HCV New Drugs And Liver Health

DDW 2013 - New Direct-Acting Antivirals Promising for Hepatitis C Treatment

2013-05-20T19:01:00.000-04:00

New Direct-Acting Antivirals Promising for Hepatitis C Treatment

By Debra Wood, RN | May 20, 2013

Antiviral hepatitis C drugs on the horizon could spur more people to accept treatment and improve patient outcomes, Andrew J. Muir, MD, MHS, associate professor of medicine and clinical director of hepatology at Duke University in Durham, NC, reported at Digestive Disease Week 2013, held May 18-21, 2013, in Orlando, Fla.

“It’s a great time in hepatitis C and for telling patients the great things that are going to come to help them,” Muir said.

According to Muir, approximately 3.2 million people have hepatitis C, and about half of the cases have been detected while one third have been referred to care. Only 5 percent to 6 percent of patients have been successfully treated, Muir said.

“I hope the new drugs and response rates will bring people out,” Muir said. “We need to be proactive to make that happen.”

The Centers for Disease Control and Prevention has recommended screening baby boomers for hepatitis C, but the U.S. Preventive Services Task Force has been less enthusiastic, issuing a Grade B recommendation for people at risk and a Grade C recommendation for people at average risk who were born between 1945 and 1965.

Muir indicated the field has been held back by the inability to prove treatment has saved lives. However, more recent studies have shown reductions in liver-related mortality and transplants.

“There is proof that effective treatment leads to improved clinical outcomes,” Muir said, later adding that “sustained virologic response rates show we can cure most people.”

But Muir noted there are still issues with side effects and treatment duration, which is currently 24 to 48 weeks. Muir called the infection rate found in the CUPIC (Compassionate Use of Protease Inhibitors in Cirrhotics) trial concerning, as more than half of the patients who had compensated cirrhosis and were taking the three drug regimen of pegylated interferon/ribavrin and telaprevir or boceprevir experienced a serious adverse event.

“The infection often began a cascade that led to their demise,” Muir said. He continues to use the therapies but indicated he has changed how he counsels patients to avoid scaring them off. Also, the U.S. Food and Drug Administration (FDA) has added a black box warning to telaprevir related to patients dying after a progressive rash and systemic symptoms.

The OPTIMIZE trial assessed whether a twice-daily regimen of telaprevir was as effective as a thrice-daily regimen when both are administered with pegylated interferon/ribavrin, and it found a similar outcome. Muir called twice-daily dosing a “reasonable option” for patients challenged by the thrice-daily regimen, though he cautioned that the FDA has not yet approved it.

Reporting on three new drugs — simeprevir, faldoprevir, and sofusbuvir — Muir noted, “We are starting to get more drugs demonstrating nice potency.” Clinical trials are also under way on interferon-free regimens. Since many patients continue to hold off on starting treatment because they are waiting for new options, Muir recommended educating them about liver wellness. For patients with significant liver disease, he suggested clinicians discuss benefits and risks and document the session.

With more treatment options in the pipeline, Muir called it an “amazingly wonderful time to be a physician in a liver clinic,” because patients have options and most who receive treatment can live well for years.

“Bottom line: Interferon-free treatments are at hand and just around the corner,” moderator Adrian M. Di Bisceglie, MD, FACP, FACP, Bander chair of internal medicine and chief of hepatology at the Saint Louis University School of Medicine, in Missouri, said after the session. He expects approvals for some uses as soon as the end of the year.

“When we have that, it will transform how we think about the treatment of hepatitis C,” Di Gisceglie added. “An easy, one- to two-drug treatment regimen — that’s what we are looking forward to.” -

See more at: http://www.hcplive.com/conferences/ddw-2013/New-Direct-Acting-Antivirals-Promising-for-Hepatitis-C-Treatment

View Additional DDW Conference Coverage @ HCPlive

What About Us? - Hepatitis C Treatment Advances But Leaves Some Parts of the World Behind

2013-05-20T12:42:00.001-04:00

Journal of Viral Hepatitis

What About Us?

