July 11, 2013

Does Successful Hepatitis C Treatment Eliminate Liver Cancer Risk?

July 11, 2013

Abigail Zuger, MD reviewing Aleman S et al. Clin Infect Dis 2013 Jul 15. Pereira OC and Feld JJ. Clin Infect Dis 2013 Jul 15.

Not in patients with cirrhosis, who still risk both decompensated cirrhosis and hepatocellular carcinoma.

Although eradication of hepatitis C virus (HCV) infection with combined antiviral therapy generally will halt or even reverse liver pathology, risk for bad outcomes such as decompensated cirrhosis or hepatocellular carcinoma (HCC) is not eliminated. But exactly how common are these life-threatening complications of HCV in patients with sustained virologic responses (SVRs) to HCV treatment?

Swedish researchers prospectively followed 351 patients with HCV-related cirrhosis for a mean 5.3 years. Among 110 patients with SVRs to interferon-based treatment, HCC incidence was 5%, compared with 13% among 198 treated patients without SVRs and 29% among 48 untreated patients. Risks for any clinical decompensation (i.e., ascites, variceal bleeding, or encephalopathy), liver-related mortality, and all-cause mortality all followed the same pattern: highest among the untreated, lower among the unsuccessfully treated, and lowest (but not zero) among the successfully treated.

Comment

Sweden's comprehensive national health registries make these data among the most precise available on the long-term outcomes of HCV treatment started after a patient already has progressed to cirrhosis. Editorialists note that risk for hepatocellular carcinoma in successfully treated cirrhotic patients is low enough that routine sonographic screening generally would not be considered cost-effective, but they endorse ongoing screening of these patients nonetheless.

Disclosures for Abigail Zuger, MD at time of publication Editorial boards Journal Watch AIDS Clinical Care; Clinical Infectious Diseases Other New York Times medical writer

Citation(s):

Aleman S et al. A risk for hepatocellular carcinoma persists long-term after sustained virologic response in patients with hepatitis C–associated liver cirrhosis. Clin Infect Dis 2013 Jul 15; 57:230. (http://dx.doi.org/10.1093/cid/cit234)

Abstract/FREE Full Text

Pereira OC and Feld JJ. Sustained virologic response for patients with hepatitis C–related cirrhosis: A major milestone, but not quite a cure. Clin Infect Dis 2013 Jul 15; 57:237. (http://dx.doi.org/10.1093/cid/cit237)

FREE Full Text

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Simeprevir Shines in Hep C Trial

Gastroenterology and Endoscopy News

In the News

ISSUE: JULY 2013 | VOLUME: 64:7

by David Wild

Orlando, Fla.—Of patients who relapsed following treatment with peginterferon (PEG-IFN)-based therapy for chronic genotype 1 (GT1) hepatitis C virus (HCV) infection, 80% experienced rapid and sustained virologic response with triple therapy including PEG-IFN-2a, ribavirin (RBV) and simeprevir, an experimental oral, once-daily HCV NS3/4A protease inhibitor (PI). Results from the Phase III PROMISE study were presented at the 2013 Digestive Disease Week meeting (abstract 869b).

The findings led Gregory Gores, MD, executive dean for research at Mayo Clinic, Rochester, Minn., to speculate that simeprevir will soon be added to the clinician’s HCV treatment toolbox.

“The surprising efficacy of simeprevir triple therapy in patients who had relapsed after prior RBV plus PEG-IFN therapy, and in patients with advanced liver fibrosis, along with its once-daily dosing, minimal drug–drug interactions and good safety profile, make it likely the drug will be approved by the FDA for use in HCV patients,” said Dr. Gores, who was not involved in the research.

