Showing posts with label International Conference on Viral Hepatitis (ICVH) 2012. Show all posts
Showing posts with label International Conference on Viral Hepatitis (ICVH) 2012. Show all posts

April 3, 2012

ICVH 2012: Highest-Risk Individuals Missed by Current HCV Screening

From Medscape Medical News

Neil Canavan

April 3, 2012 (New York, New York) — An analysis involving more than 30 million medical claims from a commercial insurance provider and from Medicare suggest that current recommendations for hepatitis C virus (HCV) testing are not being followed.

In fact, the adult demographic with the lowest incidence of HCV infection — young women — is the most likely to be tested, according to data presented here at the International Conference on Viral Hepatitis 2012.

"The CDC is looking at changing the HCV guidelines to mandate a 1-time HCV antibody test for everybody born between 1945 and 1965," said lead analyst Camilla Graham, MD, who is vice president of global medical affairs for Vertex Pharmaceuticals.

Recent studies have suggested that the 1945 to 1967 birth cohort accounts for 81% of all people diagnosed with HCV infection. "This study was done to look at who is actually getting tested for HCV in the United States under current risk-based screening recommendations."

The analysis was performed using records from the Thomson Medstat MarketScan commercial database, a resource comprising medical and outpatient pharmacy claims from employer-sponsored health insurance plans and including more than 30 million commercially insured and 3 million Medicare supplemental-insured individuals. Claims made from 2004 to 2008 were used for this study.

People who had undergone HCV testing were identified on the basis of Current Procedural Technology codes for HCV antibody or HCV RNA testing, birth cohort, and sex. People diagnosed with HCV infection after testing were identified with International Classification of Diseases, Ninth Revision (ICD-9) codes. "Filters were also employed to find people newly identified with HCV as of 2008," said Dr. Graham, "to get a sense of diagnosis trends."

For 2008, only 1.1% of individuals in the payer population and 1.7% in the Medicare population had been tested for HCV. "This is actually an increase from 2004, and a maximum for the study period," Dr. Graham noted.

"When we look at the commercial database, we see that there are more women being tested than men [62% vs 38% in 2008]," she said. The sex distribution in the Medicaid population was about even for men and women (51% vs 49%).

Although this finding seems balanced on the surface, data continue to accrue showing that men have higher exposure to HCV and a greater likelihood of having chronic HCV infection. Of the currently identified 800,000 HCV-related cases of cirrhosis in the United States, 75% are men.

Current testing practices do not reflect actual rates of HCV infection as indicated by birth cohort, Dr. Graham said. Only 32.8% of people born from 1945 to 1964 have been tested, even though this cohort has the highest rate of infection. In contrast, 48.2% of people born from 1970 to 1989 have been tested, although their rate of HCV infection is known to be much lower.

"Interestingly, in this younger group, almost twice as many women as men are being tested," she said.

An analysis of HCV diagnosis during the study period illustrates a displaced diligence in HCV screening. "When we look at the people who were actually diagnosed, young women have a much lower prevalence than older men."

For the birth period of 1945 to 1954, 3.5% of women and 7.4% of men were diagnosed with HCV. For 1955 to 1964, 2.9% of women and 5.7% of men were diagnosed with HCV.

"Medicare is a more complicated population," because some patients are enrolled on the basis of disability rather than age, said Dr. Graham. "But again, you see a shockingly high prevalence of HCV in men." Medicare data show that 16.1% of men and 10.4% of women in the 1945 to 1954 cohort and 19.1% of men and 13.3% of women in the 1955 to 1974 cohort are HCV-positive.

"Is Medicare aware of this serious HCV problem as the leading edge of the boomers are entering the program?" she wondered.

The precise reason for the tilt toward the more prevalent HCV testing of women is not known, but Dr. Graham speculated that the driver is prenatal testing.

Findings "Not a Surprise"

"I've looked at the data from my own institution," said Natalie Kil, MPH, project manager in the division of general internal medicine at Mount Sinai Hospital in New York City. "I can tell you that it is not at all common for a primary care doctor to order a routine hep C test. They're only doing it by way of known risk factors, and most clinicians, from my understanding, are not really asking about risk factors."

Through Kil's involvement in Mount Sinai's community outreach program to help identify HCV-infected individuals, she has noted no small measure of misplaced trust.

"We find that when we go out and do hep C testing, most people who are in care somewhere, who have a regular primary care doctor, think that they have already been tested. People say, 'Oh my doctor is wonderful, he tests me for everything,' but you can see from these data that this is simply not happening," Kil explained.

Dr. Graham is an employee of Vertex Pharmaceuticals. Ms. Kil has disclosed no relevant financial relationships.

International Conference on Viral Hepatitis (ICVH) 2012: Abstract 79332. Presented March 26, 2012.