Recent Advances in the Treatment of Chronic Hepatitis C Threaten to Leave Some Parts of the World Behind

F. AhmedDisclosures

J Viral Hepat. 2013;20(5):367-368.

Directly acting antiviral (DAA) agents are currently revolutionizing the treatment of chronic hepatitis C infection. The first generation of these agents have significant limitations including cost issues that are of particular concern in the developing world and a lack of efficacy in genotype 3 patients. Both of these concerns are of particular relevance in Pakistan.

One cannot attend any major international liver conference over the past 1 year and not be struck by the vast array of new directly acting antiviral (DAA) agents currently in the pipeline. Telaprevir and boceprevir have already been licensed for use in Western countries. Although these and other agents will revolutionize the treatment of chronic hepatitis C, these advances threaten to leave some parts of the world, the developing world in particular, and a large proportion of the world's hepatitis C burden, behind.

Pakistan is a case in point. Recent epidemiological data suggest that 4.9% of the Pakistani populace is chronically infected with hepatitis C.^[1] With an overall population estimated at 180 million, this translates into approximately 9 million hepatitis C patients. On a positive note, >65% of these infections are genotype 3. But many patients struggle to pay for the 6-month course of standard interferon-based therapy; some having to sell their jewellery, homes and livestock to do so. The fivefold price difference between standard and pegylated interferon is an insurmountable hurdle for many patients here, where health insurance does not exist and where the average person makes $650 per year. Owing to cost considerations and comparable efficacy, the Pakistan Society of Gastroenterology recommends that the first-line therapy for these genotype 3 patients be standard interferon and ribavirin. A genotype 3 predominance, however, may also have a downside given that recent studies have suggested the genotype 3 is associated with accelerated fibrosis progression.^[2] This is particularly consequential in a developing country, like Pakistan, where no liver transplantation program exists and where most cirrhotics lack the resources to travel abroad for liver transplant.

Where will these new DAA agents fit into the picture here? The minority of patients who have genotype 1 and those with genotype 3 who do not respond to conventional therapy could be considered candidates for newer therapies. However, given that patients here often struggle to pay for interferon-based therapy, the ability to pay for a third additional agent seems unlikely at best. Even if money was not an issue, in Pakistan, at least, the applicability of the first generation of direct-acting antiviral agents that have hit the market would be limited at best. In contrast to their spectacular results in hepatitis genotype 1 patients, telaprevir and boceprivir have limited activity against genotype 3.^[3] It is still unclear whether other agents in development will have the same genotype barriers seen with telaprevir and boceprevir. Preliminary data suggest good activity against genotype 3 of nucleoside polymerase inhibitors and cyclophilin inhibitors, but not non-nucleoside polymerase inhibitors.^[4]

Are there lessons to be learnt here? First of all, it highlights the need in Pakistan and other parts of the developing world to focus on prevention. If we cannot afford to treat these infections, perhaps the wiser approach is to try and prevent them from occurring in the first place. The vast majority of hepatitis C infections in Pakistan occur because of unsafe injections.^[5] This phenomenon has also been recognized in other parts of the developing world.^[6] We need to do a better job in maximizing the outcomes from the existing interferon and ribavirin regimen. Finally, hepatologists in developing countries need to do a better job of leveraging their hepatitis C patient volumes into clinical trials and perhaps drug development that is more relevant to their unique clinical scenarios.

A scenario may develop where hepatitis C is largely eradicated from the developing world but exits in large pockets in developing countries. Given current patterns of human migration, however, increasing numbers of these hepatitis C patients could be projected to arrive on the shores of Europe and North America.^[7] Chronic hepatitis C is a truly global problem and needs to be addressed as such. Furthermore, if the treatment of hepatitis C evolves into a multidrug antiviral combination^[8] similar to that for HIV, it is not difficult to foresee struggles over patents and intellectual property rights analogous to those that occurred in Sub-Saharan Africa in the 1990s and the early part of this decade over HIV drugs.