Eric Lawitz, MD, professor of medicine at the University of Texas Health Science Center and vice president of scientific and research development at the Texas Liver Institute in San Antonio, and his colleagues randomized 260 patients with HCV GT1 to receive the triple therapy and 133 similar patients to receive an oral placebo with PEG-IFN/RBV, both for 12 weeks, in a double-blind fashion. Simeprevir recipients who experienced a drop in HCV RNA below 25 IU/mL after four weeks of treatment and who had undetectable HCV RNA at 12 weeks received an additional 12 weeks of PEG-IFN/RBV alone, whereas those who did not meet these criteria received an additional 36 weeks of PEG-IFN/RBV treatment, for a total of 48 weeks. All placebo recipients received 36 weeks of PEG-IFN/RBV after the initial 12 weeks of placebo plus PEG-IFN/RBV treatment.

Dr. Lawitz reported that 77% of patients who received simeprevir experienced a rapid virologic response (RVR), and 79% had a sustained virologic response 12 weeks after treatment completion (SVR12). In contrast, 3% of placebo recipients achieved RVR, and 37% achieved SVR12 (P<0.001 for simeprevir vs. placebo).

SVR12 rates among various patient subgroups were higher in the simeprevir arm compared with the placebo arm, Dr. Lawitz reported. These included patients with METAVIR scores of F0-F2 (82% vs. 41%), METAVIR scores of F3 (73% vs. 20%), METAVIR scores of F4 (74% vs. 26%), HCV GT1a (70% vs. 28%), HCV GT1b (86% vs. 43%), interleukin-28 B (IL28B) genotype CC (89% vs. 53%), IL28B genotype GT CT (78% vs. 33%) and IL28B genotype GT TT (65% vs. 19%; P<0.001 for all).

Only 7% of simeprevir recipients required 48 weeks of treatment, and rates of on-treatment failure and post-treatment relapse with the drug were 3% and 19%, respectively, compared with 27% and 48% with placebo.

There were no differences in serious adverse events in the simeprevir and placebo groups.

Dr. Lawitz said the study participants were a difficult-to-treat population and included those with prior treatment failure and compensated and fibrotic liver disease.

“Hepatitis C is a complex disease, and we need multiple treatment options in order to provide our patients with the best possible chance of successful therapy,” he concluded.


Dr. Lawitz has received research support from Abbott Laboratories, Achillion Pharmaceuticals, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, GlobeImmune, Idenix Pharmaceuticals, Idera Pharmaceuticals, Intercept Pharmaceuticals, Janssen Pharmaceuticals, Medtronic, Merck & Co., Novartis, Presidio, Roche, Santaris Pharmaceuticals, Scynexis and Vertex Pharmaceuticals. Dr. Gores has no conflicts of interest.

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Interferon-free Regimen for Hepatitis C Advances

Medscape Medical News > Conference News

Neil Canavan

Jul 11, 2013

KUALA LUMPUR, Malaysia — A new interferon-free drug regimen for the treatment of hepatitis C is safe and effective in treatment-naïve patients and in those who previously had a poor response to treatment, according to the phase 2b AVIATOR trial.

The direct-acting antiviral combination, manufactured by AbbVie Pharmaceuticals, consists of the protease inhibitor ABT-450, the non-nucleoside NS5B polymerase inhibitor ABT-333, and the novel NS5A inhibitor ABT-267. When used in combination with ribavirin, it reportedly produces sustained virologic response rates of up to 99% in patients with hepatitis C.

Barry Bernstein, MD, vice president of infectious disease at AbbVie, and his team evaluated the safety and efficacy of this interferon-free regimen in combination with ribavirin to determine whether toxic events would lead to dose reductions in ribavirin and whether that would have any effect on treatment outcome.

Ribavirin is a key component of effective hepatitis C treatment, but often it cannot be used at optimum therapeutic levels when combined with interferon — the current standard of care.

Dr. Bernstein presented the results here at the 7th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention.

“These results, if they hold up, will be very significant for people coinfected with HIV and hepatitis C.”

In the AVIATOR trial, first presented last year at the annual meeting of the American Association for the Study of the Liver Diseases, patients were treated with the interferon-free combination with or without ribavirin for 12 or 24 weeks.

