Sofosbuvir
Therapeutic Class: Anti-Viral (Hepatic viral infections (Hepatitis C)
Indications:
Sofosbuvir is indicated for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen.
- Sofosbuvir efficacy has been established in subjects with HCV genotype 1, 2, 3 or 4 infections, including those with hepatocellular carcinoma meeting Milan criteria (awaiting liver transplantation) and those with HCV/HIV-1 co-infection.
Presentation:
Sofosbuvir: Each tablet contains Sofosbuvir INN 400 mg
Description:
Sofosbuvir is a direct-acting antiviral agent against the hepatitis C virus. It is an inhibitor of the HCV NS5B RNA-dependent RNA polymerase, which is essential for viral replication.
Sofosbuvir is indicated for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen.
- Sofosbuvir efficacy has been established in subjects with HCV genotype 1, 2, 3 or 4 infections, including those with hepatocellular carcinoma meeting Milan criteria (awaiting liver transplantation) and those with HCV/HIV-1 co-infection.
The following points should be considered when initiating treatment with Sofosbuvir:
- Monotherapy of Sofosbuvir is not recommended for the treatment of CHC.
- Treatment regimen and duration are dependent on both viral genotype and patient population.
- Treatment response varies based on baseline host and viral factor.
Sofosbuvir: Each tablet contains Sofosbuvir INN 400 mg
Description:
Sofosbuvir is a direct-acting antiviral agent against the hepatitis C virus. It is an inhibitor of the HCV NS5B RNA-dependent RNA polymerase, which is essential for viral replication.
Dosage & Administration:
-One 400 mg tablet taken once daily with or without food.
- Should be used in combination with Ribavirin or in combination with Pegylated Interferon and Ribavirin for the treatment of CHC.
Recommended combination therapy: (HCV Mono-infected and HCV/HIV-1 Co-infected )
- Should be used in combination with Ribavirin for treatment of CHC in patients with hepatocellular carcinoma awaiting liver transplantation for up to 48 weeks or until liver transplantation whichever occurs first
- A dose recommendation cannot be made for patients with severe renal impairment or end-stage renal disease
Side Effects:
The most common adverse events observed with Sofosbuvir in combination with Ribavirin were fatigue and headache. The most common adverse events observed with Sofosbuvir in combination with Peginterferon alfa and Ribavirin were fatigue, headache, nausea, insomnia and anaemia.
Precautions:
Pregnancy: Ribavirin may cause birth defects and fetal death and animal studies have shown interferons have abortifacient effects; avoid pregnancy in female patients and female partners of male patients. Patients must have a negative pregnancy test prior to initiating therapy, use at least 2 effective methods of contraception and have monthly pregnancy tests.
Use in Pregnancy & Lactation:
Pregnancy Category X: Use with Ribavirin or Peginterferon Alfa/Ribavirin
Extreme caution must be taken to avoid pregnancy in female patients and female partners of male patients while taking this combination. Women of childbearing potential and their male partners should not receive Ribavirin unless they are using two forms of effective contraception during treatment with Ribavirin and for 6 months after treatment has concluded.
Pregnancy Category B: Sofosbuvir monotherapy
-One 400 mg tablet taken once daily with or without food.
- Should be used in combination with Ribavirin or in combination with Pegylated Interferon and Ribavirin for the treatment of CHC.
Recommended combination therapy: (HCV Mono-infected and HCV/HIV-1 Co-infected )
- Genotype 1 or 4: Sofosbuvir + Peginterferon alfa + Ribavirin for 12 weeks
- Genotype 2:Sofosbuvir + Ribavirin for 12 weeks
- Genotype 3: Sofosbuvir + Ribavirin for 24 weeks
- Should be used in combination with Ribavirin for treatment of CHC in patients with hepatocellular carcinoma awaiting liver transplantation for up to 48 weeks or until liver transplantation whichever occurs first
- A dose recommendation cannot be made for patients with severe renal impairment or end-stage renal disease
Side Effects:
The most common adverse events observed with Sofosbuvir in combination with Ribavirin were fatigue and headache. The most common adverse events observed with Sofosbuvir in combination with Peginterferon alfa and Ribavirin were fatigue, headache, nausea, insomnia and anaemia.
Precautions:
Pregnancy: Ribavirin may cause birth defects and fetal death and animal studies have shown interferons have abortifacient effects; avoid pregnancy in female patients and female partners of male patients. Patients must have a negative pregnancy test prior to initiating therapy, use at least 2 effective methods of contraception and have monthly pregnancy tests.
Use in Pregnancy & Lactation:
Pregnancy Category X: Use with Ribavirin or Peginterferon Alfa/Ribavirin
Extreme caution must be taken to avoid pregnancy in female patients and female partners of male patients while taking this combination. Women of childbearing potential and their male partners should not receive Ribavirin unless they are using two forms of effective contraception during treatment with Ribavirin and for 6 months after treatment has concluded.
Pregnancy Category B: Sofosbuvir monotherapy
There are no adequate and well-controlled studies with Sofosbuvir in pregnant women.
Lactation: It is not known whether Sofosbuvir and its metabolites are present in human breast milk. Because of the potential for adverse reactions from the drug in nursing infants, a decision must be made whether to discontinue nursing or discontinue treatment with Ribavirin-containing regimens, taking into account the importance of the therapy to the mother.
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Pediatric Use:
The safety and effectiveness of Sofosbuvir in children less than 18 years of age have not been established.
Interaction:
Drugs that are potent intestinal P-GP inducers (e.g., rifampin, St. John’s wort) may alter the concentrations of Sofosbuvir.
Lactation: It is not known whether Sofosbuvir and its metabolites are present in human breast milk. Because of the potential for adverse reactions from the drug in nursing infants, a decision must be made whether to discontinue nursing or discontinue treatment with Ribavirin-containing regimens, taking into account the importance of the therapy to the mother.
We can say that a-line wedding dresses are a kind of classic dress model. It has been so popular from time to time. Therefore, people know it as a timeless dress cut for bridal. As with its name, the A-line dress is intentionally designed to follow the A Letter shape. It is different from a ball gown. The A-line dress has a softer silhouette to hide your big bottom with its flared skirt cut. Commonly, the most matching top cut which is usually applied on the A-line dress is a fit waistline cut. It is a waist cut that emphasizes your slim waist shape perfectly.
Pediatric Use:
The safety and effectiveness of Sofosbuvir in children less than 18 years of age have not been established.
Interaction:
Drugs that are potent intestinal P-GP inducers (e.g., rifampin, St. John’s wort) may alter the concentrations of Sofosbuvir.
Storage:
Keep out of the reach of children. Keep in a cool & dry place. Protect from light.