Indications for DOVATO:
As a complete regimen for the treatment of HIV-1 infection in adults with no antiretroviral treatment history and with no known substitutions associated with resistance to the individual components of Dovato.
Test for HBV infection prior to initiation. Take with or without food. 1 tab daily. Concomitant carbamazepine, rifampin: give additional dolutegravir 50mg separated by 12hrs from Dovato. Renal impairment (CrCl <50mL/min) or severe hepatic impairment (Child-Pugh C): not recommended.
Previous hypersensitivity reaction to dolutegravir or lamivudine. Concomitant dofetilide.
Patients co-infected with HBV and HIV-1: Emergence of lamivudine-resistant HBV and exacerbations of HBV.
Emergence of lamivudine-resistant HBV variants associated with lamivudine-containing antiretroviral regimens. Discontinuation of lamivudine-containing products and possibly Dovato may be associated with severe acute exacerbations of hepatitis B. Closely monitor patients co-infected with HBV and HIV for several months after stopping treatment; if appropriate, anti-HBV therapy may be warranted (esp. in advanced liver disease or cirrhosis). Discontinue immediately if hypersensitivity reactions develop. Increased risk for worsening/development of elevated transaminases in patients with underlying hepatitis B or C; monitor for hepatotoxicity. Suspend if lactic acidosis or pronounced hepatotoxicity (eg, hepatomegaly, steatosis) occurs. Immune reconstitution syndrome. Renal impairment (see Adults); if lamivudine dose reduction is required, use individual components. Severe hepatic impairment (see Adults). Women. Obesity. Elderly. Embryo-fetal toxicity: increased risk of neural tube defects (avoid use at time of conception through 1st trimester). Pregnancy: exclude status prior to initiation; if confirmed, switch to alternative HIV therapy. Advise females of reproductive potential to use effective contraception. Nursing mothers: not recommended.
HIV-1 integrase strand transfer inhibitor (INSTI) + nucleoside analog reverse transcriptase inhibitors (NRTIs).
See Contraindications. Concomitant other antiretrovirals: not recommended. Dolutegravir may be affected by drugs that induce or inhibit UGT1A1, CYP3A, UGT1A3, UGT1A9, BCRP, and P-gp enzymes or transporters. May potentiate drugs eliminated via OCT2 or MATE1. Avoid concomitant oxcarbazepine, phenytoin, phenobarbital, St. John’s wort. Antagonized by carbamazepine, rifampin: requires extra dolutegravir dose (see Adults). Potentiates metformin. Avoid concomitant sorbitol-containing products. Concomitant cation-containing antacids, laxatives, sucralfate, buffered drugs, or oral iron/calcium supplements (also can give together with a meal): give Dovato 2hrs before or 6hrs after.
Headache, diarrhea, nausea, insomnia, fatigue, dizziness; hypersensitivity reactions (may be fatal), hepatotoxicity (monitor).
To enroll pregnant patients exposed to Dovato in the Antiretroviral Pregnancy Registry (APR), call (800) 258-4263.