States struggle with rising Medicaid drug costs
By Nathaniel Weixel, The Hill Extra
Spending on prescription drugs has been growing in recent years, mostly because of the introduction of expensive specialty drugs, like those to treat hepatitis C. Medicaid has price controls in the form of required rebates paid by the manufacturer, as well as the ability of states and plans to negotiate supplemental rebates, but those often aren’t enough. States also need predictability to balance their budgets, but a company dramatically raising the price of its drug multiple times a year can throw that into chaos.
Continue reading...
Tuesday, October 11, 2016
Community Outreach May Reduce the Risk of Liver Cancer
Community Outreach May Reduce the Risk of Liver Cancer
Trained community partners ensure follow-through on vaccination against hepatitis B virus (HBV).
Article ID: 662540
Released: 11-Oct-2016 8:05 AM EDT
Source: Thomas Jefferson University
Trained community partners ensure follow-through on vaccination against hepatitis B virus (HBV).
Article ID: 662540
Released: 11-Oct-2016 8:05 AM EDT
Source: Thomas Jefferson University
The study aimed to identify effective approaches to increase HBV vaccinations. Most LHW studies conducted in Asian American communities have focused on increasing self-reported hepatitis B screening and knowledge, but very few went on to study whether the full course of hepatitis B vaccinations was completed.
In their study, Hee-Soon Juon Ph.D., a Professor of Medical Oncology and researcher at the Sidney Kimmel Cancer Center at Jefferson and colleagues developed a training program for lay health workers who may not have had backgrounds in healthcare, but who were members of the Asian American communities. The researchers also evaluated the program’s ability to increase the number of completed vaccinations in a randomized controlled trial. Their research was published in the journal PLOS ONE.
Between April 2013 and March 2014, Dr. Juon and colleagues recruited 645 Chinese, Korean, and Vietnamese participants to complete a survey and be screened for HBV. Of those, 232 were identified as being at-risk for contracting HBV and were randomized into either a group that either received educational pamphlets about the HBV vaccine by mail or one that received pamphlets plus a three reminder calls that gave participants a chance to discuss any hesitations with a member of the community who spoke their language.
The results showed that those who received phone-call follow ups were more likely to have one or more vaccinations than those who only received educational pamphlets, they were also more likely to have the full course of HBV vaccine plus booster shots. When asked what motivated them, 70 percent of those vaccinated said that the personal calls were the main motivating factor.
The researchers are now planning new methods of outreach that employ social media tools and video.
For more information, contact Edyta Zielinska, 215-955-5291, edyta.zielinska@jefferson.edu.
Article reference: J Juon et al., “Lay Health Worker Intervention Improved Compliance with Hepatitis B Vaccination in Asian Americans: Randomized Controlled Trial,” PLOS ONE, doi:10.1371/journal.pone.0162683, 2016.
About Jefferson
Jefferson, through its academic and clinical entities of Thomas Jefferson University and Jefferson Health, is reimagining health care for the greater Philadelphia region and southern New Jersey. Since its mergers with Abington Health and Aria Health, Jefferson now has 23,000 people dedicated to providing the highest-quality, compassionate clinical care for patients, educating the health professionals of tomorrow, and discovering new treatments and therapies to define the future of care. With a university and hospital that date to 1824, today Jefferson is comprised of six colleges, nine hospitals, 32 outpatient and urgent care locations, and a multitude of physician practices throughout the region, serving more than 96,000 inpatients, 363,000 emergency patients and 1.9 million outpatient visits annually.
For more information and a complete listing of Jefferson services and locations, visit www.jefferson.edu.
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.
Continue reading..
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).
Continue reading..
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.
Continue reading.....
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.
Continue reading..
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).
Continue reading..
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.
Continue reading.....
Gastroenterology
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
Download Full Text Article
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.....
Continue reading...
MEDPAGE TODAY
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.
Continue reading.
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.
Continue reading....
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
Download Full Text Article
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.....
Continue reading...
MEDPAGE TODAY
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.
Continue reading.
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.
Continue reading....
Herbal and dietary supplements tied to liver damage
Herbal and dietary supplements tied to liver damage
(Reuters Health) - - One in five cases of chemical-induced liver damage come from herbal and dietary supplements, a research review concludes.
