Harvoni Access
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Questions & Answers
Side Effects & Adverse Reactions
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Legal Issues
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
HARVONI™ is indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection in adults.
History
There is currently no drug history available for this drug.
Other Information
HARVONI is a fixed-dose combination tablet containing ledipasvir and sofosbuvir for oral administration. Ledipasvir is an HCV NS5A inhibitor and sofosbuvir is a nucleotide analog inhibitor of HCV NS5B polymerase.
Each tablet contains 90 mg ledipasvir and 400 mg sofosbuvir. The tablets include the following inactive ingredients: colloidal silicon dioxide, copovidone, croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The tablets are film-coated with a coating material containing the following inactive ingredients: polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.
Ledipasvir: The IUPAC name for ledipasvir is Methyl [(2S)-1-{(6S)-6-[5-(9,9-difluoro-7-{2-[(1R,3S,4S)-2-{(2S)-2-[(methoxycarbonyl)amino]-3-methylbutanoyl}-2-azabicyclo[2.2.1]hept-3-yl]-1H-benzimidazol-6-yl}-9H-fluoren-2-yl)-1H-imidazol-2-yl]-5-azaspiro[2.4]hept-5-yl}-3-methyl-1-oxobutan-2-yl]carbamate.
It has a molecular formula of C49H54F2N8O6 and a molecular weight of 889.00. It has the following structural formula:
Ledipasvir is practically insoluble (<0.1 mg/mL) across the pH range of 3.0–7.5 and is slightly soluble below pH 2.3 (1.1 mg/mL).
Sofosbuvir: The IUPAC name for sofosbuvir is (S)-Isopropyl 2-((S)-(((2R,3R,4R,5R)-5-(2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2-yl)methoxy)-(phenoxy)phosphorylamino)propanoate. It has a molecular formula of C22H29FN3O9P and a molecular weight of 529.45. It has the following structural formula:
Sofosbuvir is a white to off-white crystalline solid with a solubility of ≥2 mg/mL across the pH range of 2–7.7 at 37°C and is slightly soluble in water.
Sources
Harvoni Access Manufacturers
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Gilead Sciences, Inc
![Harvoni Access (Ledipasvir And Sofosbuvir) Tablet, Film Coated [Gilead Sciences, Inc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Harvoni Access | Gilead Sciences, Inc
2.1 Recommended Dosage in AdultsHARVONI is a two-drug fixed-dose combination product that contains 90 mg of ledipasvir and 400 mg of sofosbuvir in a single tablet. The recommended dosage of HARVONI is one tablet taken orally once daily with or without food [see Clinical Pharmacology (12.3)].
Duration of Treatment
Relapse rates are affected by baseline host and viral factors and differ between treatment durations for certain subgroups [see Clinical Studies (14)].
Table 1 below provides the recommended HARVONI treatment durations for treatment-naïve and treatment-experienced patients and those with and without cirrhosis [see Clinical Studies (14)].
Table 1 Recommended Treatment Duration for HARVONI in Patients with CHC Genotype 1 Patient Population Recommended Treatment Duration * HARVONI for 8 weeks can be considered in treatment-naïve patients without cirrhosis who have pre-treatment HCV RNA less than 6 million IU/mL [see Clinical Studies (14)]. † Treatment-experienced patients who have failed treatment with either peginterferon alfa + ribavirin or an HCV protease inhibitor + peginterferon alfa + ribavirin. Treatment-naïve with or without cirrhosis 12 weeks* Treatment-experienced† without cirrhosis 12 weeks Treatment-experienced† with cirrhosis 24 weeks 2.2 Severe Renal Impairment and End Stage Renal DiseaseNo dose recommendation can be given for patients with severe renal impairment (estimated Glomerular Filtration Rate [eGFR] <30 mL/min/1.73m2) or with end stage renal disease (ESRD) due to higher exposures (up to 20-fold) of the predominant sofosbuvir metabolite [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
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