DORAVIRINE/ ISLATRAVIR TAB,ORAL

Clinical Criteria Summary

Treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen with no history of virologic treatment failure and no known substitutions associated with resistance to DOR
Indicated as a complete regimen; co-administration with other antiretroviral agents is not recommended

Co-administration with strong CYP3A inducers due to potentially significant decreases in DOR concentrations
Co-administration with lamivudine (3TC) or emtricitabine (FTC) due to potentially significant decreases in ISL concentrations
Concomitant use of ADA inhibitors (e.g., pentostatin) is not recommended due to increased ISL concentrations
Co-administration with other dCK substrates (e.g., cytarabine, gemcitabine) may decrease ISL concentrations and is contraindicated/not recommended

One tablet (100mg DOR/0.25mg ISL) orally once daily with or without food
If co-administered with rifabutin, take one tablet of IDVYNSO once daily followed by one tablet of DOR 100mg approximately 12 hours later

If switching from strong CYP3A inducers, a minimum 4-week cessation period is recommended prior to initiation

Patients with Hepatitis B virus (HBV) co-infection should be closely monitored for potential liver injury if switching from an antiretroviral regimen with activity against HBV; specific anti-HBV therapy should be considered and initiated, as clinically appropriate
Evaluate potential for drug interactions prior to and during IDVYNSO therapy and monitor for adverse reactions
Discontinue IDVYNSO, monitor clinical status, and initiate appropriate therapy if severe skin and hypersensitivity reactions occur (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS)
Close monitoring to assess tolerability, viral suppression, adherence, and safety is recommended during the first 3 months after a regimen switch

Pregnancy: Insufficient human data; encourage utilization of the Antiretroviral Pregnancy Registry to monitor exposures and outcomes
Lactation: Insufficient human data; DOR and ISL concentrations detected in animal milk; potential risks include HIV-1 transmission, development of viral resistance, and serious adverse reactions
Renal Impairment: No dosage adjustment required for estimated glomerular filtration rate (eGFR) ≥30 mL/min; not recommended for patients with eGFR <30 mL/min; not studied in patients on dialysis
Hepatic Impairment: No dosage adjustment required for mild or moderate impairment (Child-Pugh Class A or B); not recommended for severe hepatic impairment (Child-Pugh Class C) as IDVYNSO has not been studied in this population