January 20, 2012

Many U.S. Adults Not Vaccinated for Hepatitis B


Missed opportunities lead to many new infections each year, study found

Last Updated: January 20, 2012.

Missed opportunities lead to many new infections each year, study found.

FRIDAY, Jan. 20 (HealthDay News) -- More than half (51.4 percent) of American adults at risk for hepatitis B infection have not been vaccinated, a new study says.

People at risk for hepatitis B infection, which can lead to liver disease, include those who share needles when using injectable drugs and those who engage in certain risky sexual practices. Previous research shows that 95 percent of new hepatitis B infections occur among people with these types of behavioral risk factors.

The finding about vaccination rates comes from researchers at Brown University in Providence, R.I., who analyzed data from 15,000 adults who took part in the 2007 U.S. Behavioral Risk Factor Surveillance Survey.

The study also found that more than half of those who weren't vaccinated had the potential to receive the vaccine. These missed opportunities are a reason why hepatitis B infections persist, the researchers said.

"This is a really simple thing that we could do, and if somebody ends up getting the disease because we didn't make the effort, then I think that's really a shame," study senior author Brian Montague, an assistant professor of medicine in the Warren Alpert Medical School of Brown University and a physician at the Miriam Hospital in Providence, said in a university news release.

The likelihood of vaccination was lower among people older than 33, those with less access to health insurance and those who are also unvaccinated against other diseases, such as the flu.

But even among those with access to health care, thousands of people had not been vaccinated against hepatitis B infection, the study found.

The researchers identified some locations where improved rates of hepatitis B vaccination would make a substantial difference. For example, hepatitis B vaccinations could be given when people are tested for HIV at the doctor's office, hospital, clinic or jail.

The study was published online Jan. 12 in the journal Infection.

More information

The U.S. National Institute of Diabetes and Digestive and Kidney Diseases has more about hepatitis B.

SOURCE: Brown University, news release, Jan. 19, 2012


Four-Drug Therapy Wiped Out Hepatitis C Virus in Most Cases

From Reuters Health Information

By Gene Emery

NEW YORK (Reuters Health) Jan 18 - Combining the experimental oral drugs asunaprevir and daclatasvir with the established treatment of peginterferon alfa-2a and ribavirin eliminated all traces of hepatitis C virus (HCV) in the blood of every volunteer, even after ribavirin-peginterferon alfa-2a treatment had already failed, in small phase II study released online today by the New England Journal of Medicine.

The ten patients treated with all four drugs all had undetectable viral levels 12 weeks after treatment stopped, and nine still had undetectable levels after 24 and 48 weeks.

Another 11 patients received only asunaprevir and daclatasvir, and four of them had a sustained virologic response at 12 and 24 weeks after treatment.

"This is a watershed moment in the annals of HCV therapy because it shows that a sustained virologic response can be achieved without interferon," Dr. Raymond T. Chung of Massachusetts General Hospital wrote in an editorial in the January 19 issue.

Dr. Anna Lok of the University of Michigan and chief author of the study told Reuters Health that the cure rate for the peginterferon/ribavirin regime is low. "It's only 36%. But considering that these are difficult patients to treat, 36% is not too bad," she said.

All 21 patients in the current study had genotype 1 HCV, the most common in the U.S., and all had failed to respond to peginterferon plus ribavirin (i.e., they had not had at least a 2 log10 decline in HCV RNA after at least 12 weeks of treatment).

The response was far better when the four drugs were used. By the end of treatment, at week 24, all 10 patients in that group had undetectable levels of HVC RNA. Forty-eight weeks after the end of therapy, only one had any trace of the virus, and the amount was too small to quantify, according to the researchers.

About 4.1 million people in the United States and 180 million worldwide are infected by hepatitis C, with its associated risk of cirrhosis and liver cancer.

In the randomized phase II study, where patients knew what treatment they were getting, everyone received 600 mg of asunaprevir twice daily and 60 mg of daclatasvir once daily for 24 weeks. Both are made by Bristol-Myers Squibb, which paid for the trial.

Ten of the 21 also got 180 mcg of Pegasys brand peginterferon alfa-2a each week and Copegus brand ribavirin, where the daily dose was 1,000 mg for those weighing less than 75kg and 1,200 mg for those weighing more. Both are Roche products.

