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Zepatier safe, effective in black patients with HCV, comorbidities | Zamor PJ, et al. Am J Gastroenterol. 2018;doi:10.1038/s41395-018-0053-4.

Hepatitis C Blog Posted on April 26, 2018 by Alan FranciscusApril 26, 2018

Zepatier was effective and well-tolerated in black patients with hepatitis C genotype 1 and 4 compared with overall reported safety profile, according to recently published data.

“The results from this retrospective analysis of clinical trial data support the use of [elbasvir/grazoprevir (EBR/GZR)] in black individuals with HCV… infection,” Zamor wrote. “EBR/GZR showed high efficacy across many subgroups of black participants, including those with cirrhosis, [chronic kidney disease], HIV co-infection, or sickle cell disease, as well as those taking opioid agonist therapy, and was generally well tolerated, with a safety profile similar to that reported in the general population of participants in the EBR/GZR clinical trials.”

Zamor and colleagues gathered patient data from nine international phase 2/3 studies, including 317 black patients who received Zepatier (elbasvir/grazoprevir, Merck) for 12 weeks, 15 black patients who received elbasvir/grazoprevir with ribavirin for 16 weeks, and 1,310 nonblack participants who received 12 weeks of elbasvir/grazoprevir for comparison.

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Posted in African Americans, Zepatier

OLYSIO (simeprevir), DAKLINZA (daclatasvir) and ZEPATIER (grazoprevir/elbasvir) labels were updated to include information pertaining to changes in International Normalized Ratio (INR) values in patients receiving warfarin.

Hepatitis C Blog Posted on November 13, 2017 by Alan FranciscusNovember 13, 2017

OLYSIO (simeprevir), DAKLINZA (daclatasvir) and ZEPATIER (grazoprevir/elbasvir) labels were updated to include information pertaining to changes in International Normalized Ratio (INR) values in patients receiving warfarin.

Section 7: DRUG INTERACTIONS was updated to state fluctuations in INR values may occur in patients receiving warfarin concomitant with HCV treatment. Frequent monitoring of INR values is recommended during treatment and post-treatment follow-up.

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Posted in daclatasvir, Daklinza, drug interactions, Olysio, simeprevir, Zepatier

Real-World Study Shows ZEPATIER® (Elbasvir and Grazoprevir) Resulted in High Rates of Sustained Virologic Response in Patients with Chronic Hepatitis C Infection who have Chronic Kidney Disease

Hepatitis C Blog Posted on October 21, 2017 by Alan FranciscusOctober 21, 2017

Real-World Study Shows ZEPATIER® (Elbasvir and Grazoprevir) Resulted in High Rates of Sustained Virologic Response in Patients with Chronic Hepatitis C Infection who have Chronic Kidney Disease

Observational Analysis Evaluated Patients in U.S. Veterans Affairs System

KENILWORTH, N.J., October 21, 2017 – Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the presentation of findings from a retrospective database analysis of patients with chronic hepatitis C virus (HCV) genotype (GT) 1 or 4 infection who have chronic kidney disease (CKD) and were treated with ZEPATIER® (elbasvir and grazoprevir) in the U.S. Department of Veterans Affairs (VA) healthcare system. Among patients who completed therapy, the analysis showed 95.6 percent (714/747) of patients with severe CKD (stages 4-5, defined as estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2) and 97.1 percent (758/781) of patients with moderate CKD (stage 3, defined as eGFR 30-59 mL/min/1.73 m2) achieved sustained virologic response (SVR), defined as HCV RNA below the limit of quantification at least 10-12 weeks after the end of treatment. For patients with missing HCV RNA data after at least 10-12 weeks after treatment completion, analyses were conducted on a post-hoc basis using the last HCV RNA data available after week 4 after therapy completion. The response rates in the real-world setting of the VA further supplement findings from controlled clinical studies of ZEPATIER. These findings will be presented today at The Liver Meeting® 2017 taking place in Washington, D.C.

            In the United States, ZEPATIER is indicated for the treatment of chronic HCV GT1 or GT4 infection in adults. ZEPATIER is indicated for use with ribavirin (RBV) in certain patient populations. The U.S. Prescribing Information for ZEPATIER includes a Boxed Warning about the risk of hepatitis B virus (HBV) reactivation in patients co-infected with HCV and HBV. In controlled clinical studies of ZEPATIER, SVR was the primary endpoint defined as HCV RNA less than lower limit of quantification at 12 weeks after the cessation of treatment (SVR12).

“These results demonstrate that U.S. veterans with chronic hepatitis C infection can achieve virologic cure in a real-world setting despite having co-morbid chronic kidney disease,” said Jennifer Kramer, investigator, Center for Innovations in Quality, Effectiveness and Safety at the Michael E. DeBakey VA Medical Center, Houston, Texas, and assistant professor of medicine, department of medicine, Baylor College of Medicine. “There is an ongoing need for an increased focus on screening and treating veterans and others who are disproportionately impacted by this disease.”

            The retrospective observational analysis included 5,845 patients with chronic HCV infection who received ZEPATIER (elbasvir and grazoprevir) between February 1 and December 31, 2016. Patients were identified from the VA Corporate Data Warehouse, a national repository of VA electronic medical records. Presence of chronic kidney disease was measured via eGFR, per the National Kidney Foundation’s Modification of Diet in Renal Disease equation. Of 4,693 patients evaluated in the per protocol population, 16.6 percent (781/4693) had CKD stage 3 and 15.9 percent (747/4693) had CKD stages 4 or 5. Please see additional information below about the design, methodology and limitations of this observational analysis.

“Researching the needs of veterans is part of our collective responsibility to those who have served our country,” said Susan Shiff, senior vice president, Center for Observational and Real-World Evidence, Merck. “The robust nature of VA medical data enables us to study the effectiveness of ZEPATIER for the treatment of chronic hepatitis C infection in people with kidney disease and other comorbid conditions in that real-world setting.”

