Standard DoseOne tablet once daily, without regard to food for treatment-naïve people who have no known resistance to components of the regimen: dolutegravir and lamivudine. 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. Dovato is not recommended for people who have severe liver impairment. According to the drug label, Dovato is not recommended for people with decreased kidney function (now down to a creatinine clearance less than 30 mL/min) due to the lamivudine component. This medication combination, however, is often used in reduced renal function below 30 mL/min because of the relatively minimal risk of lamivudine accumulation and side effects. In addition, reduced doses may be obtained by using the individual components of this medication as needed.
- 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. INSTIs are associated with weight gain. Dolutegravir can cause a small, reversible increase in kidney function test (serum creatinine) within the first few weeks of treatment that does not affect actual kidney function. There have been rare reports of depression and suicidal ideation with INSTIs, primarily in people with a history of psychiatric illnesses. DHHS guidelines recommend closely monitoring people with pre-existing psychiatric conditions. Prior to initiation, test for hepatitis B virus (HBV). Severe exacerbations of HBV have been reported in people with HBV co-infection who have discontinued Dovato (due to elimination of the lamivudine component, which also treats HBV). Monitor liver enzymes closely. Initiation of HBV therapy may be warranted upon Dovato discontinuation. Call your health care provider right away if you develop any of the following signs of hepatitis: yellowing of the skin or whites of the eyes; dark or tea-colored urine; pale-colored bowel movements; nausea or vomiting; loss of appetite; or pain, aching, or tenderness on the right side below the ribs.
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) 50 mg 12 hours after taking your Dovato dose. When starting or stopping dolutegravir by people on metformin, dose adjustment of metformin may be necessary to maintain optimal glycemic control or tolerability. Avoid use of sorbitol-containing medicines with lamivudine; there are many, such as acetaminophen liquid (Tylenol liquid and others). There are no known drug-drug interactions 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 minimizing the potential for side effects. At one, two, and nearly three years into 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). At the 144-week point, for the two studies, 82% (584 out of 716 individuals) had undetectable viral load, compared to 84% (599 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). The TANGO study evaluated treatment switch from TAF-containing regimens with three or more drugs to the two-drug regimen of dolutegravir/lamivudine and, at both 48 and 96 weeks, found Dovato to be non-inferior to the three-drug regimen standard of care. Weight gain is being increasingly recognized as a side effect of INSTIs. Although dolutegravir is now a preferred medication during pregnancy as well as for those who are trying to conceive, U.S. HIV perinatal treatment guidelines suggest using three-drug regimens. Find the discussion on page C-53 of perinatal guidelines at hivinfo.nih.gov. Pregnant individuals can voluntarily enroll in the Antiretroviral Pregnancy Registry through their provider; go to apregistry.com.
Dr. Melanie Thompson:
The only two-drug regimen recommended for initial treatment, Dovato is great for some people, but shouldn’t be taken if you have hepatitis B, resistance to 3TC/FTC, a viral load above 500,000 c/mL or, possibly, a CD4 count below 200/mL. Dovato isn’t ideal for same-day treatment because a genotype or hepatitis B serology will not be available to guide choice of therapy. The TANGO study showed that, at 144 weeks, persons without prior treatment failure or hepatitis B whose virus is suppressed on a TAF-based regimen can switch to DTG/3TC and maintain viral suppression. Weight gain with dolutegravir remains a concern, as well as the other possible INSTI side effects (insomnia, new or worsening depression). Drug interactions of note include increases in the levels of dofetilide (which is contraindicated), metformin, and some other drugs when taken with dolutegravir, and a decrease in dolutegravir levels occurs with some seizure or tuberculosis medicines as well as St. John’s wort and others. Concerns have decreased regarding serious birth defects (specifically neural tube defects) in infants when dolutegravir is taken at the time of conception. The very small and not statistically significant risk should be discussed with persons of childbearing potential who are starting Dovato. For more information on dolutegravir, see the discussion of Tivicay.
Activist Michael Broder:
Dovato (approved in 2019) should not be taken by people with a viral load greater than 500,000 copies, or by people with hepatitis B virus (HBV). Concerns have emerged about weight gain on INSTI-containing regimens. As always, your provider should help you weigh the benefits against the risks.