A decade ago, less than one in 10 cases could be linked to supplements, researchers report in the journal Hepatology.
Up to half of U.S. adults consume supplements that contain ingredients such as vitamins, minerals, teas and proteins to improve diet, as well as illegal anabolic steroids, which are synthetic versions of testosterone used to boost athletic performance, the study found.
Continue reading....
Of Interest
March 2017
Herbal/dietary supplements linked to liver injury requiring transplant
Herbal or dietary supplements are the fourth most common cause of drug-induced acute hepatic necrosis requiring liver transplantation in the United States, according to a study of liver transplant registry data.
Watch
JAMA Report: Research Shows Little Benefit for Dietary Supplements, but Industry Continues to Boom
Dietary supplements are a 32 billion dollar a year industry in the U.S. Although numerous studies have found little evidence of benefit, the supplement industry continues to grow. A new study examined the trends in dietary supplement use among U.S. adults from 1999-2013. Researchers found that the proportion of users stayed consistent throughout the study period at just over 50%.
(Reuters Health) - - One in five cases of chemical-induced liver damage come from herbal and dietary supplements, a research review concludes.
A decade ago, less than one in 10 cases could be linked to supplements, researchers report in the journal Hepatology.
Up to half of U.S. adults consume supplements that contain ingredients such as vitamins, minerals, teas and proteins to improve diet, as well as illegal anabolic steroids, which are synthetic versions of testosterone used to boost athletic performance, the study found.
Continue reading....
Of Interest
March 2017
Herbal/dietary supplements linked to liver injury requiring transplant
Herbal or dietary supplements are the fourth most common cause of drug-induced acute hepatic necrosis requiring liver transplantation in the United States, according to a study of liver transplant registry data.
Watch
JAMA Report: Research Shows Little Benefit for Dietary Supplements, but Industry Continues to Boom
Dietary supplements are a 32 billion dollar a year industry in the U.S. Although numerous studies have found little evidence of benefit, the supplement industry continues to grow. A new study examined the trends in dietary supplement use among U.S. adults from 1999-2013. Researchers found that the proportion of users stayed consistent throughout the study period at just over 50%.
Thursday, October 6, 2016
Watch - Debrief Recording of EASL Recommendations on Treatment of Hepatitis C 2016
Watch Pr. Jean-Michel Pawlotsky review the highlights of EASL’s recommendations on treatment of Hepatitis C 2016
EASLEurope
EASLEurope
Effectiveness of Elbasvir and Grazoprevir, With or Without Ribavirin, Treatment-Experienced Patients with Chronic Hepatitis C Infection
Article summary @ MPR
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.....
Articles in Press
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
This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
PDF - Accepted Manuscript
Download Full Text Article
DOI: http://dx.doi.org/10.1053/j.gastro.2016.09.045
Abstract
Background & Aims
Patients infected with hepatitis C virus (HCV) genotype 1, 4, or 6, with or without cirrhosis, previously treated with peg-interferon and ribavirin, are a challenge to treat. We performed a phase 3 randomized controlled open-label trial to assess the effects of 12 or 16 weeks of treatment with once-daily elbasvir (an HCV NS5A inhibitor, 50 mg) and grazoprevir (an HCV NS3/4A protease inhibitor, 100 mg), in a fixed-dose combination tablet, with or without twice-daily ribavirin, in this patient population.
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.....
Articles in Press
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
This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
PDF - Accepted Manuscript
Download Full Text Article
DOI: http://dx.doi.org/10.1053/j.gastro.2016.09.045
Abstract
Background & Aims
Patients infected with hepatitis C virus (HCV) genotype 1, 4, or 6, with or without cirrhosis, previously treated with peg-interferon and ribavirin, are a challenge to treat. We performed a phase 3 randomized controlled open-label trial to assess the effects of 12 or 16 weeks of treatment with once-daily elbasvir (an HCV NS5A inhibitor, 50 mg) and grazoprevir (an HCV NS3/4A protease inhibitor, 100 mg), in a fixed-dose combination tablet, with or without twice-daily ribavirin, in this patient population.
