Not recommended alone in patients with resistance-associated integrase substitutions or suspected INSTI resistance due to insufficient dolutegravir dose in Triumeq in these subpopulations.
Adults and Children:
<40kg: not recommended. ≥40kg: 1 tab daily. Concomitant efavirenz, fosamprenavir/ritonavir, tipranavir/ritonavir, carbamazepine, rifampin: give additional dolutegravir 50mg separated by 12hrs from Triumeq.
Presence of HLA-B*5701 allele. Previous hypersensitivity reaction to any of the components. Concomitant dofetilide. Moderate or severe hepatic impairment.
Hypersensitivity reactions. Exacerbation of hepatitis B.
Screen for presence of HLA-B*5701 allele prior to starting therapy or reinitiation; if (+), abacavir is contraindicated. Discontinue immediately if hypersensitivity is suspected, regardless of HLA-B*5701 status and even when other diagnoses are possible. If hypersensitivity cannot be ruled out, do not restart. If stopped for reasons other than hypersensitivity, restart only if medical care can be readily accessed. Lamivudine not established for chronic HBV infection; closely monitor patients co-infected with HBV and HIV for several months after stopping treatment (discontinuing therapy may exacerbate HBV infection); if appropriate, initiate anti-hepatitis B therapy may be warranted. Increased risk for worsening/development of elevated transaminases in patients with underlying hepatitis B or C. Suspend if lactic acidosis or pronounced hepatotoxicity (eg, hepatomegaly, steatosis) occurs. Possible risk of MI; minimize risk factors for coronary heart disease (eg, hypertension, hyperlipidemia, diabetes, smoking). Renal impairment (CrCl <50mL/min): not recommended; if lamivudine dose reduction is required, use individual components. Mild hepatic impairment: if abacavir dose reduction is required, use individual components. Women. Obesity. Elderly. Pregnancy. Nursing mothers: not recommended.
Dolutegravir may be affected by drugs that induce or inhibit UGT1A1, CYP3A, UGT1A3, UGT1A9, BCRP, and P-gp enzymes or transporters. Avoid concomitant nevirapine, oxcarbazepine, phenytoin, phenobarbital, St. John’s wort. Concomitant etravirine without atazanavir/ritonavir, darunavir/ritonavir, or lopinavir/ritonavir: not recommended. Concomitant efavirenz, fosamprenavir/ritonavir, tipranavir/ritonavir, carbamazepine, rifampin: requires extra dolutegravir dose (see Adults and Children). Potentiates metformin (limit metformin dose to 1g/day); adjust metformin dose when stopping Triumeq; monitor blood glucose. Avoid concomitant sorbitol-containing products. Concomitant cation-containing antacids or laxatives, sucralfate, buffered drugs, oral calcium/iron supplements, multivitamins; give Triumeq 2hrs before or 6hrs after; alternatively, oral calcium/iron can be used at the same time when taken with food. Ethanol may increase abacavir levels. Abacavir may antagonize methadone. Monitor for toxicities (eg, hepatic decompensation) with IFN-α ± ribavirin (consider reducing dose or discontinue one or both drugs).
Insomnia, headache, fatigue; hypersensitivity reactions (may be fatal), lactic acidosis, hepatomegaly with steatosis, immune reconstitution syndrome, hepatotoxicity (monitor).