Top HCV stories of 2014

Hepatitis C virus infection entered a new era this year, following FDA approvals of multiple treatment regimens, and new, groundbreaking clinical data produced by the top researchers in the field. Using web analytics, social media and expert opinion, Healio.com/Hepatology has compiled a list of some of the most important, relevant research and news on hepatitis C virus infection presented during the past year.

FDA approves Harvoni for HCV treatment

Using the breakthrough therapy designation, the FDA approved the first combination pill for treatment of chronic hepatitis C virus genotype 1 that does not require interferon or ribavirin for administration.

Treatment-naive participants showed a 94% sustained virologic response rate after 8 weeks of treatment and a 96% SVR rate after 12 weeks. Treatment-naive patients with and without cirrhosis showed a 99% SVR rate after 12 weeks. Among treatment-experienced participants with and without cirrhosis, ribavirin did not improve response rates in any of the trials. Read more

FDA approves Viekira Pak for treatment of HCV

The FDA approved a treatment for patients with hepatitis C virus genotype 1 infection, including those with cirrhosis.

Ed Cox

Edward Cox

“The new generation of therapeutics for hepatitis C virus is changing the treatment paradigm for Americans living with the disease,” Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “We continue to see the development of new all-oral treatments with very high virologic response rates and improved safety profiles compared to some of the older interferon-based drug regimens.” Read more

Special HCV patient populations may be a thing of the past

CHICAGO — When it comes to the latest HCV regimens, so-called “special” patient populations may have to accept the fact that they are actually quite ordinary.

Nancy S. Reau

Nancy S. Reau

“Special populations are no longer special,” said Nancy S. Reau, MD, assistant professor of medicine at the University of Chicago, and HCV Next Editorial Board member, during a presentation. “Sorry, you don’t get to have special privileges anymore — you’re just as generic as the rest of us.” Read more

HCV predicted to become rare by 2036

Hepatitis C virus could become a rare disease in the next 22 years, as a result of recently approved, highly effective new therapies.

“Making hepatitis C (HCV) a rare disease would be a tremendous, life-saving accomplishment,” Mina Kabiri, doctoral student at the University of Pittsburgh Graduate School of Public Health, and study co-investigator, said in a press release. “However, to do this, we will need improved access to care and increased treatment capacity, primarily in the form of primary care physicians who can manage the care of infected people identified through increased screening.” Read more

UNITY 2: Fixed-dose combination with BMS-791325 yields SVR12 in treatment-naive, experienced patients

BOSTON — A fixed-dose combination involving the novel compound BMS-791325 was associated with SVR12 rates of around 90% in treatment-naive and experienced patients, according to findings from the UNITY trials series presented at The Liver Meeting.

“Current treatments for treatment experienced patients with cirrhosis require 24 weeks,” Andrew J. Muir, MD, of the Duke Clinical Research Institute at the Duke University School of Medicine in North Carolina, said.  “This study demonstrates that a 12-week regimen can cure this patient group with high SVR rates.  Ribavirin was important for the genotype 1a patients to maximize chance of cure.” Read more

Congressional committee questions price of company’s HCV drug

Members of the House of Representatives Committee on Energy and Commerce have asked Gilead Sciences Inc. to explain the price for Sovaldi, the company’s recently approved drug to treat hepatitis C virus.

“Our concern is that a treatment will not cure patients if they cannot afford it,” a letter addressed to John C. Martin, PhD, chief executive officer of Gilead Sciences Inc., said. “These costs are likely to be too high for many patients, both those with public insurance and those with private insurance.” Read more

C-WORTHY: Grazoprevir/elbasvir regimen yielded high SVR rates in patients with HCV genotype 1

BOSTON — A number of patients with hepatitis C virus genotype 1 infection, with and without cirrhosis, and patients coinfected with HIV and HCV, achieved sustained virologic response when treated with grazoprevir and elbasvir, according to data presented at The Liver Meeting.

Eric Lawitz

Eric J. Lawitz

“Grazoprevir and elbasvir, with or without ribavirin, demonstrated high efficacy,” Eric J. Lawitz, MD, of The Texas Liver Institute, University of Texas Health Science Center, San Antonio, said in the hepatitis plenary. “High efficacy was achieved regardless of the presence or absence of ribavirin or extended treatment duration from 12 to 18 weeks.” Read more  

DAA regimen yielded high SVR rates without ribavirin

CHICAGO — A regimen of three direct-acting antivirals demonstrated high rates of sustained virologic response in hepatitis C virus genotype 1b-infected patients who previously failed treatment with pegylated interferon and ribavirin, according to results from the PEARL-II study, presented at Digestive Disease Week 2014.

