also have hepatitis B virus (HBV) and take Dovato, your hepatitis may become worse if you stop taking it. The lamivudine in Dovato also works against HBV. Do not stop taking Dovato without first talking with your healthcare provider.
The dolutegravir in Dovato has been linked to a small risk of neural tube birth defects in infants born to mother who took the medication during early pregnancy. The Food and Drug Administration recommends that women avoid dolutegravir around the time of conception through the first trimester of pregnancy. If you are thinking of becoming pregnant, discuss this with your provider before starting Dovato.
Dovato should not be use with Tikosyn (dofetilide), a medication for heart problems.
For a review of other drug interactions, including prescription and over-the-counter medications and supplements that should not be taken with Dovato or may require dose adjustments, consult the Juluca package insert.
Before taking this medication, tell your doctor if you have kidney disease or liver disease (including hepatitis B). In addition, tell your doctor if you are pregnant or planning to become pregnant; if you are breast feeding, and all your medical conditions, including all prescription and over-the-counter medications and supplements you are taking.
Last Reviewed: April 9, 2019