Catherine Kolonko

A recent analysis suggests that liver disease and treatment costs for people with hepatitis C varies depending on a patient’s genotype—and people with genotype 3 appear to have a greater severity of liver disease.

Researchers analyzed data from selected health insurance claims in the United States, and identified varying disease progression and healthcare costs based on genotype.

“This study provides evidence of variation by hepatitis C genotype in liver and non-liver related comorbidities, liver disease severity, and healthcare costs,” the authors wrote in the journal 

Chronic hepatitis C infection can cause serious liver damage, cirrhosis, and also lead to liver cancer. There are six major strains, or genotypes, of the virus. While genotype 1 is the most prevalent in the United States, genotype 3 appears to be the most difficult to treat.

The retrospective study collected data on patient demographic and clinical characteristics provided in healthcare claims from a large US health plan and laboratory data. All patients had at least 18 months of a continuous pharmacy and medical insurance. Potential participants were excluded if age, sex, geographic region, and health insurance were unknown.

Most of the patients were male (63.5%) and average age came out to 50.6 years. Out of the more than 10,000 patients included in the review, 79.1% had genotype 1, 12.8% had genotype 2, and 8.1% had genotype 3.

Patients with genotype 3 had the highest percentage of liver-related comorbidities and advanced liver disease. They were about one-third more likely to have advanced liver disease than were patients with the genotype 1 strain of the virus. The highest rates of steatosis, liver transplant, and hepatocellular carcinoma (the most common form of liver cancer) were also among patients with genotype 3.

“These findings support the notion that genotype 3 variant of the virus imparts a unique pathophysiology throughout the disease course,” the authors stated, also noting that the findings were similar to previous studies.

Those with genotype 1 took the hardest financial hit with the highest all-cause costs, while genotype 2 patients had the lowest costs and lower healthcare resource utilization.

“These differences may reflect differing rates of non-liver-related comorbidities and all-cause care,” the authors explained. “Multivariable analyses showed that genotype was a significant predictor of costs and liver disease severity: compared with patients having genotype 1, those with genotype 3 were significantly more likely to have advanced liver disease. Patients with genotype 2 were significantly less likely to have advanced disease and more likely to have lower all-cause costs.”

One limitation of the study is that results may not generally represent other patients outside the represented insurance plans, the authors noted.

“The findings highlight the importance of effective hepatitis C treatment for all patients and support guidelines for treatment of high-risk patients,” including patients with genotype 3 of the virus, the team concluded.

, “Clinical characteristics, healthcare costs, and resource utilization in hepatitis C vary by genotype,” was published in 

, and was sponsored by Bristol-Myers Squibb.

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A new analysis suggests there’s a need for frequent testing after the hepatitis C virus has been cleared.

Data from three European countries and the United Kingdom indicate a rise in reinfection of acute hepatitis C among men with the human immunodeficiency virus (HIV) who have sex with men.

Moderate cure rates of acute hepatitis C have been reported in the last decade among men who have sex with men and also are infected with HIV. However, many who either clear the infection spontaneously or through treatment are later reinfected, researchers noted.

“With a high treatment uptake in this population even in the interferon era and with higher response rates to treatment in the acute phase of infection, reinfections are most likely occurring due to maintained risk behaviors,” the study authors wrote in the 

Chronic infection of hepatitis C can lead to cirrhosis and other serious liver damage, including liver cancer. The authors pointed out that for patients with HIV, liver disease is a major cause of morbidity and mortality.

The research team examined more than a decade of data on patients with a documented cure of acute hepatitis C between 2002 and 2014. It included data from eight centers in Austria, France, Germany, and the UK, which are part of the NEAT consortium (European AIDS Treatment Network). Information gathered for the analysis included age, genotype, diagnosis date, as well as the date of cure and whether it was from treatment or spontaneous clearance of the hepatitis C virus and the date of last follow-up visit.

Among the 606 patients, 494 men (81.5%) had achieved sustained virologic response—indicating a cure&mdash;after being treated for the virus with pegylated interferon and ribavirin. One hundred and eleven men (18.3%) cleared the virus spontaneously. Documentation and details were lacking for the remaining one patient.

Results showed that 149 of the 606 men (24.6%) later presented with subsequent hepatitis C infection. In some cases, patients became reinfected for a second, third, or fourth time.

“Thirty out of 70 (43%) who cleared again or were successfully treated, presented with a second reinfection, five with a third, and one with a fourth reinfection,” wrote lead author, Patrick Ingiliz, MD, of the Center for Infectiology in Berlin, Germany, and colleagues. “The reinfection incidence was 7.3/100 person-years (95% CI 6.2—8.6).”

The authors found the incidence of reinfection “alarming” and noted that the study findings underline a need for intervention during follow-up care after a patient is cured of hepatitis C. They recommended prevention strategies such as testing for reinfection of hepatitis C every three to six months among this high-risk group.

“Prevention strategies — both treatment and behavioral – are needed to target high risk groups to reduce morbidity and treatment costs,” the team concluded. “Patients as well as clinicians have to be aware of the specific risk behavior in this setting and counseling should be accompanied by behavioral interventions to avoid reinfections.”

, “HCV reinfection incidence and spontaneous clearance rates in HIV-positive men who have sex with men in Western Europe” appears in the February issue of the 

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Top-line results for an investigational drug regimen proved a 99% success rate for hepatitis C.

Glecaprevir/pibrentasvir is indicated as an eight-week treatment for hepatitis C among patients without cirrhosis. It’s a once daily co-formulation dosed in three tablets, which the pharmaceutical company, AbbVie, has tested in several clinical trials. Glecaprevir is a NS3/4A protease inhibitor and pibrentasvir is a NS5A inhibitor.