Methods
We analyzed data from 420 patients (35% with cirrhosis, 64% with a null or partial response to peg-interferon and ribavirin) who were randomly assigned (1:1:1:1) to groups given elbasvir and grazoprevir once daily, with or without twice-daily ribavirin, for 12 or 16 weeks, at 65 study centers in 15 countries in Europe, Asia, and Central and North America. Randomization was stratified by cirrhosis status and type of peg-interferon and ribavirin treatment failure. HCV RNA was measured using COBAS TaqMan v2.0. The primary end point was HCV RNA below 15 IU/mL, 12 weeks after completion of treatment (SVR12). We aimed to determine whether the proportion of patients achieving an SVR12 in any group was was greater than the reference rate (58%).
We analyzed data from 420 patients (35% with cirrhosis, 64% with a null or partial response to peg-interferon and ribavirin) who were randomly assigned (1:1:1:1) to groups given elbasvir and grazoprevir once daily, with or without twice-daily ribavirin, for 12 or 16 weeks, at 65 study centers in 15 countries in Europe, Asia, and Central and North America. Randomization was stratified by cirrhosis status and type of peg-interferon and ribavirin treatment failure. HCV RNA was measured using COBAS TaqMan v2.0. The primary end point was HCV RNA below 15 IU/mL, 12 weeks after completion of treatment (SVR12). We aimed to determine whether the proportion of patients achieving an SVR12 in any group was was greater than the reference rate (58%).
Results
With 12 weeks of treatment, an SVR12 was achieved by 92.4% of patients given elbasvir and grazoprevir and 94.2% of patients given elbasvir and grazoprevir with ribavirin. With 16 weeks of treatment, an SVR12 was achieved by 92.4% of patients given elbasvir and grazoprevir and 98.1% of patients given elbasvir and grazoprevir with ribavirin. Among patients treated for 12 weeks without ribavirin, virologic failure occurred in 6.8%, 0%, and 12.5% of patients with HCV genotype 1a, 1b, or 4 infection, respectively. Also among patients given elbasvir and grazoprevir for 12 weeks, virologic failure occurred in 0% of patients infected with HCV genotype 1 and 7.5% infected with HCV genotype 4, respectively, who relapsed after completing peg-interferon and ribavirin or with a null or partial response to peg-interferon and ribavirin. Among patients treated for 16 weeks who received ribavirin, there were no incidences of virologic failure. Common adverse events were fatigue (23.1%), headache (19.8%), and nausea (11.0%).
With 12 weeks of treatment, an SVR12 was achieved by 92.4% of patients given elbasvir and grazoprevir and 94.2% of patients given elbasvir and grazoprevir with ribavirin. With 16 weeks of treatment, an SVR12 was achieved by 92.4% of patients given elbasvir and grazoprevir and 98.1% of patients given elbasvir and grazoprevir with ribavirin. Among patients treated for 12 weeks without ribavirin, virologic failure occurred in 6.8%, 0%, and 12.5% of patients with HCV genotype 1a, 1b, or 4 infection, respectively. Also among patients given elbasvir and grazoprevir for 12 weeks, virologic failure occurred in 0% of patients infected with HCV genotype 1 and 7.5% infected with HCV genotype 4, respectively, who relapsed after completing peg-interferon and ribavirin or with a null or partial response to peg-interferon and ribavirin. Among patients treated for 16 weeks who received ribavirin, there were no incidences of virologic failure. Common adverse events were fatigue (23.1%), headache (19.8%), and nausea (11.0%).
Conclusions
The combination tablet of elbasvir and grazoprevir, with or without ribavirin, was highly efficacious in inducing an SVR12 in patients with HCV genotype 1, 4, or 6 infection failed by previous treatment with peg-interferon and ribavirin, including patients with cirrhosis and/or a prior null response. The treatment was generally well tolerated. ClinicalTrials.gov no: NCT02105701.
Gastroenterology - Full Text Article
The combination tablet of elbasvir and grazoprevir, with or without ribavirin, was highly efficacious in inducing an SVR12 in patients with HCV genotype 1, 4, or 6 infection failed by previous treatment with peg-interferon and ribavirin, including patients with cirrhosis and/or a prior null response. The treatment was generally well tolerated. ClinicalTrials.gov no: NCT02105701.