After 24 weeks of therapy, all 10 patients getting the four-drug regimen and five of the 11 patients receiving the non-interferon regimen had no trace of virus in their blood.

The six patients in the non-interferon group who had viral breakthrough during the treatment period all had HCV genotype 1a. Another patient in that group had viral recurrence after treatment ended.

By 24 weeks after treatment ended, the virus had returned in one of the 10 getting all four drugs. But that one person was retested 13 days after recurrence and levels of HCV RNA were undetectable, a phenomenon that was seen in other patients, said Dr. Lok. "Because it was not persistent, we believe 100% actually maintained virus clearance all the way to week 48."

"To be able to get to 90% or 100% is very remarkable," she said. "On the other hand, we all know that a lot of patients can't handle interferon and ribavirin because of the side effects. What we hear from the patients is that they hate interferon. They prefer not to get treatment. Everyone is looking for when can we have an interferon-free regimen."

In the new study, the side effects were similar in the two experimental groups. The three most common were diarrhea, fatigue and headache, reported by 45% to 73% of patients. Six patients had transient elevations of alanine aminotransferase to more than 3 times the upper limit of normal. Side effect rates were complicated by the fact six of the 11 volunteers randomized to receive only daclatasvir and asunaprevir received rescue therapy with interferon and ribavirin after a viral breakthrough.

None of the 21 dropped out because of the side effects.

Dr. Lok said 48 weeks of peginterferon and ribavirin usually costs about $40,000. Adding a protease inhibitor as a third drug costs another $50,000, and new biologicals often go for a comparable amount.

The eventual price of the experimental drugs is not known, assuming they are approved.

Thus, a four-drug regimen would add to the cost, Dr. Lok said, but "if this pans out, it's only 24 weeks of treatment. And if you get a cure once and for all, you don't have to worry about managing the complications of cirrhosis, liver transplant, liver cancer down the road."

SOURCE: http://bit.ly/A5JnBy

N Engl J Med 2012; 366:216-224.


Also See:

  1. First Hepatitis C Treatment Data Demonstrating Proof of Principle with Direct-Acting Antiviral-only Therapy Published
  2. Hepatitis C treatment with antivirals is effective: study
  3. Bristol-Myers Hepatitis C Pills Clear Virus Without Interferon
  4. New Combo KOs HCV Without Interferon, Ribavirin
  5. Combination of oral drugs suppresses common type of hepatitis C

Hepatitis C infection identified as leading risk factor for HCC

Posted on HemOncToday.com January 19, 2012

Yang JD. Mayo Clin Proc. 2012;87:9-16.

Liver-scarring diseases such as cirrhosis from alcohol consumption continue to present a high risk for the development hepatocellular carcinoma, but hepatitis C infection has been identified as the leading risk factor, according study results published in Mayo Clinic Proceedings.

Researchers analyzed trends in incidence, etiology and treatment of liver cancer among residents in Olmsted County, Minn. Using medical records from a community-wide medical record linkage system, they identified 104 residents aged older than 20 years diagnosed with hepatocellular carcinoma (HCC) from 1976 to 2008.

Divided into three eras based on time of diagnosis, the analysis demonstrated that the age- and sex-adjusted incidence rate for HCC in Olmsted County was 3.5/100,000 person-years for the first era (1976-1990), 3.8/100,000 for the second era (1991-2000) and 6.9/100,000 for the third era (2001-2008).

In the first era, alcohol use was identified as the most common cause of HCC, with no diagnoses of hepatitis C virus (HCV). In the second era, however, the percentage of HCCs attributable to HCV had risen to 25%, including 7.1% who were observed to have joint HCV and alcohol use as causes of HCC. In the third era, 21 of 47 patients diagnosed with HCC had evidence of chronic HCV infection.

The increase in the proportion of HCV most significantly affected patients aged 50 to 59 years — seven of eight exhibited HCV in the most recent era. Additionally, coexisting alcoholic liver disease was common in HCV patients who developed HCC at an age younger than 60 years: Six of eight HCV patients aged younger than 60 years had coexisting alcoholic liver disease, whereas only one (6.3%) of 16 patients aged 60 years or older had this coexisting disease (P,.01).

