Hepcinat Lp
Treats chronic hepatitis C virus infection by inhibiting viral replication, resulting to sustained virological response and elimination of the virus from the body.
- 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
- Conditions
- Chronic Hepatitis C Genotype 1 Infection in Adults · Chronic Hepatitis C Genotype 4 Infection in Adults · Chronic Hepatitis C Genotype 5 Infection in Adults · Chronic Hepatitis C Genotype 6 Infection in Adults · Chronic Hepatitis C in Paediatric Patients Aged 3 Years and Above · Chronic Hepatitis C Genotype 1 Infection with Decompensated Cirrhosis in Combination with Ribavirin · Chronic Hepatitis C Genotype 1 or 4 Infection in Liver Transplant Recipients Without Cirrhosis or with Compensated Cirrhosis in Combination with Ribavirin
- 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
Treats chronic hepatitis C virus infection by inhibiting viral replication, resulting to sustained virological response and elimination of the virus from the body.
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
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.