p; phenobarbital oxcarbazepine
↓ sofosbuvir
↓ GS-331007
Coadministration of SOVALDI with carbamazepine, phenytoin, phenobarbital or oxcarbazepine is expected to decrease the concentration of sofosbuvir, leading to reduced therapeutic effect of SOVALDI. Coadministration is not recommended.
Antimycobacterials:
rifabutin rifampin rifapentine
↓ sofosbuvir
↓ GS-331007
Coadministration of SOVALDI with rifabutin or rifapentine is expected to decrease the concentration of sofosbuvir, leading to reduced therapeutic effect of SOVALDI. Coadministration is not recommended.
SOVALDI should not be used with rifampin, a potent intestinal P-gp inducer [See Warnings and Precautions (5.2)].
Herbal Supplements:
St. John’s wort (Hypericum perforatum)
↓ sofosbuvir
↓ GS-331007
SOVALDI should not be used with St. John’s wort, a potent intestinal P-gp inducer [See Warnings and Precautions (5.2)].
HIV Protease Inhibitors:
tipranavir/ritonavir
↓ sofosbuvir
↓ GS-331007
Coadministration of SOVALDI with tipranavir/ritonavir is expected to decrease the concentration of sofosbuvir, leading to reduced therapeutic effect of SOVALDI. Coadministration is not recommended.
a. This table is not all inclusive.
b. ↓ = decrease.
Drugs without Clinically Significant Interactions with SOVALDI
In addition to the drugs included in Table 5, the interaction between SOVALDI and the following drugs was eva luated in clinical trials and no dose adjustment is needed for either drug: cyclosporine, darunavir/ritonavir, efavirenz, emtricitabine, methadone, raltegravir, rilpivirine, tacrolimus, or tenofovir disoproxil fumarate.
USE IN SPECIFIC POPULATIONS
Renal Impairment
No dose adjustment of SOVALDI is required for patients with mild or moderate renal impairment. The safety and efficacy of SOVALDI have not been established in patients with severe renal impairment (eGFR <30 mL/min/1.73m2) or end stage renal disease (ESRD) requiring hemodialysis. No dose recommendation can be given for patients with severe renal impairment or ESRD. Refer also to ribavirin and peginterferon alfa prescribing information for patients with CrCl <50 mL/min.
Hepatic Impairment
No dose adjustment of SOVALDI is required for patients with mild, moderate or severe hepatic impairment (Child-Pugh Class A, B or C). Safety and efficacy of SOVALDI have not been established in patients with decompensated cirrhosis. See peginterferon alfa prescribing information for contraindication in hepatic decompensation.
Patients with HCV/HIV-1 Co-infection
The safety and efficacy of SOVALDI was assessed in 223 HCV/HIV-1 co-infected subjects [See Clinical Studies (14.4)]. See Dosage and Administration (2.1)