AbbVie is seeking review of the regimen in a New Drug Application (NDA) it filed in December with the US Food and Drug Administration (FDA). If granted approval, the drug would offer an eight-week ribavirin-free treatment option for patients with hepatitis C across the six major genotypes of the virus.

Results on the trial, dubbed the Certain-1 study, involved Japanese patients who were chronically infected with genotype 1 hepatitis C and did not have cirrhosis. It is estimated that more than a million people are infected with hepatitis C in Japan, which has one of the highest infection rates of the virus in the industrialized world.

The phase 3 clinical trial showed that 105 out of 106 patients (99%) had sustained virologic response (SVR) 12 weeks after treatment with glecaprevir/pibrentasvir ended; one patient was lost to follow up, according to a company news release. Treatment is considered successful when a patient achieves SVR, an indication that the virus is no longer detectable in the blood.

"Due to patient characteristics and virological considerations, people living with hepatitis C in Japan have specific treatment challenges and needs," Michael Severino, MD, executive vice president, research and development and chief scientific officer of AbbVie, stated in the release.

Among those treated with glecaprevir/pibrentasvir who achieved SVR after eight weeks of treatment, 23 patients had the Y93H variant of the virus, which is associated with reduced cure rates. Japan treatment guidelines recommend that before receiving treatment, some patients involved in a clinical trial get tested for Y93H, an altered amino acid that makes some patients with hepatitis C resistant to first generation NS5A inhibitor-based therapies, a company spokesperson explained.

“The study demonstrated the potential of G/P in patients with specific treatment challenges, including those with the Y93H resistance-associated variant,” AbbVie senior manager of public affairs, Markeisha Marshall, told 

The safety and efficacy of eight weeks of glecaprevir/pibrentasvir regimen with 12 weeks of ombitasvir/paritaprevir/ritonavir, an approved AbbVie hepatitis C drug, which is marketed in Japan under the brand name Viekirax. The company said it met the study’s primary endpoint, which was to show that the investigational drug was not inferior to that of the 12-week comparator regimen.

Among patients with genotype 1 of the virus who did not have cirrhosis and were treated with glecaprevir/pibrentasvir, no one discontinued treatment as a result of adverse events. The most common side effects were inflammation of the throat and nasal passages and itchiness.

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Phase 3 Trial Reveals High Hepatitis C Success Rate with Investigational Drug

Doctors have completed a transplant in the first operation of a clinical trial meant to test use of hepatitis C-infected kidneys as organ donations.

The Penn Medicine clinical trial uses kidneys from deceased donors who were infected with the hepatitis C virus, according to a news release from Perelman School of Medicine at the University of Pennsylvania. The first person in the trial received a kidney transplant in July and then underwent treatment with a regimen of Zepatier, one of the direct acting antiviral drugs approved recently to treat the virus.

The patient’s doctors announced earlier this month that the patient, a woman from East Stroudsburg, no longer has evidence of the virus in her blood. Without the operation, she could have been on an organ donation wait list for as long as five years while undergoing weekly dialysis, the release stated.

The clinical trial is designed to test the safety and efficacy of transplanting kidneys from hepatitis C-positive donors into patients who do not have the virus but are in end-stage renal disease and are on a kidney transplant wait list, the release stated. The trial is being conducted by David S. Goldberg, MD, and Peter Reese, MD, who are assistant professors of Medicine and Epidemiology at Penn.

The doctors noted in the release that currently people who are infected with hepatitis C can only donate organs to other people who also have the virus.

“More than 99,000 Americans are awaiting a kidney transplant,” Reese said in the release. “Yet despite very long waiting times for transplant, hundreds of otherwise good kidneys from deceased donors infected with hepatitis C are discarded each year.”

Hepatitis C virus (HCV) is a bloodborne disease that if left unchecked can seriously damage the liver over time. Part of the study involves treating transplant patients for the hepatitis C virus with Zepatier, which is among the new hepatitis C drug regimens that works faster and have higher cure rates than older, traditional treatments.

The clinical trial is enrolling patients, 40 to 65 years old, who do not have hepatitis C and are receiving chronic dialysis. A rigorous informed consent process includes a discussion on the risk of a participant becoming infected with HCV, which may never clear even after treatment with Zepatier, according to the release.

 “If we can demonstrate that it’s possible to eradicate HCV from patients who contract the virus from a transplant, this approach could open up access to an entirely new pool of donor organs that are currently being discarded,” stated Reese. “Ultimately, our hope is that this trial will show that it is possible, and will then afford far more patients who are on the waiting list an opportunity to receive a lifesaving transplant much sooner.”

Kidney transplants have historically been used to treat patients who are on dialysis as a result of kidney failure. However, thousands of patients who don’t have a relative or matching unrelated donors end up waiting for years for a suitable deceased donor, according to the release.

Only donated kidneys that are infected with genotype 1 HCV will be used in transplants performed in the trial, since the selected drug regimen has a 95% success rate in eradicating that strain of hepatitis C in the general population, according to the release. In addition, measures are in place to ensure that the donated kidneys used for the transplants are of good quality, the release stated.

“While these kidney quality criteria may be more selective than our usual approach to choosing organs, we are aiming to evaluate safety and efficacy in only the most viable organs in this initial pilot phase of the clinical trial,” Goldberg, who is also the medical director for Living Donor Liver Transplantation at Penn, stated in the release. “We realized that the amazing transformation of treatment options for hepatitis C should also transform how we think about organs with hepatitis C. At this very early point in the study, we are pleased with how our first patients have responded to transplantation and antiviral treatment.”

The Penn Medicine clinical trial uses kidneys from deceased donors who were infected with the hepatitis C virus. The first person in the trial received a kidney transplant in July and then underwent treatment with a regimen of Zepatier, one of the direct acting antiviral drugs approved recently to treat the virus.

Catherine Kolonko

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