Hepatitis C eradication by direct-acting antivirals improved carotid atherosclerosis in patients with severe fibrosis regardless of the presence of additional metabolic risk factors, according to recently published data.

"Emerging data ... support a link between HCV infection and cardiovascular alterations," Salvatore Petta, MD, PhD, from the Università di Palermo, Italy, and colleagues wrote. "In our cohort of HCV patients with severe fibrosis and, in two-thirds of cases, compensated cirrhosis, HCV eradication by DAA improved carotid atherosclerosis in terms of reduction of both [intima-media thickness (IMT)] and carotid thickening."

The study comprised 182 patients with advanced chronic HCV or compensated cirrhosis due to HCV who underwent DAA therapy. As controls, Petta and colleagues reviewed data of 76 patients with HCV who previously underwent observation for atherosclerosis progression and had not undergone DAA therapy.

"Concerning this topic, available results on cohorts of patients who underwent [interferon]-based therapies are very controversial, ranging from no impact of liver fibrosis to an improvement in cardiometabolic prognosis, to a more pronounced effect in patients with mild disease or in patients with advanced fibrosis/cirrhosis," Petta and colleagues wrote.

Among the study cohort, 14% were obese, 41.8% had hypertension, 20% had diabetes and 42.9% had carotid thickening and carotid plaques. Mean IMT was 0.94 mm.

The researchers observed that older age was independently linked with carotid thickening (OR = 1.07; 95% CI, 1.03-1.1) and both older age (OR = 1.04; 95% CI, 1.01-1.08) and lower platelets (OR = 1; 95% CI, 1-1.01) were risk factors for carotid plaques.

From baseline to follow-up at 9 months to 12 months, mean IMT decreased significantly after patients achieved sustained virologic response with DAA therapy (0.94 vs. 0.81 mm; P < .001). The researchers also observed a significant reduction in the proportion of patients with carotid thickening (42.8% vs 17%; P < .001).

Blood glucose levels improved in both patients with (134.7 vs. 90.7; P < .001) and without (95.7 vs. 88.6; P < .001) diabetes. Some patients with diabetes achieved a reduced need for insulin or oral antidiabetic drugs.

In a subgroup analysis, the researchers found that IMT and carotid thickening (IMT > 1 mm) improved significantly in patients younger than 65 years (P = .001) and those older than 65 years (P < .001), patients without obesity (P < .001), both smokers (P= .003) and nonsmokers (P < .001), patients with (P = .007) and without diabetes (P< .001), patients with (P = .002) and without hypertension (P < .001), and patients with (P = .03) and without hypercholesterolemia (P < .001).

"We found that SVR by DAA leads to reduction in IMT and in the prevalence of patients with carotid thickening at risk for cerebro-cardiovascular events, while no changes were observed in untreated patients," the researchers concluded. "We also found that the effect of SVR on carotid atherosclerosis was maintained independently of the severity of liver damage - cirrhosis vs. advanced fibrosis and lower vs. higher platelet values." - by Talitha Bennett

Disclosure: The authors report no relevant financial disclosures.

So, it seems HCV cures are good, for everyone, on many levels!   C.

Treating recipients of a kidney from a donor with HCV with direct-acting antiviral medications before and after transplantation is safe and prevents chronic HCV infection, according to findings published in Annals of Internal Medicine.

"Right now, most of the usable organs from donors with hepatitis C are discarded because there are very few hepatitis C-positive recipients on the waiting list," Niraj Desai, MD, from Johns Hopkins University School of Medicine, said in a press release. "Figuring out how to use these kidneys is a way to do more transplants and save more lives."

Desai and colleagues conducted an open-label nonrandomized trial to investigate whether using direct-acting antivirals before and after kidney transplant from donors with HCV to recipients without HCV is feasible and well-tolerated.

The researchers enrolled 10 patients aged 50 years or older without HCV who received a kidney transplant from a deceased HCV-positive donor. Immediately before transplantation, patients received a dose of Zepatier (100-mg grazoprevir/50-mg elbasvir, Merck).