Explore efficacy data

From my perspective, sitting in my office in Karachi, Pakistan, the new directly acting antiviral agents represent an exciting leap forward in the field of hepatitis C virology but are not obviously clinically relevant to my practice. Issues relating to cost, access and applicability will affect hepatologists in the developing world, in particular, in the coming years. Further advances in this field need to take into account the global hepatitis C burden. Perhaps most importantly, a greater emphasis on prevention is needed. My colleagues and I need to do a better job of marketing our 9 million Pakistani hepatitis C patients to make them more attractive to drug companies involved in new drug development and international aid donors, as do hepatologists in other parts of the developing world. For now, I will have to be content with marvelling at the science behind these new discoveries and envy those hepatologists who have access to new tools in the fight against this global menace.

Source - Medscape

SCOTLAND'S APPROACH TO FIGHTING HEPATITIS C

2013-05-20T11:45:00.000-04:00

SCOTLAND'S APPROACH TO FIGHTING HEPATITIS C

The Wall Street Journal has an in-depth article about how Scotland is taking an "aggressive" approach to fighting hepatitis C.

Unlike many countries, Scotland considers injection drug abusers for treatment and conducts widespread testing of injection drug users for the disease and offers them medication, the paper says.

In many other countries injection drug abusers are considered too unreliable to turn up for appointments or to stick to the costly treatment regimen lasting many months, according to the newspaper.

The country was a hit by a wave of hepatitis C in the 1980s and because the disease can take 20 years or so to begin to affect the liver, Scotland is only just beginning to see the increase in end-stage liver disease, according to the article.

Scotland's 100 million pound programme started in 2008 and ends in 2015 and diagnoses and treats anyone with hepatitis C, regardless of their history, even though medication can cost between $10,000 and $40,000 per patient, the WSJ reports.

About half of the 38,000 Scots estimated to have been chronically infected have now been diagnosed, compared with 39% in 2007.

Of those around 1,100 new patients a year are receiving treatment, nearly triple the number from 2007 with the aim is to reach 2,000 new patients a year, which should prevent up to 5,200 cases of liver cirrhosis by 2030, according to the article.

The article also quotes research by Dundee University, comparing outcomes in hepatitis C patients who never injected drugs with outcomes in injection drug using patients.

Results from 291 patients found 61% of non-injection drug abusers achieved sustained virologic response, compared with 55% of former users and 47% of active users.

Authors concluded that active injection drug use "is not a barrier to treatment or a successful achievement of SVR," the WSJ points out.

The Scottish approach is also being trialled in California, the article reports, although in the US a lack of medical insurance among many drug users makes tackling the disease harder, according to the newspaper.

Source
WSJ Article

DDW 2013 - New therapy for patients with hepatitis C examined

2013-05-20T11:31:00.000-04:00

Pharmaceutical advances offer new options for health outcomes

Research presented at DDW® 2013 feature new drugs for IBS, hepatitis C

Orlando, FL (May 20, 2013) — Research presented at Digestive Disease Week® (DDW) explores pharmaceutical advances for treating irritable bowel syndrome with diarrhea (IBS-D) and hepatitis C.

An international study holds promising results for patients suffering from IBS-D. In the phase II study, researchers found that the drug ibodutant significantly improved symptoms in more than 50 percent of the individuals treated.

"While there's been a lot of progress in medicines for IBS with constipation, we haven't seen the same in IBS with diarrhea," said Jan Tack, MD, professor and director of the division of gastroenterology and internal medicine at Leuven University in Belgium. "Up to this point, we haven't been able to provide a pharmaceutical option for this patient group that successfully manages the pain associated with the condition."

IBS is an extremely common condition, affecting an estimated 10 percent of adults. Funded by Menarini, the double-blind, multinational study recruited 559 patients with IBS-D who were randomized and treated with 1, 3 or 10 mg of ibodutant or a placebo. Patients took an oral tablet once daily for eight consecutive weeks. Researchers found that 10 mg was the most effective dose and that it worked best for females.

