DOVATO is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults with no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of DOVATO.

All patients with HIV-1 should be tested for the presence of HBV prior to or when initiating DOVATO. Emergence of lamivudine-resistant HBV variants associated with lamivudine-containing antiretroviral regimens has been reported. If DOVATO is used in patients co-infected with HIV-1 and HBV, additional treatment should be considered for appropriate treatment of chronic HBV; otherwise, consider an alternative regimen.

Severe acute exacerbations of HBV have been reported in patients who are co-infected with HIV-1 and HBV and have discontinued lamivudine, a component of DOVATO. Closely monitor hepatic function in these patients and, if appropriate, initiate anti-HBV treatment.

Perform pregnancy testing before initiation of DOVATO in individuals of childbearing potential.

Because DOVATO is a fixed-dose tablet and cannot be dose adjusted, DOVATO is not recommended in patients with creatinine clearance less than 50 mL per minute.

DOVATO is not recommended in patients with severe hepatic impairment (Child-Pugh Score C).

As dolutegravir is highly bound to plasma proteins, it is unlikely that it will be significantly removed by dialysis.

DOVATO is contraindicated in patients receiving dofetilide, due to the potential for increased dofetilide plasma concentrations and the risk for serious and/or life-threatening events.

Safety and efficacy of lamivudine have not been established for treatment of chronic HBV in subjects dually infected with HIV-1 and HBV. Emergence of HBV variants associated with resistance to lamivudine has been reported in HIV-1–infected subjects who have received lamivudine-containing antiretroviral regimens in the presence of concurrent infection with HBV. If a decision is made to administer DOVATO to patients co-infected with HIV-1 and HBV, additional treatment should be considered for appropriate treatment of chronic HBV; otherwise, consider an alternative regimen.

Hypersensitivity reactions have been reported with the use of dolutegravir, a component of DOVATO, and were characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury.

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues, including lamivudine (a component of DOVATO). A majority of these cases have been in women. Female sex and obesity may be risk factors for the development of lactic acidosis and severe hepatomegaly with steatosis in patients treated with antiretroviral nucleoside analogues.

Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including DOVATO. During the initial phase of combination antiretroviral treatment, patients whose immune systems respond may develop an inflammatory response to indolent or residual opportunistic infections (such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia [PCP], or tuberculosis), which may necessitate further evaluation and treatment.

Autoimmune disorders (such as Graves’ disease, polymyositis, and Guillain-Barré syndrome) have also been reported to occur in the setting of immune reconstitution; however, the time to onset is more variable, and can occur many months after initiation of treatment.

DOVATO is a complete regimen for the treatment of HIV-1 infection; therefore, co-administration with other antiretroviral drugs for the treatment of HIV-1 infection is not recommended.

Dolutegravir may increase plasma concentrations of drugs eliminated via OCT2 or MATE1 such as dofetilide and metformin.

Co-administration of dolutegravir with polyvalent cation-containing products may lead to decreased absorption of dolutegravir.

Co-administration of Dofetilide with DOVATO is contraindicated.

Co-administration with Carbamazepine or Rifampin, an additional dolutegravir 50-mg dose should be taken, separated by 12 hours from DOVATO.

Co-administration of St. John’s wort with DOVATO is contraindicated.

Avoid co-administration of Oxcarbazepine, Phenytoin, Phenobarbital with DOVATO.

Co-administration of medications containing polyvalent cations (e.g., Mg or Al): cation-containing antacids
or laxatives, Sucralfate, Buffered medications, administer DOVATO 2 hours before or 6 hours after taking medications containing polyvalent cations.

When possible, avoid use of sorbitol-containing medicines with DOVATO.

Data from a birth outcome surveillance study have identified an increased risk of neural tube defects when dolutegravir, a component of DOVATO, is administered at the time of conception compared with non-dolutegravir-containing antiretroviral regimens. As defects related to closure of the neural tube occur from conception through the first 6 weeks of gestation, embryos exposed to dolutegravir from the time of conception through the first 6 weeks of gestation are at potential risk. In addition, 2 of the 5 birth defects (encephalocele and iniencephaly) that have been observed with dolutegravir use, although often termed neural tube defects, may occur post-neural tube closure, the time period of which may be later than 6 weeks of gestation, but within the first trimester. Due to the limited understanding of the types of reported neural tube defects associated with dolutegravir use and because the date of conception may not be determined with precision, an alternative treatment to DOVATO should be considered at the time of conception through the first trimester of pregnancy. Initiation of DOVATO is not recommended in individuals actively trying to become pregnant unless there is no suitable alternative.

Initiation of DOVATO is not recommended in individuals actively trying to become pregnant unless there is no suitable alternative.

The Centers for Disease Control and Prevention recommends that HIV-1–infected mothers in the United States not breastfeed their infants to avoid risking postnatal transmission of HIV-1 infection. Lamivudine, a component of DOVATO, is present in human milk. It is not known whether dolutegravir, a component of DOVATO, is present in human milk.

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• Use in patients under the age of 18. GoToSource

Flares of underlying hepatitis B. GoToSource

Fanconi syndrome (disorder of kidney tubule function). GoToSource

Liver failure. GoToSource

Toxic epidermal necrolysis (severe skin reaction). GoToSource

Myocarditis (inflammation of the heart muscle). GoToSource

Insomnia, anxiety, depression, paraesthesia (abnormal sensation), muscle-skeletal pain and impaired cognition and concentration. GoToSource

Immune reconstitution syndrome (paradoxical worsening of preexisting infectious processes following the initiation of antiretroviral therapy). GoToSource

Thrombocytopenia (low blood platelet count). GoToSource

Hyperamylasemia (excess of amylase in the blood) and pancreatitis (inflammation of the pancreas). GoToSource

Lactic acidosis (buildup of lactic acid). GoToSource

Colitis (inflammation of inner lining of colon). GoToSource

Rhabdomyolysis (breakdown of skeletal muscle). GoToSource

Hyperglycaemia (high blood sugar). GoToSource

No major injury lawsuits reported.