In the study cohort, 159 patients were treatment-naïve and 88 were previous nonresponders to ribavirin. Median age was 50 years, and was 86% of the cohort was white. All patients had chronic infection with hepatitis C genotype 1 and plasma HCV RNA levels above 50,000 IU/mL.

The primary end points were safety and sustained virologic response at 24 weeks.

Four patients (1.6%) discontinued treatment because of adverse events, 1 patient experienced a serious adverse event (arthralgia), and 16 patients (6.5%) had hemoglobin levels below 10 g/dL.

In 24 of the 247 (10%) patients, the dose of ribavirin was reduced because of adverse events. Of these, 20 were treatment-naïve and 4 were previous nonresponders.

The incidence of ribavirin dose reductions was similar in the 12- and 24-week treatment groups.

The most common adverse events were anemia, with 10 events reported, and fatigue, with 3 events reported. Other events, with 2 reports each, were diarrhea, dizziness, and pruritus.

There were more adverse events in treatment-naïve patients than in nonresponders.

All 24 patients whose dose of ribavirin was reduced achieved a sustained virologic response at 24 weeks. For those without a dose reduction, 92.1% of the treatment-naïve patients and 94.0% of the nonresponders achieved a sustained virologic response at 24 weeks

"Significantly, ribavirin dose reduction occurred less frequently than in previous studies of peg-interferon-containing regimens," said Dr. Bernstein. As important, he noted, is the fact that when dose reductions did occur, response rates were not negatively affected.

Toward Interferon-free Treatment

Preliminary trials to determine drug–drug interactions with HIV medications are near completion, and a trial of this drug combination in patients coinfected with HIV and hepatitis C will start soon, Dr. Bernstein said.

These results, if they hold up, will be very significant for people coinfected with HIV and hepatitis C, said Tom Campbell, MD, a principal investigator of the Colorado AIDS Clinical Trial Unit. "The exciting thing is that they don't require the use of interferon, which is very poorly tolerated, particularly in people with coinfection."

The need for interferon-free regimens is clear. "We have patients who are waiting for new drugs before they are willing to be treated, particularly those who have less advanced hepatitis C infection who don't need immediate treatment," Dr. Campbell explained. He acknowledged that "it will be a few years before these drugs are approved for HIV and hepatitis C coinfection, so it is a bit of a gamble to wait."

However, he understands the reluctance of these patients to be treated now. "It's a decision that the patient should make in consultation with their care provider."

Dr. Bernstein is an employee of AbbVie Pharmaceuticals. Dr. Campbell has disclosed no relevant financial relationships.

7th International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention: Abstract TUAB0103. Presented July 2, 2013.

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Hepatitis C Reinfection Rising Among HIV Patients

Medscape Medical News > Conference News

Neil Canavan

Jul 11, 2013

KUALA LUMPUR, Malaysia — Nearly 25% of HIV patients infected with and subsequently cured of the hepatitis C virus went on to acquire a second or even third infection within 24 months at one hospital in the United Kingdom.

"Liver disease is one of the leading non-AIDS causes of death in HIV-infected individuals," said lead investigator Thomas Martin, from the Chelsea and Westminster Hospital in London, United Kingdom. In fact, hepatitis C accounted for "roughly two thirds of those cases."

These results suggest that much better educational initiatives related to coinfection with HIV and hepatitis C are needed, he noted.

It has previously been shown that coinfection with HIV reduces the spontaneous clearance of hepatitis C infection, reduces the rate of successful treatment, and can lead to a 3-fold increase in the rate of progression to cirrhosis.

However, the extent to which HIV patients are reinfected with hepatitis C has not been established.

To look at this issue, Dr. Martin and his team analyzed reinfection rates in 191 HIV patients with a primary hepatitis C infection treated at the Chelsea and Westminster Hospital.

Dr. Martin presented the results here at the 7th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention.

“Liver disease is one of the leading non-AIDS causes of death in HIV-infected individuals.”