Adverse event data were not collected as part of this real-world data analysis.

Most patients with chronic kidney disease in the analysis were male (96.9%, 1481/1528); African American (67.5%, 1031/1528) and either had GT1a infection (52.2%, 798/1528) or GT1b infection (42.1%, 644/1528). The mean age for patients in the study with chronic kidney disease was 64.9 years. Comorbid conditions as defined by ICD-9/10 codes in the VA database included depression (58.5%, 894/1528), diabetes (69.2%, 1057/1528), compensated cirrhosis (18.6%, 284/1528), and HIV (5.0%, 76/1528). In the study, 19.9 percent of patients (304/1528) were coded as having decompensated cirrhosis; ZEPATIER is not for use in patients with moderate or severe hepatic impairment (Child Pugh B or C). See Selected Safety Information below for more information.

Study Methodology

The database included patients ages 18 and older with chronic HCV infection who initiated treatment with ZEPATIER between February 1, 2016, and December 31, 2016, and had at least one inpatient or outpatient visit within a year prior to treatment (n=5845). The study excluded patients without ≥2 eGFR values at least 90 days apart or on-treatment HCV RNA data, patients who did not receive 12-16 weeks of treatment with ZEPATIER and patients who received RBV >1 month after initiating treatment (n=1152).

SVR was defined in the protocol for these analyses as HCV RNA below the limit of quantification at least 10-12 weeks after the end of treatment. For patients with missing HCV RNA data at week 10-12 after treatment completion, analyses were conducted on a post-hoc basis using HCV RNA data captured starting from week 4 after therapy completion. SVR data at least 12 weeks after completion of therapy was available for 81.9% of the analysis population.

 

About Real-World Data Analyses and Associated Limitations

Real-world studies analyze data generated outside of randomized clinical trials, such as through analyses of electronic medical records or claims databases, to provide insight into how medicines perform or are used from a clinical and economic viewpoint in real-world clinical settings. Information from real-world analyses alone does not provide sufficient evidence to validate efficacy or safety of a therapeutic regimen and does not provide a substitute for evidence obtained from randomized controlled clinical trials.

This study is subject to certain limitations. The VA population may not be generalizable to the entire U.S. population, due in part to the potential for a differing demographic make-up and/or risk factors. Bias may exist as diagnoses and co-morbidities were identified through ICD-9/10 codes. Treatment completion was identified through prescription records which may not reflect adherence. Database analyses are also prone to errors in coding and missing data, including unavailable SVR data. Additionally, some laboratory data including data on the presence of baseline NS5A resistance associated substitutions was not available at the time of this analysis.

 About the VA Corporate Data Warehouse (CDW)

The Department of Veterans Affairs Veterans Healthcare Administration (VHA) is supported by one of the largest integrated healthcare information systems in the United States. The VHA’s Corporate Data Warehouse (CDW) was developed in 2006 to accommodate the massive amounts of data being generated from more than 20 years of use and to streamline the process of knowledge discovery to application.

 About ZEPATIER® (elbasvir and grazoprevir) 50mg/100mg Tablets

ZEPATIER is a fixed-dose combination product containing elbasvir, a HCV NS5A inhibitor, and grazoprevir, an HCV NS3/4A protease inhibitor. In the United States, ZEPATIER is indicated for the treatment of chronic HCV GT1 or 4 infection in adults. ZEPATIER is indicated for use with ribavirin (RBV) in certain patient populations. The efficacy of ZEPATIER has not been established in patients who have previously failed treatment with other regimens that included an NS5A inhibitor.

Selected Safety Information about ZEPATIER

The US Prescribing Information for ZEPATIER contains a Boxed Warning about the risk of hepatitis B virus (HBV) reactivation in patients coinfected with HCV and HBV. Healthcare professionals should test all patients for evidence of current or prior HBV infection by measuring hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) before initiating treatment with ZEPATIER. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct-acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Healthcare professionals should monitor HCV/HBV coinfected patients for clinical and laboratory signs of hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Healthcare professionals should initiate appropriate patient management for HBV infection as clinically indicated.

HBV reactivation has been reported in HBsAg positive patients and also in patients with serologic evidence of resolved HBV infection (ie, HBsAg negative and anti-HBc positive). The risk of HBV reactivation may be increased in patients receiving some immunosuppressant or chemotherapeutic agents. HBV reactivation is characterized as an abrupt increase in HBV replication manifesting as a rapid increase in serum HBV DNA level. In patients with resolved HBV infection, reappearance of HBsAg can occur. Reactivation of HBV replication may be accompanied by hepatitis, ie, increases in aminotransferase levels and, in severe cases, increases in bilirubin levels, liver failure, and death can occur.

ZEPATIER (elbasvir and grazoprevir) is not for use in patients with moderate or severe hepatic impairment (Child Pugh B or C). ZEPATIER is also not for use with inhibitors of organic anion transporting polypeptides 1B1/3 (OATP1B1/3) that are known or expected to significantly increase grazoprevir plasma concentrations (e.g., atazanavir, darunavir, lopinavir, saquinavir, tipranavir, cyclosporine), strong cytochrome P450 3A (CYP3A) inducers (e.g., carbamazepine, phenytoin, rifampin, St. John’s Wort), and efavirenz. If ZEPATIER (elbasvir and grazoprevir) is administered with RBV, healthcare professionals should refer to the prescribing information for RBV as the contraindications, warnings and precautions, adverse reactions and dosing for RBV also apply to this combination regimen.

Elevations of alanine transaminase (ALT) to greater than 5 times the upper limit of normal (ULN) occurred in 1% of subjects, generally at or after treatment week 8. These late ALT elevations were typically asymptomatic and most resolved with ongoing or completion of therapy. Healthcare professionals should perform hepatic lab testing on patients prior to therapy, at treatment week 8, and as clinically indicated. For patients receiving 16 weeks of therapy, additional hepatic lab testing should be performed at treatment week 12.

