Drug updated on 11/1/2024
| Dosage Form | Tablet (oral; ledipasvir/sofosbuvir [90mg/400mg, 45mg/ 200mg]); Pellet (oral; ledipasvir/sofosbuvir [45mg/200mg, 33.75mg/150mg]) |
| Drug Class | Hepatitis C virus (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.
Latest News
Summary
- This summary is based on the review of four systematic review(s)/meta-analysis(es). [1-4]
- Harvoni (ledipasvir/sofosbuvir) Effectiveness in HCV: In patients with end-stage renal disease (ESRD) infected with hepatitis C virus (HCV), Harvoni achieved a high sustained virologic response (SVR) rate of 98.7% (95% CI (confidence interval), 93.0%-100.0%) in genotype 3. In drug users with HCV, pooled SVR12 rates were 89.8% (95% CI, 85.9%-92.7%) overall and 92.4% (95% CI, 88.6%-95.0%) for genotype 1 drug users. For genotypes 5 and 6, SVR12 rates were also high, reaching 99.2% (95% CI, 96.5%-100%) for genotype 6.
- Comparative Efficacy of DAAs in HCV: Among patients with HCV and ESRD, the Glecaprevir/pibrentasvir (G/P) regimen demonstrated top pan-genotypic efficacy with a pooled SVR (sustained virologic response) of 99.4% (95% CI, 98.6%-100%), while the Ombitasvir/paritaprevir/ritonavir (OBV/PTV/R) regimen also ranked highly, particularly in genotype-specific responses.
- Safety of Harvoni (ledipasvir/sofosbuvir): In studies targeting genotypes 5 and 6, no treatment-related serious adverse events were reported, and non-serious adverse events were similar across other genotypes.
- Comparative Safety in ESRD Patients: Among HCV-infected patients with ESRD, the Glecaprevir/pibrentasvir (G/P) regimen without Ribavirin or SOF had the lowest adverse event rate at 49.9% (95% CI, 38.4%-61.5%). Additionally, SOF-based DAAs, including Harvoni, were linked to temporary LDL increases during the initial 4 weeks of treatment.
- Harvoni (ledipasvir/sofosbuvir) demonstrated high efficacy and safety in HCV-infected patients with end-stage renal disease (ESRD), with a pooled SVR12 rate of 98.7% (95% CI, 93.0%-100.0%) among genotype 3 patients, and similar effectiveness in a subgroup of 2,377 patients on hemodialysis and 202 with cirrhosis.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Harvoni (ledipasvir and sofosbuvir) Prescribing Information. | 2020 | Gilead Sciences, Inc., Foster City, CA |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| The efficacy and safety of direct-acting antiviral regimens for end-stage renal disease patients with HCV infection: a systematic review and network meta-analysis | 2023 | Frontiers in Public Health |
| Effect of sofosbuvir-based DAAs on changes in lower-density lipoprotein in HCV patients: a systematic review and meta-analysis | 2021 | BMC Infectious Diseases |
| Efficacy and safety of ledipasvir/sofosbuvir for hepatitis C among drug users: a systematic review and meta-analysis | 2021 | Virology Journal |
| Systematic Review with Meta-Analysis: Efficacy and Safety of Direct-Acting Antivirals for Chronic Hepatitis C Genotypes 5 and 6 | 2019 | BioMed Research International |