#最小單位貼紙

抗病毒藥品 HIV-1 infection, treatment:
1. In adults with no antiretroviral treatment history
2. To replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without history of treatment failure.
3. Not a recommended initial regimen in patients with HIV RNA >500,000 copies/mL, hepatitis B virus (HBV) coinfection, or if antiretroviral treatment is going to be started before the results of genotypic resistance testing for reverse transcriptase or HBV testing are available.

Dolutegravir: Integrase Inhibitor (Anti-HIV)
inhibits HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral DNA integration
Lamivudine: Nucleoside Reverse Transcriptase Inhibitor (Anti-HIV)
lamivudine is triphosphorylated, the principle mode of action is inhibition of HIV reverse transcription via viral DNA chain termination; inhibits RNA- and DNA-dependent DNA polymerase activities of reverse transcriptase

Absorption:
1. Food increased the extent of absorption and slowed the rate of absorption of dolutegravir
2. Time to peak: 2 to 3 hours
Distribution:
Vd/F: ~17.4 L; Protein binding: Dolutegravir >98.9%; Lamivudine <36%
Metabolism:
Dolutegravir: Primarily metabolized via UGT1A1 with some contribution from CYP3A; Lamivudine: Minor
Half-life elimination:
Dolutegravir ~14 hours; Lamivudine 5~7 hours, increased with renal impairment
Excretion:
Feces; urine (Lamivudine primarily urine)

1. Hypersensitivity to dolutegravir, lamivudine, or any component of the formulation.
2. Concurrent use with dofetilide.

1. Does not recommend use of this combination during the first trimester of pregnancy
2. For patients who become pregnant while taking this combination as a complete regimen, the regimen should be changed, or additional agents added (2-drug regimens are not recommended during pregnancy)

Dolutegravir and lamivudine are present in breast milk. Refer to individual monographs for additional information.

Hepatotoxicity, hypersensitivity reactions (rash, constitutional findings, organ dysfunction), immune reconstitution syndrome, lactic acidosis

One tablet (dolutegravir 50 mg/lamivudine 300 mg) once daily

1. CrCl >30 mL/min: No dosage adjustment necessary
2. CrCl consistently between 30~50: monitor hematologic toxicities; if new or worsening neutropenia or anemia develop, requiring dose adjustment of lamivudine, then use renal dose-adjusted individual components of dolutegravir and lamivudine
3. CrCl <30 mL/min: Use is not recommended

1. Mild or moderate impairment (Child-Pugh class A or B): No dosage adjustment necessary
2. Severe impairment (Child-Pugh class C): Use is not recommended (has not been studied)