Patients should be instructed to consult their healthcare professional without delay if they have onset of fatigue, weakness, lack of appetite, nausea and vomiting, jaundice or discolored feces. Healthcare providers should consider discontinuing ZEPATIER (elbasvir and grazoprevir) if ALT levels remain persistently greater than 10 times ULN. ZEPATIER should be discontinued if ALT elevation is accompanied by signs or symptoms of liver inflammation or increasing conjugated bilirubin, alkaline phosphatase, or international normalized ratio.

The concomitant use of ZEPATIER with certain drugs may lead to adverse reactions or reduced therapeutic effect due to drug interactions. Certain strong CYP3A inhibitors may increase the plasma concentration of ZEPATIER, leading to possibly clinically significant adverse reactions. Moderate CYP3A inducers may decrease the plasma concentration of ZEPATIER, leading to reduced therapeutic effect and possible development of resistance. Coadministration of ZEPATIER with these drugs is not recommended. Physicians should consult the Prescribing Information for potential drug interactions.

In subjects receiving ZEPATIER for 12 weeks, the most commonly reported adverse reactions of all intensity (greater than or equal to 5% in placebo-controlled trials) were fatigue, headache and nausea. In subjects receiving ZEPATIER with RBV for 16 weeks, the most commonly reported adverse reactions of moderate or severe intensity (greater than or equal to 5%) were anemia and headache.

Selected Dosage and Administration Information for ZEPATIER® (elbasvir and grazoprevir)

ZEPATIER is a single tablet taken once daily. The recommended dosing is 12 or 16 weeks with or without RBV, depending on HCV genotype, prior treatment history and, for patients with genotype 1a infection, presence of certain baseline NS5A resistance-associated polymorphisms. See Prescribing Information for ZEPATIER for specific dosage regimens and durations. Refer to RBV prescribing information for RBV dosing and dosage modifications when ZEPATIER is given with RBV. To determine dosage regimen and duration of ZEPATIER for genotype 1a patients, testing for the presence of virus with one or more baseline NS5A resistance-associated polymorphisms at positions 28, 30, 31, or 93 is recommended prior to initiating treatment.

About Merck

For more than a century, Merck, a leading global biopharmaceutical company known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world – including cancer, cardio-metabolic diseases, emerging animal diseases, Alzheimer’s disease and infectious diseases including HIV and Ebola. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.

 Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA  

            This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

            Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

            The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2016 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

# # #

 Please see Prescribing Information for ZEPATIER (elbasvir and grazoprevir), including the Boxed Warning about the risk of hepatitis B virus (HBV) reactivation in patients coinfected with HCV and HBV, at http://www.merck.com/product/usa/pi_circulars/z/zepatier/zepatier_pi.pdf and the Patient Information for ZEPATIER at http://www.merck.com/product/usa/pi_circulars/z/zepatier/zepatier_ppi.pdf

Ashley Paskalis

Media Specialist

Biosector 2

Direct   +1 212-845-5620

Mobile  +1 508-331-0689

ashley.paskalis@inventivhealth.com

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Posted in AASLD 2017, VA (Veterans Administration), Zepatier

Merck to Present New Data on ZEPATIER® (elbasvir and grazoprevir) for the Treatment of Chronic Hepatitis C Virus Infection at The Liver Meeting® 2017

Hepatitis C Blog Posted on October 3, 2017 by Alan FranciscusOctober 3, 2017

Tuesday, October 3, 2017 6:55 am EDT

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 KKENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced that data from the company’s chronic hepatitis C clinical development programs and real-world studies are scheduled to be presented at The Liver Meeting® 2017. These data presentations include new analyses of ZEPATIER ® (elbasvir and grazoprevir) in real-world settings and follow-up analyses from Phase 3 clinical trials, including findings from the C-EDGE CO-STAR three-year observational follow-up study evaluating chronic hepatitis C virus (HCV) reinfection incidence and risk behaviors in patients who were treated with ZEPATIER while on opioid agonist therapy (OAT). The Liver Meeting®2017 will take place in Washington, D.C., from Oct. 20-24, 2017.

“Merck has been a leader in chronic hepatitis C for more than 30 years. Now, with the availability of treatments such as ZEPATIER, we believe our focus needs to be on understanding its application in the real world,” said Dr. Michael Robertson, executive director of clinical research, Merck Research Laboratories. “Analysis of data from patients treated with ZEPATIER around the world provides important insights that may help inform elimination efforts, particularly among difficult-to-treat populations.”

In the United States, ZEPATIER is indicated for the treatment of chronic HCV genotype (GT) 1 or 4 infection in adults. ZEPATIER is indicated for use with ribavirin in certain patient populations. The U.S. Prescribing Information for ZEPATIER contains a Boxed Warning about the risk of hepatitis B virus (HBV) reactivation in patients coinfected with HCV and HBV.

