Sofosbuvir

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Generic Name of Sofosbuvir - Learn More

Sofosbuvir

Sofosbuvir Precaution - What You Need to Know

Before starting Sofosbuvir, it is essential for patients to consult their healthcare provider to ensure the medication is appropriate for their specific condition. Sofosbuvir is a direct-acting antiviral (DAA) medication used to treat hepatitis C, but certain precautions must be considered:

- Renal Impairment: Sofosbuvir is primarily cleared by the kidneys, so patients with severe renal dysfunction, especially those with eGFR (estimated glomerular filtration rate) less than 30 mL/min, should be closely monitored or may require dose adjustments, as there is a risk of drug accumulation and toxicity.
- Pregnancy: Sofosbuvir should not be used during pregnancy unless absolutely necessary, and it should not be combined with certain medications, such as ribavirin, which is teratogenic (can cause birth defects). If used, women of childbearing potential should be advised to use effective contraception during treatment and for at least six months after the end of treatment.
- Breastfeeding: It is not known whether Sofosbuvir is excreted in breast milk, so caution is advised when breastfeeding, particularly when combined with other antiviral agents.
- Drug Resistance: In cases of chronic hepatitis C, baseline resistance testing may be advised to assess for specific viral strains that may be resistant to Sofosbuvir.
- Hepatic Impairment: Patients with severe liver impairment should be monitored closely as Sofosbuvir may affect liver function further, especially when combined with other hepatitis treatments.

Sofosbuvir Indication - Uses and Benefits

Sofosbuvir is primarily indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults and, in some cases, children aged 12 years and older. Its therapeutic uses include:

- Chronic Hepatitis C: Sofosbuvir is used in combination with other antiviral agents such as ledipasvir, velpatasvir, or ribavirin, depending on the genotype of the virus, to achieve sustained virologic response (SVR), which means the virus is undetectable in the blood after treatment.
- HCV Genotypes 1, 2, 3, and 4: Sofosbuvir is effective against several genotypes of HCV, making it versatile in treating a range of patients. Its efficacy is highest when used as part of a combination therapy regimen, as monotherapy with Sofosbuvir alone is generally not recommended.
- Hepatitis C in Co-infected Patients: Sofosbuvir is also indicated for use in individuals co-infected with HIV and hepatitis C, providing a valuable treatment option for people living with both conditions.

The goal of Sofosbuvir treatment is to reduce the viral load and achieve the sustained elimination of the virus, preventing complications like liver cirrhosis, liver failure, or hepatocellular carcinoma.

Sofosbuvir Contraindications - Important Warnings

Sofosbuvir has specific contraindications that should be carefully considered before initiating therapy:

- Hypersensitivity: The drug should not be used by patients with known hypersensitivity to Sofosbuvir or any of its components, as this could lead to severe allergic reactions, including rash, difficulty breathing, or swelling.
- Combination with Certain Medications: Sofosbuvir is contraindicated in patients taking rifampin (an antibiotic) and carbamazepine (an anticonvulsant), as these drugs can significantly reduce Sofosbuvir's efficacy by inducing enzymes that metabolize the drug.
- Severe Renal Impairment: Sofosbuvir is contraindicated in patients with severe renal impairment (eGFR < 30 mL/min), as the drug is primarily excreted through the kidneys, and impaired renal function may lead to drug accumulation and an increased risk of toxicity.
- Monotherapy: Sofosbuvir should not be used as monotherapy for HCV treatment due to the risk of developing resistance. It must be used in combination with other antiviral agents.

Sofosbuvir Side Effects - What to Expect

Sofosbuvir is generally well-tolerated, but like any medication, it can cause side effects. The common and serious side effects include:

- Common Side Effects:
- Fatigue: A frequent complaint among patients undergoing Sofosbuvir treatment, especially when combined with other antivirals.
- Headache: Some patients may experience mild to moderate headaches during treatment.
- Nausea: Mild gastrointestinal symptoms, including nausea, may occur in some patients.
- Anemia: Sofosbuvir, when used with other drugs like ribavirin, may cause anemia, leading to fatigue, weakness, and shortness of breath.

