What is this medication?
Antihepaciviral, NS5A Inhibitor; Polymerase Inhibitor; NS5B RNA Polymerase Inhibitor
HARVONI is a fixed-dose combination of ledipasvir, a hepatitis C virus (HCV) NS5A inhibitor, and sofosbuvir, an HCV nucleotide analog NS5B polymerase inhibitor, and is indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection in adult.
Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with ledipasvir/sofosbuvir. HBV reactivation has been reported in hepatitis C virus (HCV)/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.
How does this medication work?
Ledipasvir inhibits the HCV NS5A protein necessary for viral replication.
Sofosbuvir is a prodrug that is converted to its pharmacologically active form GS-461203. The active form inhibits NS5B RNA-dependent RNA polymerase, also essential for viral replication, and acts as a chain terminator.
How should I take this medication?
Oral: Take one tablet (sofosbuvir 400 mg/ledipasvir 90 mg) once daily for 8-24 weeks in combination with other agents that vary with virus genotype.
How to Take: Follow instructions provided by physician/pharmacy label, take consistently at same times each day with or without food unless otherwise directed, store at room temperature.
What should I watch for while using this medication?
Before starting Sofosbuvir+Ledipasvir, Harvoni make sure your physician is aware of any allergies or medications you currently take, if you have diabetes, hepatitis B, are pregnant, or breastfeeding.
Significant drug interactions exist, requiring dose/frequency adjustment or avoidance so avoid starting any new medications without consulting prescriber.
What if I miss a dose?
If you miss a dose of medication, try to take it as soon as possible. However, if it is almost time for your next dose, take only that scheduled dose. Do not take double or extra doses.
How should I store this medication?
Keep out of the reach of children at all times. Store at room temperature, 59 to 86° F (15 to 30° C). Protect from light. Keep the container tightly closed. Properly dispose of any unused medication after the expiration date.
What are the possible side effects of using this medication?
Fatigue, headache, insomnia, chills, irritability, pruritus, skin rash, nausea, decreased appetite, diarrhea, anemia, neutropenia, asthenia, myalgia, flu-like symptoms, fever.
Note this is not a complete list of side effects for HARVONI (Ledipasvir/Sofosbuvir), only common ones.