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March 30, 2012

ICVH 2012: Boceprevir, Interferon Alfa-2a, Ribavirin Effective in HCV

From Medscape Medical News > Conference News

Neil Canavan

March 30, 2012 (New York, New York) — Peginterferon alfa-2a, in combination with the protease inhibitor boceprevir and ribavirin (R), was shown to have efficacy equivalent or superior to that seen with historical use of the same regimen with peginterferon alfa-2a — the standard of care — for treating hepatitis C virus (HVC) infection, according to data reported here at the International Conference on Viral Hepatitis (ICVH) 2012.

These results provide a definitive rationale for the inclusion of the alfa-2a interferon variant in the treatment regimen, allowing for greater ease of administration by the patient infected with HCV.

"This is the first trial in which peginterferon alfa-2a was used as a backbone instead of alfa-2b," said study investigator John Howe, PhD, senior principal scientist, Merck & Co., Inc, Whitehouse, New Jersey.

In a previous study of the combination with alfa-2b, the RESPOND-2 (Retreatment with HCV Serine Protease Inhibitor Boceprevir and PegIntron/Rebetol 2) trial, patients who were previously nonresponders or had relapsed after treatment with ribavirin and interferon alfa-2b showed significant improvement in sustained viral response (SVR) with the addition of boceprevir (66% vs 21% for controls).

The current investigation was a double-blind, placebo-controlled study that randomly assigned 201 HCV genotype-1 relapsers and nonresponders in a 1:2 fashion to 1 of 2 treatment groups. Treatment group 1 received 4 weeks of peginterferon alfa-2a and ribavirin followed by 44 weeks of placebo plus ribavirin plus peginterferon alfa-2a (standard of care). Treatment group 2 received 4 weeks of ribavirin plus peginterferon alfa-2a followed by boceprevir plus ribavirin plus peginterferon alfa-2a for 44 weeks.

Therapy was discontinued in both treatment groups if HCV RNA was undetectable at week 12 (defined as HCV RNA level of 9.3 IU/mL).

Results showed a superior efficacy for the boceprevir combination; 64% of patients achieved an SVR as compared with 21% in the control group (P < .0001).

The rate of relapse with the protease inhibitor combination, 12%, was lower than that with the standard of care, 33% (P value not reported).

"These results are consistent with RESPOND-2," said Dr. Howe.

Reasons for a non-SRV outcome in the boceprevir/peginterferon alfa-2a/ribavirin treatment group for a total of 44 patients were as follows: viral breakthrough on treatment after initially being undetectable for 1 patient; incomplete virologic response for 4 patients; relapse after treatment for 11 patients; and nonresponse for the remaining 28 non-SVR patients (this figure includes patients who discontinued treatment for any reason).

Samples from 33 of 44 patients who received boceprevir/peginterferon alfa-2a/ribavirin who did not achieve SVR were subjected to sequence analysis of postbaseline resistance-associated variants (RAVs). This analysis revealed that 8 of the 33 patients had RAVs; the total included 1 patient with viral breakthrough, 3 patients who had incomplete responses, 2 patients who relapsed, and 2 nonresponders.

By resistance locus, overall RAV profiles were similar to those in all other studies in which peginterferon alfa-2b was used as part of an HCV treatment combination. "The resistance data collected in this trial are consistent with results reported in SPRINT-2 and RESPOND-2," said Dr. Howe.

Treatment Choices With HCV

"I believe that these two interferons [alfa-2a, alfa-2b] are similar," commented Ayse Aytaman, MD, chief of gastroenterology and hepatology, Veterans Affairs New York Harbor Health Care System, Brooklyn, New York. "But we use the alfa-2a more commonly because it's easier for the patient. It is a prepared syringe, you don't have to give weight-based dosing, and it comes in different dosages. It is much simpler. It's particularly good for patients who have trouble understanding instructions."

As for choosing between the 2 new protease inhibitors now at her disposal (boceprevir and telaprevir), "We are trying to learn how to deal with them," she said. "Yes, they are very potent, but they have a lot of side effects."

Before adding interferon on top of a protease inhibitor, Dr. Aytaman cautioned that there are some patients for whom the physician may want to wait for better pharmacologic options before treating.

"When I look at a patient who is 60 years old, I have to consider that I'm going to take a year out of this person's life with them coming to me weekly, or biweekly, injecting himself, being miserable with flu-like symptoms… Why?" Even if the patient has early-stage cirrhotic disease, Dr. Aytaman is willing to wait for an all-oral HCV treatment combination with fewer side effects.

If she has to choose between the protease inhibitors available now, side effect profile is one consideration; cost is another.

"There is a huge cost difference. Telaprevir, even though it's only [given] for 3 months, is much more expensive than boceprevir. If it wasn't for that, every hepatologist I know would go for telaprevir because it's so much simpler, with a much shorter duration of treatment."

