ECThe antiviral activity of lamivudine against HIV-1 was assessed in a number of cell lines including monocytes and PBMCs using standard susceptibility assays. Formula: 50 mg dolutegravir; 600 mg abacavir; 300 mg lamivudine; How to take it: A person can take Triumeq with or without food. Through 144 weeks, the rate of adverse events leading to discontinuation was 4% in subjects receiving TIVICAY + EPZICOM and 14% in subjects receiving ATRIPLA once daily.Treatment-emergent ADRs of moderate to severe intensity observed in at least 2% of subjects in either treatment arm of SINGLE are provided in Table 2.SAILING is an international, double-blind trial in INSTI-naive, antiretroviral treatment-experienced adult subjects. In mice, no significant increases in the incidence of drug-related neoplasms were observed at the highest doses tested, resulting in dolutegravir AUC exposures approximately 26-fold higher than those in humans at the recommended dose of 50 mg once daily. In HIV-2 mutants, combinations of substitutions A153G/N155H/S163G and E92Q/T97A/N155H/S163D conferred 4-fold decreases in dolutegravir susceptibility, and E92Q/N155H and G140S/Q148R showed 8.5-fold and 17-fold decreases in dolutegravir susceptibility, respectively.Cross-resistance has been observed among NRTIs. Recommended Dosage. Ethanol decreases the elimination of abacavir causing an increase in overall exposure.There was no significant pharmacokinetic interaction between lamivudine and interferon alfa in a trial of 19 healthy male subjects.In a trial of 11 HIV-1–infected subjects receiving methadone-maintenance therapy (40 mg and 90 mg daily), with 600 mg of abacavir twice daily (twice the currently recommended dose), oral methadone clearance increased 22% (90% CI: 6% to 42%) [see Lamivudine and sorbitol solutions were coadministered to 16 healthy adult subjects in an open-label, randomized-sequence, 4-period, crossover trial. A decrease in creatinine clearance, as determined by 24-hour urine collection, was observed with both doses of dolutegravir after 14 days of treatment in subjects who received 50 mg once daily (9% decrease) and 50 mg twice daily (13% decrease). See full prescribing information for EPIVIR (lamivudine). Because a negligible amount of lamivudine was removed via Do not use TRIUMEQ for a condition for which it was not prescribed. TRIUMEQ tablets are purple, biconvex, oval, debossed with “572 Tr1” on one side and contain the inactive ingredients D-mannitol, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate. When administered to lactating rats, dolutegravir was present in milk (see Because of the potential for (1) HIV-1 transmission (in HIV-negative infants), (2) developing viral resistance (in HIV-positive infants), and (3) adverse reactions in a breastfed infant similar to those seen in adults, instruct mothers not to breastfeed if they are receiving TRIUMEQ.Dolutegravir was the primary drug-related component excreted into the milk of lactating rats following a single oral dose of 50 mg per kg on lactation Day 10, with milk concentrations of up to approximately 1.3 times that of maternal plasma concentrations observed 8 hours postdose.Perform pregnancy testing in adolescents and adults of childbearing potential before initiation of TRIUMEQ [see In adolescents and adults of childbearing potential currently on TRIUMEQ who are actively trying to become pregnant, or if pregnancy is confirmed in the first trimester, assess the risks and benefits of continuing TRIUMEQ versus switching to another antiretroviral regimen and consider switching to an alternative regimen [see Counsel adolescents and adults of childbearing potential who are taking TRIUMEQ to consistently use effective contraception.The clinical data supporting use of TRIUMEQ in HIV-1 infected pediatric patients weighing at least 40 kg is derived from the following previously conducted pediatric trials using the individual components of TRIUMEQ:TRIUMEQ is a fixed-dose combination tablet which cannot be adjusted for patients weighing less than 40 kg [see Clinical trials of abacavir, dolutegravir, or lamivudine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. TRIUMEQ. Mice were administered doses of up to 500 mg per kg, and rats were administered doses of up to 50 mg per kg. Binding to plasma protein is low. Evidence of early embryolethality was seen in the rabbit at systemic exposures (AUC) similar to those observed in humans, but there was no indication of this effect in the rat at plasma concentrations (Cmax) 35 times higher than human exposure at the recommended daily dose. Advise adolescents and adults of childbearing potential to contact their healthcare provider if they plan to become pregnant, become pregnant, or if pregnancy is suspected during treatment with TRIUMEQ [see Counsel adolescents and adults of childbearing potential taking TRIUMEQ to consistently use effective contraception [see Advise patients to inform their healthcare provider immediately of any signs and symptoms of infection as inflammation from previous infection may occur soon after combination antiretroviral therapy, including when TRIUMEQ is started [see Inform patients that there is an antiretroviral pregnancy registry to monitor fetal outcomes in those exposed to TRIUMEQ during pregnancy [see Instruct mothers with HIV-1 infection not to breastfeed because HIV-1 can be passed to the baby in the breast milk [see Instruct patients that if they miss a dose of TRIUMEQ, to take it as soon as they remember.Advise patients not to double their next dose or take more than the prescribed dose [see Instruct patients to read the Medication Guide before starting TRIUMEQ and to re-read it each time the prescription is renewed.

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