NOT RECOMMENDED REGIMENS IN HCV TREATMENT
Although regimens of sofosbuvir and ribavirin or PEG-IFN/ribavirin plus sofosbuvir, simeprevir, telaprevir, or boceprevir are FDA-approved for particular genotypes, they are inferior to the current recommended regimens. The efficacy of sofosbuvir plus ribavirin for 24 weeks is well demonstrated to be inferior to combination DAA therapy for genotype 1 and 3. For genotype 4, it has not been compared head-to-head with DAA combination therapy, but shorter, well-tolerated DAA combination regimens are now available. The IFN-containing regimens are associated with higher rates of serious adverse events (eg, anemia and rash), longer treatment duration in some cases, high pill burden, numerous drug-drug interactions, more frequent dosing, and higher intensity of monitoring for safety or treatment response.
IFN should not be given to patients with decompensated cirrhosis (moderate or severe hepatic impairment; CTP class B or C) because of the potential for worsening hepatic decompensation. Minimal data exist for the use of simeprevir in patients with decompensated cirrhosis (Modi, 2016). Until additional data become available, simeprevir should not be used in patients with decompensated cirrhosis. No data exist for the use of currently approved doses of elbasvir and grazoprevir for patients with decompensated cirrhosis, and this combination should not be used in this population until additional data become available.
Recent data reported by the US FDA have demonstrated that some patients with compensated HCV genotype 1 cirrhosis treated with paritaprevir, ombitasvir, and dasabuvir may develop rapid onset of direct hyperbilirubinemia within 1 to 4 weeks of starting treatment without ALT elevations that can lead to rapidly progressive liver failure and death. A multicenter cohort study from Israel reported 7 patients who received PrOD and also developed decompensation within 1 to 8 weeks of starting therapy, including 1 patient who died (Zuckerman, 2016). Therefore, this antiviral treatment regimen is CONTRAINDICATED in all patients with decompensated HCV cirrhosis due to concerns of hepatotoxicity. In addition, all patients with cirrhosis receiving this regimen should be monitored for clinical signs and symptoms of hepatic decompensation and undergo hepatic laboratory testing at baseline and at least every 4 weeks on therapy.
Changes made July 6, 2016.