Participants who received kidneys from donors with genotype 1 infection continued to take grazoprevir/elbasvir after the transplantation for 12 weeks. Recipients of kidneys from donors with genotype 2 or 3 infection took 400 mg of Sovaldi (sofosbuvir, Gilead Sciences) in addition to the combination of grazoprevir/elbasvir for 12 weeks.

Data showed that adverse events attributable to treatment were not experienced by any of the transplant recipients. After the 12 weeks of treatment, there was no evidence of HCV RNA found in any participants.

"In this era of organ shortages, it's difficult to watch good organs get discarded," Christine Durand, MD, coauthor of the study from Johns Hopkins University School of Medicine, said in the release. "This was a great opportunity to take a neglected public health resource and put it to good use."

The researchers noted that if these results are confirmed in larger studies, using this method for transplantation could significantly increase organ options and decrease mortality risks. - by Alaina Tedesco

Disclosure: Durand reports receiving grants from Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Merck Sharp and Dohme Corp., GlaxoSmithKline and ViiV Healthcare, and personal fees from Bristol-Myers Squibb, Gilead Sciences and Merck Sharp and Dohme Corp. Please see study for all other authors relevant financial disclosures.

Tom West

Hologic Inc. announced today that the FDA has granted premarket approval to the company’s Aptima HBV Quant Assay. 

The assay is designed to measure hepatitis B virus DNA across all major genotypes, according to a press release. It uses a dual-target approach for accurate quantification over a broad linear range (from 10 IC/mL to 1 billion IU/mL) and can tolerate various mutations in the HBV genome. 

The Aptima HBV Quant Assay is the newest viral load assay that runs on the Panther system, which provides sample-to-result automation, the release said. It can be used in parallel with the Aptima HCV Quant Dx Assay for hepatitis C virus and the Aptima HIV-1 Quant Assay, which recently received WHO prequalification status. 

“This approval represents a milestone for Hologic’s growing virology assay menu,” Tom West, president of the Diagnostic Solutions Division at Hologic Inc., said in the release. “We now have available on a single system the three major viral load assays that most laboratories are asked to run for patients.” 

Other assays that run on the Panther system can test for chlamydia, gonorrhea, trichomonas, HPV and herpes simplex virus. 

“We hear repeatedly from clinical laboratory customers that menu consolidation is a top priority,” West said in the release. “Offering a robust virology and women’s health menu on a single automated platform will enable them to reach their efficacy goals.” 

Disclosure: West is an employee of Hologic Inc

Reference Article

Australia, Brazil, Egypt, Georgia, Germany, Iceland, Japan, the Netherlands and Qatar are on course to eradicate hepatitis C by 2030, according to data presented at the World Hepatitis Summit in Brazil. 

“This new data shows that elimination of hepatitis C is possible. It also shows more must be done to support governments in tackling viral hepatitis,” Charles Gore, president of the World Hepatitis Alliance, said in a press release. 

At this year’s summit, Brazil, Egypt, Australia and Georgia were given special attention for their work to eliminate viral hepatitis. Egypt is committed to screening 30 million people for HCV before 2019 and mass produce generic versions of direct-acting antivirals (DAAs) to lower costs of treatment (less than $200 per 12-week course), according to the release... (cont)

WASHINGTON — Reaching sustained virologic response with direct-acting antivirals reduced the occurrence of hepatocellular carcinoma by 71%, but all treatments that cleared the virus saw a similar reduction in risk, according to a presenter at The Liver Meeting 2017. 

“Our results show that DAA-induced SVR is associated with a 71% reduction in HCC,” George N. Ioannou, MD, from the University of Washington, said in his presentation. “Eradication of HCV is associated with a similar reduction in HCC  irrespective of the regimen used to achieve that eradication.

Link to Healio article

Cost, insurance and apprehension of side effects were the leading barriers to hepatitis C treatment, according to results from a recent survey of individuals either cured or not cured of HCV.

Sara Hayes

Hepatitis C in America was the third annual survey by Health Union and primarily included community members from HepatitisC.net. The survey design was to evaluate the community’s perceptions of HCV and HCV treatment, how those perceptions may have changed over time, and to engage newly diagnosed people.

