harvoni combination therapy (Gilead Sciences)
97
Structured Review
Gilead Sciences
harvoni combination therapy
Harvoni Combination Therapy, supplied by Gilead Sciences, used in various techniques. Bioz Stars score: 97/100, based on 945 PubMed citations. ZERO BIAS - scores, article reviews, protocol conditions and more
https://www.bioz.com/product/harvoni+combination+therapy/Harvoni/fda_document____drugsatfda_docs_slash_label_slash_2019_slash_205834s029lbl-7-135-135
Average 97 stars, based on 945 article reviews
Harvoni Combination Therapy, supplied by Gilead Sciences, used in various techniques. Bioz Stars score: 97/100, based on 945 PubMed citations. ZERO BIAS - scores, article reviews, protocol conditions and more
https://www.bioz.com/product/harvoni+combination+therapy/Harvoni/fda_document____drugsatfda_docs_slash_label_slash_2019_slash_205834s029lbl-7-135-135
Average 97 stars, based on 945 article reviews
harvoni combination therapy - by Bioz Stars,
2026-10
97/100 stars
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Virus:Article Title: Article Snippet: Hepatitis B virus (HBV) reactivation has been reported, in some cases resulting in fulminant hepatitis, hepatic failure, and death. (5.1) ------------------------------RECENT MAJOR CHANGES ---------------------- Indications and Usage (1) 8/2019 Dosage and Administration Recommended Treatment Regimen and Duration in Patients 3 Years of Age and Older with Genotype 1, 4, 5, or 6 HCV (2.2) 8/2019 Recommended Dosage in Pediatric Patients 3 Years of Age and Older (2.4) 8/2019 Preparation and Administration of Oral Pellets (2.5) 8/2019 -------------------------------INDICATIONS AND USAGE-----------------------HARVONI is a fixed-dose combination of ledipasvir, a hepatitis C virus (HCV) NS5A inhibitor, and sofosbuvir, an HCV nucleotide analog NS5B polymerase inhibitor, and is indicated for the treatment of chronic hepatitis C virus (HCV) in adults and pediatric patients 3 years of age and older: Genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis Genotype 1 infection with decompensated cirrhosis, in combination with ribavirin Genotype 1 or 4 infection who are liver transplant recipients without cirrhosis or with compensated cirrhosis, in combination with ribavirin. (1) ------------------------DOSAGE AND ADMINISTRATION--------------------- Testing prior to the initiation of therapy: Test all patients for HBV infection by measuring HBsAg and anti-HBc. (2.1) Recommended treatment regimen and duration in patients 3 years of age and older: (2.2) HCV Genotype Patient Population Regimen and Duration Treatment-naïve without cirrhosis or with compensated cirrhosis (Child-Pugh A) HARVONI 12 weeks Genotype 1 Treatment-experienced without cirrhosis HARVONI 12 weeks Treatment-experienced with compensated cirrhosis (ChildPugh A) HARVONI 24 weeks Treatment-naïve and treatmentexperienced with decompensated cirrhosis (ChildPugh B or C) HARVONI + ribavirin 12 weeks Genotype 1 or 4 Treatment-naïve and treatmentexperienced liver transplant recipients without cirrhosis, or with compensated cirrhosis (Child-Pugh A) HARVONI + ribavirin 12 weeks Genotype 4, 5, or 6 Treatment-naïve and treatmentexperienced without cirrhosis or with compensated cirrhosis (Child-Pugh A) HARVONI 12 weeks Recommended dosage in adults: One tablet (90 mg of ledipasvir and 400 mg of sofosbuvir) taken orally once daily with or without food. (2.3) Recommended dosage in pediatric patients 3 years and older: Recommended dosage of HARVONI in pediatric patients 3 years of age and older is based on weight. .. Refer to Table 2 of the full prescribing information for specific dosing guidelines based on body weight. (2.4) HCV/HIV-1 coinfection: For adult and pediatric patients with HCV/HIV-1 coinfection, follow the dosage recommendations in the tables in the full prescribing information. (2.3, 2.4) If used in combination with ribavirin, follow the recommendations for ribavirin dosing and dosage modifications. (2.3, 2.4) A dosage recommendation cannot be made for