Dolutegravir/rilpivirine Disease Interactions

Dolutegravir has not been studied in patients on dialysis, so caution is recommended if used in these patients.

Patients with underlying hepatitis B or C may be at increased risk for worsening or development of transaminase elevations with the use of dolutegravir. In some cases there was hepatitis B reactivation particularly in a setting where anti- hepatitis treatment was withdrawn. Appropriate laboratory testing prior to initiating treatment and monitoring for hepatotoxicity during therapy is recommended in patients with underlying hepatitis B or C.

The effect of severe hepatic impairment (Child - Pugh C) on the pharmacokinetics of dolutegravir has not been studied, therefore dolutegravir is not recommended for use on these patients. No dosage adjustment is needed for patients with mild or moderate hepatic impairment.

Depressive symptoms including suicide ideation and suicide attempts have been reported with the use of rilpivirine. Patients should be monitored for the appearance of these symptoms and should seek medical evaluation immediately if severe depressive symptoms occur. Caution should be used in patients with a history of depression or other psychiatric conditions.

Hepatic adverse events have been reported in patients taking rilpivirine. Patients with underlying hepatitis B or C virus infection or marked transaminase elevations prior to therapy may be at increased risk for worsening or development of transaminase elevations; a few cases of hepatic toxicity have been reported in patients without preexisting hepatic disease or other known risk factors. Appropriate laboratory testing before starting therapy and monitoring for hepatotoxicity during therapy are recommended in patients with underlying hepatic disease (e.g., hepatitis B or C virus infection) or in patients with marked baseline transaminase elevations. Rilpivirine has not been studied in patients with severe liver dysfunction (Child-Pugh C); caution is recommended.

Rilpivirine should be used with caution and with increased monitoring for side effects in patients with severe renal dysfunction or end-stage renal disease, as drug concentrations can be increased due to alteration of drug absorption, distribution, and metabolism secondary to renal dysfunction. No dose adjustment is required in patients with mild or moderate renal dysfunction.