Key presentations at The Liver Meeting® 2017 will include:

ZEPATIER ® (elbasvir and grazoprevir) 50mg/100mg tablets

Saturday, October 21

  • Effectiveness of Elbasvir/Grazoprevir in Patients With Chronic Hepatitis C and Chronic Kidney Disease: Results From the Veterans Affairs System (Poster presentation, Abstract 1113, 2:00 p.m. – 7:30 p.m. EDT)
  • A Pragmatic Approach to Optimizing the Efficacy of Elbasvir/Grazoprevir Using Baseline Viral Load in Participants With Hepatitis C Virus (HCV) Genotype (GT)1a Infection: A Post Hoc Analysis of 11 Clinical Trials (Poster presentation, Abstract 1124, 2:00 p.m. – 7:30 p.m. EDT)
  • Impact of Treatment Duration and Ribavirin (RBV) Addition on Real-World Effectiveness of Elbasvir/Grazoprevir (EBR/GZR) in Select Patient Subgroups With Genotype 1 (GT1) Chronic Hepatitis C (HCV): Retrospective Data Analyses From the Trio Network. (Poster presentation, Abstract 1128, 2:00 p.m. – 7:30 p.m. EDT)
  • Real-World Cost-Effectiveness of Elbasvir/Grazoprevir (EBR/GZR) in Treatment-Naive (TN) Patients With Chronic Hepatitis C (CHC) Virus Genotype 1 (GT1) in the United States (US) (Poster presentation, Abstract 1155, 2:00 p.m. – 7:30 p.m. EDT)

Sunday, October 22

  • Safety and Efficacy of Elbasvir/Grazoprevir in Asian Participants With Hepatitis C Virus Genotypes 1 and 4 Infection: An Integrated Analysis of Data From 11 Phase 2/3 Trials (Poster presentation Abstract 1522, 8:00 a.m. – 5:30 p.m. EDT)
  • Co-Morbidities and Clinically Relevant Drug-Drug Interactions (DDIs) in Patients Undergoing Treatment of Chronic HCV Genotype 1 (GT1) Infection With Elbasvir (EBR)/Grazoprevir (GZR): Results From the German Hepatitis C Registry (DHC-R) (Poster presentation, Abstract 1546, 8:00 a.m. – 5:30 p.m. EDT)
  • Utilization and Effectiveness of Elbasvir/Grazoprevir (EBR/GZR) in Treatment Naïve (TN) Genotype 1a (G1a) Chronic Hepatitis C Virus (HCV) Patients With/Without Baseline NS5A Resistance-Associated Substitutions (RASs) (Poster presentation, Abstract 1568, 8:00 a.m. – 5:30 p.m. EDT)
  • Safety and Efficacy of Elbasvir (EBR)/Grazoprevir (GZR) in Hepatitis C Virus (HCV) GT1- and GT4-infected Participants 65 Years and Older: An Integrated Analysis of Twelve Clinical Trials (Poster presentation, Abstract 1589, 8:00 a.m. – 5:30 p.m. EDT)

Monday, October 23

  • Hepatitis C Virus (HCV) Reinfection and Injecting Risk Behavior Following Elbasvir (EBR)/Grazoprevir (GZR) Treatment in Participants on Opiate Agonist Therapy: Co-STAR Part B (Oral presentation, Abstract 195, 3:30 p.m. – 3:45 p.m. EDT)

ADDITIONAL STUDIES OF NOTE

Saturday, October 21

  • Epidemiologic Impact of Expanding Chronic Hepatitis C (CHC) Treatment in People who Inject Drug (PWID) in the United States (US): A Mathematical Model Using Data From the C-EDGE CO-STAR Study (Poster presentation, Abstract 976, 2:00 p.m. – 7:30 p.m. EDT)
  • Economic Burden of Chronic Hepatitis C (CHC) in Medicaid and Commercially Insured Patients in the United States (Poster presentation, Abstract 1008, 2:00 p.m. – 7:30 p.m. EDT)
  • Perceived Barriers Related to the Management of HCV Infection Among Physicians Prescribing Opioid Agonist Therapy: The C-SCOPE Study (Poster presentation, Abstract 1064, 2:00 p.m. – 7:30 p.m. EDT)

For more information, including a complete list of abstract titles at the meeting, please visit: http://www.aasld.org/events-professional-development/liver-meeting.

Selected Safety Information about ZEPATIER

The US Prescribing Information for ZEPATIER contains a Boxed Warning about the risk of hepatitis B virus (HBV) reactivation in patients coinfected with HCV and HBV. Healthcare professionals should test all patients for evidence of current or prior HBV infection by measuring hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) before initiating treatment with ZEPATIER. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct-acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Healthcare professionals should monitor HCV/HBV coinfected patients for clinical and laboratory signs of hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Healthcare professionals should initiate appropriate patient management for HBV infection as clinically indicated.

HBV reactivation has been reported in HBsAg positive patients and also in patients with serologic evidence of resolved HBV infection (ie, HBsAg negative and anti-HBc positive). The risk of HBV reactivation may be increased in patients receiving some immunosuppressant or chemotherapeutic agents. HBV reactivation is characterized as an abrupt increase in HBV replication manifesting as a rapid increase in serum HBV DNA level. In patients with resolved HBV infection, reappearance of HBsAg can occur. Reactivation of HBV replication may be accompanied by hepatitis, ie, increases in aminotransferase levels and, in severe cases, increases in bilirubin levels, liver failure, and death can occur.

ZEPATIER (elbasvir and grazoprevir) is not for use in patients with moderate or severe hepatic impairment (Child Pugh B or C). ZEPATIER is also not for use with inhibitors of organic anion transporting polypeptides 1B1/3 (OATP1B1/3) that are known or expected to significantly increase grazoprevir plasma concentrations (e.g., atazanavir, darunavir, lopinavir, saquinavir, tipranavir, cyclosporine), strong cytochrome P450 3A (CYP3A) inducers (e.g., carbamazepine, phenytoin, rifampin, St. John’s Wort), and efavirenz. If ZEPATIER (elbasvir and grazoprevir) is administered with RBV, healthcare professionals should refer to the prescribing information for RBV as the contraindications, warnings and precautions, adverse reactions and dosing for RBV also apply to this combination regimen.

Elevations of alanine transaminase (ALT) to greater than 5 times the upper limit of normal (ULN) occurred in 1% of subjects, generally at or after treatment week 8. These late ALT elevations were typically asymptomatic and most resolved with ongoing or completion of therapy. Healthcare professionals should perform hepatic lab testing on patients prior to therapy, at treatment week 8, and as clinically indicated. For patients receiving 16 weeks of therapy, additional hepatic lab testing should be performed at treatment week 12.