“The liver scarring from hepatitis C can take 20 to 30 years to develop into cancer,” W. Ray Kim, MD, principal investigator in the study, said in a press release. “We’re now seeing cancer patients in their 50s and 60s who contracted hepatitis C 30 years ago and didn’t even know they were infected.”

Disclosure: Study researcher Lewis R. Roberts, MBChB, PhD, reports receiving research grants from Bristol-Myers Squibb and MDS Nordion.


American Red Cross Fined Millions for “Shoddy” Blood Collection—Again


January 20, 2012
Ruth McCambridge

January 19, 2012; Source: Care2 | The American Red Cross has been fined $9.6 million after the U.S. Food and Drug Administration (FDA) found hundreds of violations in its blood collection procedures. The fines have been levied against half of the blood collection centers nationwide. The violations—which include having donated blood infected with HIV, Hepatitis C and the West Nile Virus—were detailed in a 32-page Adverse Determination Letter (ADL) written by Evelyn Bonnin, the FDA Director of the Baltimore District and issued by the FDA. The letter details problems including poorly trained staff and inadequate record keeping where donated blood was mishandled or misplaced. In some cases, potentially infected blood was transfused into patients.

The Red Cross has responded that they are disappointed in the FDA for relying on the results of an inspection carried out 15 months ago. They say that they have cleaned up their procedures in the meantime and that their blood supply is “safer than ever.” But this argument may be difficult to sell since this is not the first time the Red Cross has been fined for such infractions. In fact, they have apparently been fined $47 million for similar violations since 2003. The FDA letter states, “many of the violations recounted in this letter are virtually identical to violations charged in previous ADLs. [The Red Cross] has known of these continuing problems and has failed to take adequate steps to correct them.” –Ruth McCambridge


Surveillance for Hepatocellular Carcinoma in Patients With Cirrhosis

From Clinical Gastroenterology and Hepatology

Ju Dong Yang; W. Ray Kim

Posted: 01/19/2012; Clin Gastroenterol Hepatol. 2012;10:16-21. © 2012 AGA Institute

Clinical Scenario

A59-year-old man was referred to liver transplantation clinic for the evaluation of enlarging abdominal girth and swelling of feet during the preceding 2 months. The patient was a Cambodian native who immigrated to the United States 5 years ago. The patient was first diagnosed with chronic hepatitis B virus (HBV) infection shortly after his entry into the United States. However, he was not further evaluated, treated, or followed. He had no personal or family history of liver disease or liver cancer. Physical examination of the abdomen showed mild hepatosplenomegaly with positive shifting dullness from a moderate amount of ascites. There was no abdominal tenderness. Laboratory results included platelet count, 95,000/μL; aspartate aminotransferase, 100 U/L; alanine aminotransferase, 45 U/L; and Model for End-Stage Liver Disease score, 13. Viral serology showed hepatitis B surface antigen–positive and eantigen– positive and HBV DNA of 5 million IU/mL. Serum alpha-fetoprotein (AFP) was normal at 4 ng/mL. An abdominal ultrasound (US) showed cirrhotic liver contour and evidence of portal hypertension. An esophagogastroduodenoscopy showed large esophageal varices. The patient was started on the following medications: spironolactone and furosemide for the ascites, propranolol for the varices, and entecavir for HBV. Patient was further assessed and then listed for liver transplantation.

During the ensuing 12 months, the patient had substantial clinical improvement including resolution of ascites as well as hepatitis B e seroconversion. He also underwent abdominal US and serum AFP measurement on a 6-month interval. An abdominal US performed 18 months after his presentation showed a new 2.1-cm hyperechoic nodule in the right lobe of the liver along with mild elevation of serum AFP at 22 ng/mL. A subsequent triphasic abdominal computed tomography (CT) scan showed a 2.2-cm well-circumscribed vascular mass that had arterial enhancement and venous washout, thus meeting the radiographic diagnosis criteria for hepatocellular carcinoma (HCC) of the American Association for the Study of Liver Disease (AASLD). The patient underwent transarterial chemoembolization and subsequently received a liver transplant. Four years later, the patient is doing well with satisfactory liver function with no evidence of recurrent HBV or HCC.

