In the Journals

Viekira Pak produces high SVR for patients with HCV despite use of acid-inducing agents

According to a study published in American Journal of Gastroenterology, Viekira Pak with or without ribavirin was well-tolerated and produced high sustained virologic response rates in patients with hepatitis C virus infection who were also taking acid-inducing agents or proton-pump inhibitors.

Researchers, including Mitchell L. Shiffman, MD, of the Liver Institute of Virginia and Bon Secours Health System, conducted a post hoc analysis using data of 2,053 patients with HCV genotype 1 enrolled in the TURQUOISE and SAPPHIRE clinical trials. The patients were a mixture of treatment-naive, pegylated interferon or ribavirin treatment-experienced; presented with or without compensated cirrhosis; and previously received an antiviral regimen of Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets with dasabuvir tablets, AbbVie) with or without weight-based ribavirin.

Mitchell L. Shiffman, MD

Mitchell L. Shiffman

Twenty-percent of patients dosed also received a concomitant acid-inducing agent at the same time (n = 410), including 21.6% of patients who received Viekira Pak with ribavirin, and 15% who received Viekira Pak alone. Fifteen-percent of patients received a proton-pump inhibitor during therapy.

Results indicated SVR rates remained high regardless of whether or not a patient also received concomitant acid-inducing agents or a proton-pump inhibitor at the same time as antiviral therapy. Patients who received an acid-inducing agent had an overall 95.9% SVR rate at 12 weeks compared with 96.3% of patients who did not receive one. Patients who received a proton-pump inhibitor had a 95.1% SVR12 rate compared with 96.4% of patients who did not receive one.

Adverse events were common in the overall cohort of patients who received acid-reducing agents during treatment. However, more severe and serious adverse events were observed in patients who received acid-reducing agents and Viekira Pak with ribavirin compared with patients who did not receive ribavirin.

The researchers concluded: “The findings of this post hoc analysis provide reassurance that the co-administration of [Viekira Pak] with [acid-inducing agents and proton-pump inhibitors] does not negatively affect the chance for viral eradication. High SVR rates were achieved despite advanced fibrosis and concomitant [acid-inducing agents and proton-pump inhibitors] use.” – by Melinda Stevens

Disclosure: Shiffman reports multiple financial relationships with multiple institutions. Please see the full study for a list of Shiffman’s and all other authors’ relevant financial disclosures.

According to a study published in American Journal of Gastroenterology, Viekira Pak with or without ribavirin was well-tolerated and produced high sustained virologic response rates in patients with hepatitis C virus infection who were also taking acid-inducing agents or proton-pump inhibitors.

Researchers, including Mitchell L. Shiffman, MD, of the Liver Institute of Virginia and Bon Secours Health System, conducted a post hoc analysis using data of 2,053 patients with HCV genotype 1 enrolled in the TURQUOISE and SAPPHIRE clinical trials. The patients were a mixture of treatment-naive, pegylated interferon or ribavirin treatment-experienced; presented with or without compensated cirrhosis; and previously received an antiviral regimen of Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets with dasabuvir tablets, AbbVie) with or without weight-based ribavirin.

Mitchell L. Shiffman, MD

Mitchell L. Shiffman

Twenty-percent of patients dosed also received a concomitant acid-inducing agent at the same time (n = 410), including 21.6% of patients who received Viekira Pak with ribavirin, and 15% who received Viekira Pak alone. Fifteen-percent of patients received a proton-pump inhibitor during therapy.

Results indicated SVR rates remained high regardless of whether or not a patient also received concomitant acid-inducing agents or a proton-pump inhibitor at the same time as antiviral therapy. Patients who received an acid-inducing agent had an overall 95.9% SVR rate at 12 weeks compared with 96.3% of patients who did not receive one. Patients who received a proton-pump inhibitor had a 95.1% SVR12 rate compared with 96.4% of patients who did not receive one.

Adverse events were common in the overall cohort of patients who received acid-reducing agents during treatment. However, more severe and serious adverse events were observed in patients who received acid-reducing agents and Viekira Pak with ribavirin compared with patients who did not receive ribavirin.

The researchers concluded: “The findings of this post hoc analysis provide reassurance that the co-administration of [Viekira Pak] with [acid-inducing agents and proton-pump inhibitors] does not negatively affect the chance for viral eradication. High SVR rates were achieved despite advanced fibrosis and concomitant [acid-inducing agents and proton-pump inhibitors] use.” – by Melinda Stevens

Disclosure: Shiffman reports multiple financial relationships with multiple institutions. Please see the full study for a list of Shiffman’s and all other authors’ relevant financial disclosures.