The researchers defined reinfection as any newly positive hepatitis C virus RNA polymerase chain reaction result 24 weeks or more after the end of hepatitis C treatment, spontaneous clearance of the virus, or the emergence of a different hepatitis C genotype in a 24-month period.

In the study cohort, the rate of hepatitis C reinfection was 7.8 per 100 patient-years (95% confidence interval, 5.8 - 10.5). "That's approximately 5 to 10 times the baseline primary infection incidence of hepatitis C in this population," Dr. Martin explained.

Of the 32 reinfected patients, the hepatitis C infection was cleared with treatment or spontaneous remission in 17 patients. Of those, 8 went on to acquire a third hepatitis C infection, resulting in an infection rate of 23.2 per 100 patient-years.

Overall, the second and third reinfections cleared spontaneously in 20% of patients, and a complete viral clearance was achieved with standard-of-care treatment in 80%.

"We saw no evidence of protective immunity from the initial hepatitis C infection," said Dr. Martin. "In fact, these individuals remain at high risk for reinfection."

Coinfection Education Needed

"We're becoming increasingly aware that gay men have this elevated risk of sexual acquisition of hepatitis C," said Charles Hicks, MD, professor of medicine at Duke University in Durham, North Carolina.

However, the high frequency of reinfection over a fairly short period after the initial hepatitis C diagnosis is "striking," Dr. Hicks told Medscape Medical News. "That was alarming to me. It means we need to do a better job of counseling gay men who have hepatitis C that just because their first infection has been managed successfully, it doesn't mean they are no longer at risk." Prevention here is key.

It also has implications for future monitoring of patients. Typically, an active hepatitis C infection is detected with an antibody test, he explained. "But in cases of previous viral clearance, you're going to have to use an RNA viral load test to find cases of reinfection."

Dr. Marin and Dr. Hicks have disclosed no relevant financial relationships.

7th International AIDS Society (IAS) Conference on HIV Pathogenesis: Abstract TUAB0101. Presented July 2, 2013.

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Renal impairment common with telaprevir, boceprevir therapy for HCV

Provided by Healio

Mauss S. Hepatology. 2013;doi:10.1002/hep.26602.

July 11, 2013

Patients with chronic hepatitis C treated with pegylated interferon, ribavirin and either telaprevir or boceprevir frequently experienced renal impairment that typically resolved after switching to dual therapy in a recent study.

As part of the noninterventional PAN study — which includes patients with HCV treated with peginterferon alfa-2a and ribavirin with or without telaprevir or boceprevir — researchers evaluated the estimated glomerular filtration rate (eGFR) of 895 patients with HCV genotype 1 who received at least 12 weeks of therapy and 591 who received 24 weeks or more. Five hundred seventy-five telaprevir patients, 211 taking boceprevir and 109 on dual therapy were in the 12-week group.The 24-week arm had 398 patients on telaprevir, 113 on boceprevir and 80 on dual therapy.

The 12-week analysis measured the impact of treatment on eGFR; the 24-week review determined whether this effect could be reversed after discontinuing telaprevir or boceprevir.

All participants had an eGFR above 60 mL/min at baseline. In the 12-week cohort, 5.5% of patients experienced an eGFR decrease to below 60 mL/min, which was more common among telaprevir (6.6%) and boceprevir (4.7%) recipients than those who received peginterferon/ribavirin alone (0.9%) (P<.05). Multivariate analysis indicated associations between this decrease and advanced age (P<.001), high baseline creatinine levels (P<.001), receipt of telaprevir or boceprevir (P<.01) and arterial hypertension (P<.05).

In the 24-week analysis, 8.3% of telaprevir and 3.5% of boceprevir recipients experienced eGFR decreases to below 60 mL/min after 12 weeks, compared with 1.3% of dual therapy recipients (P<.05). After telaprevir discontinuation at 12 weeks, eGFR below 60 mL/min was observed in 1.3% of those who had received telaprevir, compared with 4.4% of boceprevir recipients and 1.3% of dual therapy recipients (P<.05 for boceprevir vs. dual therapy).