The Problem

Our patient represents a case in which implementation of HCC surveillance likely improved his ultimate outcome. HCC is a major global health problem because it is the third leading cause of cancer-related death in the world. GloboCan reported that the incidence and mortality of HCC continued to increase as of 2008. In general, HCCs tend to be asymptomatic until the tumor is in an advanced stage. Although there has been substantial progress in the treatment of HCC, long-term survival is only achievable in a small proportion of patients— those presenting in an early stage where potentially curative modalities such as liver transplantation and surgical resection are feasible. Therefore, it is widely held and recommended that early detection of HCC is imperative in improving the prognosis.

Screening is defined as application of diagnostic tests in patients at risk for a condition (eg, HCC) without a high index of suspicion that the condition is already present. Surveillance is conducted by repeated application of screening tests. In the case of HCC, the stated goal of surveillance is to decrease HCC mortality or at least to increase the meaningful duration of life through the early detection of HCC in asymptomatic patients. Existing evidence indicates that HCCs detected by surveillance are more likely to be amenable to curative treatment. Because long-term survival can be achieved in a majority of patients eligible for liver transplantation or resection, surveillance might decrease HCC mortality. This is a main rationale for which HCC surveillance is recommended in high-risk individuals.

There have been 2 randomized controlled trials that investigated the efficacy of surveillance. Both studies were conducted in China in patients with HBV infection. The first study, involving 19,000 patients, showed that surveillance is efficacious in reducing HCC mortality. Patients assigned to semiannual surveillance with serum AFP and abdominal US had a 37% decrease in HCC mortality compared with patients not under surveillance. Although the study was limited by a high dropout rate of study participants and suboptimal randomization and concealment schemes, it provides the best evidence to date that has shown the benefit of surveillance on "hard end points" in HCC. The other study was performed with 5581 HBV patients. In contrast to the first study, it used serum AFP as the primary tool for surveillance. This study showed that surveillance increased the detection of early-stage tumors but did not affect overall survival and liver cancer mortality. Besides these trials, a number of observational studies have suggested that surveillance improves survival in HCC patients (Table 1).

Although HCC surveillance is generally accepted, its implementation is suboptimal in real-life practices. In the United States, a study that used the Surveillance Epidemiology and End Results-Medicare database showed that only 17% of cirrhotic patients were under regular surveillance 3 years before the diagnosis of HCC. In a more recent study involving 13,000 cirrhotic hepatitis C virus patients at Veterans Administration health care facilities throughout the United States, only 12% received routine HCC surveillance.

Management Strategies and Supporting Evidence
Who Are the Candidates for Hepatocellular Carcinoma Surveillance?

Hepatocellular carcinoma surveillance should be performed in a group of patients whose risk for HCC development is sufficiently high to make it cost-effective (Table 2). Surveillance is considered effective if it increases life expectancy by more than 3 months and considered cost-effective if less than $50,000 is needed to increase 1 quality-adjusted life-year. Under this concept, the incidence of HCC is the primary determinant of the cost-effectiveness of surveillance.

The first category of candidates for surveillance is patients with cirrhosis. Cirrhosis is the single most important risk factor for HCC, and most patients with HCC have underlying liver cirrhosis. According to a guideline from AASLD, surveillance is recommended when the HCC incidence is higher than 1.5% in a patient with cirrhosis. This category of patients includes those with cirrhosis from viral hepatitis, nonalcoholic steatohepatitis, and primary biliary cirrhosis, and thus these patients should be under a surveillance program. In addition, experts recommend patients with other types of cirrhosis to receive surveillance, although firm data about the incidence of HCC in this group of patients are lacking.

In implementing surveillance, one of the common challenges is to identify patients with cirrhosis. Because viral hepatitis is easily recognizable, patients at risk for chronic viral hepatitis infection need to be screened for HBV and/or hepatitis C virus according to the established guidelines. It is also important to have a high index of suspicion of chronic liver disease in patients with abnormal liver function test, significant alcohol history, or metabolic syndrome.

