Drug updated on 4/17/2024
| Dosage Form | Tablet (oral; ledipasvir/sofosbuvir [90mg/400mg, 45mg/ 200mg]); Pellet (oral; ledipasvir/sofosbuvir [45mg/200mg, 33.75mg/150mg]) |
| Drug Class | HCV NS5A inhibitors and HCV nucleotide analog NS5B polymerase inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of chronic hepatitis C virus (HCV) in adults and pediatric patients 3 years of age and older with genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis.
- Indicated for the treatment of chronic hepatitis C virus (HCV) in adults and pediatric patients 3 years of age and older with genotype 1 infection with decompensated cirrhosis, in combination with ribavirin.
- Indicated for the treatment of chronic hepatitis C virus (HCV) in adults and pediatric patients 3 years of age and older with genotype 1 or 4 infection who are liver transplant recipients without cirrhosis or with compensated cirrhosis, in combination with ribavirin.
Summary
- Ledipasvir/sofosbuvir is indicated for the treatment of chronic hepatitis C virus in adults and pediatric patients 3 years of age and older with genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis. It is also used to treat those with genotype 1 infection who have decompensated cirrhosis when combined with ribavirin.
- Four studies provided a comprehensive analysis of the safety and effectiveness of ledipasvir/sofosbuvir compared to other direct-acting antiviral regimens for treating chronic hepatitis C virus across various populations.
- Among patients with end-stage renal disease, including those undergoing hemodialysis, ledipasvir/sofosbuvir demonstrated high efficacy, making it a preferred option alongside glecaprevir/pibrentasvir and ombitasvir/paritaprevir/ritonavir plus dasabuvir.
- In individuals using drugs infected with HCV, ledipasvir/sofosbuvir displayed an impressive sustained virological response at twelve weeks rate of nearly ninety percent for all genotypes, indicating its robust efficacy in this population group.
- For hepatocellular carcinoma patients treated using DAAs like ledipasvir/sofosbuvir, slightly lower SVR rates were observed as compared to non-HCC individuals, suggesting that while effective, these drugs might have reduced efficiency among active cancer sufferers, necessitating more aggressive treatments.
- When comparing ledipasvir/sofosbuvir's performance against other DAAs such as glecaprevir/pibrentasvir, it was found that glecaprevir/pibrentasvir had broader efficacy across genotypes than ledipasvir/sofosbuvir but still matched or surpassed the efficacy levels of ombitasvir/paritaprevir/ritonavir plus dasabuvir in certain subgroups.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Harvoni (ledipasvir and sofosbuvir) prescribing information. | 2020 | Gilead Sciences, Inc., Foster City, CA |