“Renal impairment has not been an issue with dual therapy [interferon and ribavirin],” researcher Stefan Mauss, MD, Center for HIV and Hepatogastroenterology in Dusseldorf, Germany, told Healio.com. “[However,] with the current triple therapy, it has to be added to the adverse event list. Include creatinine in your checklist, and keep an eye in particular on patients with additional risk factors for renal impairment, [such as] older age, arterial hypertension [or] diabetes mellitus.”

Disclosure: See the study for a full list of relevant disclosures.

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Tenofovir Lowers HIV Risk in Drug Abusers by Half

Medscape Medical News > Conference News

Neil Canavan

Jul 11, 2013

KUALA LUMPUR, Malaysia — A large study of intravenous drug users has found a surprisingly high rate of adherence to pre-exposure prophylaxis with tenofovir, resulting in a marked reduction in new HIV infections.

"The study tells us that pre-exposure prophylaxis can work for all populations at risk for HIV, including people who inject drugs," said study investigator Michael Martin, MD, from the Centers for Disease Control and Prevention in Atlanta, Georgia.

Dr. Martin presented findings here at the 7th International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention.

The double-blind placebo-controlled Bangkok Tenofovir Study involved 2413 intravenous drug users. The cohort was 80% male, and the average age was 31 years.

Investigators randomized participants to receive daily oral tenofovir 300 mg or placebo. "We provided monthly HIV testing, participant-centered risk-reduction and adherence counseling, blood safety testing every 3 months, condoms, and methadone treatment," said Dr. Martin.

Participants were asked to record their medication use in an adherence diary or were directly observed taking the study drug. At monthly visits, the staff and the participant reviewed the adherence diary and did a pill count.

Results showed that participants took the drug 84% of the time, which translated into a substantial reduction in the rate of HIV infection. "We had 17 new infections in the tenofovir group and 33 in the placebo group," Dr. Martin reported. "This translates into a 49% reduction in risk (P = .01)."

Adherence did not differ by treatment group (P = .16). However, older participants were more adherent than younger participants (P < .001), and women were more adherent than men (P = .04).

"Needle sharing and sexual risk were similar in the 2 study arms," Dr. Martin explained. However, participants reported that these behaviors declined substantially during the trial. "This was true for both treatment groups."

Despite the positive data that continue to emerge for pre-exposure prophylaxis, real-world use remains limited. Antiretroviral medications for pre-exposure prophylaxis are "not flying off the shelf," Robert Grant, MD, lead investigator of the landmark Pre-Exposure Prophylaxis Initiative (iPrEx) trial, told reporters attending a news conference.

Perceptions From the iPrEx Trial

"We're finding that demand for such services and people interested in providing pre-exposure prophylaxis to their clients remain relatively low. We think that part of this is that it takes time for people to get their heads around new ideas, but part of it is that we really do need to learn more about how best to provide pre-exposure prophylaxis and how best to promote it's effective use."

At the IAS meeting, Dr. Grant reported recent findings from an open-label extension of the iPrEx trial, in which 65% of the original 2340 patients participated. Of the 1451 participants who were not infected with HIV at the time of enrollment in the extension study, 1038 chose to receive pre-exposure prophylaxis.

"We were impressed that 72% of those offered pre-exposure prophylaxis chose to participate, and of those who did, 72% had detectable drug levels," he reported.

That said, it's obvious that pre-exposure prophylaxis is not for everyone, Dr. Grant noted. "It's for people who perceive themselves to be at risk. If roughly half of iPrEx participants are able to appropriately use pre-exposure prophylaxis, that's a substantial number."

Dr. Martin has disclosed no relevant financial relationships. Dr. Grant reports serving as an advisor and consultant for Siemens AG.

The 7th International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention: Abstracts WELBC05 and WELBC02. Presented July 3, 2013.

