Treatment of HIV infection.
Black Box Warning: All patients with HIV-1 should be tested for the presence of HBV prior to or when initiating dolutegravir/lamivudine. Emergence of lamivudine-resistant HBV variants associated with lamivudine-containing antiretroviral regimens has been reported. If dolutegravir/lamivudine is used in patients co-infected with HIV-1 and HBV, additional treatment should be considered for appropriate treatment of chronic HBV. Severe acute exacerbations of HBV have been reported in patients who are co-infected with HIV-1 and HBV and have discontinued lamivudine. Closely monitor hepatic function in these patients and, if appropriate, initiate anti-HBV treatment.
Test for HBV prior to or when initiating therapy.
Monitor for hepatotoxicity in all patients and for signs of severe acute exacerbations of HBV in patients who are coinfected with HIV-1 and HBV and have discontinued lamivudine; monitor with both clinical and laboratory follow-up for at least several months after stopping treatment.
Monitor for suspected lactic acidosis and severe hepatomegaly with steatosis.
Monitor for hypersensitivity reactions including rash, constitutional findings, and organ dysfunction, including liver injury.
Common
Serious
Contraindications:
Drug interactions:
Antimicrobial class: Antiretroviral, Integrase inhibitor, Nucleoside reverse transcriptase inhibitor
Average serum half life: 14 hours (Dolutegravir), 13-19 hours (Lamivudine)
Precautions: Monitoring recommended in hepatitis B or C, hepatotoxicity, liver injury and lactic acidosis and severe hepatomegaly with steatosis.
Discontinue use immediately if hypersensitivity reactions develop.
Immune reconstitution syndrome has been reported with combination antiretroviral therapy; further evaluation and treatment may be required.