"These are exciting findings that could bring a lot of relief to many patients," said Dr. Tack said. "We're looking forward to moving into phase III to confirm our findings with a much larger sample of patients."

New therapy for patients with hepatitis C examined

New research suggests that an investigational therapy for patients with hepatitis C can achieve high response rates in a wide range of patients, even those who respond poorly to current treatments. The study examined the safety and efficacy of interferon-free regimens, including three direct-acting antiviral drugs with and without ribavirin, for 12 or 24 weeks, in patients with chronic hepatitis C who were either treatment-naïve or had previously failed standard treatment with peginterferon and ribavirin.

In the phase II study, researchers found that the treatment regimens achieved high sustained virologic response (SVR) rates, an efficacy measure of a hepatitis C treatment, in non-cirrhotic patients with HCV genotype-1 (GT 1). SVR was achieved by 98.7 percent of treatment-naïve patients and 93.3 percent of prior nonresponders after 12 weeks of treatment with three direct-acting agents with ribavirin.

"Hepatitis C genotype 1 is the most common type of hepatitis in the U.S., and many of these patients are still quite difficult to treat with current interferon-based therapies," said Frederick Nunes, MD, clinical associate professor of medicine at Penn Medicine. "This includes specific populations such as African Americans and patients with high body mass or pre-diabetes. These results suggest that highly effective regimens like this one may overcome that difficulty, without the need for interferon."
###

Assigning 247 patients to 12- or 24-week regimens, researchers found that four weeks after treatment, SVR rates were high regardless of patient characteristics previously associated with poorer response to interferon therapy. Funded by AbbVie (formerly Abbott), the study's results hold particular significance for patients who are older, black, Hispanic or have a higher body mass index.

Dr. Tack will present data from the study "Efficacy of ibodutant, a selective antagonist of neurokinin 2 receptors, in irritable bowel syndrome with diarrhoea (IBS-D): the results of a double-blind, randomised, placebo-controlled, parallel-group phase II study (The IRIS-2)," abstract 520, on Monday, May 20, at 8 a.m. ET in Room 300 of the Orange County Convention Center.

Dr. Nunes will present data from the study "Interferon-free Regimens of ABT-450/r, ABT-267, ABT-333, and Ribavirin Achieve High Sustained Virologic Response 4 Weeks Post-Treatment (SVR4 ) Rates in Patients With Chronic HCV Genotype 1 Regardless of Race, Ethnicity, or Other Baseline Characteristics" abstract 514, on Monday, May 20, at 8 a.m. ET in Room 203AB of the Orange County Convention Center.

Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 18 to 21, 2013, at the Orange County Convention Center, Orlando, FL. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at http://www.ddw.org.

DDW 2013- HCV patients with late viral breakthrough have similar characteristics

2013-05-19T16:55:00.000-04:00

HCV patients with late viral breakthrough have similar characteristics
May 19, 2013

ORLANDO, Fla. — Viral breakthrough during the interferon/ribavirin phase of hepatitis C triple therapy was associated with genotype 1a and advanced liver fibrosis, similar to findings in previous clinical trials, according to study data presented here at Digestive Disease Week.

“We’ve noticed that there are patients who were experiencing viral breakthrough later in treatment,” Kali Zhou, MD, a resident in the department of medicine at the University of California, Los Angeles, told Infectious Disease News. “We did see later viral breakthrough in clinical trials, but we haven’t evaluated whether the characteristics of our breakthrough patients were similar to those who broke through in clinical trials.”...
Continue reading @ Healio

HCV prevalence higher among Asian-Americans
May 19, 2013

ORLANDO, Fla. — There was a higher prevalence of hepatitis C infection among Asian-Americans than among non-Asians who received care at a free community clinic, researchers reported at Digestive Disease Week.