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New Insights Into Genetic Basis Of Deadly Liver Cancer

New-Insights-Into-Genetic-Basis-Of-Deadly-Liver-Cancer

Health & Medicine
July 12, 2013

Researchers have tracked down recurrent genetic abnormalities in hepatocellular carcinoma, a deadly form of liver cancer

Asian Scientist (Jul. 12, 2013) - An international team of researchers has used whole-genome sequencing to track down recurrent genetic abnormalities in hepatocellular carcinoma (HCC), a deadly form of liver cancer.

HCC is more common in parts of Africa and Asia, where the patients with hepatitis B or C have a higher risk of developing liver cancer.

In their study, published online in Genome Research, the researchers found that the tumor suppressor gene TP53 was mutated in more than one-third of tumors when they sequenced tumor and normal tissue samples from 88 HCC patients in Hong Kong.

Patients with tumors containing TP53 mutations were also less likely to survive.

An oncogene called beta-catenin was often altered, too, they found, as were other components of the beta-catenin pathway and a signaling pathway that includes JAK1 and STAT gene products.

“Liver cancer is intractable to nearly all currently available anti-cancer targeted therapies. Our findings in this study provide a better understanding of molecular basis of hepatocarcinogenesis and provide new clues to improving the diagnosis and treatment of liver cancer in the future,” said Hancheng Zheng, a leader of the project.

The researchers are hopeful that existing drugs targeting these key genes in HCC, particularly JAK1, can be tested for the treatment of HCC in the near future.

The article can be found at: Kan et al. (2013) Whole Genome Sequencing Identifies Recurrent Mutations In Hepatocellular Carcinoma.

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Provided by Medical Xpress

July 11, 2013

Using the same type of mathematical formulas used to draw political redistricting maps, Johns Hopkins researchers say they have developed a model that would allow for the more equitable allocation of livers from deceased donors for transplantation.

Currently, in the United States, where you live dictates the availability of a liver transplant. Studies show that geography can mean the difference between a 10 percent chance of dying while on the waiting list for a donor liver, and a 90 percent chance, the researchers say. The new model depends not on the longstanding relationships among medical centers used to create the current unbalanced system, but on making the distribution of organs as equitable as possible, they say.

"This is gerrymandering for the public good," says study leader Dorry L. Segev, M.D., Ph.D., an associate professor of surgery and epidemiology at the Johns Hopkins University School of Medicine. "We have applied to transplantation the same math used for political redistricting, school assignments, wildlife preservation and zoning issues." A report on the research is published in online in the American Journal of Transplantation.

"Some geographic areas have very good access to donated organs and some have desperate gaps between organ supply and organ demand," says co-author Sommer Gentry, Ph.D., a research associate in the department of surgery at Johns Hopkins and an associate professor of mathematics at the U.S. Naval Academy. "Our model helps decrease geographic disparity. It's not fair that where you live so vastly affects your ability to get a transplant. We want to fix that."

Currently, patients with the most severe disease go to the top of the liver transplant waiting list. But the list isn't a single national list; instead, it is subdivided according to location. Thus, the sickest person in one region may be much sicker than the person in a nearby region who gets a new liver, simply because the second region has a greater supply—or smaller demand—for organs.

In 2009, the late Apple founder Steve Jobs, who lived in Northern California, famously underwent a liver transplant in Memphis, Tenn. There, he had put himself on one of the shortest waiting lists in the country. In Tennessee in 2006, it took 48 days to receive a liver transplant, compared with 306 days nationally. Jobs was able to do this because he had the financial resources to immediately fly to Tennessee when the liver became available. His situation brought national attention to the large geographic disparities in liver transplantation.

Segev, a transplant surgeon, says that if a patient from San Francisco or New York City needed a liver transplant, it would be difficult to recommend one of the great transplant centers in those cities because the wait is so long.

In developing their new allocation model, the Johns Hopkins researchers essentially redistricted the regions by analyzing supply, demand and access factors for 6,700 deceased donors, 28,063 liver transplant candidates and 242,727 changes in 2010 to what is known as MELD (Model for End-Stage Liver Disease), a score that categorizes the sickest patients on the list at any given time.

