Standard DoseOne tablet once daily, without regard to food for treatment-naïve people who have no known resistance to the dolutegravir and lamivudine components of the regimen. Tablet contains 50 mg of the INSTI dolutegravir plus 300 mg of the NRTI lamivudine.
Take missed dose as soon as possible, unless it is closer to the time of your next dose. Do not double up on your next dose. See package insert when available for guidance on dosing in the setting of kidney impairment. Dovato is not recommended for people who have a CrCl less than 50 mL/min or who have severe liver impairment.
See the individual drugs contained in this medication: Tivicay and Epivir.
See package insert for more complete information on potential side effects and interactions.
Potential Side Effects and Toxicity
Dolutegravir and lamivudine are both generally well tolerated. Side effects occurring in at least 2% of study participants receiving Dovato included headache, nausea, diarrhea, insomnia, fatigue, and dizziness. New data associate INSTIs and TAF with weight gain; see the article, “Weighty Concerns,” and go to aidsinfo.nih.gov. Dolutegravir can cause a small, reversible increase in kidney function test (serum creatinine) within the first few weeks of treatment without affecting actual kidney function. There have been rare reports of depression and suicidal ideation, primarily in patients with a history of psychiatric illnesses, in people receiving INSTI-based regimens. The DHHS guidelines recommend closely monitoring patients with pre-existing psychiatric conditions on an INSTI. Liver enzymes should be monitored in people with hepatitis B or C and taking dolutegravir. 3TC can treat both HIV and HBV, but must be used in combination with another hep B drug (such as tenofovir) to treat the hep B. If you are co-infected with HBV and HIV, you should not stop 3TC without medical supervision because it can cause your HBV to flare and cause you to experience signs and symptoms of acute hepatitis. HBV should be closely monitored by your provider.
Potential Drug Interactions
Do not take Dovato with Epivir-HBV. When taking carbamazepine or rifampin, take an additional dose of dolutegravir (in the form of one Tivicay tablet) 50mg 12 hours after taking your Dovato dose. When starting or stopping dolutegravir in people on metformin, dose adjustment of metformin may be necessary to maintain optimal glycemic control. Avoid use of sorbitol-containing medicines with lamivudine; there are many, such as acetaminophen liquid (Tylenol liquid and others). Should be okay to take with Daklinza, Epclusa, Harvoni, Olysio, Sovaldi, Viekira Pak, or Zepatier. Not intended to be taken with other HIV medications, unless prescribed that way. Tell your provider or pharmacist about all medications, herbals, and supplements you are taking or thinking of taking, prescribed or not, as there are other drug interactions which are not listed here.
Approved in April 2019. Basically, this medicine is Triumeq without the abacavir component (brand name Ziagen, also found in Epzicom). Dolutegravir is from the powerhouse drug class of integrase inhibitors, which are highly effective and generally tolerable. The benefits of using a two-drug regimen for HIV include less exposure to HIV medication while maintaining viral suppression and also minimizing the potential for side effects. At one year in the GEMINI-1 and GEMINI-2 studies, DTG plus 3TC was found to be non-inferior to the triple drug regimen of DTG plus Truvada (emtricitabine and tenofovir DF combined in one pill). For the two studies, 91% (655 out of 716 individuals) had undetectable viral load, compared to 93% (669 out of 717) of those taking the three-drug therapy. Everyone in the study was taking HIV treatment for the first time, and 20% of them had a high viral load of more than 100,000 copies per mL when entering the clinical trials. Dovato has also been successful for treatment-experienced people switching to it after being undetectable (viral load less than 50 copies per mL). Results from week 48 study called TANGO evaluated treatment switch from TAF-containing regimens with three or more drugs to the 2-drug regimen of dolutegravir/lamivudine. Dolutegravir is now a preferred medication in pregnancy as well as an alternative drug for those who are trying to conceive, according to U.S. HIV perinatal treatment guidelines updated in December 2019 (go to aidsinfo.nih.gov/guidelines/html/3/perinatal-guidelines/0). This clears preliminary concerns over the potential for birth defects with dolutegravir raised in 2018 by a study in Botswana.
Dr. Ross Slotten says: Dovato is an intriguing STR approved for treatment-naïve individuals. It contains only two drugs, dolutegravir and the NRTI lamivudine (3TC). In clinical trials, it has been shown to be equivalent in potency to 3-drug combinations in patients who have never been treated for HIV in the past. Its primary virtue is that it doesn’t contain TDF, with its risks for kidney toxicity and loss of bone density. Except in patients who can’t tolerate or in whom TDF (or TAF) is contraindicated, like people with chronic kidney disease (even TAF-containing regimens should only be prescribed for patients with a creatinine clearance of greater than 30 mL/minute), its role is limited.
Activist Bridgette Picou says: HIV treatment modalities have changed over the years, and continue to change rapidly with research. While once waiting for CD4 counts to drop into the low 200s, we are now starting within days of diagnosis; we’ve gone from multiple drugs multiple times a day, to more simplified regimens. Enter Dovato. The second two-drug STR option on the market, the concept is still fairly new, but clinical trials have shown it to be non-inferior to three-drug combos. Less drug translates into less drug toxicity in the long term. That’s a definite plus considering people are living 30-plus years with HIV. Gaining popularity as a rapid start option, the components offer a high barrier for resistance with minimal side effects reported.