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Dovato
dolutegravir/ lamivudine
Black Box Warnings .
HBV Resistance
test for HBV infection prior to tx start; resistant HBV emergence assoc. w/ lamivudine-containing antiretroviral tx reported; initiate additional anti-HBV tx if HBV co-infection or consider alternative antiretroviral regimen
Hepatitis B Exacerbation
severe acute HBV exacerbations in HBV/HIV co-infected pts upon lamivudine D/C; monitor hepatic fxn closely in HBV/HIV co-infected pts who D/C lamivudine; initiate anti-HBV tx if needed
Adult Dosing .
Dosage forms: TAB: 50 mg/300 mg
HIV infection
- [tx-naive pts]
- Dose: 1 tab PO qd; Info: for pts w/ HIV-1 RNA <500,000 and no baseline resistance to dolutegravir or lamivudine
- [tx-experienced pts]
- Dose: 1 tab PO qd; Info: for pts w/ HIV-1 RNA <50 and no known tx failure or resistance to dolutegravir or lamivudine
renal dosing
- [see below]
- CrCl 30-49: avoid use if lamivudine-related toxicities, dose adjustment not possible w/ fixed-dose combo, otherwise no adjustment; CrCl <30: avoid use, dose adjustment not possible w/ fixed-dose combo
- HD/PD: avoid use, dose adjustment not possible w/ fixed-dose combo
hepatic dosing
- [see below]
- Child-Pugh Class A or B: no adjustment; Child-Pugh Class C: not defined
Peds Dosing .
- Dosage forms: TAB: 50 mg/300 mg
HIV infection
- [tx-naive pts, 12 yo and older, >25 kg]
- Dose: 1 tab PO qd; Info: for pts w/ HIV-1 RNA <500,000 and no baseline resistance to dolutegravir or lamivudine
- [tx-experienced pts, 12 yo and older, >25 kg]
- Dose: 1 tab PO qd; Info: for pts w/ HIV-1 RNA <50 and no known tx failure or resistance to dolutegravir or lamivudine
renal dosing
- [see below]
- CrCl 30-49: avoid use if lamivudine-related toxicities, dose adjustment not possible w/ fixed-dose combo, otherwise no adjustment; CrCl <30: avoid use, dose adjustment not possible w/ fixed-dose combo
- HD/PD: avoid use, dose adjustment not possible w/ fixed-dose combo
hepatic dosing
- [see below]
- Child-Pugh Class A or B: no adjustment; Child-Pugh Class C: not defined