“The regimen was generally well-tolerated, as evidenced by the low rate of treatment discontinuation and serious adverse events,” Pietro Andreone, MD, of the University of Bologna in Italy, said during the presentation. Read more

FDA approves simeprevir to be used with sofosbuvir for HCV genotype 1

The FDA approved changes to the Olysio label reflecting that it can be used in combination with Sovaldi to treat patients with chronic hepatitis C virus genotype 1 infection.

Olysio (Simeprevir, Janssen Therapeutics) is a NS3/4A protease inhibitor that functions by blocking the viral protease enzyme HCV uses to replicate. It was approved by the FDA in November 2013 as part of an antiviral treatment regimen with pegylated interferon and ribavirin for patients with chronic HCV genotype 1. Read more

Study finds rising incidence of HCV in young, non-urban injection drug users

New data indicate a rising incidence of hepatitis C infection among young, primarily white, non-urban people who inject drugs.

From 2006 to 2012, there were 7,169 cases of acute hepatitis C reported to the CDC. Among the 7,077 cases with a documented age, 44% were young people. In 2012, 49% of the cases were young people, whereas in 2006, 36% were young people. The majority of the cases were white and non-Hispanic, and the cases were equally among men and women. Read more

WHO releases HCV treatment guidelines

LONDON — WHO unveiled its first-ever treatment guidelines for HCV during a press conference at the International Liver Congress, the annual meeting of the European Association for the Study of the Liver. Read more

St. Louis University to test sofosbuvir/ribavirin in pediatric HCV cases

In a multicenter clinical study, researcher Jeffrey Teckman, MD, professor of pediatrics at SLU, will analyze the combination of sofosbuvir (Sovaldi, Gilead Sciences) and ribavirin among children aged 3 to 17 years in an effort to cure the infection while limiting side effects. Read more

Sofosbuvir regimen outperformed other therapies in reducing liver complications in HCV patients

CHICAGO — Chronic hepatitis C virus-infected patients treated with a sofosbuvir-based regimen showed a reduced number of liver disease complications, compared with patients receiving other treatments, according to research presented at Digestive Disease Week 2014.

“Sofosbuvir-based therapy is considered dominant in terms of efficacy and lower costs,” Sammy Saab, MD, MPH, AGAF, of UCLA Medical Center, said at the conference. Read more

TURQUOISE-II: Three-drug regimen yields high SVR in genotype 1 cirrhotic patients

LONDON — Multitargeted therapy of ABT-450 with ritonavir, ombitasvir and dasabuvir yielded strong response rates with few discontinuations among patients with cirrhosis and hepatitis C genotype 1 treated for 12 or 24 weeks, according to findings presented at EASL 2014.

“For genotype 1b disease, almost everyone achieved SVR,” HCV Next Editorial Board member Fred Poordad, MD, of The Texas Liver Institute and University of Texas Health Science Center in San Antonio, said. “The rate was almost 100% except for a prior partial responder. “When measured by surrogates of portal hypertension and hepatic function, high SVR rates were achieved with no appreciable difference between either arm.” Read more

Ribavirin unnecessary addition to three-drug combination for HCV treatment

BOSTON — Sustained virologic response rates of nearly 100% were reported in a multiple-drug combination with or without ribavirin, according to findings presented here at the 2014 Conference on Retroviruses and Opportunistic Infections.

Researchers with the PEARL-III study investigated three drugs from AbbVie with or without ribavirin for non-cirrhotic, treatment-naive hepatitis C virus genotype 1b disease: the protease inhibitor ABT-450/r, which is dosed with ritonavir 100 mg; the NS5A inhibitor ABT-267; and the non-nucleoside polymerase inhibitor ABT-333. Read more

HCV prevalence, cost burden continue to rise

The hepatitis C virus has a profound negative impact on patients’ quality of life, both in its clinical manifestations and its overall economic burden.