The optimal regional sharing map they created would reduce geographic disparity by half, while significantly reducing waitlist deaths.

Segev, the director of clinical research for transplant surgery at Johns Hopkins, says that the geographic disparity in the current allocation system violates government rules that say geography shouldn't affect organ supply.

He says he hopes the United Network for Organ Sharing, the private, nonprofit organization that manages the nation's organ transplant system under contract with the federal government, will act on this new model.

Explore further: Most liver transplant candidates receive donation offers

Journal reference: American Journal of Transplantation

Provided by Johns Hopkins University School of Medicine

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The Medical Journal of Australia

Letters

Joshua S Davis, Anuja C Kulatunga and Krispin Hajkowicz

Med J Aust 2013; 199 (1): 23. doi: 10.5694/mja13.10083

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Authors    References

To the Editor: Chronic hepatitis C virus (HCV) infection affects over 225 000 Australians1 and is a leading cause of the need for liver transplantation and of liver-related death, but curative treatments are available. Ethnicity is a major determinant of treatment responsiveness, with the lowest sustained virological response (SVR) rates reported in African patients, and the highest in Asian patients.2 Much of this difference is accounted for by racial differences in polymorphisms in the interleukin-28B (IL28B) gene;3 however, it is unknown how common these polymorphisms are in Indigenous Australians, and no studies have been published about hepatitis C treatment outcomes among Indigenous Australians.

The hepatitis C treatment service for the Top End of the Northern Territory is run from a community-based sexual health clinic in Darwin. As clinicians working at this service, our perception was that Indigenous people rarely accessed the service or received treatment for HCV infection. Further, we were concerned that — due to social, cultural and linguistic barriers — Indigenous people who accessed the service may be less likely to commence treatment and to successfully complete treatment and achieve an SVR. Following ethics approval from the Human Research Ethics Committee of the Northern Territory Department of Health and Families, we performed a retrospective case-note audit to determine the number of Indigenous people accessing the hepatitis C treatment service and their characteristics and treatment outcomes.

During the period 1 January 2006 to 31 December 2010, 243 patients were seen on at least two occasions for assessment of HCV infection; all were adults and 22 (9%) were Indigenous. During the audit period, HCV infection was treated with pegylated interferon-α plus ribavirin for 24–48 weeks. There were no significant differences in the proportion of patients who went on to commence and complete treatment, and to achieve an SVR, between Indigenous and non-Indigenous patients (Box). Of five Indigenous patients tested for IL28B genotype, all had the favourable CC polymorphism at the rs12979860 locus. Compared with the unfavourable TT and CT polymorphisms, the CC polymorphism at this locus is associated with at least a twofold higher chance of achieving a cure of HCV with interferon treatment, due to enhanced host immune responsiveness to interferon.3

In conclusion, Indigenous people in the NT who access hepatitis C treatment services have a similar chance of achieving a cure (SVR) to non-Indigenous people. This may be partly because they are likely to carry the favourable CC polymorphism at the IL28B gene.

Indigenous (n = 22)

Non-Indigenous (n = 221)

P


Age, median (interquartile range)

41.0 (36.2–45.0)

47.3 (39.3–52.1)

0.14

Men

15/22 (68% [45%–86%])

144/221 (65% [58%–71%])

0.78

HCV genotype 1

10/18 (56% [31%–78%])

87/173 (50% [43%–58%])

0.67

Commenced HCV treatment

11/22 (50% [28%–72%])

99/221 (45% [38%–52%])

0.58

Completed HCV treatment

9/11 (82% [48%–98%])

80/99 (81% [72%–88%])

0.94

Achieved sustained virological response

4/8 (50% [16%–84%])

54/88 (61% [50%–72%])

0.53


HCV = hepatitis C virus. * Data are number/denominator (% [95% CI]) unless otherwise indicated. Denominators represent those patients for whom 6-month post-treatment blood test results were available.