Gastroenterology - Full Text Article
Wednesday, October 5, 2016
October Recruiting and upcoming hepatitis C clinical trials
Recruiting and upcoming hepatitis C clinical trials
The clinical trials listed on this page can be found online at at ClinicalTrials.gov. A Web site maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH). This is not a complete list of clinical trials, to find out if a study is enrolling patients in your area please click here.
For viral hepatitis clinical trials listed by state visit CenterWatch. CenterWatch does not conduct clinical research. CenterWatch is a publishing company that posts clinical trials information on behalf of sponsor companies, contract research organizations, clinical research sites and other interested parties.
To learn more about drugs used to treat hepatitis C I highly suggest you begin with this incredible new blog recently launched by HCV Advocate; HCV Medications Blog. The blog is easy to navigate with treatment information listed clearly by HCV genotype.
As a reference point the following news and research articles correlate with the drugs used in this small list of clinical trials.
News and Research
Gilead
GS-9857 (voxilaprevir), in combination with sofosbuvir and velpatasvir
Oct 20
Gilead SVR12 Rates SOF/VEL/VOX; (GS-9857), Treatment-Naïve/Treatment-Experienced HCV Geno 1-6
Gilead Announces SVR12 Rates From Four Phase 3 Studies of a Once-Daily, Fixed-Dose Combination of Sofosbuvir, Velpatasvir and Voxilaprevir in Treatment-Naïve and Treatment-Experienced Genotype 1-6 Chronic HCV-Infected Patients
- If Approved, SOF/VEL/VOX Would Be the First Once-Daily Single Tablet Regimen Available for Salvage for Patients Who Have Failed Prior HCV Therapy with Oral Direct-Acting Antiviral Agent Regimens -
- U.S. NDA Planned for Q4 2016 -
Oct 20
Gilead SVR12 Rates SOF/VEL/VOX; (GS-9857), Treatment-Naïve/Treatment-Experienced HCV Geno 1-6
Gilead Announces SVR12 Rates From Four Phase 3 Studies of a Once-Daily, Fixed-Dose Combination of Sofosbuvir, Velpatasvir and Voxilaprevir in Treatment-Naïve and Treatment-Experienced Genotype 1-6 Chronic HCV-Infected Patients
- If Approved, SOF/VEL/VOX Would Be the First Once-Daily Single Tablet Regimen Available for Salvage for Patients Who Have Failed Prior HCV Therapy with Oral Direct-Acting Antiviral Agent Regimens -
- U.S. NDA Planned for Q4 2016 -
Oct 2016
Editorial
Hepatitis C Therapy: Game Over!
Hepatitis C Therapy: Game Over!
NS5B polymerase inhibitor sofosbuvir, NS5A inhibitor velpatasvir, and the new protease inhibitor GS-9857 (voxilaprevir)
April 2016
A triple combination of Gilead Sciences' sofosbuvir, velpatasvir and GS-9857 demonstrated a high sustained response rate for treatment-experienced people with all hepatitis C virus (HCV) genotypes who previously were not cured with prior direct-acting antivirals (DAAs), according to two presentations yesterday at the 2016 International Liver Congress in Barcelona.
AbbVie
Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir (Viekira Pak)
**Currently, VIEKIRA PAK is taken twice daily as three tablets in the morning and one tablet in the evening. VIEKIRA XR is a fixed-dose formulation and is given once-daily as three oral tablets
*Both must be taken with a meal because administration under fasting conditions may result in reduced virologic response and possible development of resistance.
Sept 2016
98 percent of previously untreated genotype 1b (GT1b) chronic hepatitis C virus (HCV) infected patients without cirrhosis achieved SVR12 in Phase 3b GARNET study.
Glecaprevir (ABT-493)/Pibrentasvir (ABT-530)
Investigational HCV drug combo yields high SVR12 rates in compensated cirrhosis
The ABT-493/ABT-530 investigational direct-acting antiviral combination cured nearly all patients with compensated cirrhosis and genotype 1 or 3 hepatitis C virus infection.
AbbVie's HCV Regimen glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) Receives FDA Breakthrough Therapy Designation
Sept. 30, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for the investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) for the treatment of patients with chronic hepatitis C virus (HCV) who failed previous therapy with direct-acting antivirals (DAAs) in genotype 1 (GT1), including therapy with an NS5A inhibitor and/or protease inhibitor.