Patients should be instructed to consult their healthcare professional without delay if they have onset of fatigue, weakness, lack of appetite, nausea and vomiting, jaundice or discolored feces. Healthcare providers should consider discontinuing ZEPATIER (elbasvir and grazoprevir) if ALT levels remain persistently greater than 10 times ULN. ZEPATIER should be discontinued if ALT elevation is accompanied by signs or symptoms of liver inflammation or increasing conjugated bilirubin, alkaline phosphatase, or international normalized ratio.

The concomitant use of ZEPATIER with certain drugs may lead to adverse reactions or reduced therapeutic effect due to drug interactions. Certain strong CYP3A inhibitors may increase the plasma concentration of ZEPATIER, leading to possibly clinically significant adverse reactions. Moderate CYP3A inducers may decrease the plasma concentration of ZEPATIER, leading to reduced therapeutic effect and possible development of resistance. Coadministration of ZEPATIER with these drugs is not recommended. Physicians should consult the Prescribing Information for potential drug interactions.

In subjects receiving ZEPATIER for 12 weeks, the most commonly reported adverse reactions of all intensity (greater than or equal to 5% in placebo-controlled trials) were fatigue, headache and nausea. In subjects receiving ZEPATIER with RBV for 16 weeks, the most commonly reported adverse reactions of moderate or severe intensity (greater than or equal to 5%) were anemia and headache.

Selected Dosage and Administration Information for ZEPATIER ® (elbasvir and grazoprevir)

ZEPATIER is a single tablet taken once daily. The recommended dosing is 12 or 16 weeks with or without RBV, depending on HCV genotype, prior treatment history and, for patients with genotype 1a infection, presence of certain baseline NS5A resistance-associated polymorphisms. See Prescribing Information for ZEPATIER for specific dosage regimens and durations. Refer to RBV prescribing information for RBV dosing and dosage modifications when ZEPATIER is given with RBV. To determine dosage regimen and duration of ZEPATIER for genotype 1a patients, testing for the presence of virus with one or more baseline NS5A resistance-associated polymorphisms at positions 28, 30, 31, or 93 is recommended prior to initiating treatment.

Merck’s Commitment to HCV

For more than 30 years, Merck has been at the forefront of the response to the HCV epidemic. Merck’s chronic HCV clinical development programs have included more than 135 clinical trials in approximately 40 countries and have enrolled nearly 10,000 participants. As part of our longstanding leadership in infectious diseases, Merck collaborates with the scientific and patient communities to develop and deliver innovative solutions to support people living with chronic HCV worldwide.

About Merck

For more than a century, Merck, a leading global biopharmaceutical company known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world – including cancer, cardio-metabolic diseases, emerging animal diseases, Alzheimer’s disease and infectious diseases including HIV and Ebola. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2016 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Please see Prescribing Information for ZEPATIER (elbasvir and grazoprevir), including the Boxed Warning about the risk of HBV reactivation in patients coinfected with HCV and HBV, at http://www.merck.com/product/usa/pi_circulars/z/zepatier/zepatier_pi.pdf and Patient Information for ZEPATIER at http://www.merck.com/product/usa/pi_circulars/z/zepatier/zepatier_ppi.pdf

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Michael Close, 267-305-1211
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Amy Klug, 908-740-1898

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Posted in AASLD 2017, Zepatier

DAA Linked to High Response in Vets With HCV

Hepatitis C Blog Posted on May 3, 2017 by Alan FranciscusMay 3, 2017

A retrospective database analysis of U.S. veterans with hepatitis C virus and a high incidence of comorbidities showed that elbasvir-grazoprevir (Zepatier, Merck) achieved a high sustained virologic response (SVR) rate, according to a presentation at the International Liver Congress 2017, in Amsterdam.

The researchers conducted the analysis of 2,436 chronic HCV patients in the Department of Veterans Affairs (VA) health care system, identified from the VA Corporate Data Warehouse, a national repository of VA electronic medical records. The patients were treated with elbasvir-grazoprevir between Feb. 1, 2016 and Aug. 1, 2016. Study outcomes included real-world use and SVR rates.

“U.S. veterans are three times more likely to have chronic hepatitis C compared with the general U.S. population, and a high proportion suffer comorbid conditions that can make treatment challenging,” said Jennifer Kramer, from Michael E. DeBakey VA Medical Center, and an assistant professor of medicine, Department of Medicine, Baylor College of Medicine, both in Houston, and a study investigator. “This study shows that chronic hepatitis C antiviral treatment can result in a high rate of sustained virologic response in U.S. veterans.”

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Posted in EASL 2017, Veterans, Zepatier

Real-World Observational Study in the U.S. Veterans Affairs System Evaluating Use of Merck’s ZEPATIER® (Elbasvir and Grazoprevir) Shows High Sustained Virologic Response Rates in Patients with Chronic Hepatitis C

Hepatitis C Blog Posted on April 21, 2017 by Alan FranciscusApril 21, 2017

Release Date: Friday, April 21, 2017 10:00 am EDT

Dateline City:
KENILWORTH, N.J.

Study Evaluated VA Population with High Incidence of Co-Morbidities

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the presentation of findings from a retrospective database analysis of patients with chronic hepatitis C virus (HCV) infection who were administered ZEPATIER® in the U.S. Department of Veterans Affairs (VA) healthcare system. For the evaluable population (n=2,436), 95.6 percent of veterans treated with ZEPATIER achieved the primary outcome of sustained virologic response (SVR), defined as undetectable HCV RNA at least twelve weeks after the end of treatment. For patients with no HCV RNA measurements at or after 12 weeks (19% of the study cohort), the analysis used HCV RNA measurements available at least four and less than 12 weeks after the end of treatment. The response rates in the real-world setting of the VA supplement the overall findings from the controlled clinical studies of ZEPATIER. These findings will be presented today in an oral session (abstract #PS-095) at The International Liver Congress™ 2017 being held in Amsterdam, the Netherlands.