A panel of hepatologists, experienced with evidence assessment, was convened to estimate how HCV affects patient outcomes. The researchers used the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology. Read more

 

Hepatitis C virus infection entered a new era this year, following FDA approvals of multiple treatment regimens, and new, groundbreaking clinical data produced by the top researchers in the field. Using web analytics, social media and expert opinion, Healio.com/Hepatology has compiled a list of some of the most important, relevant research and news on hepatitis C virus infection presented during the past year.

FDA approves Harvoni for HCV treatment

Using the breakthrough therapy designation, the FDA approved the first combination pill for treatment of chronic hepatitis C virus genotype 1 that does not require interferon or ribavirin for administration.

Treatment-naive participants showed a 94% sustained virologic response rate after 8 weeks of treatment and a 96% SVR rate after 12 weeks. Treatment-naive patients with and without cirrhosis showed a 99% SVR rate after 12 weeks. Among treatment-experienced participants with and without cirrhosis, ribavirin did not improve response rates in any of the trials. Read more

FDA approves Viekira Pak for treatment of HCV

The FDA approved a treatment for patients with hepatitis C virus genotype 1 infection, including those with cirrhosis.

Ed Cox

Edward Cox

“The new generation of therapeutics for hepatitis C virus is changing the treatment paradigm for Americans living with the disease,” Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “We continue to see the development of new all-oral treatments with very high virologic response rates and improved safety profiles compared to some of the older interferon-based drug regimens.” Read more

Special HCV patient populations may be a thing of the past

CHICAGO — When it comes to the latest HCV regimens, so-called “special” patient populations may have to accept the fact that they are actually quite ordinary.

Nancy S. Reau

Nancy S. Reau

“Special populations are no longer special,” said Nancy S. Reau, MD, assistant professor of medicine at the University of Chicago, and HCV Next Editorial Board member, during a presentation. “Sorry, you don’t get to have special privileges anymore — you’re just as generic as the rest of us.” Read more

HCV predicted to become rare by 2036

Hepatitis C virus could become a rare disease in the next 22 years, as a result of recently approved, highly effective new therapies.

“Making hepatitis C (HCV) a rare disease would be a tremendous, life-saving accomplishment,” Mina Kabiri, doctoral student at the University of Pittsburgh Graduate School of Public Health, and study co-investigator, said in a press release. “However, to do this, we will need improved access to care and increased treatment capacity, primarily in the form of primary care physicians who can manage the care of infected people identified through increased screening.” Read more

UNITY 2: Fixed-dose combination with BMS-791325 yields SVR12 in treatment-naive, experienced patients

BOSTON — A fixed-dose combination involving the novel compound BMS-791325 was associated with SVR12 rates of around 90% in treatment-naive and experienced patients, according to findings from the UNITY trials series presented at The Liver Meeting.

“Current treatments for treatment experienced patients with cirrhosis require 24 weeks,” Andrew J. Muir, MD, of the Duke Clinical Research Institute at the Duke University School of Medicine in North Carolina, said.  “This study demonstrates that a 12-week regimen can cure this patient group with high SVR rates.  Ribavirin was important for the genotype 1a patients to maximize chance of cure.” Read more

PAGE BREAK

Congressional committee questions price of company’s HCV drug

Members of the House of Representatives Committee on Energy and Commerce have asked Gilead Sciences Inc. to explain the price for Sovaldi, the company’s recently approved drug to treat hepatitis C virus.

“Our concern is that a treatment will not cure patients if they cannot afford it,” a letter addressed to John C. Martin, PhD, chief executive officer of Gilead Sciences Inc., said. “These costs are likely to be too high for many patients, both those with public insurance and those with private insurance.” Read more

C-WORTHY: Grazoprevir/elbasvir regimen yielded high SVR rates in patients with HCV genotype 1

BOSTON — A number of patients with hepatitis C virus genotype 1 infection, with and without cirrhosis, and patients coinfected with HIV and HCV, achieved sustained virologic response when treated with grazoprevir and elbasvir, according to data presented at The Liver Meeting.

Eric Lawitz

Eric J. Lawitz

“Grazoprevir and elbasvir, with or without ribavirin, demonstrated high efficacy,” Eric J. Lawitz, MD, of The Texas Liver Institute, University of Texas Health Science Center, San Antonio, said in the hepatitis plenary. “High efficacy was achieved regardless of the presence or absence of ribavirin or extended treatment duration from 12 to 18 weeks.” Read more  

DAA regimen yielded high SVR rates without ribavirin

CHICAGO — A regimen of three direct-acting antivirals demonstrated high rates of sustained virologic response in hepatitis C virus genotype 1b-infected patients who previously failed treatment with pegylated interferon and ribavirin, according to results from the PEARL-II study, presented at Digestive Disease Week 2014.