"The reality is, I'm given a budget to treat patients. If I can treat more patients for fewer dollars, I will," said Dr. Aytaman, "That said, I do use both. Most of my patients get boceprevir, but for previous null responders, or if I'm anticipating significant anemia or cytopenia, I go for telaprevir."

Dr. Howe is an employee of Merck & Co. Dr. Aytaman has disclosed no relevant financial relationships, and her opinions are expressed as a physician, not as an employee of the US government.

International Conference on Viral Hepatitis (ICVH) 2012. Abstract # 79317. Presented March 26, 2012.

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March 28, 2012

ICVH 2012: Next-Generation HCV Protease Inhibitor Shows Promise

From Medscape Medical News

Megan Brooks

March 28, 2012 (New York, New York) — In vitro data on a next-generation hepatitis C virus (HCV) NS3/4A protease inhibitor garnered considerable interest here at the International Conference on Viral Hepatitis 2012.

MK-5172, being developed by Merck & Co, demonstrated "potent activity" against the majority of primary first-generation protease inhibitor resistance-associated variants (RAVs) in biochemical and cell-based phenotype assays, reported Richard J. Barnard, PhD, from Merck & Co.

MK-5172 also inhibited patient-derived NS3 proteases across HCV genotypes and retained activity against HCV proteases isolated from 5 patients with vaniprevir RAVs.

In his presentation, Dr. Barnard noted that virologic failure with first-generation protease inhibitors is often associated with the emergence of RAVs; it is important that next-generation molecules are pangenotypic and active against first-generation protease inhibitor RAVs. "MK-5172 fulfills the profile expected of a next-generation" HCV protease inhibitor, he said.

Douglas T. Dieterich, MD, professor of medicine from the division of liver diseases at Mount Sinai School of Medicine in New York City, who was not involved in the study, told Medscape Medical News that "MK-5172 represents a promising potential best-in-class second-generation protease inhibitor."

"MK-5172 is a truly second-generation protease inhibitor," he explained. "This is really good news for the people who have already failed treatment with a first-generation protease inhibitor."

MK-5172, Dr. Dieterich said, "has activity against the most common resistance mutations caused by telaprevir and boceprevir. Even more encouraging for global use, it is active against genotypes 1, 2, 4, 5, and 6."

Dr. Barnard reports being an employee of Merck & Co and owning stock in the company. Dr. Dieterich reports financial relationships with Bristol-Myers Squibb, Gilead Sciences, Roche Laboratories, and Boehringer Ingelheim.

International Conference on Viral Hepatitis (ICVH) 2012: Oral Abstract: 79340. Presented March 26, 2012.

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ICVH 2012: Study Supports Need for HCV Testing Guidance

From Medscape Medical News

Megan Brooks

March 28, 2012 (New York, New York) — In the United States, testing for hepatitis C virus (HCV) infection is happening most often in the people least likely to be infected with the virus, according to a study presented here at the International Conference on Viral Hepatitis 2012.

"Hepatitis C is primarily a disease of older men, but they aren't the ones actually getting tested. The majority of testing is happening in young women. I'm not sure anyone has ever shown this before," study presenter Camilla S. Graham, MD, MPH, from Vertex Pharmaceuticals in Cambridge, Massachusetts, told Medscape Medical News.

There is a need for targeted age-based guidelines for HCV testing, Dr. Graham said. Roy M. Gulick, MD, from Weill Cornell Medical College in New York City, agrees. "Focused testing for hepatitis C makes sense," he told attendees during his keynote address. HCV testing recommendations are currently being developed by the US Centers for Disease Control and Prevention.

Wrong Sex, Wrong Age Group

An estimated 4.1 million Americans (1.6% of the population) are infected with HCV; the majority of these individuals were born between 1945 and 1965. Dr. Graham said the goal of her study was "to see who exactly is being tested in the United States right now."

She and her colleagues analyzed HCV testing and diagnosis rates in the commercially insured and Medicare populations from 2004 to 2008 using the Thomson Medstat MarketScan commercial database and the Medicare 5% database.

They identified individuals tested for HCV using outpatient claims with Current Procedural Terminology codes for anti-HCV antibody or HCV RNA diagnostic tests. They used International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) diagnosis codes to identify individuals diagnosed with HCV infection.

They found that in 2008, the HCV testing rate was 1.1% in the commercially insured population and 1.7% in the Medicare population, which might explain the high proportion of undiagnosed individuals, the researchers say.

"Overall, practically nobody was getting tested, although it went up from 2004 to 2008. There are other data to support this level of testing in the United States," Dr. Graham noted.

Only 32.8% of the tests were performed in baby boomers born between 1945 and 1965, who are at the highest risk for HCV infection; 48.2% of HCV tests were performed in individuals born between 1970 and 1989.

