ght-colored stools) to their health care provider. If a sofosbuvir; velpatasvir recipient develops signs of HBV reactivation, consult a physician with expertise in the management of hepatitis infections. The FDA has identified and confirmed 24 cases of hepatitis B exacerbation (including fulminant hepatitis, hepatic failure requiring liver transplant n = 1, and death n = 2) in coinfected patients treated with a DAA-based HCV regimen between November 2013 and July 2016. The exact mechanism is unknown; however, a commonly reported sequence of events included initiation of a DAA-based HCV regimen, rapid drop in HCV RNA to undetectable levels within 1 to 2 weeks of liver enzyme normalization, followed by a rise in HBV DNA (with or without increased transaminases) between treatment weeks 4 and 8. Of the 24 reported cases: 8 discontinued the DAA when transaminases began to rise; 12 received HBV treatment with tenofovir or entecavir; 6 did not receive HBV treatment; and 6 did not report whether HBV treatment was used.
ADVERSE REACTIONS
Moderate
anemia / Delayed / 26.0-26.0
depression / Delayed / 1.0-1.0
hyperbilirubinemia / Delayed / Incidence not known
Mild
fatigue / Early / 15.0-32.0
headache / Early / 11.0-22.0
insomnia / Early / 5.0-11.0
nausea / Early / 9.0-11.0
diarrhea / Early / 10.0-10.0
asthenia / Delayed / 5.0-5.0
rash (unspecified) / Early / 2.0-5.0
irritability / Delayed / 5.0
DRUG INTERACTIONS
Aldesleukin, IL-2: Use caution when administering velpatasvir with aldesleukin, IL-2. Taking these drugs together may increase velpatasvir plasma concentrations, potentially resulting in adverse events. Aldesleukin increases IL-6 concentrations, and IL-6 is a CYP3A4 inhibitor; velpatasvir is a substrate of CYP3A4.
Alectinib: Use caution when administering velpatasvir with alectinib. Taking these drugs together may increase the plasma concentrations of velpatasvir, potentially resulting in adverse events. Velpatasvir is a substrate of the drug transporters P-glycoprotein (P-gp) and Breast Cancer Resistance Protein (BCRP); alectinib is an inhibitor of both P-gp and BCRP.
Aliskiren; Amlodipine: Use caution when administering velpatasvir with amlodipine. Taking these drugs together may increase velpatasvir plasma concentrations, potentially resulting in adverse events. Amlodipine is a weak CYP3A4 inhibitor; velpatasvir is a substrate of CYP3A4.
Aliskiren; Amlodipine; Hydrochlorothiazide, HCTZ: Use caution when administering velpatasvir with amlodipine. Taking these drugs together may increase velpatasvir plasma concentrations, potentially resulting in adverse events. Amlodipine is a weak CYP3A4 inhibitor; velpatasvir is a substrate of CYP3A4.
Alogliptin; Pioglitazone: Use caution when administering velpatasvir with pioglitazone. Taking these drugs together may decrease velpatasvir plasma concentrations, potentially resulting in loss of antiviral efficacy. Velpatasvir is a CYP3A4 substrate; pioglitazone is a weak inducer of CYP3A4.
Aluminum Hydroxide: Separate the use of antacids and velpatasvir administration by 4 hours. Velpatasvir solubility decreases as pH increases; therefore, drugs that increase gastric pH are expected to decrease the concentrations of velpatasvir, potentially resulting in loss of antiviral efficacy.
Aluminum Hydroxide; Magnesium Carbonate: Separate the use of antacids and velpatasvir administration by 4 hours. Velpatasvir solubility decreases as pH increases; theref |