“Among non-Asians, the prevalence of HCV was similar to what was seen in NHANES data,” Mindie Nguyen, MD, associate professor of medicine at Stanford University, told Infectious Disease News. “Worldwide, a large amount of the HCV burden is in Asia, and we lacked data on whether Asian-Americans have a higher HCV prevalence that is similar to that in their countries of origin. We found that the prevalence of HCV among Asian-Americans was similar to the reported prevalence in many parts of Asia and Southeast Asia.”
Continue reading@ Healio

Additional headlines from Digestive Disease Week 2013 Meeting @ Healio

No difference in IVF success rates in IPAA vs non-IPAA patients
May 19, 2013
Meeting News Coverage

Long-term study data indicates sustained improvement in GERD
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HCV prevalence higher among Asian-Americans
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H. pylori infection less common among patients with Barrett's esophagus, erosive esophagitis
May 19, 2013
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HCV patients with late viral breakthrough have similar characteristics
May 19, 2013
Meeting News Coverage

Patients with Medicaid less likely to receive HCV treatment
May 18, 2013
Meeting News Coverage

Coffee consumption linked to reduced risk for primary sclerosing cholangitis
May 18, 2013
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HBV may increase risk for non-Hodgkin lymphoma
May 18, 2013
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Patterns of exhaled volatile organic compounds differ between obese, healthy children
May 18, 2013

In Case You Missed It Sunday- Watch:100,000+ infected with Hep C in MA, 75% don't know

2013-05-19T13:55:00.001-04:00

EASL 2013: New Wave of Hepatitis C Treatments On the Way

2013-05-19T11:59:00.001-04:00

EASL 2013: New Wave of Hepatitis C Treatments On the Way

May 13, 2013, by Liz Highleyman

Studies presented at the EASL International Liver Congress, held April 24–28 in Amsterdam, confirm the expectation that a new generation of safer and more effective therapies for hepatitis C will be available within the next few years. These include both better add-ons to interferon and the first interferon-free combinations of direct-acting antivirals (DAAs).

An estimated three million people in the U.S. have hepatitis C, but most do not know they’re infected. The CDC this week reiterated its recommendation that all “baby boomers” born between 1945 and 1965 get a test for HCV antibodies and, if positive, a viral load test to determine if they’re still infected. “You may not remember what you did in the 60s and 70s, but your liver does,” said CDC director Thomas Frieden.

Testing is crucial because chronic HCV infection can lead to cirrhosis, liver cancer, and death. Now is a good time because better hepatitis C treatments that can stop liver disease progression are on the way.

Interferon Add-Ons

The current standard of care adds one of the first approved DAAs—boceprevir (Victrelis) or telaprevir (Incivek)—to pegylated interferon and ribavirin. Triple therapy works better than interferon/ribavirin alone, but comes with added side effects.

Some people with advanced liver disease cannot wait for better options, but data presented at the EASL meeting show that these regimens carry a high risk of serious complications for patients with cirrhosis and liver transplant recipients.

For people who can wait a bit longer, several studies showed promising outcomes when adding more effective and better-tolerated second-generation DAAs to interferon-based therapy:
Daclatasvir (HCV NS5A inhibitor)
Faldaprevir (HCV protease inhibitor)
MK-5172 (HCV protease inhibitor)
Simeprevir (HCV protease inhibitor)
Sofosbuvir (nucleotide analog HCV polymerase inhibitor)
Vaniprevir (HCV protease inhibitor)

These new drugs produced cure rates in the 80% to 90% range even for difficult-to-treat patients. They can often shorten treatment to three to six months (down from six months to a year) and generally do not cause more side effects than interferon and ribavirin alone. (For more detailed coverage of this study and others presented at EASL 2013, visit HIVandHepatitis.com.)

“DAAs are ready for prime time,” EASL Secretary General Mark Thursz said at an April 24 press conference kicking off the congress.

The first new DAAs are expected to become available by late 2013 or early 2014, initially for use with interferon. Simeprevir and sofosbuvir were submitted for FDA approval in March and April, with a review timeline of six months.

“Interferon is not dead yet,” Thursz emphasized. “Twelve weeks of an interferon triple regimen is tolerable for a large number of patients…and it may be better than waiting another year for a suitable all-oral regimen.”

