Standard DoseOne tablet once daily, without regard to food. 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. Lamivudine dosing needs to be adjusted for adults and children who have decreased kidney function (creatinine clearance less than 50 mL/min). See package insert when available for guidance on dosing in the setting of kidney impairment. Dolutegravir is not recommended for people with severe liver impairment.
AWPNot yet established.
Potential Side Effects and Toxicity
• See the individual drugs contained in this medication: Tivicay and Epivir.
• See package insert when available for more complete information on potential side effects and interactions.
Dolutegravir and lamivudine are both generally well tolerated. The most common adverse events (in 5% or more of people taking it) in the GEMINI-1 and GEMINI-2 studies combined were headache (10%), diarrhea (9%), and nasopharyngitis (allergy-like symptoms, 8%). 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) 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.
May be approved in 2019. Basically, this medicine is Triumeq without the abacavir (brand name Ziagen, also found in Epzicom). Dolutegravir is from the powerhouse drug class of integrase inhibitors, which are highly effective and generally tolerable. This coformulated STR is recommended by guidelines to be used in ART-naïve adults with baseline viral load less than 500,000 in instances where ABC, TDF, and TAF cannot be used or are not optimal. (Other considerations for switching meds when one has undetectable viral load are also given.) 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. See data online. New preliminary data from an observational study in Botswana suggest that there may be an increased risk of birth defects in infants born to those who were receiving dolutegravir at the time of conception. Until more information is available, regimens containing dolutegravir are not recommended for use in ART-naïve patients who are pregnant and within 12 weeks of conception. Additionally, regimens containing dolutegravir should not be used in people of childbearing potential who are sexually active and not using effective contraception or who are planning to become pregnant. It is unclear whether dolutegravir is the only integrase inhibitor with the potential to cause these birth defects (neural tube defects), or if other integrase inhibitors also carry this risk. Consult your provider to discuss guidance on how to manage regimens containing dolutegravir or a different integrase inhibitor if there is any possibility of conception.
Dr. David Hardy says:
This combination is based upon the results of the GEMINI 1 and 2 studies, in which treatment-naïve PLWH were assigned to receive either the 2-drug combination regimen of Tivicay plus Epivir or the 3-drug combination of Tivicay and Truvada, which showed undetectable viral loads in 91% vs. 93% of study participants, respectively, after one year of treatment. Adverse events were uncommon and similar between the two regimens, although there was more blood biochemical evidence of bone and kidney damage with the 3-drug (tenofovir DF-containing) regimen compared to the 2-drug regimen. Of note, virologic failure was seen in 4 and 2 study participants, respectively, with no evidence of any virologic resistance with either regimen. These two clinical trials are the first to show that a 2-drug, non-boosted regimen works as well as a 3-drug regimen. How HIV-treating medical care providers and PLWH will accept this paradigm-changing, 2-drug regimen as first-line therapy is yet to be seen. Of note, both the DHHS and IAS-USA guidelines include this regimen only as an alternative regimen when Truvada, TAF, or Epzicom cannot be tolerated. The TANGO study is randomizing 550 treatment-experienced PLWH with undetectable viral loads and no history of viral resistance to switch to Tivicay/Epivir (in a fixed-dose-combination tablet) or remain on their current ART regimen. TANGO began enrollment in February 2018 and is expected to produce results in 2020.
Activist Moisés Agosto-Rosario says:
When you are HIV positive, if you are in treatment, and virally suppressed, your life expectancy increases. Lifetime drug adherence is needed to fully get the benefits of the HIV drug regimen taken. By the same token, one is exposed to potential long-term adverse effects. Some are known and others, those that might show after longtime exposure, are still not known completely. Dual-drug HIV treatment regimens can potentially lessen drug exposure, not only for those on treatment but also for those considering treatment for the first time. Development of drug cross-resistance is something to take into consideration when you start treatment for the first time. The challenge is to find powerful drugs with a high genetic barrier to drug resistance. Recent research (GEMINI 1 and 2 studies) has proven that dual treatment with the two-drug combination of dolutegravir (DTG) plus lamivudine (3TC) is not inferior to triple ART combination. GEMINI 1 and 2 are identically designed studies. Both are large Phase 3 studies in which 700 treatment-naïve individuals were randomized to either DTG+3TC or DTG+TDF/FTC. The primary endpoint was reaching plasma viral load less than 50 copies at week 48. This treatment strategy looks promising. More research needs to be done.