The diagnosis of cirrhosis is straightforward in patients with hepatic decompensation, on the basis of the characteristic symptoms of portal hypertension and liver failure. Hepatocellular carcinoma surveillance in this group of patients would be most meaningful if liver transplantation is available. Under the current allocation system, an early-stage HCC within the socalled Milan criteria increases the priority of receiving a liver transplant from a deceased donor. In contrast, if liver transplantation is not available, surveillance in patients with hepatic decompensation severe enough to disallow meaningful therapy is unlikely to be beneficial.

Diagnosing patients with compensated liver cirrhosis might present a challenge because patients are usually asymptomatic without an overt sign of portal hypertension. Although histology is considered the gold standard for the diagnosis of cirrhosis, a liver biopsy is invasive and subject to sampling variability. Various laboratory data and mathematical models have been proposed to noninvasively identify patients with cirrhosis. Transient elastographic techniques with magnetic resonance imaging (MRI) or US measure the stiffness of the liver, which correlates with hepatic fibrosis. As data accumulate in support of accuracy of these techniques in identifying asymptomatic cirrhotic patients, they are gaining wider acceptance in clinical practice.

The other category of candidates for surveillance is HBV carriers who might develop HCC without cirrhosis. In those subjects, surveillance is warranted when the HCC incidence is higher than 0.2%/year. These high-risk hepatitis B carriers include Asian men older than 40 years and Asian women older than 50 years. Although the annual incidence of HCC in individuals of African race or those with family history of HCC cannot be firmly established, they are also recommended to undergo surveillance starting at an earlier age (Table 2).

What Modality is to be Used for Surveillance?

Most guidelines advocate abdominal US as the standard surveillance test for HCC. It has sensitivity greater than 60% and specificity greater than 90% as a screening test for HCC. It is widely available and less expensive than CT or MRI. It does not expose patients with repeated radiation. However, there are several weaknesses of US as a surveillance test for HCC. Abdominal US is highly dependent on the operator. Because small HCC often presents with a nonspecific appearance, detecting an early HCC nodule can be challenging, particularly in a patient with a nodular cirrhotic liver. Sensitivity of US is further decreased in obese subjects. Because of the high prevalence of obesity in the United States, the utility of US as an HCC surveillance test in those patients has been questioned.

These limitations of US have prompted some clinicians to use abdominal CT or MRI in select patient groups, eg, those waiting for liver transplantation. However, the risk of repeated radiation and contrast exposure and high cost are obvious limitations that prevent its routine use in the broader population at risk. Finally, serum AFP is commonly used as an adjunct to abdominal US, although its use as a surveillance test for HCC remains controversial.

What is the Next Step if a Suspicious Lesion is Found by a Surveillance Test? (Recall Policy)

Once a suspicious lesion is found on US, a systematic algorithm, also known as the recall policy, can be followed to appropriately and expeditiously diagnose an HCC (Figure 1). If the nodule is smaller than 1 cm, a close follow-up with a repeat US at 3 months is recommended. If the lesion is found to enlarge to a size larger than 1 cm, a dynamic imaging study (CT or MRI) should be performed. If the size of the lesion remains the same for more than 2 years, the original 6-month follow-up might be resumed.


Figure 1. Lesions on surveillance US: recall policy.

For lesions that appear larger than 1 cm on US, a contrastenhanced dynamic CT or MRI must be performed. If characteristic vascular features (arterial enhancement and venous washout) are seen, a diagnosis of HCC is established. If the imaging characteristics are not typical, a second dynamic scan should be performed (if the first modality was CT, then MRI, and vice versa). If it shows the characteristic vascular features, a diagnosis of HCC might be made. If not, a percutaneous biopsy of the lesion should be considered, although the biopsy might not always be diagnostic. Finally, if there is considerable increase in serum AFP in the absence of a demonstrable lesion on US, a contrast-enhanced dynamic CT or MRI should be performed.

Areas of Uncertainty
Is Serum Alpha-Fetoprotein Beneficial?