Interferon-Free Combos

People with early or stable liver disease may be able to wait for all-oral regimens that eliminate interferon, which can cause flu-like symptoms and depression. Some combos also dispense with ribavirin, which can cause anemia.

All-oral regimens have gotten the lion’s share of attention at recent conferences (including the Conference on Retroviruses and Opportunistic Infections in March). While several interferon-free regimens continue to look good, enthusiasm at EASL was somewhat tempered by setbacks among difficult-to-treat patients.

A quad regimen containing DAAs developed by AbbVie (formerly Abbott)—HCV protease inhibitor ABT450 boosted with ritonavir + NS5A inhibitor ABT-267 + non-nucleoside polymerase inhibitor ABT-333 + ribavirin—cured 96% of treatment-naive patients with HCV genotype 1 and 93% of prior interferon non-responders treated for 12 weeks in the Aviator study.

This combo is especially promising because it worked for more than 90% of previously untreated or treatment-experienced patients, people with harder-to-treat HCV subtype 1a or easier-to-treat 1b, and those with mild or moderate liver fibrosis, though people with cirrhosis—who have the poorest response—were excluded.

AbbVie announced this week that the FDA has given this regimen a “breakthrough therapy” designation, intended to speed development and review of promising drugs for serious or life-threatening conditions.

Gilead’s sofosbuvir/ribavirin 12-week dual regimen previously demonstrated 100% sustained virological response (SVR) for previously untreated people with HCV genotypes 2 or 3 and no liver cirrhosis. SVR at 12 or 24 weeks after completing treatment (known as SVR12 and SVR24) is considered a cure.

But researchers at EASL reported lower cure rates in the larger treatment-naive FISSION and treatment-experienced FUSION trials, in which 20%–30% of participants had cirrhosis. SVR12 rates were 67% using a 12-week regimen in FISSION, and 50% with a 12-week regimen or 73% with a 16-week regimen in FUSION.

The major surprise was that people with genotype 2 and genotype 3—usually considered together as a single “easier-to-treat” category compared with genotype 1—responded differently.

Among those with genotype 2, SVR rates were excellent: 97% in FISSION and 86%–94% in FUSION. People with genotype 3 did not fare as well, with cure rates of 56% and 30%–62%—no better than pegylated interferon/ribavirin. The difference was even more pronounced among people with cirrhosis, with cure rates falling as low as 34% in FISSION and 19% in FUSION.

Presenter Edward Gane from Auckland City Hospital suggested that genotypes 2 and 3 should no longer be lumped together, as genotype 3 is “behaving as a harder-to-treat virus.”

Turning to genotype 1, further results from the ELECTRON trial confirmed that sofosbuvir/ribavirin alone is not adequate for such patients. Adding the NS5A inhibitor ledipasvir, however, raised the cure rate to 100% for both treatment-naives and prior null responders.

Gilead announced last week that a coformulation of sofosbuvir/ledipasvir without ribavirin for eight or 12 weeks led to 95%–100% sustained response at four or eight weeks post-treatment—promising, but too soon to declare a cure.

Study findings reported in 2012 showed that sofosbuvir plus Bristol-Myers Squibb’s NS5A inhibitor daclatasvir cured 100% of treatment-naive genotype 1 patients. Gilead decided not to pursue this combination in Phase 3 trials in favor of its own ledipasvir, but some smaller studies have gone forward.

Mark Sulkowski from Johns Hopkins University reported that sofosbuvir plus daclatasvir cured all previously treated genotype 1 patients who did not respond to interferon-based triple therapy using boceprevir or telaprevir, providing some of the first data on “rescue therapy” after failure of the current standard-of-care.

Finally, a three-drug DAA combo containing daclatasvir, the HCV protease inhibitor asunaprevir, and the non-nucleoside polymerase inhibitor BMS-791325, taken for 12 or 24 weeks, cured 88%–94% of previously untreated genotype 1 patients without cirrhosis, with treatment “failures” mostly due to missing data rather than viral breakthrough or relapse.

