Generic Name: dolutegravir + lamivudine
Abbreviation: DTG + 3TC
Drug Class: Complete Regimens
Company: ViiV Healthcare
Approval Status: Approved
Generic Version Available: No
Dovato is approved both for adults who have not previously received treatment for HIV and for those with an undetectable viral load who wish to switch to a new antiretroviral regimen.
The U.S. Department of Health and Human Services (DHHS) Panel on Antiretroviral Guidelines for Adults and Adolescents lists Dovato as a recommended initial regimen, except for people with a viral load above 500,000, those with hepatitis B virus (HBV) and those who are starting treatment right away, before the results of HIV resistance testing or HBV testing are available. The guidelines also list Dovato as a successful strategy for switching from a three-drug to a two-drug regimen.
Visit https://aidsinfo.nih.gov/guidelines/html/1/adult-and-adolescent-arv-guidelines/0 for the full DHHS guidelines.
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 for frst-time treatment in April 2019, with an expanded indication as a switch option in August 2020.
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.
For an overview of 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 Dovato 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: August 7, 2019