There is broad agreement that serum AFP alone is inadequate as an independent tool for HCC surveillance and must not be used. For example, investigators of the Hepatitis C Antiviral Long-term Treatment Against Cirrhosis trial serially measured the serum AFP every 3 months before the diagnosis of HCC and reported that serum AFP has inadequate efficacy as a surveillance test. Many other studies investigating the performance of AFP were in the setting of diagnosis rather than surveillance, where pretest probabilities are higher and the performance of the test is overestimated. The biggest limitation of serum AFP, when used alone, is its low sensitivity. Whereas the test might be made sufficiently specific if a high cutoff value is used, modest elevations might be seen in patients with viral hepatitis especially hepatitis C, pregnant women, and in those with tumors other than HCC, most notably gonadal tumors. Thus, depending on the cutoff value, serum AFP has suboptimal sensitivity and/or specificity. More recent serum markers such as des-carboxy prothrombin and the ratio of lecithinbound AFP to total AFP are even less sensitive than AFP for the detection of early-stage HCCs and have not been shown to be useful for surveillance.

Compared with US alone, the combination of US and serum AFP might slightly enhance the sensitivity to detect an HCC lesion. A study from China showed that the combination of US and serum AFP increases the liver cancer detection rate by 9%. However, the combination was associated with a 2.4-fold increase in false positivity and a 2.2-fold decrease in the positive predictive value. A cost-effectiveness analysis performed in the United States showed abdominal US is most cost-effective, and addition of AFP to US in HCC surveillance provides a small gain at a significant increase in cost. This increase in cost stems not only from adding the cost of AFP testing but also from the expenses needed to investigate false-positive results. For this reason, the AASLD guideline recommends the use of US alone for the surveillance of HCC.

Despite these limitations of serum AFP, a recent study that used the Surveillance Epidemiology and End Results-Medicare database reported that the combination of serum AFP and US, followed by serum AFP alone, is most commonly used for HCC surveillance in the United States. The reality in practice is that AFP is widely available and inexpensive. Proponents point out that given the poor adherence to US-based surveillance, even a suboptimal test might still be better than complete lack of any surveillance. This might be more relevant in settings with limited health care access and resources, such as in Alaskan natives with chronic HBV infection in whom serum AFP was found to be beneficial.

How Often Should Tests be Repeated?

Most guidelines recommend surveillance to be conducted every 6 months. The principle for determining the interval for surveillance is that it should not be based on the anticipated incidence of HCC, but on the rate of tumor growth. Even if the incidence is high, if all of the tumors grow slowly, infrequent surveillance would be sufficient. On the other hand, if many tumors grow fast, frequent surveillance is needed for any hope of early diagnosis to exist. Thus, the absolute risk (incidence) of HCC determines whether surveillance should be performed, whereas the rate of tumor growth dictates the interval for surveillance.

It is currently uncertain whether surveillance every 6 months is superior to every 12 months in decreasing HCC mortality and improving patient survival (Table 3). Several retrospective studies showed that there is no difference in survival between 6-month and 12-month surveillance intervals. However, the most recent study showed that surveillance every 6 months improved patient survival compared with that every 12 months. In short, to date, there is no robust evidence from a randomized controlled trial to determine the optimal surveillance interval. Most hepatologists tend to err on being more conservative with frequent (ie, semiannual) surveillance.

Published Guidelines and Summary

Most practice guidelines suggest that patients at risk of HCC undergo surveillance. Published guidelines for HCC surveillance are summarized in Table 4. Although not ideal, US is the preferred modality for surveillance. The AASLD guideline recommends patients with cirrhosis from any cause to undergo HCC surveillance by using abdominal US at 6-month intervals. AFP is inadequate as a surveillance test. The European Association for the Study of the Liver recommends that the ideal target population is Child–Pugh class A cirrhotic patients without severe comorbid conditions. Patients not suitable for curative therapy might be excluded from surveillance. The Asian Pacific Association for the Study of the Liver specifies cirrhotic patients with HBV and HCV as candidates for surveillance in whom the combination of US and AFP is to be used every 6 months. In contrast to these liver societies, the National Cancer Institute calls for additional data before HCC surveillance is routinely recommended, even in high-risk patients. They note that data to date suffer from several methodological flaws and limited generalizability and thus have not proved that surveillance decreases HCC mortality.