Taken together, these findings add to the evidence that effective and well-tolerated DAA therapy will be able to cure most people with chronic hepatitis C within the coming years.

“If a patient has early stage [liver disease], lots of physicians are recommending their patients wait” for all-oral regimens, Thursz summarized. For those with more advanced disease, “treating with the standard of care is probably the way to go”—unless they have very advanced disease, in which case they have “significant risk of dying from septic complications” if treated with current triple therapy.

Liz Highleyman (liz (at) hivandhepatitis.com) is a freelance medical writer and editor-in-chief of HIVandHepatitis.com.

View EASL 2013 Coverage

DDW 2013 - Patients with Medicaid less likely to receive HCV treatments

2013-05-18T21:43:00.001-04:00

Patients with Medicaid less likely to receive HCV treatment

May 18, 2013

ORLANDO — Although diagnosed hepatitis C infection was more common among people with Medicaid insurance, the treatment rates were lower compared with people who had commercial insurance, research presented here at Digestive Disease Week suggests.

“These results were pretty much what we expected,” Jenny Griffith, PharmD, senior manager of clinical epidemiology at AbbVie, told Infectious Disease News. “We knew that people who have Medicaid insurance are typically sicker, and we expected to find the same thing in HCV. The one thing that was unexpected was that the rate of diagnosed HCV was double in the Medicaid group. One hypothesis for this is that people with Medicaid typically have a lower socioeconomic status, and according to NHANES data, there is a higher prevalence of HCV among those with a lower socioeconomic status.”

Griffith and colleagues conducted a retrospective analysis that included approximately 28 million commercial beneficiaries from Jan. 2000 to Dec. 2009 and 3.2 million Medicaid beneficiaries from July 1999 to June 2009. They evaluated the prevalence of HCV and treatment estimates, as well as comorbidities and possible contraindications to treatment.

The 10-year prevalence of HCV was 302 per 100,000 among people with commercial insurance and 663 per 100,000 among people with Medicaid. The prevalence of treatment, however, was 26.5% among patients with commercial insurance and 19.5% among Medicaid beneficiaries. Those with Medicaid had higher rates of most evaluated comorbidities, including drug abuse, ascites, COPD, depression, autoimmune disease and pregnancy. More patients on Medicaid also had possible contraindications to treatment with ribavirin and/or interferon.

“The take-home message is that if you have someone who has Medicaid insurance, they are more than likely to be sicker and have more comorbidities that will make it more difficult to treat them,” Griffith said. “The development of interferon-free treatment may increase eligibility for treatment and hopefully eliminate this gap.”

For more information:
Griffith J. #Sa1066. Presented at: Digestive Disease Week; May 18-21, 2013; Orlando.

Disclosure: Griffith is an employee of AbbVie.

Source Healio

Additional headlines from Digestive Disease Week 2013Meeting @ Healio

HBV may increase risk for non-hodgkin lymphoma
Coffee consumption linked to reduced risk for primary sclerosing cholangitis

DDW 2013 - HBV may increase risk for non-hodgkin lymphoma

2013-05-18T18:42:00.001-04:00

Healio › Infectious Disease › Gastrointestinal Infections › News

HBV may increase risk for non-hodgkin lymphoma

May 18, 2013

ORLANDO — Infection with hepatitis B virus may be a risk factor for non-hodgkin lymphoma, according to data presented here at Digestive Disease Week 2013

Researchers from the Marshfield Clinic in Wisconsin conducted a meta-analysis that included 19 case-control studies performed throughout the world. The analysis included a total of 13,947 cases and 1,559,448 controls. In nine of the studies, the controls were non-lymphoma cancer/hospital patients; eight studies incorporated healthy controls, and two studies included both types of controls. In most of the studies (17), patients were diagnosed with hepatitis B by detection of HBsAg, while hepatitis B was self-reported in the remaining two studies. All incidences of non-hodgkin lymphoma (NHL) were diagnosed with histopathology.