In the United States, ZEPATIER is indicated for the treatment of chronic HCV GT1 or GT4 infection in adults. ZEPATIER is indicated for use with ribavirin (RBV) in certain patient populations. The U.S. Prescribing Information for ZEPATIER includes a Boxed Warning about the risk of hepatitis B virus (HBV) reactivation in patients co-infected with HCV and HBV. In controlled clinical studies of ZEPATIER, SVR was the primary endpoint defined as HCV RNA less than lower limit of quantification (LLOQ) at 12 weeks after the cessation of treatment (SVR12).

“U.S. veterans are three times more likely to have chronic hepatitis C compared to the general U.S. population and a high proportion suffer co-morbid conditions that can make treatment challenging,” said Jennifer Kramer, investigator, Michael E. DeBakey VA Medical Center, Houston, Texas, and assistant professor of medicine, department of medicine, Baylor College of Medicine. “This study shows that chronic hepatitis C antiviral treatment can result in a high rate of sustained virologic response in U.S. veterans.”

This retrospective database analysis included patients with chronic HCV treated with ZEPATIER (elbasvir and grazoprevir) in the VA healthcare system between February 1, 2016 and August 1, 2016. Study outcomes include real-world utilization and SVR rates. Please see additional information about the design, methodology and limitations of this observational study below.

After applying study exclusion criteria, 2,436 patients were included in the evaluable population cohort. The mean age of subjects was 63.5 years. The prevalence of co-morbidities as determined by ICD-9 and CPT codes as recorded in the VA database was as follows: cirrhosis (33.2%), diabetes (53.2%), depression (57.2%) and HIV co-infection (3%). Additionally, more than half of the patients had a history of drug (53.9%) or alcohol (60.5%) abuse. The population included 1,988 previously untreated patients and 448 treatment-experienced patients (322 of whom previously received an interferon-based regimen with or without an NS3/4A HCV protease inhibitor, and 126 of whom previously received an interferon-free direct-acting antiviral regimen).

A total of 95.6 percent (2,328/2,436) of patients in the evaluable population achieved SVR following treatment with ZEPATIER. The SVR rates by genotype (GT) were as follows: all GT1, 95.4 percent (2218/2324); GT1a, 93.4 percent (788/844); GT1b, 96.6 percent (1379/1428); and GT4, 96.9 percent (62/64). The SVR rates by baseline viral load (BVL) were as follows: BVL greater than 800,000 IU/ml, 94.7 percent (1497/1580); and BVL less than or equal to 800,000 IU/ml, 97.3 percent (726/746).

The SVR rates by baseline patient characteristics were as follows: male, 95.5 percent (2,245/2,350); female, 96.5 percent (83/86); African American, 95.9 percent (1,342/1,400); Hispanic, 95.1 percent (77/81); White, 95.0 percent (783/824); previously untreated, 96.1 percent (1,910/1,988); treatment-experienced, 93.3 percent (418/448); cirrhosis, 95.5 percent (772/808); without cirrhosis, 95.6 percent (1556/1628); stage 3 chronic kidney disease (CKD) (eGFR 30 to 59 mL/min/1.73m2), 96.7 percent (380/393); stage 4-5 CKD (eGFR less than 30 mL/min/1.73m2), 96.3 percent (392/407); HIV positive, 98.6 percent (73/74); HIV negative, 95.5 percent (2255/2362); history of alcohol abuse, 95.9 percent (1412/1473); no history of alcohol abuse, 95.1 percent (916/963); history of drug abuse, 95.3 percent (1251/1313); no history of drug abuse, 95.9 percent (1077/1123).

Adverse event data were not collected as part of this real-world data analysis.

“Analysis of data from real-world medical settings can provide useful insights to supplement knowledge gained from randomized clinical trials,” said Susan Shiff, senior vice president, center for observational and real-world evidence, Merck. “These data from a real-world VA setting add to the body of evidence on ZEPATIER (elbasvir and grazoprevir) and help deepen scientific understanding of the treatment of this complex disease affecting diverse, sometimes difficult to treat, patient populations.”

Study Methodology

Patients with chronic HCV treated with ZEPATIER from February 1 to August 1, 2016 were identified from the VA Corporate Data Warehouse, a national repository of VA electronic medical records. Inclusion criteria specified initiation of ZEPATIER therapy, at least 18 years of age, positive HCV RNA, and at least one inpatient or outpatient visit within a one-year period prior to treatment initiation (n=2,985). Patients were excluded if they had RBV added greater than one month after treatment initiation (n=23). Patients without SVR data or on-treatment HCV RNA data (n=494), or those treated with ZEPATIER for greater than seventeen weeks (n=32), were excluded as well. The total number of patients in the evaluable population was 2,436.

SVR was assessed based on undetectable HCV RNA at least twelve weeks after the end of treatment. For patients with no HCV RNA measurements at or after 12 weeks, the analysis used HCV RNA measurements available at least four and less than 12 weeks after the end of treatment. SVR was evaluated based on HCV RNA measurement at least 12 weeks post treatment in 81 percent of the study population.

About Real-World Data Analyses and Associated Limitations

Real-world studies analyze data generated outside of randomized clinical trials, such as through analyses of electronic medical records or claims databases, to provide insight into how medicines perform or are used from a clinical and economic viewpoint in real-world clinical settings. Information from real-world analyses alone does not provide sufficient evidence to validate efficacy or safety of a therapeutic regimen and does not provide a substitute for evidence obtained from randomized controlled clinical trials.

