Hepcinat Lp
Ledipasvir and sofosbuvir tablets for chronic hepatitis C. One of the newer direct-acting antiviral combinations, taken as a course to clear the virus.
- Category
- Hepatitis Treatment
- Active ingredients
- Ledipasvir · Sofosbuvir
- Route
- Oral use
- Form
- Film-coated tablet; Granules
- Strengths
- 90mg + 400mg
Prescription and consultation requirements for Hepcinat Lp vary by destination and are determined by the fulfilment partner.
Hepcinat Lp details
- Condition
- Chronic Hepatitis C
- Alternative names
- Harvoni
- Pharmacological class
- HCV NS5A inhibitor; HCV NS5B nucleotide polymerase inhibitor
- Dosage forms
- Film-coated tablet; Granules
- Administration route
- Oral use
- Supply category
- Prescription-only medicine (POM)
- Manufacturer
- Natco Pharma Limited
- Storage instructions
- Store below 30°C. Keep in the original container. Protect from light.
Therapeutic class
Direct-acting antiviral agents for hepatitis C; Antivirals for treatment of HCV infections
Contraindications
hypersensitivity to ledipasvir, sofosbuvir or any excipient; co-administration with rosuvastatin; co-administration with strong p-glycoprotein inducers including carbamazepine, phenobarbital, phenytoin, rifampicin, rifabutin and st. john's wort
Precautions and warnings
risk of hepatitis b virus reactivation in patients co-infected with hbv and hcv; severe symptomatic bradycardia when co-administered with amiodarone particularly in patients also receiving beta blockers or with underlying cardiac comorbidities; no dose recommendation for patients with severe renal impairment or end-stage renal disease; caution with concomitant use of moderate p-gp inducers such as oxcarbazepine; contains lactose and sunset yellow which may cause allergic reactions; ns5a resistance mutations may persist long-term and limit retreatment options in patients who fail therapy
Minor side effects
fatigue; headache; nausea; diarrhoea; insomnia; asthenia; rash; pruritus; irritability; myalgia; arthralgia; cough; dyspnoea; dizziness; decreased appetite; pyrexia; abdominal pain; constipation; back pain; muscle spasms
Moderate side effects
hepatitis b reactivation; severe bradycardia; angioedema; stevens-johnson syndrome; pancreatitis; acute kidney injury; hepatic decompensation; hepatic failure
Serious side effects
severe symptomatic bradycardia, requires immediate medical attention; signs of hepatitis b reactivation including jaundice, dark urine, abdominal pain, requires immediate medical attention; angioedema with swelling of face, lips, tongue or throat, requires immediate medical attention; severe cutaneous reactions including widespread rash with blistering, requires immediate medical attention; signs of pancreatitis including severe upper abdominal pain radiating to the back, requires immediate medical attention; signs of hepatic decompensation including confusion, abdominal swelling, jaundice, requires immediate medical attention
Patient summary
Ledipasvir and sofosbuvir tablets for chronic hepatitis C. One of the newer direct-acting antiviral combinations, taken as a course to clear the virus.
Mechanism of action
Hepcinat LP contains ledipasvir and sofosbuvir. Ledipasvir blocks the hepatitis C virus NS5A protein needed for viral RNA replication. Sofosbuvir is a nucleotide prodrug that converts to its active form inside liver cells and acts as a chain terminator, stopping the virus from copying its genetic material. Together, these medicines prevent the hepatitis C virus from multiplying and allow the body to clear the infection.
Drug interactions
amiodarone; rifampicin; rifabutin; carbamazepine; phenobarbital; phenytoin; st. john's wort; oxcarbazepine; rosuvastatin; pravastatin; atorvastatin; digoxin; dabigatran; tenofovir disoproxil fumarate; antacids; h2 receptor antagonists; proton pump inhibitors; rifapentine; tipranavir; ritonavir; simeprevir
Age restrictions
Not recommended in paediatric patients below 3 years of age. Safety and efficacy not established.
Pregnancy and breastfeeding
Pregnancy: No adequate and well-controlled studies in pregnant women. As a precautionary measure, it is preferable to avoid use during pregnancy. Fertile women must use effective contraception during treatment. Breastfeeding: Confirm breastfeeding suitability with a qualified clinician or pharmacist before use.