Among the patients with NHL, 1,205 had hepatitis B infection and among the controls, there were 40,592 cases of infection. The risk of hepatitis B was higher for patients with NHL compared with controls (OR=2.53; 95% CI, 2.10-3.03). Significant heterogeneity was not observed across the evaluated studies.

The increased risk of hepatitis B infection was present in both developing and developed countries in subgroup analysis. There was also no difference in risk among controls based in the hospital- and population-based controls.

For more information:
Kanth R. #Sa1020. Presented at: Digestive Disease Week; May 18-21, 2013; Orlando.
Disclosure: The researchers report no relevant financial disclosures

NATAP - Summary EASL 2013 - New HCV DAAs on their way soon: what do the phase III studies tell us?

2013-05-18T17:12:00.000-04:00

Summary from EASL 2013 for Hepatitis C - New HCV DAAs on their way soon: what do the phase III studies tell us?

Jürgen K. Rockstroh M.D., Professor of Medicine
University of Bonn, Germany

Correspondence:
Prof. Dr. J.K. Rockstroh
Department of Medicine I
University of Bonn
Sigmund-Freud-Str. 25
53105 Bonn
Germany

Introduction

Ever since the first DAA based triple therapy for HCV became available treatment paradigms for HCV therapy have subsequently changed significantly and promise cure of HCV infection in around two thirds of treatment naïve HCV-genotype-1 infected patients undergoing triple therapy. Nevertheless, with more widespread use of boceprevir and telaprevir based triple therapy the current challenges of HCV therapy have become quite evident: Adherence issues due to high pill burden and food requirements with tablet intake, high rate of adverse events particularly in patients with more advanced liver disease, multiple drug-drug interactions and finally also significantly lower response rates in more challenging patient populations (cirrhosis, previous null-response to dual therapy, post-transplant treatment etc.). So not so surprisingly after an initial euphoria to offer triple therapy to HCV patients who had waited a long time for more efficacious HCV treatment options, many physicians and patients likewise now seem to wait for easier to take and potentially better tolerated and at best even interferon free new treatment options in the near future. At this year's EASL in Amsterdam with over 9600 delegates the phase III study results for the two "second wave HCV protease inhibitors" faldaprevir and simeprevir each in combination with pegylated interferon (PEG-IFN) and ribavirin (RBV) for HCV genotype 1 patients were presented as well as the phase III findings for the polymerase inhibitor sofosbuvir again in combination with PEG-IFN/RBV for treatment of genotypes 1,4,5 and 6. In addition phase III results of the first interferon free combination of sofosbuvir with ribavirin for treatment of genotype 2 and 3 were presented. As these new drugs have been or are about to be filed for licensing it can be expected that at least for the US, approval of these new HCV drugs can be expected 2013/2014. Therefore, with most likely less than a year ahead before these new drugs hit the market the question who to treat now and in whom to wait for improved HCV treatment options has become even more pertinent.

But clearly there is an even more promising future behind these new HCV agents, suggesting interferon free regimens will become available even in more difficult to treat patient populations and for all genotypes in the upcoming years. Again several studies which were presented at EASL allowed a glimpse into this highly promising future. Nevertheless, issues around the potential cost of the HCV drugs to come as well as the question which prediction factors allow us to decide which patient needs how many DAAs and what kind of combination suits which type of patient remain unanswered to the very day. Indeed the high number of compounds and combinations makes it increasingly difficult to follow all studies. Also 100% sustained virological response rates in easy to treat naïve HCV patients with early fibrosis stages and an IL28b CC genotype as well as a 1b infection cannot be automatically transferred to more challenging patient populations. In summary, the HCV field is moving fast and new HCV compounds promising simpler treatment regimens with increased tolerability and shortened treatment durations can be expected soon. In addition first interferon-free treatment approach for genotype 2 and 3 will be available shortly. A successful interferon-free HCV treatment strategy for all patients however, still has not yet arrived.

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