This study is subject to certain limitations. The VA population may not be generalizable to the entire U.S. population, due in part to the potential for a differing demographic make-up and/or risk factors. Bias may exist as diagnoses and co-morbidities were identified through ICD-9 and CPT codes. Treatment completion was identified through prescription records which may not reflect adherence. Database analyses are also prone to errors in coding and missing data, including unavailable SVR data at or after the 12-week post-treatment time point. Additionally, some laboratory data including data on the presence of baseline NS5A resistance associated substitutions was not available at the time of this analysis.

About the VA Corporate Data Warehouse (CDW)

The Department of Veterans Affairs Veterans Healthcare Administration (VHA) is supported by one of the largest integrated healthcare information systems in the United States. The VHA’s Corporate Data Warehouse (CDW) was developed in 2006 to accommodate the massive amounts of data being generated from more than 20 years of use and to streamline the process of knowledge discovery to application.

About ZEPATIER ® (elbasvir and grazoprevir) 50mg/100mg Tablets

ZEPATIER is a fixed-dose combination product containing elbasvir, a HCV NS5A inhibitor, and grazoprevir, an HCV NS3/4A protease inhibitor. In the United States, ZEPATIER is indicated for the treatment of chronic HCV GT1 or 4 infection in adults. ZEPATIER is indicated for use with ribavirin (RBV) in certain patient populations. The efficacy of ZEPATIER has not been established in patients who have previously failed treatment with other regimens that included an NS5A inhibitor.

Selected Safety Information about ZEPATIER

The US Prescribing Information for ZEPATIER contains a Boxed Warning about the risk of hepatitis B virus (HBV) reactivation in patients coinfected with HCV and HBV. Healthcare professionals should test all patients for evidence of current or prior HBV infection by measuring hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) before initiating treatment with ZEPATIER. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct-acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Healthcare professionals should monitor HCV/HBV coinfected patients for clinical and laboratory signs of hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Healthcare professionals should initiate appropriate patient management for HBV infection as clinically indicated.

HBV reactivation has been reported in HBsAg positive patients and also in patients with serologic evidence of resolved HBV infection (ie, HBsAg negative and anti-HBc positive). The risk of HBV reactivation may be increased in patients receiving some immunosuppressant or chemotherapeutic agents. HBV reactivation is characterized as an abrupt increase in HBV replication manifesting as a rapid increase in serum HBV DNA level. In patients with resolved HBV infection, reappearance of HBsAg can occur. Reactivation of HBV replication may be accompanied by hepatitis, ie, increases in aminotransferase levels and, in severe cases, increases in bilirubin levels, liver failure, and death can occur.

ZEPATIER (elbasvir and grazoprevir) is not for use in patients with moderate or severe hepatic impairment (Child Pugh B or C). ZEPATIER is also not for use with inhibitors of organic anion transporting polypeptides 1B1/3 (OATP1B1/3) that are known or expected to significantly increase grazoprevir plasma concentrations (e.g., atazanavir, darunavir, lopinavir, saquinavir, tipranavir, cyclosporine), strong cytochrome P450 3A (CYP3A) inducers (e.g., carbamazepine, phenytoin, rifampin, St. John’s Wort), and efavirenz. If ZEPATIER (elbasvir and grazoprevir) is administered with RBV, healthcare professionals should refer to the prescribing information for RBV as the contraindications, warnings and precautions, adverse reactions and dosing for RBV also apply to this combination regimen.

Elevations of alanine transaminase (ALT) to greater than 5 times the upper limit of normal (ULN) occurred in 1% of subjects, generally at or after treatment week 8. These late ALT elevations were typically asymptomatic and most resolved with ongoing or completion of therapy. Healthcare professionals should perform hepatic lab testing on patients prior to therapy, at treatment week 8, and as clinically indicated. For patients receiving 16 weeks of therapy, additional hepatic lab testing should be performed at treatment week 12.

Patients should be instructed to consult their healthcare professional without delay if they have onset of fatigue, weakness, lack of appetite, nausea and vomiting, jaundice or discolored feces. Healthcare providers should consider discontinuing ZEPATIER (elbasvir and grazoprevir) if ALT levels remain persistently greater than 10 times ULN. ZEPATIER should be discontinued if ALT elevation is accompanied by signs or symptoms of liver inflammation or increasing conjugated bilirubin, alkaline phosphatase, or international normalized ratio.

The concomitant use of ZEPATIER with certain drugs may lead to adverse reactions or reduced therapeutic effect due to drug interactions. Certain strong CYP3A inhibitors may increase the plasma concentration of ZEPATIER, leading to possibly clinically significant adverse reactions. Moderate CYP3A inducers may decrease the plasma concentration of ZEPATIER, leading to reduced therapeutic effect and possible development of resistance. Coadministration of ZEPATIER with these drugs is not recommended. Physicians should consult the Prescribing Information for potential drug interactions.

In subjects receiving ZEPATIER for 12 weeks, the most commonly reported adverse reactions of all intensity (greater than or equal to 5% in placebo-controlled trials) were fatigue, headache and nausea. In subjects receiving ZEPATIER with RBV for 16 weeks, the most commonly reported adverse reactions of moderate or severe intensity (greater than or equal to 5%) were anemia and headache.

Selected Dosage and Administration Information for ZEPATIER ® (elbasvir and grazoprevir)

ZEPATIER is a single tablet taken once daily. The recommended dosing is 12 or 16 weeks with or without RBV, depending on HCV genotype, prior treatment history and, for patients with genotype 1a infection, presence of certain baseline NS5A resistance-associated polymorphisms. See Prescribing Information for ZEPATIER for specific dosage regimens and durations. Refer to RBV prescribing information for RBV dosing and dosage modifications when ZEPATIER is given with RBV. To determine dosage regimen and duration of ZEPATIER for genotype 1a patients, testing for the presence of virus with one or more baseline NS5A resistance-associated polymorphisms at positions 28, 30, 31, or 93 is recommended prior to initiating treatment.