"Eighty-one percent of people with hepatitis C in this country were born between 1945 and 1965, but we found that only a third of the tests were actually happening in that age group," Dr. Graham told Medscape Medical News. "Conversely, younger people had almost half of the tests."

In the younger (commercially insured) population, women were more likely than men to be tested; 62.0% of HCV tests were performed in women, most of whom were in their reproductive years. In the Medicare population, testing was more evenly distributed between men and women.

As expected, rates of diagnosis were consistently higher in the older (Medicare) population — the baby boomers — than in the younger population. They were also higher in men.

Women and men born between 1970 and 1989 had a 0.45% and 1.18% rate, respectively, of HCV diagnosis after testing. "Almost none of these young women had hepatitis C," Dr. Graham noted. "But when you look at the baby boomer men, between 5.7% and 7.4% of them had hepatitis C."

Help on the Way

Dr. Graham noted that "an estimated 800,000 people in the United States have cirrhosis. Within the next 10 years, it will be about 1 million people, and 75% of those people are men. Men are disproportionately likely to have hepatitis C and disproportionately more likely to develop severe fibrosis with hepatitis C."

"Clearly, we need a lot of education on who to test for hepatitis C," Dr. Graham said, adding that the forthcoming age-based screening guidelines for HCV testing should help. "The focus will be on people born between 1945 and 1965 who are at highest risk for the infection. We should have them sometime this year," Dr. Graham said.

Dr. Graham reports being an employee and stock owner of Vertex Pharmaceuticals, which commissioned the study. Dr. Gulick reports financial relationships with Bristol-Myers Squibb, Gilead Sciences, Janssen Pharmaceuticals, Merck & Co., and ViiV Healthcare.

International Conference on Viral Hepatitis (ICVH) 2012: Abstract 79332. Presented March 27, 2012.

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March 27, 2012

ICVH 2012: Eliminating HIV/HCV Among Injection Drug Users Is Possible

From Medscape Medical News

Megan Brooks

March 27, 2012 (New York, New York) — Scaling up prevention and treatment programs will help control and possibly eliminate the transmission of HIV and hepatitis C virus (HCV) among people who inject drugs, according to a poster abstract presented here at the International Conference on Viral Hepatitis 2012.

"With prevention efforts like syringe exchange, drug dependence treatment, and treatment for hepatitis C and HIV, we really have the potential to either eliminate transmission of those viruses among people who inject drugs or get it down to close to trivial levels," study author Don C. Des Jarlais, PhD, noted in an interview with Medscape Medical News. Dr. Des Jarlais is director of research at the Rothschild Chemical Dependency Institute, Beth Israel Medical Center, in New York City.

"People who inject drugs are at very high risk of infection with HIV and hepatitis C," Dr. Des Jarlais explained. "Is it going to be possible to eliminate HIV and HCV in people who inject drugs? We did a literature review and meta-analysis looking specifically at combined prevention and treatment and concluded that yes, it is certainly conceivable to eliminate transmission of those viruses among people who inject drugs," he said.

Moving in the Right Direction

Current estimates put the number of injection drug users at 16 million. Of these, 10 million are HCV-seropositive and 3 million are HIV-seropositive. Most live in low/middle-income countries; however, there has been a recent increase in new injectors in the United States, the researchers report. The estimated incidence of HCV infection ranges from 10 to 40 per 100 person-years; for HIV, it ranges from approximately 0.5 to 10.0 per 100 person-years.

On the basis of their analysis, Dr. Des Jarlais and colleagues estimate that combined prevention programs — particularly needle-exchange programs, drug dependence treatment, counseling, and testing — should be able to reduce HIV incidence to less than 0.5 per 100 person-years.

If this were the case, it would be "providing effective control," he said. The same programs applied to HCV could reduce incidence to 2.5 to 5.0 per 100 person-years, they report.

They also say that treatment for HCV infection, including new direct-acting antivirals, "might substantially reduce HCV transmission below these levels, but would be required on a large-scale basis, with 70% or more of currently infected persons treated."

"It's going to take prevention efforts like syringe exchange, pharmacy sales of syringes, and providing treatment for drug dependence," Dr. Des Jarlais said. "We are moving in that direction; certainly the new direct-acting antivirals are a huge advance. Without them, one wouldn't really consider the likelihood of treating large numbers of people who are infected with hepatitis C because the old treatments were really not that good," he told Medscape Medical News.

He also noted that although "many more people are getting screened, there are still a lot of gaps in getting someone screened, evaluated, and successfully treated. There is a big fall off at each of those steps."

Dr. Des Jarlais has disclosed no relevant financial relationships.

International Conference on Viral Hepatitis (ICVH) 2012: Poster abstract 79359. Presented March 26, 2012.

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