Drug Interactions between emtricitabine / lopinavir / ritonavir / tenofovir disoproxil and maribavir

Ritonavir may increase the blood levels and effects of tenofovir. This can increase the risk of side effects including serious ones like kidney or liver damage and a condition known as lactic acidosis, which is a buildup of lactic acid in the blood. You should seek immediate medical attention if you develop symptoms of these conditions. Symptoms of kidney damage may include swelling, weight gain, shortness of breath, drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea, vomiting, pain in your lower back, and urinating more or less than usual or not at all. Symptoms of liver damage may include fever, chills, joint pain or swelling, unusual bleeding or bruising, skin rash, itching, loss of appetite, fatigue, nausea, vomiting, dark colored urine, and/or yellowing of the skin or eyes. Symptoms of lactic acidosis may include fatigue, unusual muscle pain, difficulty breathing, stomach pain, nausea, vomiting, lightheadedness, dizziness, and a fast or irregular heartbeat. You may need a dose adjustment or more frequent monitoring by your doctor to safely use both medications. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

Consumer information for this interaction is not currently available.

MONITOR: Coadministration with maribavir may increase the plasma concentrations of drugs that are substrates of the P-glycoprotein (P-gp) and/or breast cancer resistance protein (BCRP) efflux transporters, both of which have been shown to be inhibited in vitro by maribavir at clinically relevant concentrations. Inhibition of transporter-mediated efflux in the intestine and possibly other organs such as the liver and kidney can increase the systemic bioavailability and decrease the clearance of affected substrates. When a single 0.5 mg dose of digoxin, a sensitive P-gp substrate, was coadministered with maribavir 400 mg twice daily in 18 study subjects, mean digoxin peak plasma concentration (Cmax) and systemic exposure (AUC) increased by 25% and 21%, respectively, compared to digoxin administered alone. There are no clinical data regarding the use of maribavir with BCRP substrates, but increases in plasma concentrations of sensitive substrates such as rosuvastatin are expected according to the prescribing information.

MANAGEMENT: Caution is advised when maribavir is prescribed with drugs that are P-gp and/or BCRP substrates, particularly sensitive substrates or those with a narrow therapeutic range. Clinical and laboratory monitoring as well as dosage adjustments may be appropriate for some drugs whenever maribavir is added to or withdrawn from therapy. The prescribing information for concomitant medications should be consulted to assess the benefits versus risks of coadministration of P-gp/BCRP inhibitors and for any dosage adjustments that may be required.

Lopinavir may increase the blood levels and effects of tenofovir. This can increase the risk of side effects including serious ones like kidney or liver damage and a condition known as lactic acidosis, which is a buildup of lactic acid in the blood. You should seek immediate medical attention if you develop symptoms of these conditions. Symptoms of kidney damage may include swelling, weight gain, shortness of breath, drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea, vomiting, pain in your lower back, and urinating more or less than usual or not at all. Symptoms of liver damage may include fever, chills, joint pain or swelling, unusual bleeding or bruising, skin rash, itching, loss of appetite, fatigue, nausea, vomiting, dark colored urine, and/or yellowing of the skin or eyes. Symptoms of lactic acidosis may include fatigue, unusual muscle pain, difficulty breathing, stomach pain, nausea, vomiting, lightheadedness, dizziness, and a fast or irregular heartbeat. You may need a dose adjustment or more frequent monitoring by your doctor to safely use both medications. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

Consumer information for this interaction is not currently available.

MONITOR: Coadministration with maribavir may increase the plasma concentrations of drugs that are substrates of the P-glycoprotein (P-gp) and/or breast cancer resistance protein (BCRP) efflux transporters, both of which have been shown to be inhibited in vitro by maribavir at clinically relevant concentrations. Inhibition of transporter-mediated efflux in the intestine and possibly other organs such as the liver and kidney can increase the systemic bioavailability and decrease the clearance of affected substrates. When a single 0.5 mg dose of digoxin, a sensitive P-gp substrate, was coadministered with maribavir 400 mg twice daily in 18 study subjects, mean digoxin peak plasma concentration (Cmax) and systemic exposure (AUC) increased by 25% and 21%, respectively, compared to digoxin administered alone. There are no clinical data regarding the use of maribavir with BCRP substrates, but increases in plasma concentrations of sensitive substrates such as rosuvastatin are expected according to the prescribing information.

MANAGEMENT: Caution is advised when maribavir is prescribed with drugs that are P-gp and/or BCRP substrates, particularly sensitive substrates or those with a narrow therapeutic range. Clinical and laboratory monitoring as well as dosage adjustments may be appropriate for some drugs whenever maribavir is added to or withdrawn from therapy. The prescribing information for concomitant medications should be consulted to assess the benefits versus risks of coadministration of P-gp/BCRP inhibitors and for any dosage adjustments that may be required.