LediHep (Ledipasvir 90 mg plus Sofosbuvir 400 mg) is a combinational drug intended for patients suffering from Hepatitis C viral (HCV) infection with genotype 1 or 4. The combination imparts unique properties in HCV patients like,
- A sustained virologic response (SVR) in between 93% to 99% after 12 weeks of treatment
- Assist in HCV infection along with infection caused by HIV
Both ledipasvir and sofosbuvir are direct-acting antiviral (DAA) drugs assisting in reducing the viral load in the body. Both the molecules selectively inhibit a crucial protein used for multiplication (RNA replication and virion assembly) of viral cells. The HCV NS5A protein is inhibited by ledipasvir whereas sofosbuvir inhibits the HCV NS5B protein.
Administration of LediHep (ledipasvir 90 mg + sofosbuvir 400 mg):
The drug is administered in a form a fixed-dose combination i.e. 1 tablet (ledipasvir + sofosbuvir combination) once daily. It can be taken with or without food.
HCV Genotype | Type of HCV patients | Dosage regimen | Duration (weeks) |
Type 1 or 4 | Patients without any earlier treatment and scarring of the liver (cirrhosis) | LediHep (ledipasvir and sofosbuvir) (1 tablet) | 12
|
Patients without any earlier treatment but having cirrhosis | LediHep (ledipasvir and sofosbuvir) and ribavirin | ||
Patients who had a therapy earlier but lack cirrhosis | LediHep (ledipasvir and sofosbuvir) (1 tablet) | 12 | |
Patients who had a therapy earlier and have cirrhosis | 24 |
Note: Earlier therapy mentioned in the table includes a failed therapy which consists of,
- Peginterferon/ribavirin
- Peginterferon alfa/ribavirin/HCV protease inhibitor
Other properties of the FDC combination drug:
Once swallowed, ledipasvir takes about 4 hours and 30 minutes to completely absorb (bio-available) whereas sofosbuvir takes 30 minutes to 2 hours roughly. After entering the system, the binding affinity of ledipasvir (99.8%) is greater than sofosbuvir (61% to 65%). Once all activities are done, the approximate time for 50% of the drug to be expelled out from the body is 47 hours and 40 minutes to 27 hours for ledipasvir and sofosbuvir respectively.
When should LediHep (ledipasvir 90mg + sofosbuvir 400mg) be avoided or used cautiously?
- If the patient has taken the ledipasvir and sofosbuvir combinational drug, within 4 hours avoid taking any antacid (acidity) drug
- Avoid having intercourse (sex) without condoms, HCV may spread to your partner if you are under treatment
- If patients are suffering from or had a history of Hepatitis B viral infection
- If patients feel their heartbeat is very slow (bradycardia), immediately consult your doctor
- If patients are taking any sort of non-prescribed or prescribed drugs, herbal medicines, or dietary supplementary
- If patients are allergic to food, medicines or other substances
- If patients are suffering from kidney disease or undergoing dialysis or other severe medical condition
- If patients had a liver transplant before the initiation of dosage
- If patients have complications in the liver other than HCV infection
- If patients are pregnant and planning to breastfeed
Side-effects of LediHep (ledipasvir 90mg + sofosbuvir 400mg):
Most common side-effects:
- Headache
- Tiredness (Fatigue)
Severe side-effects: Slow heart-rate (bradycardia)
Severe allergic reactions:
- Rashes and itching on skin
- Difficulty in breathing (Dyspnea)
- Chest tightness
- Swelling in the mouth, face, lips or tongue
Uncommon side-effects:
- Diarrhea
- Nausea
- Lack of sleep (Insomnia)
- General weakness
Note: These are not all possible side-effects of LediHep (ledipasvir 90mg + sofosbuvir 400mg), please ask your doctor for more information regarding the same.
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