The active ingredient present in Generic Harvoni is a two drug combination for the treatment of hepatitis C. It is administered as a single daily pill containing 90 mg of the viral NS5A inhibitor ledipasvir and 400 mg of sofosbuvir, a nucleotide inhibitor of the viral RNA polymerase.
Sofosbuvir is a nucleotide analog used in combination with other drugs for the treatment of hepatitis C virus (HCV) infection. Sofosbuvir inhibits the RNA polymerase that the hepatitis C virus uses to replicate its RNA.
Ledipasvir (formerly GS-5885) is a drug for the treatment of hepatitis C. Ledipasvir is an inhibitor of the hepatitis C virus NS5A protein.
The ledipasvir/sofosbuvir combination is a direct-acting antiviral agent that interferes with HCV replication and can be used to treat patients with genotypes 1a or 1b without 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; 8 weeks can be considered if pretreatment HCV RNA 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
-Relapse rates are affected by baseline host and viral factors and differ between durations of therapy for some subgroups.
-Therapy-experienced patients are those patients who have failed treatment with either peginterferon alfa/ribavirin or peginterferon alfa/ribavirin/HCV protease inhibitor.
Use: For the treatment of chronic hepatitis C genotype 1 infection
You should not use Generic Harvoni if you are allergic to ledipasvir or sofosbuvir, or if you are also taking sofosbuvir tablets.
To make sure Generic Harvoni is safe for you, tell your doctor if you have: -liver problems other than hepatitis C; -kidney disease (or if you are on dialysis); -HIV or AIDS; or a heart rhythm problem for which you take a medicine called amiodarone (Cordarone, Pacerone).
You should not use Generic Harvoni with ribavirin if you have: -severe kidney disease; -a hemoglobin blood cell disorder such as sickle-cell anemia or thalassemia; or if you are pregnant, or if you are a man and your sexual partner is pregnant.
Generic Harvoni is not expected to harm an unborn baby. But Generic Harvoni is sometimes used together with ribavirin which can cause birth defects or death in an unborn baby. You may need to have a negative pregnancy test before taking ribavirin and every month during your treatment.
Avoid taking an antacid within 4 hours before or 4 hours after you take Generic Harvoni. This especially includes antacids that contain aluminum or magnesium.
Taking Generic Harvoni will not prevent you from passing hepatitis C to other people.
Generic Harvoni is not approved for use by anyone younger than 18 years old.
Drinking alcohol while taking Generic Harvoni can cause dangerous or unwanted side effects.
If you are a woman, do not take ribavirin if you are pregnant. If you are a man, do not take ribavirin if your sexual partner is pregnant. An unborn baby could also be harmed if a man fathers the child while he is taking ribavirin. Tell your doctor right away if a pregnancy occurs while either the mother or the father is taking ribavirin.
It is not known whether ledipasvir and sofosbuvir passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
Possible side effect
Common Generic Harvoni side effects may include: weakness; headache; or tired feeling.
If you also take a heart medication called amiodarone, call your doctor at once if you have: extreme tiredness; unusual weakness or lack of energy; confusion or memory problems; a light-headed feeling, like you might pass out; slowed breathing; or chest pain, slow heartbeats, weak pulse.
This is not a complete list of side effects and others may occur. You may report side effects to FDA at 1-800-FDA-1088.
Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Generic Harvoni, especially: amiodarone; ribavirin; Atripla; digoxin; other drugs to treat hepatitis C, such as simeprevir or sofosbuvir; ritonavir when used with tipranavir; rosuvastatin; St. John's wort; Stribild; tenofovir when used in combination with atazanavir, darunavir, lopinavir, or ritonavir; seizure medicine - carbamazepine, oxcarbazepine, phenobarbital, phenytoin; stomach acid reducers - cimetidine, esomeprazole, famotidine lansoprazole, nizatidine, omeprazole, pantoprazole, ranitidine, and others; or tuberculosis medicine - rifabutin, rifampin, rifapentine.
This list is not complete. Other drugs may interact with ledipasvir and sofosbuvir, including prescription and over-the-counter medicines, vitamins, and herbal products.
If you miss taking a dose of Generic Harvoni and it is within 18 hours of when you were supposed to take it, take it as soon as possible. If it is after 18 hours from when you were supposed to take it, wait and take the next tablet at your regular time. Do not take a double dose. If you find that you are not able to take your medication as prescribed and directed, talk to your nurse or doctor right away.
If you think you have used too much of Generic Harvoni - seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Store this medicine at 25°C (77°F), with excursions permitted between 15°C and 30°C (59°F and 86°F), away from moisture and heat. Keep all drugs out of the reach children and pets.
We provide only general information about medications which does not cover all directions, possible drug integrations, or precautions. Information at the site cannot be used for self-treatment and self-diagnosis. Any specific instructions for a particular patient should be agreed with your health care adviser or doctor in charge of the case. We disclaim reliability of this information and mistakes it could contain. We are not responsible for any direct, indirect, special or other indirect damage as a result of any use of the information on this site and also for consequences of self-treatment.