“The regimen was generally well-tolerated, as evidenced by the low rate of treatment discontinuation and serious adverse events,” Pietro Andreone, MD, of the University of Bologna in Italy, said during the presentation. Read more

FDA approves simeprevir to be used with sofosbuvir for HCV genotype 1

The FDA approved changes to the Olysio label reflecting that it can be used in combination with Sovaldi to treat patients with chronic hepatitis C virus genotype 1 infection.

Olysio (Simeprevir, Janssen Therapeutics) is a NS3/4A protease inhibitor that functions by blocking the viral protease enzyme HCV uses to replicate. It was approved by the FDA in November 2013 as part of an antiviral treatment regimen with pegylated interferon and ribavirin for patients with chronic HCV genotype 1. Read more

Study finds rising incidence of HCV in young, non-urban injection drug users

New data indicate a rising incidence of hepatitis C infection among young, primarily white, non-urban people who inject drugs.

From 2006 to 2012, there were 7,169 cases of acute hepatitis C reported to the CDC. Among the 7,077 cases with a documented age, 44% were young people. In 2012, 49% of the cases were young people, whereas in 2006, 36% were young people. The majority of the cases were white and non-Hispanic, and the cases were equally among men and women. Read more

PAGE BREAK

WHO releases HCV treatment guidelines

LONDON — WHO unveiled its first-ever treatment guidelines for HCV during a press conference at the International Liver Congress, the annual meeting of the European Association for the Study of the Liver. Read more

St. Louis University to test sofosbuvir/ribavirin in pediatric HCV cases

In a multicenter clinical study, researcher Jeffrey Teckman, MD, professor of pediatrics at SLU, will analyze the combination of sofosbuvir (Sovaldi, Gilead Sciences) and ribavirin among children aged 3 to 17 years in an effort to cure the infection while limiting side effects. Read more

Sofosbuvir regimen outperformed other therapies in reducing liver complications in HCV patients

CHICAGO — Chronic hepatitis C virus-infected patients treated with a sofosbuvir-based regimen showed a reduced number of liver disease complications, compared with patients receiving other treatments, according to research presented at Digestive Disease Week 2014.

“Sofosbuvir-based therapy is considered dominant in terms of efficacy and lower costs,” Sammy Saab, MD, MPH, AGAF, of UCLA Medical Center, said at the conference. Read more

TURQUOISE-II: Three-drug regimen yields high SVR in genotype 1 cirrhotic patients

LONDON — Multitargeted therapy of ABT-450 with ritonavir, ombitasvir and dasabuvir yielded strong response rates with few discontinuations among patients with cirrhosis and hepatitis C genotype 1 treated for 12 or 24 weeks, according to findings presented at EASL 2014.

“For genotype 1b disease, almost everyone achieved SVR,” HCV Next Editorial Board member Fred Poordad, MD, of The Texas Liver Institute and University of Texas Health Science Center in San Antonio, said. “The rate was almost 100% except for a prior partial responder. “When measured by surrogates of portal hypertension and hepatic function, high SVR rates were achieved with no appreciable difference between either arm.” Read more

Ribavirin unnecessary addition to three-drug combination for HCV treatment

BOSTON — Sustained virologic response rates of nearly 100% were reported in a multiple-drug combination with or without ribavirin, according to findings presented here at the 2014 Conference on Retroviruses and Opportunistic Infections.

Researchers with the PEARL-III study investigated three drugs from AbbVie with or without ribavirin for non-cirrhotic, treatment-naive hepatitis C virus genotype 1b disease: the protease inhibitor ABT-450/r, which is dosed with ritonavir 100 mg; the NS5A inhibitor ABT-267; and the non-nucleoside polymerase inhibitor ABT-333. Read more

HCV prevalence, cost burden continue to rise

The hepatitis C virus has a profound negative impact on patients’ quality of life, both in its clinical manifestations and its overall economic burden.

A panel of hepatologists, experienced with evidence assessment, was convened to estimate how HCV affects patient outcomes. The researchers used the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology. Read more