1. Aschenbrenner, Diane S. MS, RN


* A new drug, Dolutegravir (Tivicay), has been approved to treat HIV-1 infection in both treatment-naive patients and those who have received prior therapy against HIV infection.


* Possible serious adverse effects of the drug include hypersensitivity and abnormal liver function if the patient is coinfected with hepatitis B or hepatitis C.



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Dolutegravir (Tivicay) has been approved to treat HIV-1 infection in both treatment-naive patients and patients who've received therapy against HIV infection. Dolutegravir is a once-daily pill taken as part of combination therapy with other antiretroviral drugs. In regimens with drugs that induce the metabolism of dolutegravir, it will need to be taken twice daily. (See the drug's labeling for a complete list of these drugs.)


Dolutegravir is the second drug in a class known as integrase strand transfer inhibitors. The first drug in the class, raltegravir (Isentress), was approved in 2007 and, unlike dolutegravir, must be taken twice daily. In adults, dolutegravir may be used in patients who've taken raltegravir in the past; although it's approved for use in children 12 years of age or older (and weighing at least 40 kg), dolutegravir shouldn't be used in children who've previously taken raltegravir.


After the HIV virus attaches to a CD4+ cell via the coreceptors CCR5 and CXCR4, the single-stranded RNA of the virus is replicated with the enzyme reverse transcriptase to make the RNA into DNA. The HIV DNA then enters the CD4+ cell's nucleus and, with the assistance of an enzyme known as integrase, combines with the host cell's DNA. This allows the HIV DNA to be replicated with each division of the host's CD4+ cell. Integrase strand transfer inhibitors prevent the integration of the HIV DNA with the host's CD4+ cell DNA.


Common adverse effects in clinical trials included insomnia and headache. The incidence of these adverse effects was similar to their occurrence with raltegravir treatment during clinical trials designed to test the efficacy of dolutegravir. Potentially serious adverse effects of dolutegravir include hypersensitivity reactions, as well as abnormal liver function in patients coinfected with hepatitis B or hepatitis C.


Nurses should monitor patients beginning dolutegravir therapy closely for hypersensitivity reactions, which can include poor organ function (including liver dysfunction) in addition to typical hypersensitivity reactions. Patients should be taught the signs and symptoms of hypersensitivity and liver dysfunction. If hypersensitivity is suspected, the drug should be discontinued immediately to prevent life-threatening reactions. If the patient has a hypersensitivity reaction, dolutegravir shouldn't be restarted.


If a patient has underlying hepatitis B or C infection, the nurse should confirm that baseline transaminase levels have been obtained because dolutegravir increases the risk of the development or worsening of elevated transaminase levels. Transaminase levels should also be monitored throughout therapy, according to instructions on the drug's labeling. If the patient is taking drugs that will prevent effective absorption of dolutegravir (antacids, laxatives, sucralfate, oral iron supplements, oral calcium supplements, or buffered medications), the nurse should help the patient create a schedule in which dolutegravir is taken either two hours before or six hours after any of these medications. Dolutegravir may be taken either with or without food. The nurse should assess for the use of dofetilide (Tikosyn), a class III antiarrythmic drug used to convert atrial fibrillation to normal sinus rhythm and maintain normal sinus rhythm, because the coadministration of dofetilide and dolutegravir can increase dofetilide concentrations and the risk of serious and even life-threatening events, such as arrhythmias and lengthening of the QT interval.


Complete prescribing information is available at