Merck
MK-3682 with MK-8408
EASL Conference April 2016
High Efficacy of an 8-Week, 3-Drug Regimen of MK-3682/Grazoprevir/MK-8408 in HCV Genotype 1, 2, or 3-Infected Patients: SVR24 Data from the Phase 2 C-CREST 1 and 2 Studies
Grazoprevir(MK-5172)
August 2016
Grazoprevir plus ribavirin linked to rapid, sustained suppression of HCV RNA
“Overall, the tolerability and safety profile of [grazoprevir] plus [ribavirin] were largely consistent with the well-reported safety profile of [ribavirin],” Gane and colleagues wrote. “The combination of [grazoprevir] plus [ribavirin] was associated with rapid virologic suppression, with 84% of patients in the [per-protocol] population achieving undetectable HCV RNA by [treatment week 4] and 88% (22/25) achieving undetectable HCV RNA at the end of 12 weeks of therapy.”
Elbasvir/grazoprevir (Zepatier®)
May 2016
Elbasvir/Grazoprevir: A Review of the Latest Agent in the Fight against Hepatitis C
Elbasvir/grazoprevir (Zepatier®) is a combination product with an FDA-approved indication for the treatment of chronic HCV genotypes (GTs) 1 and 4 in adults
Sept 27 2016
Full Text
Effectiveness of Elbasvir and Grazoprevir Combination, With or Without Ribavirin, for Treatment-Experienced Patients with Chronic Hepatitis C Infection
The combination tablet of elbasvir and grazoprevir, with or without ribavirin, was highly efficacious in inducing an SVR12 in patients with HCV genotype 1, 4, or 6 infection failed by previous treatment with peg-interferon and ribavirin, including patients with cirrhosis and/or a prior null response
Article summary @ MPR
Effectiveness of Elbasvir and Grazoprevir Combination, With or Without Ribavirin, for Treatment-Experienced Patients with Chronic Hepatitis C Infection
Fixed-Dose HCV Combo Drug Effective in Hard-to-Treat Patients
Recruiting
The ABT-493/ABT-530 investigational direct-acting antiviral combination cured nearly all patients with compensated cirrhosis and genotype 1 or 3 hepatitis C virus infection.
AbbVie's HCV Regimen glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) Receives FDA Breakthrough Therapy Designation
Sept. 30, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for the investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) for the treatment of patients with chronic hepatitis C virus (HCV) who failed previous therapy with direct-acting antivirals (DAAs) in genotype 1 (GT1), including therapy with an NS5A inhibitor and/or protease inhibitor.
Merck
MK-3682 with MK-8408
EASL Conference April 2016
High Efficacy of an 8-Week, 3-Drug Regimen of MK-3682/Grazoprevir/MK-8408 in HCV Genotype 1, 2, or 3-Infected Patients: SVR24 Data from the Phase 2 C-CREST 1 and 2 Studies
Grazoprevir(MK-5172)
August 2016
Grazoprevir plus ribavirin linked to rapid, sustained suppression of HCV RNA
“Overall, the tolerability and safety profile of [grazoprevir] plus [ribavirin] were largely consistent with the well-reported safety profile of [ribavirin],” Gane and colleagues wrote. “The combination of [grazoprevir] plus [ribavirin] was associated with rapid virologic suppression, with 84% of patients in the [per-protocol] population achieving undetectable HCV RNA by [treatment week 4] and 88% (22/25) achieving undetectable HCV RNA at the end of 12 weeks of therapy.”
