Summary

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• Zepatier (elbasvir and grazoprevir) is indicated for the treatment of chronic HCV genotype 1 or 4 infection in adults and pediatric patients 12 years of age and older or weighing at least 30 kg, and for use with ribavirin in certain patient populations.
• This summary is based on the review of three systematic review(s)/meta-analysis(es). ^[1-3]
• End-of-Treatment Response (ETR): Grazoprevir plus elbasvir demonstrated a significant improvement in ETR compared to placebo (RR 174.99, 95% CI 11.03 to 2775.78) in a study with 173 participants. PEG interferon may improve ETR (RR 1.53, 95% CI 1.09 to 2.15), while high-dose PEG interferon may have little or no effect compared to low-dose PEG interferon (RR 1.42, 95% CI 0.51 to 3.90).
• Sustained Virological Response (SVR): Grazoprevir/elbasvir ± ribavirin achieved an SVR rate of 95.6% (95% CrI, 91.7-98.1%) in HIV/HCV co-infected patients. Other regimens, such as sofosbuvir-ledipasvir ± ribavirin, showed similar effectiveness with an SVR rate of 95.2% (95% CrI, 93.7-96.6%), while some combinations, like sofosbuvir-ribavirin, had SVR rates below 90%.
• Relapse Rates: PEG interferon plus ribavirin may reduce relapse rates compared to other treatments (RR 0.33, 95% CI 0.23 to 0.48).
• Among 1743 participants receiving grazoprevir/elbasvir for 12 weeks, 61.3% reported at least one adverse event, with drug-related adverse events occurring in 28.2% of participants. The most frequent adverse events included headache (10.6%), fatigue (8.7%), nasopharyngitis (5.8%), nausea (5.1%), and diarrhea (5.0%).
• Serious adverse events were reported by 2.1% of participants, with 0.7% discontinuing treatment due to an adverse event. Safety was consistent across various subgroups, including those with CKD stage 4/5, inherited blood disorders, and those on opioid agonist therapy, though ribavirin addition increased the frequency of some adverse events, particularly fatigue, headache, and nausea.
• Grazoprevir plus elbasvir demonstrated significant improvement in ETR for CKD patients on dialysis and achieved a high SVR rate of 95.6% in HIV/HCV co-infected patients; safety profiles were consistent across populations, including those with CKD, inherited blood disorders, and those on opioid agonist therapy, with adverse events similar between cirrhotic and non-cirrhotic individuals.