Against the backdrop of these recommendations, in the particular case of our patient, we have little doubt that he benefited from the surveillance because it led to detection of an early HCC lesion, followed by successful liver transplantation. He was "fortunate" to have experienced hepatic decompensation that drew close medical attention to his liver disease, which resulted in institution of surveillance for HCC. Because he had not been followed for his HBV, he could very well have presented with advanced HCC, if his liver disease had remained compensated. Although our patient would have been a candidate for surveillance according to most guidelines, he belonged in the majority of patients in whom surveillance is not practiced as a result of patient preference, lack of socioeconomic or health insurance support, or poor awareness of or adherence to guideline recommendations by the physician.

Among human malignancies, HCC is unique in that cirrhosis or advanced fibrosis is essentially a prerequisite condition, which makes it relatively straightforward to identify subjects who should be subjected to surveillance. However, it is obvious that not all patients with cirrhosis develop HCC, and the best informed surveillance strategy should include accurate risk stratification. As of today, we lack detailed knowledge for individualized risk stratification, which prevents formulation of an optimal surveillance program. Clearly, more high-quality data are needed to improve the outcome of patients with HCC, whose incidence is rising in the United States and globally. In the meantime, the clinician is encouraged by cases like ours that careful adherence to surveillance in at-risk individuals provides opportunities to make a meaningful difference in the patient's outcome.


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GAO asked to review VA quality-of-care policies

By Patricia Kime - Staff writer
Posted : Thursday Jan 19, 2012 17:57:33 EST

The top Democrats on the House and Senate Veterans’ Affairs committees are seeking an investigation of the Veterans Affairs Department’s handling of several incidents involving improper sterilization of reusable medical equipment.

The lawmakers say those problems could be an indication that VA leaders are not following their own guidelines for investigating such incidents or disciplining those responsible.

In a Jan. 19 letter to Government Accountability Office Comptroller Gene Dodaro, Sen. Patty Murray, D-Wash., and Rep. Bob Filner, D-Calif., asked for a GAO review of VA’s procedures and policies.

“We continue to hear about the same types of quality-of-care incidents at VA medical facilities and we are concerned this is an indication that VA is not effectively learning from these incidents and subsequently translating these lessons into system-wide improvements,” Murray and Filner wrote.

In the past seven years, more than 13,000 veterans treated at VA health facilities have been placed at risk for exposure to infectious disease such as hepatitis and HIV after undergoing procedures with improperly sterilized equipment.

From 2004 to 2009, 11,000 veterans at the Murfreesboro, Tenn., Augusta, Ga., and Miami VA medical centers were notified of their risk after they underwent colonoscopies with improperly prepared endoscopes.

At least 25 veterans contracted Hepatitis C, eight developed Hepatitis B and five tested positive for HIV.

In January 2011, surgeries at the St. Louis VA Medical Center were halted after VA found 1,812 vets were placed at risk from improperly sterilized surgical equipment.

And in Dayton, Ohio, VA offered to test 500 veterans for possible exposure after leaders determined a dentist didn’t change his latex gloves between patients.

“On numerous occasions, VA has reported to Congress about the various investigations it has conducted and the problems these investigations have identified, which they claim to have led to the development of new processes and procedures to reduce risk,” the lawmakers wrote.

In October, members of the House Veterans’ Affairs Committee were surprised to learn that Miami VA Medical Center Chief Mary Berrocal still had her job.

Berrocal received a letter of admonition in 2009 after the colonoscopy scandal surfaced but remained as chief until November, roughly a month after she testified that conditions at the facility were improving.

Her testimony came a week after a Miami VA employee was arrested for selling the names and personal information of 18 patients and compromising the personal data of 3,000 veterans, and three months after a veteran was allowed to leave the medical center when she should have been placed on suicide watch.

Veteran Catawba Howard was shot by police just hours after she left the medical center.

“This raises concerns as to whether VA’s leadership is taking appropriate actions, including appropriate disciplinary actions, to effectively address the problems across the system,” the lawmakers wrote.

VA spokesman Josh Taylor said Thursday that the department is committed to providing safe, high-quality care.

He said VA agrees with Murray and Filner that “every health care provider must ensure they follow good infection-control practices and that they send equipment for proper reprocessing. Failure to do so is unacceptable.”

Taylor added that VA has been recognized by the New England Journal of Medicine for its patient disclosure policy, what he called a “reflection of VA’s commitment to transparency.”