“We find that these are a lot of the questions they want to be asked because they might not be asked these questions by anybody else and they like to see how they stack up against others,” Sara Hayes, MPH, Senior Director of Community Development at Health Union, told Healio.com/Hepatology. “It’s nice to take a survey, see the results, and say, ‘Wow, I thought I was the only one experiencing this’ — to know that a large percentage of other people, in your community, are going through exactly what you’re going through.”

From May 3 to June 26, 2017, 296 individuals cured of their infection and 313 individuals with current HCV infection responded to the survey. Most respondents were women aged between 50 and 60 years, or the baby boomer generation.

While 62% of respondents were aware of HCV prior to their diagnosis, 33% were unaware of what the infection was. Of the 55% who knew how they were infected, 47% reported current or previous injection drug use.

Thirty-nine percent of the respondents received an HCV diagnosis due to a health care provider recognizing related symptoms. Other respondents received a diagnosis after routine medical exams (31%) or after they donated blood (14%). Fatigue was the most common symptom among both respondents who were cured (79%) and not cured (85%). Fatigue (70%), depression (69%) and anxiety (63%) affected respondents’ daily lives the most.

Barriers to treatment

Most of the respondents not cured said they actively seek out information on the latest treatments and play an active role in treatment decisions for their HCV. However, 52% of the uncured respondents have yet to receive treatment and 33% received treatment in the past but are no longer on treatment.

“Upon diagnosis, one of the top concerns that respondents had was how they were going to afford treatment in addition to how it would affect their body,” Hayes said. “There is a large percentage who reported they’re not sure what their next step is, and they don’t really have any plans. Anecdotally, based on what we see in the community, there are a lot of people who have a bit of hopelessness and feel they may never be able to access a life-saving cure for them.”

Respondents who have not yet received treatment said they are worried they cannot afford treatment (53%), their insurance provider denied coverage for HCV treatment (25%), they have not decided with their doctor what course to take (19%), or they are worried about the potential side effects of treatment (19%).

Of those who received HCV treatment, either cured or not cured, 28% stopped treatment early. The reason for 40% of those who stopped early was drug-related side effects. Overall, 148 respondents reported they had received treatment but were not cured.

“When treatment fails, there’s both an emotional and physical toll that it takes on people,” Hayes said. “It can be really brutal to go through a whole treatment regimen and really get your hopes up and then hear that you haven’t cleared the virus. There are some open-ended responses and one respondent wrote that when the virus came back after treatment, ‘I had never been so depressed in my life.’”

Education and awareness

Among 52% of the respondents who said they had never used manufacturer-sponsored financial support programs, 37% were unaware that those programs existed for HCV.

Most of the uncured respondents (69%) were interested in HCV clinical trials as means to benefit themselves (67%) and benefit others (60%), because it may be the only way they can receive treatment (55%), or because it may be the only way they can afford treatment (47%).

Educational topics that most interested respondents included complications related to HCV, long-term outcomes, related symptoms, new HCV treatments, and managing the infection.

Resources respondents turned to most often included health care professionals (62%), HCV-specific websites (56%), internet searches (46%), general health websites (28%), and social media outlets (26%).

Respondents also listed community as an important resource, as most of those cured (93%) said they still feel like they are part of the HCV community and 30% continue to engage in community activities such as support groups, liver walks, and work with the American Liver Foundation.

According to Hayes, while recent awareness efforts have been successful, she was concerned that a focus on risk factors, such as injection drug use, could affect outreach. “It’s important for both the general public and health care professionals to be aware that a risk factor someone had for a very short amount of time 30 years ago could influence what’s going on in their health today.

“It’s really an emotional battle that many are going through because there is still so much stigma that surrounds hepatitis C,” Hayes concluded. “If we could see people for who they really are, beyond just the condition or what the label represents to you, it’s important to really see people for what their struggle is and not necessarily what the condition represents.” – by Talitha Bennett

Reference: Health Union. Hepatitis C in America 2017 Findings. July 2017. Accessed October 11, 2017.