Summary

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• Harvoni (ledipasvir/sofosbuvir) is 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; 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; and 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.
• This summary is based on the review of four systematic review(s)/meta-analysis(es). ^[1-4]
• In HCV-infected end-stage renal disease (ESRD) patients, the SOF/LDV regimen showed a sustained virologic response (SVR) rate of 98.7% (95% CI, 93.0%-100.0%) for genotype 3, ranking among the top efficacy regimens.
• In drug users, the pooled SVR12 rate with LDV/SOF-based regimens was 89.8% (95% CI, 85.9%-92.7%), with a higher SVR12 rate of 92.4% (95% CI, 88.6%-95.0%) in genotype 1 drug users.
• In patients with hepatocellular carcinoma (HCC), those with active/residual HCC had a lower SVR rate of 73.1%, compared to 92.6% in those with inactive/ablated HCC, and 97.8% in patients without HCC treated with LDV/SOF.
• HCV-infected ESRD patients: DAA regimens without Ribavirin or SOF had the lowest rates of adverse events at 49.9% (95% CI, 38.4%-61.5%).
• Drug users, patients with and without HCC, and genotypes 5 and 6 patients: No specific safety concerns or serious adverse events were reported, and non-serious adverse events were comparable across different populations and genotypes.
• The evidence highlights specific populations: HCV-infected ESRD patients (including those on hemodialysis), drug users, patients with HCC (active, inactive, or absent), and patients with HCV genotypes 5 and 6. Key findings include the effectiveness of SOF/LDV across these groups, with notably lower SVR in patients with active HCC and high effectiveness in genotypes 5 and 6, alongside no serious adverse events reported for these genotypes.