Elbasvir/grazoprevir (Zepatier®)
May 2016
Elbasvir/Grazoprevir: A Review of the Latest Agent in the Fight against Hepatitis C
Elbasvir/grazoprevir (Zepatier®) is a combination product with an FDA-approved indication for the treatment of chronic HCV genotypes (GTs) 1 and 4 in adults
Sept 27 2016
Full Text
Effectiveness of Elbasvir and Grazoprevir Combination, With or Without Ribavirin, for Treatment-Experienced Patients with Chronic Hepatitis C Infection
The combination tablet of elbasvir and grazoprevir, with or without ribavirin, was highly efficacious in inducing an SVR12 in patients with HCV genotype 1, 4, or 6 infection failed by previous treatment with peg-interferon and ribavirin, including patients with cirrhosis and/or a prior null response
Article summary @ MPR
Effectiveness of Elbasvir and Grazoprevir Combination, With or Without Ribavirin, for Treatment-Experienced Patients with Chronic Hepatitis C Infection
Fixed-Dose HCV Combo Drug Effective in Hard-to-Treat Patients
United States, Maryland
ClinicalTrials.gov Identifier: NCT02745535
Purpose
Purpose
This study will evaluate the safety, tolerability, and efficacy of sofosbuvir/velpatasvir/GS-9857 (SOF/VEL/GS-9857) in adults with chronic hepatitis C infection who have failed to eradicate hepatitis C despite previous combination directly acting antiviral therapy.
Recruiting
Recruiting
United States, Maryland
ClinicalTrials.gov Identifier: NCT02468648
Condition: Chronic Hepatitis C
Interventions: Drug: Sofosbuvir; Drug: GS-5816
Condition: Chronic Hepatitis C
Interventions: Drug: Sofosbuvir; Drug: GS-5816
Detailed Description:
Up to 140 patients with chronic hepatitis C, genotypes 1-4, who were never treated or previously treated but failed a course of therapy with any interferon and ribavirin combination regimen will be eligible to be enrolled into this pilot study to evaluate the combination of sofosbuvir and GS-5816 as a fixed dose tablet to improve response to antiviral therapy. To enrich the study population with subjects with a greater likelihood of virological relapse after stopping therapy, we plan to enroll a minimum of 60% treatment-experienced subjects and 50% with cirrhosis. These two drugs inhibit key enzymes that are necessary for viral replication. Sofosbuvir, an NS5B polymerase inhibitor is already approved for use in combination with interferon and ribavirin for the treatment of HCV genotype 1 infection. GS-5816 is an NS5A replication complex inhibitor with potent activity against most strains of hepatitis C virus. Combining these two agents into a single pill should improve patient compliance and improve tolerability because interferon and ribavirin will not be part of the regimen. After medical evaluation and liver biopsy, patients will receive combination therapy with sofosbuvir and GS-5816 one pill a day for 12 weeks. The baseline liver biopsy is necessary to assess the amount of liver damage caused by the HCV and to measure expression of genes associated with clearance of HCV. Blood samples will be collected to monitor safety and response to therapy and for research purposes. HCV RNA levels will be monitored frequently for the initial 4 weeks and then at monthly intervals for the remaining 8 weeks of antiviral therapy. All subjects will undergo a second liver biopsy, 4 weeks after starting therapy. The second biopsy is being performed for research purposes so investigators can determine specifically which liver genes are associated with failure of therapy (and response to therapy). Subjects who refuse the second liver biopsy will continue to receive SOF/GS-5816 treatment for the planned 12 week duration Patients in whom serum HCV RNA is greater than or equal to lower limit of quantification (LLOQ) after 2 consecutive HCV RNA < LLOQ or who have a confirmed > 1 log10 increase from nadir will discontinue therapy (because continuing therapy is considered futile i.e. it is unlikely to work). The major endpoints will be changes in interferon stimulated gene and protein expression in the liver and changes in HCV RNA levels in liver and serum between baseline and 4 weeks and rates of sustained virologic response at post-treatment week 12. Secondary endpoints will be safety and sustained virologic response at post-treatment week 24 weeks.
Recruiting
Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in Canada (AMBER)
ClinicalTrials.gov Identifier: NCT02581189
Purpose
This study seeks to provide evidence of the effectiveness and obtain patient reported outcome (PRO) data for the interferon-free ABBVIE REGIMEN ± RBV in participants with chronic hepatitis C (CHC) in a real life setting across clinical practice patient populations in Canada.
This study seeks to provide evidence of the effectiveness and obtain patient reported outcome (PRO) data for the interferon-free ABBVIE REGIMEN ± RBV in participants with chronic hepatitis C (CHC) in a real life setting across clinical practice patient populations in Canada.
