Sunday, October 9, 2016

October Updates: New hepatitis C product covers all six genotypes

Pharmacy Today
October 2016 Volume 22, Issue 10, Page 36

New hepatitis C product covers all six genotypes
Maria G. Tanzi
In late June, FDA approved the first all-oral, once-daily, single-tablet regimen containing sofosbuvir and velpatasvir (Epclusa—Gilead) for management of adults with genotypes 1 through 6 chronic hepatitis C virus (HCV) infections...

When asked about the current HCV market and evidence-based treatment recommendations to manage this disease, C. Wayne Weart, PharmD, BCPS, FASHP, FAPhA, a professor of clinical pharmacy and outcome sciences at South Carolina College of Pharmacy, told Pharmacy Today that, based upon the updated guidelines from July 2016 and the new FDA-approved hepatitis C once-a-day, single-pill medications, “I am suggesting that the following agents replace ledipasvir and sofosbuvir (Harvoni—Gilead), which costs approximately $95,000 for 12 weeks of therapy and even more if you need 24 weeks of therapy. The most cost-effective therapy for patients who are candidates for and can take it would be Merck’s elbasvir and grazoprevir tablets (Zepatier).”

According to Weart, the cost is approximately $55,000 for 12 weeks of therapy.
Weart recommended that treatment-naive patients with no cirrhosis and genotype 1a infection undergo testing for virus with NS5A resistance–associated variant polymorphisms (RAVs) to determine the best therapy. If no baseline NS5A RAVs are present, monotherapy for 12 weeks with elbasvir and grazoprevir should be given, but if baseline NS5A RAVs are present, ribavirin should be added to 16 weeks of treatment with elbasvir and grazoprevir. Patients with genotype 1b or 4 should receive elbasvir and grazoprevir once daily for 12 weeks.

“For those with genotypes 2, 3, 5, and 6, I would recommend this new therapy, sofosbuvir and velpatasvir, to be given for 12 weeks, which comes in at an approximate cost of $75,000,” said Weart.
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Managed Healthcare Connect
Oct 7
Zepatier less costly, more effective than Harvoni, Epclusa for Hepatitis C
​According to recent research presented at AMCP Nexus 2016, hepatitis C genotype 1 treatment with Zepatier (elbasvir/grazoprevir; Merck) was more effective and less expensive when compared to Harvoni (ledipasvir/sofosbuvir; Gilead) and Epclusa‎ (sofosbuvir/velpatasvir; Gilead).
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Irish Medical Times
Hepatitis C drugs now effective for most genotypes
Oct 5
There are two or three options for the treatment of genotypes one and four. Currently, one treatment is preferred for genotype 3 (sofosbuvir and daclatasvir are used — with or without ribavirin depending on whether the patient has cirrhosis). Newer agents held out the prospect of further options, said Dr Feeney.
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Articles in Press
Sept 16
Effectiveness of Elbasvir and Grazoprevir Combination, With or Without Ribavirin, for Treatment-Experienced Patients with Chronic Hepatitis C Infection
Paul Kwo, Edward Gane, Cheng-Yuan Peng, Brian Pearlman, John M. Vierling, Lawrence Serfaty, Maria Buti, Stephen Shafran, Paul Stryszak, Li Lin, Jacqueline Gress, Stuart Black, Frank J. Dutko, Michael Robertson, Janice Wahl, Lisa Lupinacci, Eliav Barr, Barbara Haber
PDF - Accepted Manuscript
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Article summary @ MPR
Oct 6
Fixed-Dose HCV Combo Drug Effective in Hard-to-Treat Patients
For patients with hepatitis C virus (HCV) genotype 1, 4, or 6 infection who have previously failed peg-interferon and ribavirin treatment, the combination of elbasvir and grazoprevir, with or without ribavrin, was effective in inducing sustained virologic response 12 weeks after the end of treatment (SVR12). Results of this study were published online in the journal Gastroenterology.....
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AGA Reading Room
Oct 6
Direct-Acting Antiviral Agents for Patients With Hepatitis C Virus Genotype 1 Infection are Cost Saving
In conclusion, our systematic re-analysis of cost-effectiveness studies found that HCV treatment with second-generation DAAs is highly cost-effective and could likely result in cost-savings at currently available discounts. Therefore, timely treatment with DAAs without restrictions for HCV should be a priority to improve public health.
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Investigational HCV drug combo yields high SVR12 rates in compensated cirrhosis
Oct 1
Author: Amy Karon
A once-daily regimen of two investigational, direct-acting anti-HCV agents, ABT-493 and ABT-530, was well tolerated and achieved sustained viral response at 12 weeks (SVR12) for nearly all patients with compensated cirrhosis and chronic genotype (GT) 1 or 3 hepatitis C virus infection, according to open-label phase II studies.
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