- Serious Side Effects:
- Severe Allergic Reactions: Though rare, Sofosbuvir can cause severe allergic reactions, such as rash, difficulty breathing, and swelling of the face or throat. Immediate medical attention is required if these symptoms occur.
- Bradycardia: When used in combination with certain drugs like amiodarone, Sofosbuvir may cause bradycardia (slow heart rate), which can be life-threatening.
- Liver Injury: In rare cases, Sofosbuvir may cause liver problems, including hepatitis flares upon discontinuation, especially in patients with cirrhosis.

Patients experiencing any severe or unusual symptoms should seek medical help promptly.

Sofosbuvir Pregnancy Category ID - Safety Information

2

Sofosbuvir Mode of Action - How It Works

Sofosbuvir is a nucleoside analogue that inhibits the NS5B RNA-dependent RNA polymerase enzyme in the hepatitis C virus (HCV). This enzyme is essential for the replication of the virus, and by blocking it, Sofosbuvir prevents the virus from multiplying in the liver.

- Mechanism of Action: Sofosbuvir mimics the natural building blocks of RNA and gets incorporated into the growing RNA strand during viral replication. Once incorporated, it causes premature termination of the RNA chain, effectively halting the replication process and preventing further spread of the virus.
- Viral Replication Inhibition: By disrupting the replication of the HCV genome, Sofosbuvir helps to reduce the viral load in the patient’s body, allowing the immune system to clear the infection over time. This leads to the resolution of acute infection and the prevention of liver damage in chronic infections.

Sofosbuvir Drug Interactions - What to Avoid

Sofosbuvir can interact with several medications and substances, which may either reduce its efficacy or increase the risk of side effects. Some of the most significant interactions include:

- Anticonvulsants (e.g., phenytoin, carbamazepine): These drugs can reduce the effectiveness of Sofosbuvir by increasing the metabolism of the drug. A different anticonvulsant with minimal interaction, such as lamotrigine, may be recommended.
- Rifampin: This antibiotic induces liver enzymes that break down Sofosbuvir, leading to suboptimal levels of the drug and reduced therapeutic effect.
- St. John's Wort: This herbal supplement can also induce liver enzymes, similarly decreasing the efficacy of Sofosbuvir.
- P-glycoprotein Inhibitors (e.g., digoxin): Certain drugs that inhibit P-glycoprotein may affect the absorption and efficacy of Sofosbuvir.
- Antacids and Proton Pump Inhibitors: These can alter the absorption of Sofosbuvir in the stomach, especially when used in combination with drugs like ledipasvir or velpatasvir, so timing of doses may need to be adjusted.

Patients should inform their healthcare provider about all medications they are taking, including herbal supplements, to prevent harmful interactions.

Sofosbuvir Pregnancy Category Note - Key Information

Pregnancy Category: B; Category X when used in combination with ribavirin or peginterferon alfa/ribavirin

Sofosbuvir Adult Dose - Recommended Dosage

For adults, the usual recommended dose of Sofosbuvir is 400 mg once daily. It is typically prescribed in combination with other antiviral agents, depending on the genotype and condition being treated:

- For genotype 1, 4, 5, or 6 HCV infection: Sofosbuvir is usually combined with ledipasvir or velpatasvir for a treatment duration of 12 weeks.
- For genotype 2 and 3 HCV infection: Sofosbuvir is often used in combination with ribavirin, with treatment durations varying from 12 to 24 weeks based on the clinical situation.

The exact combination regimen and duration of treatment will be determined by a healthcare provider based on the patient's specific HCV genotype, viral load, and other factors.

Sofosbuvir Child Dose - Dosage for Children

Sofosbuvir is not approved for use in children under the age of 12 years due to a lack of sufficient safety and efficacy data in pediatric populations. For children aged 12 years and older, dosing typically follows adult recommendations but should always be adjusted according to individual circumstances, including genotype and comorbidities. Treatment should be managed by a specialist experienced in pediatric hepatitis C care.

Patients should always follow their healthcare provider's instructions, and pediatric dosing should be guided by a medical professional.

Sofosbuvir Renal Dose - Dosage for Kidney Conditions

In patients with renal impairment, Sofosbuvir should be used cautiously:

- For patients with eGFR less than 30 mL/min, Sofosbuvir is contraindicated due to the risk of drug accumulation and potential toxicity.
- For those with mild to moderate renal impairment, the usual dose is typically safe, but renal function should be monitored closely during treatment.

In cases of severe renal impairment or end-stage renal disease, alternative treatment options may be considered by the healthcare provider.