Recruiting
Germany
ClinicalTrials.gov Identifier: NCT02615145
Purpose
The interferon-free combination regimen of Paritaprevir/r - Ombitasvir with or without Dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC) has been shown to be safe and effective in randomized controlled clinical trials with strict inclusion and exclusion criteria under well controlled conditions.
This observational study is the first effectiveness research examining the ABBVIE REGIMEN ± RBV, used according to local label, under real world conditions in Germany in a clinical practice patient population.
Recruiting
Hungary
Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Hungary - VERITAS ClinicalTrials.gov Identifier: NCT02636608
Purpose
The study seeks to provide evidence of the effectiveness and obtain patient reported outcome (PRO) and work productivity data of the interferon-free regimen of Paritaprevir (PTV)/ritonavir (r) + Ombitasvir (OBV), ± Dasabuvir (DSV), ± Ribavirin in chronic hepatitis C virus infected participants.
Recruiting
Hungary
Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Hungary - VERITAS ClinicalTrials.gov Identifier: NCT02636608
Purpose
The study seeks to provide evidence of the effectiveness and obtain patient reported outcome (PRO) and work productivity data of the interferon-free regimen of Paritaprevir (PTV)/ritonavir (r) + Ombitasvir (OBV), ± Dasabuvir (DSV), ± Ribavirin in chronic hepatitis C virus infected participants.
Recruiting
United States Australia Belarus France Germany Poland Puerto Rico Russian Federation United Kingdom
ClinicalTrials.gov Identifier: NCT02738138
Purpose
Purpose
The purpose of this study is to assess the efficacy and safety of ABT-493/ABT-530 in adults with chronic hepatitis C virus genotype 1-6 infection and human immunodeficiency virus-1 co-infection.
Recruiting
United States
ClinicalTrials.gov Identifier: NCT02194998
Purpose
HIV and hepatitis C virus (HCV) infection are diseases that share the same risk factors and routes of transmission. For this reason, many people infected with HIV are also infected with HCV. Interferon (IFN) is a drug used to treat HCV; however, in people coinfected with HIV and HCV, IFN treatment often does not work well and can cause unwanted side effects. The purpose of this study is to evaluate the safety, tolerability, and effectiveness of IFN-free HCV treatment in HIV/HCV coinfected adults who are taking antiretroviral (ARV) therapy.
Recruiting
United States France Germany Spain Sweden
ClinicalTrials.gov Identifier: NCT02613403
Purpose
This is a randomized, multicenter, open-label trial of the combination regimen of MK-5172 (grazoprevir [GZR]) (100 mg), MK-3682 (450 mg) and MK-8408 (ruzasvir) (60 mg) for 16 weeks with ribavirin (RBV) or 24 weeks without RBV in cirrhotic (C) or non-cirrhotic (NC) hepatitis C virus (HCV) genotype (GT) 1 or GT3-infected participants who have previously failed a direct-acting antiviral regimen (DAA). The combination regimen will be administered as two fixed-dose combination (FDC) tablets, referred to as MK-3682B, given once-daily.
The study will evaluate the efficacy of the combination regimen of MK-5172 (GZR), MK-3682 and MK-8408 (ruzasvir) with or without ribavirin as assessed by the proportion of participants achieving Sustained Virologic Response 12 weeks (SVR12) after the end of all study therapy.
Recruiting
United States, Texas
Efficacy and Safety of MK-3682 With MK-8408 in Adults With Chronic Hepatitis C Genotype 1, 2, 3, 4, 5 or 6 Infection (MK-3682-035)
ClinicalTrials.gov Identifier: NCT02759315
Purpose
The study is a single-center, multiple-arm investigation of co-administration of MK-3682 450 mg and MK-8408 60 mg in participants with chronic Hepatitis C Virus (HCV) Genotype (GT)1, GT2, GT3, GT4, GT5, or GT6. The impact of the study treatment regimen on Sustained Virologic Response (SVR)12 (undetectable HCV ribonucleic acid [RNA] 12 weeks after ending study treatment) for each HCV Genotype will be evaluated in cirrhotic participants and non-cirrhotic participants.
Recruiting
Brazil
ClinicalTrials.gov Identifier: NCT02624063
Purpose
The purpose of the study is to study the combination of Sofosbuvir in Combination With Daclatasvir or Simeprevir for 12 Weeks in Non-cirrhotic Subjects Infected With Chronic Hepatitis C Virus (HCV) Genotype 1.
