Hepcvir L (Ledipasvir & Sofosbuvir)

Hepcvir L general information

What is Hepcvir L used for?

Hepcvir L tablets are used to treat chronic hepatitis C virus genotype 1 infection in adults.  Hepatitis C is a disease of the liver caused by infection with the Hepatitis C virus (HCV) that is carried in the blood.  Infection is spread by direct contact with infected blood or blood products, such as intravenous injection of drugs using unsterilised needles, tattooing or body piercing using unsterile equipment, blood transfusion or received blood products using unscreened blood, organ transplant, healthcare needle stick injury.  Infection with HCV can result in acute disease or chronic disease.  Although acute symptoms may not always appear, they can appear within a few weeks or up to 6 months after infection, ranging from mild to severe, and include abdominal pain, loss of appetite, dark coloured urine, grey coloured faeces, nausea, upset stomach, fatigue.  Acute HCV can result in jaundice, which causes yellowing of skin and the whites of the eyes.  If the virus is not cleared from the body, which does occur spontaneously in a proportion of those infected, then they can develop symptoms of chronic HCV many years after the initial infection.  Chronic HCV infection causes inflammation of the liver and can lead to other more serious diseases such as liver fibrosis (early stages of liver damage and scarring) and cirrhosis (build-up of scar tissue), liver carcinoma and liver failure requiring liver transplant.  Other parts of the body can be infected as the immune system produces antibodies to fight the infection and this can result in kidney failure and skin rash.  HCV exists in different forms known as genotypes.  Genotype 1 is the most common type of HCV genotype and is also the most difficult to treat using other treatments.  Hepcvir L tablets are effective for most genotypes but are particularly effective for genotype 1, even if the liver is damaged by cirrhosis.  A cure from HCV infection is defined as no more detectable virus in the blood, which persists for at least 12 weeks after treatment.  Hepcvir L tablets reduce the amount of virus in the blood and can even cure the disease, with an improved cure rate of HCV infection over other treatments. 

How does Hepcvir L work?

Hepcvir L tablets contain a fixed dose combination of two direct-acting antiviral agents, ledipasvir 90mg and sofosbuvir 400mg that are used to treat chronic HCV infection.  Each drug targets a different stage in the viral replication cycle.  Ledipasvir in Hepcvir L tablets inhibits the viral specific NS5A protein, which has no enzymatic activity but is essential for HCV RNA replication and post-replication assembly of the virus particle (virion).  It is highly effective at very low doses.  Sofosbuvir in Hepcvir L tablets is a direct-acting nucleotide analogue inhibitor that blocks the action of the HCV NS5B polymerase, an enzyme that is essential to viral replication.  It is a nucleotide prodrug that is converted to its active form, the uridine analog triphosphate (GS-461203), which is incorporated into HCV RNA by the action of NS5B polymerase.  This action of sofosbuvir in Hepcvir L tablets causes chain termination of viral RNA synthesis thereby inhibiting viral replication.  Ledipasvir and sofosbuvir in Hepcvir L tablets work together to lower the amount of hepatitis C virus in the blood and may also lead to a cure of HCV infection over a number of weeks. 

What does Hepcvir L contain?

Hepcvir L tablets contain two active ingredients, ledipasvir 90mg and sofosbuvir 400mg, which are antiviral agents that are used in combination to treat chronic Hepatitis C virus (HCV) infection.  They also contain the colours ferric oxide USP-NF Red, ferric oxide USP-NF Yellow, titanium dioxide IP.

Treating Hepatitis C infection with Hepcvir L

Hepcvir L tablets contain a fixed dose combination of two antiviral drugs, ledipasvir 90mg and sofosbuvir 400mg that are used to treat chronic HCV infection.  Hepatitis C is a disease of the liver caused by infection with the Hepatitis C virus (HCV) that is carried in the blood.  Infection is spread by direct contact with infected blood or blood products, such as intravenous injection of drugs using unsterilised needles, tattooing or body piercing using unsterile equipment, blood transfusion or received blood products using unscreened blood, organ transplant, healthcare needle stick injury.  Chronic HCV infection develops if the initial infection is not cleared from the body and causes inflammation of the liver and can lead to other more serious diseases such as liver fibrosis (early stages of liver damage and scarring) and cirrhosis (build-up of scar tissue), liver carcinoma and liver failure requiring liver transplant.  Other parts of the body can be infected as the immune system produces antibodies to fight the infection and this can result in kidney failure and skin rash.  Hepcvir L tablets are effective for treating most forms (genotypes) of Hepatitis C virus, particularly the most common but also most difficult to treat genotype 1, even if the liver is damaged by cirrhosis.  Hepcvir L tablets work by blocking the replication of the virus, thereby lowering the amount of virus in the blood and may also lead to a cure of HCV infection over a number of weeks, which is defined as no more virus is detected in the blood, and persists for at least 12 weeks after treatment. 

What are the side effects of Hepcvir L?

The most commonly reported side effects when taking Hepcvir L include headache, rash, cough, weakness (asthenia) and fatigue.

When should Hepcvir L not be used?

You should not use Hepcvir L tablets if you:

• are allergic to ledipasvir or sofosbuvir or any ingredients in Hepcvir L
• are pregnant or are breastfeeding
• have kidney disease
• have liver disease other than hepatitis C
• are taking either ledipasvir or sofosbuvir separately
• are taking medicines that interact with Hepcvir L, including the antiarrhythmic amiodarone, acid reducing drugs for reflux like antacids, cimetidine and omeprazole, digoxin for heart failure, anticonvulsants like carbamazepine and phenytoin, the antibacterial rifampicin, some antivirals for HIV like tenofovir, St. John’s wort, the statin Rosuvastatin for high cholesterol

What medications interact with Hepcvir L?

Several medications interact with Hepcvir L and should either not be taken while you are taking Hepcvir L tablets or only after discussion and instruction from your doctor:

• Drugs that cause a serious reaction with Hepcvir L: the antiarrhythmic amiodarone can cause severe bradycardia (slow heartbeat)
• Drugs that affect Hepcvir L: acid reducing drugs for reflux like antacids, cimetidine and omeprazole, anticonvulsants like carbamazepine and phenytoin, the antibacterial rifampicin, St. John’s wort
• Drugs that are affected by Hepcvir L: digoxin for heart failure, some antivirals for HIV like tenofovir, the statin Rosuvastatin for high cholesterol

How should Hepcvir L be taken?

You should take your Hepcvir L tablets swallowed whole with a glass of water once daily with or without food at the same time each day.  You should continue to take your Hepcvir L tablets for as long as recommended by your doctor which is usually 12-24 weeks, depending on the amount of liver damage.

How long should you take Hepcvir L?

You should continue to take your Hepcvir L tablets for as long as recommended by your doctor which is usually 12-24 weeks, depending on the amount of liver damage.

Missed dose of Hepcvir L

If you miss a dose of Hepcvir L tablets take it as soon as you remember, unless it is time to take the next dose, then skip the missed dose.  Do not take a double dose.

How should Hepcvir L be stored?

You should store your Hepcvir L tablets below 25°C in a cool dry place.