Common Use

Generic Harvoni contains a two-drug combination for treating hepatitis C. It is taken as a single daily pill, which includes 90 mg of ledipasvir (a viral NS5A inhibitor) and 400 mg of sofosbuvir (a nucleotide inhibitor of viral RNA polymerase).

Sofosbuvir is a nucleotide analog used alongside other drugs to treat hepatitis C virus (HCV) infection. It inhibits the RNA polymerase that HCV uses to replicate its RNA.

Ledipasvir is a drug specifically designed to treat hepatitis C. It works by inhibiting the HCV NS5A protein.

The ledipasvir/sofosbuvir combination is a direct-acting antiviral agent that disrupts HCV replication. It is effective for treating patients with genotypes 1a or 1b without the need for PEG-interferon or ribavirin.

Dosage and Direction

Usual Adult Dose for Chronic Hepatitis C: 1 tablet orally once a day.

Duration of Therapy:

• Therapy-naive patients without cirrhosis: 12 weeks. An 8-week course can be considered if pretreatment HCV RNA is less than 6 million international units/mL.
• Therapy-naive patients with cirrhosis: 12 weeks.
• Therapy-experienced patients without cirrhosis: 12 weeks.
• Therapy-experienced patients with cirrhosis: 24 weeks.

Comments:

• Relapse rates can vary based on baseline host and viral factors and may differ between therapy durations for certain subgroups.
• Therapy-experienced patients are those who have previously failed treatment with peginterferon alfa/ribavirin or peginterferon alfa/ribavirin/HCV protease inhibitor.

Use: For the treatment of chronic hepatitis C genotype 1 infection.

Precautions

Do not use Generic Harvoni if you are allergic to ledipasvir or sofosbuvir, or if you are already taking sofosbuvir tablets.

Inform your doctor if you have:

• Liver problems other than hepatitis C.
• Kidney disease or if you are on dialysis.
• HIV or AIDS.
• A heart rhythm problem treated with amiodarone (Cordarone, Pacerone).

Avoid using Generic Harvoni with ribavirin if you have:

• Severe kidney disease.
• A hemoglobin blood cell disorder like sickle-cell anemia or thalassemia.
• If you are pregnant or if you are a man with a pregnant sexual partner.

Generic Harvoni is not expected to harm an unborn baby. However, it is sometimes used with ribavirin, which can cause birth defects or death in an unborn baby. A pregnancy test may be required before and during ribavirin treatment.

Avoid antacids within 4 hours before or after taking Generic Harvoni, especially those containing aluminum or magnesium.

Taking Generic Harvoni does not prevent the transmission of hepatitis C to others.

Generic Harvoni is not approved for individuals younger than 18 years old.

Contraindications

Drinking alcohol while taking Generic Harvoni may cause dangerous or unwanted side effects.

Do not take ribavirin if you are pregnant or if your sexual partner is pregnant. An unborn baby could be harmed if either parent is taking ribavirin. Notify your doctor immediately if pregnancy occurs during treatment.

It is unknown whether ledipasvir and sofosbuvir pass into breast milk or harm a nursing baby. Inform your doctor if you are breastfeeding.

Possible Side Effects

Common side effects of Generic Harvoni include:

• Weakness.
• Headache.
• Tiredness.

If you are also taking amiodarone, contact your doctor immediately if you experience:

• Extreme tiredness.
• Unusual weakness or lack of energy.
• Confusion or memory problems.
• Light-headedness or fainting.
• Slowed breathing.
• Chest pain, slow heartbeats, or weak pulse.

This is not a complete list of side effects. Others may occur. Report side effects to the FDA at 1-800-FDA-1088.

Drug Interactions

Inform your doctor about all medications you use, including those you start or stop during treatment with Generic Harvoni, especially:

• Amiodarone.
• Ribavirin.
• Atripla.
• Digoxin.
• Other hepatitis C drugs like simeprevir or sofosbuvir.
• Ritonavir with tipranavir.
• Rosuvastatin.
• St. John's wort.
• Stribild.
• Tenofovir with atazanavir, darunavir, lopinavir, or ritonavir.
• Seizure medications like carbamazepine, oxcarbazepine, phenobarbital, or phenytoin.
• Stomach acid reducers like cimetidine, esomeprazole, famotidine, lansoprazole, nizatidine, omeprazole, pantoprazole, or ranitidine.
• Tuberculosis medications like rifabutin, rifampin, or rifapentine.

This list is not exhaustive. Other drugs, including prescription, over-the-counter, vitamins, and herbal products, may interact with ledipasvir and sofosbuvir.

Missed Dose

If you miss a dose of Generic Harvoni and it is within 18 hours of the scheduled time, take it as soon as possible. If more than 18 hours have passed, skip the missed dose and take the next one at the regular time. Do not double the dose. If you struggle to take your medication as prescribed, consult your nurse or doctor immediately.

Overdose

If you suspect an overdose of Generic Harvoni, seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Storage

Store Generic Harvoni at 25°C (77°F), with excursions permitted between 15°C and 30°C (59°F and 86°F). Keep it away from moisture and heat. Ensure all medications are out of reach of children and pets.

Disclaimer

The information provided here is general and does not cover all directions, drug interactions, or precautions. It should not be used for self-treatment or self-diagnosis. Always consult your healthcare adviser or doctor for specific instructions tailored to your condition. We disclaim any liability for the reliability of this information or any consequences of its use. We are not responsible for any direct, indirect, special, or other damages resulting from the use of this information or self-treatment.