Merck’s Commitment to HCV

For more than 30 years, Merck has been at the forefront of the response to the HCV epidemic. Merck’s chronic HCV clinical development programs have included more than 135 clinical trials in approximately 40 countries and have enrolled nearly 10,000 participants. As part of our longstanding leadership in infectious diseases, Merck collaborates with the scientific and patient communities to develop and deliver innovative solutions to support people living with chronic HCV worldwide.

About Merck

For more than a century, Merck, a leading global biopharmaceutical company known as MSD outside of the United States and Canada, has been bringing forward medicines and vaccines for many of the world’s most challenging diseases. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world – including cancer, cardio-metabolic diseases, emerging animal diseases, Alzheimer’s disease and infectious diseases including HIV and Ebola. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2016 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Please see Prescribing Information for ZEPATIER (elbasvir and grazoprevir) at http://www.merck.com/product/usa/pi_circulars/z/zepatier/zepatier_pi.pdf and the Patient Information for ZEPATIER at http://www.merck.com/product/usa/pi_circulars/z/zepatier/zepatier_ppi.pdf

Language:
English
Contact:

Merck & Co., Inc.
Media:
Doris Li, 908-740-1903
or
Michael Close, 267-305-1211
or
Investors:
Teri Loxam, 908-740-1986
or
Amy Klug, 908-740-1898

Ticker Slug:
Ticker:
MRK
Exchange:
NYSE
@Merck
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Posted in EASL 2017, Zepatier

Safety and Efficacy of Elbasvir/Grazoprevir in Patients with Hepatitis C Virus Infection and Compensated Cirrhosis: an Integrated Analysis—Ira M. Jacobson et al.

Hepatitis C Blog Posted on March 21, 2017 by Alan FranciscusMarch 21, 2017

Article: Safety and Efficacy of Elbasvir/Grazoprevir in Patients with Hepatitis C Virus Infection and Compensated Cirrhosis: an Integrated Analysis—Ira M. Jacobson et al.

Source: http://dx.doi.org/10.1053/j.gastro.2017.01.050

 Study Aims and Results

This was a retrospective study—looking back at prior studies—to analyze the results of Merck’s two drug combination of elbasvir plus grazoprevir (Zepatier) with or without ribavirin to treat patients infected with chronic hepatitis C who had compensated cirrhosis.  The study combined data from 6 clinical studies.

Conclusion

The analysis of the studies included 402 patients with HCV genotype 1, 4, or 6.  The patients were treated for 12 to 18 weeks.  The goal of the study was to find the number of people who were cured of hepatitis C.

In those who received Zepatier (without ribavirin) 97.8% (135 of 138 patients) of treatment-naïve and 88.9% (48 of 54 pts) of treatment-experienced were cured of hepatitis C.

In those who received Zepatier for 12 weeks the addition of ribavirin did not increase the cure rates—treatment naïve-90.3% (28 of 31 pts) or treatment experienced -91.4% (74 of 81 pts).

All of the patients who received Zepatier and ribavirin for 16 or 18 weeks were cured, and 93.9% (46 of 49 pts) of patients were cured who received Zepatier without ribavirin treated for 16 or 18 weeks.

People with HCV genotype 1a infection and those who had not responded to a previous course of interferon therapy were less likely to be cured compared to those with HCV genotype 1b.  Baseline testing for resistant associated variants was recommended to ascertain the best course of treatment duration and if the addition of ribavirin is needed for treatment of HCV genotype 1a.  Patients with the baseline RAVs had a 73% (8 of 11 pts) cure rate compared to a 98% (96 of 98 pts) cure rate in those who did not have baseline RAVs.  The patients who had HCV genotype 1a infection with baseline RAVs who received 16 or 18 weeks of Zepatier plus ribavirin were cured reinforcing the need for ribavirin to overcome baseline RAVs.

There were 3% of serious adverse events but they did not lead to a decompensated event.

 Editorial Comments

The pooled analysis of Zepatier clinical studies of people with compensated cirrhosis showed very high cure rates, low side effect profile and in the vast majority of cases no ribavirin is needed.  From this analysis the only cases that ribavirin may be of benefit is in patients with HCV genotype 1a baseline RAVs.

To read the entire newsletter, click here

Alan Franciscus is the Executive Director of the Hepatitis C Support Project and the Editor-in-Chief of the HCV Advocate Website.

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Posted in by Alan Franciscus, Zepatier

ZEPATIER® now covered in Quebec for the treatment of chronic hepatitis C

Hepatitis C Blog Posted on March 21, 2017 by Alan FranciscusMarch 21, 2017

KIRKLAND, QC, March 21, 2017 /CNW Telbec/ – Merck Canada Inc. today announced that ZEPATIER® (elbasvir/grazoprevir) will be listed among the drugs covered by Quebec’s health insurance board, the Régie de l’assurance maladie du Québec (RAMQ), as of March 22. Quebec joins other jurisdictions that have approved the product for reimbursement under their public healthcare plans for chronic hepatitis C patients presenting with recognized criteria. Zepatier is indicated for the treatment of chronic infection by genotypes 1, 3 or 4 of the hepatitis C virus in adults.1 The product monograph, including detailed product information and indication, is available online by clicking here.

“This announcement reflects the hepatitis C agreement between Merck and the pan-Canadian Pharmaceutical Alliance (pCPA). We are proud to contribute a solution in the fight against this disease, all the while helping reduce the cost pressure on the healthcare system,” says Chirfi Guindo, President and Managing Director of Merck Canada Inc.

Hepatitis C patients without significant hepatic fibrosis who present with certain comorbidities or specific conditions will be eligible for the treatment, including those who have chronic kidney disease, who are co-infected with the human immunodeficiency virus (HIV) or the hepatitis B virus (HBV), who have undergone an organ transplant or who present with extrahepatic manifestations of the disease.

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Posted in Canada, Zepatier

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