patients with severe renal impairment or end stage renal disease. (2.6) -----------------------DOSAGE FORMS AND STRENGTHS------------------ Tablets: 90 mg of ledipasvir and 400 mg of sofosbuvir; 45 mg of ledipasvir and 200 mg of sofosbuvir. (3) Oral Pellets: 45 mg of ledipasvir and 200 mg of sofosbuvir; 33.75 mg of ledipasvir and 150 mg of sofosbuvir. (3) --------------------------------CONTRAINDICATIONS----------------------------If used in combination with ribavirin, all contraindications to ribavirin also apply to Infection:Article Title: Article Snippet: Hepatitis B virus (HBV) reactivation has been reported, in some cases resulting in fulminant hepatitis, hepatic failure, and death. (5.1) ------------------------------RECENT MAJOR CHANGES ---------------------- Indications and Usage (1) 8/2019 Dosage and Administration Recommended Treatment Regimen and Duration in Patients 3 Years of Age and Older with Genotype 1, 4, 5, or 6 HCV (2.2) 8/2019 Recommended Dosage in Pediatric Patients 3 Years of Age and Older (2.4) 8/2019 Preparation and Administration of Oral Pellets (2.5) 8/2019 -------------------------------INDICATIONS AND USAGE-----------------------HARVONI is a fixed-dose combination of ledipasvir, a hepatitis C virus (HCV) NS5A inhibitor, and sofosbuvir, an HCV nucleotide analog NS5B polymerase inhibitor, and is indicated for the treatment of chronic hepatitis C virus (HCV) in adults and pediatric patients 3 years of age and older: Genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis Genotype 1 infection with decompensated cirrhosis, in combination with ribavirin Genotype 1 or 4 infection who are liver transplant recipients without cirrhosis or with compensated cirrhosis, in combination with ribavirin. (1) ------------------------DOSAGE AND ADMINISTRATION--------------------- Testing prior to the initiation of therapy: Test all patients for HBV infection by measuring HBsAg and anti-HBc. (2.1) Recommended treatment regimen and duration in patients 3 years of age and older: (2.2) HCV Genotype Patient Population Regimen and Duration Treatment-naïve without cirrhosis or with compensated cirrhosis (Child-Pugh A) HARVONI 12 weeks Genotype 1 Treatment-experienced without cirrhosis HARVONI 12 weeks Treatment-experienced with compensated cirrhosis (ChildPugh A) HARVONI 24 weeks Treatment-naïve and treatmentexperienced with decompensated cirrhosis (ChildPugh B or C) HARVONI + ribavirin 12 weeks Genotype 1 or 4 Treatment-naïve and treatmentexperienced liver transplant recipients without cirrhosis, or with compensated cirrhosis (Child-Pugh A) HARVONI + ribavirin 12 weeks Genotype 4, 5, or 6 Treatment-naïve and treatmentexperienced without cirrhosis or with compensated cirrhosis (Child-Pugh A) HARVONI 12 weeks Recommended dosage in adults: One tablet (90 mg of ledipasvir and 400 mg of sofosbuvir) taken orally once daily with or without food. (2.3) Recommended dosage in pediatric patients 3 years and older: Recommended dosage of HARVONI in pediatric patients 3 years of age and older is based on weight. .. Refer to Table 2 of the full prescribing information for specific dosing guidelines based on body weight. (2.4) HCV/HIV-1 coinfection: For adult and pediatric patients with HCV/HIV-1 coinfection, follow the dosage recommendations in the tables in the full prescribing information. (2.3, 2.4) If used in combination with ribavirin, follow the recommendations for ribavirin dosing and dosage modifications. (2.3, 2.4) A dosage recommendation cannot be made for patients with severe renal impairment or end stage renal disease. (2.6) -----------------------DOSAGE FORMS AND STRENGTHS------------------ Tablets: 90 mg of ledipasvir and 400 mg of sofosbuvir; 45 mg of ledipasvir and 200 mg of sofosbuvir. (3) Oral Pellets: 45 mg of ledipasvir and 200 mg of sofosbuvir; 33.75 mg of ledipasvir and 150 mg of sofosbuvir. (3) --------------------------------CONTRAINDICATIONS----------------------------If used in combination with ribavirin, all contraindications to ribavirin also apply to |