This study is not yet open for participant recruitment
ClinicalTrials.gov Identifier: NCT02890719
Conditions: Liver Transplantation; Hepatitis C
Purpose
Conditions: Liver Transplantation; Hepatitis C
Purpose
Pilot, single center, open-label study to evaluate the efficacy and tolerability of Grazoprevir and Elbasvir in HCV GT1 and 4 liver transplant recipients.30 liver transplant recipients with hepatitis C recurrence.
Contacts
Contact: Xavier Forns, MD +34 93 2275400 xforns@clinic.ub.es
Contact: Anna Cruceta, MD +34 93 2275400 ext 4380 acruceta@clinic.ub.es
Recruiting
Evaluate the Safety and Effectiveness of Sovaldi Treatment Regimens in Patients With Chronic Hepatitis C Virus (HCV) Infection in a Korean Real-World Setting
ClinicalTrials.gov Identifier: NCT02907996
Condition: Hepatitis C Virus
Intervention: Drug: Sofosbuvir
Of Interest
Oct 5
RedHill Announces Initiation of Phase II Study with YELIVA™ in Hepatocellular Carcinoma at the Medical University of South Carolina
Contacts
Contact: Xavier Forns, MD +34 93 2275400 xforns@clinic.ub.es
Contact: Anna Cruceta, MD +34 93 2275400 ext 4380 acruceta@clinic.ub.es
Recruiting
Evaluate the Safety and Effectiveness of Sovaldi Treatment Regimens in Patients With Chronic Hepatitis C Virus (HCV) Infection in a Korean Real-World Setting
ClinicalTrials.gov Identifier: NCT02907996
Condition: Hepatitis C Virus
Intervention: Drug: Sofosbuvir
Oct 5
RedHill Announces Initiation of Phase II Study with YELIVA™ in Hepatocellular Carcinoma at the Medical University of South Carolina
European regulator limits some Gilead hep C patent claims
European regulator limits some Gilead hep C patent claims
By Ed Silverman @Pharmalot
In a setback for Gilead Sciences, European regulators decided not to uphold all of its patent claims for the best-selling Sovaldi hepatitis C treatment, a move that could lead to generic versions of the medicine becoming available four years sooner than had been expected.
Continue reading....
By Ed Silverman @Pharmalot
In a setback for Gilead Sciences, European regulators decided not to uphold all of its patent claims for the best-selling Sovaldi hepatitis C treatment, a move that could lead to generic versions of the medicine becoming available four years sooner than had been expected.
Continue reading....
Charity scores small win in Hep C drug battle
October 5, 2016
Patient groups around the world have accused Gilead Sciences of charging exorbitant prices for its blockbuster sofosbuvir drug, which is highly effective but can cost up to $1,000 per pill.
In France, a 12-week course of treatment costs 41,000 euros ($46,000).
To open the way to a low-cost generic version of the drug, sold under the brand name Sovaldi, the group Medecins du Monde (Doctors of the World) had launched a legal challenge against the firm's patent.
Ruling on the claim, the European Patent Office in Munich said it had upheld the patent filed by Gilead but "in an amended form", leaving only the components used in the drug under intellectual protection, not sofosbuvir itself.
The MdM charity said the impact of the ruling was difficult to interpret but it at least created a legal limbo that could give European governments leverage to renegotiate prices with Gilead.
October 5, 2016
Patient groups around the world have accused Gilead Sciences of charging exorbitant prices for its blockbuster sofosbuvir drug, which is highly effective but can cost up to $1,000 per pill.
In France, a 12-week course of treatment costs 41,000 euros ($46,000).
To open the way to a low-cost generic version of the drug, sold under the brand name Sovaldi, the group Medecins du Monde (Doctors of the World) had launched a legal challenge against the firm's patent.
Ruling on the claim, the European Patent Office in Munich said it had upheld the patent filed by Gilead but "in an amended form", leaving only the components used in the drug under intellectual protection, not sofosbuvir itself.
The MdM charity said the impact of the ruling was difficult to interpret but it at least created a legal limbo that could give European governments leverage to renegotiate prices with Gilead.
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