By Liz Highleyman

Chronic hepatitis B virus (HBV) and hepatitis C virus (HCV) are often asymptomatic, and many people with chronic infection are not diagnosed until they progress to advanced stages of disease. And, since treatment is only indicated if liver fibrosis is progressing, a significant proportion of patients do not need therapy at all.

Yet even among individuals who are diagnosed with HBV or HCV and could benefit from therapy, many do not receive timely and appropriate treatment, according to 2 recent reports.

Hepatitis C

At the recent Digestive Disease Week annual meeting (DDW 2009) in Chicago, Ramsey Cheung and colleagues presented results from a study of current treatment practices for chronic hepatitis C.

Studies from the Veterans Administration have found that only 12% of veterans with chronic hepatitis C receive antiviral therapy, and a small insurance company database showed that 30% received treatment, the researchers noted as background, but similar figures are not available for a broader mix of patient, which would be more reflective of current practice.

To determine the national trend of prescribing antiviral therapy for hepatitis C, the investigators conducted a retrospective cross-sectional analysis of the National Ambulatory Medical Care Survey (NAMCS) and the National Hospital Ambulatory Medical Care Survey (NHAMCS), encompassing all ambulatory visits from 2000 to 2006.

All ICD-9 (International Classification of Disease) codes indicating hepatitis C were included in a search of the "diagnosis" fields of patient medical records. Antiviral therapy was defined as prescription for any alfa interferon (conventional or pegylated) or consensus interferon preparations.

Results

	During 2000-2006, there were a total of 7.7 billion ambulatory patient visits in the U.S.
	Of these, 16.5 million visits (0.21%) were associated with a diagnosis of hepatitis C.
	A majority (65%) of patients diagnosed with hepatitis C were men, 71% were white, and 22% were black.
	With regard to age, 2% were under 25 years, 29% were 25-44, 58% were 45-64, and 11% were over 64.
	47% of these patients had private insurance, 24% were on Medicaid, and 12% were on Medicare.
	Only 9.1% of these patients were prescribed antiviral therapy.
	There were no significant differences between individuals who received antiviral therapy and those not prescribed treatment in term of sex, race/ethnicity, age, or insurance status

Based on these findings, the researchers concluded, "Less than 10% of the ambulatory visits for hepatitis C have an associated prescription for antiviral therapy."

"Insurance status and age does not appear to play a role," they added. "[The] reason for the low treatment rate is not clear but deserves further investigation."

Division of Gastroenterology & Hepatology, Stanford University, Palo Alto, CA.

Hepatitis B

In the second study, described in the March 23, 2009 online edition of the Journal of Clinical Gastroenterology, Edoardo Giannini and colleagues looked at treatment of chronic hepatitis B in Italy.

An estimated 1%-2% of the general Italian population has chronic hepatitis B, the authors noted as background, but it is not known how many are eligible for antiviral therapy and not receiving treatment.

The investigators evaluated 362 chronic hepatitis B patients (without HCV or HIV coinfection) who were followed for at least 1 year at tertiary referral centers in the Liguria region.

Patients' data were evaluated using the Panel of Experts algorithm for the management of HBV, indicating that treatment is warranted if HBV DNA levels are > 20,000 IU/mL in hepatitis B "e" antigen (HBeAg) positive patients or > 2000 IU/mL in HBeAg negative patients, along with biochemical and/or histological evidence of active disease.

Results

	116 chronic hepatitis B patients (32%) with detectable HBV viral load were not on antiviral therapy (33 HBeAg positive and 83 HBeAg negative).
	Serum HBV DNA was > 20,000 IU/mL in 32 HBeAg positive patients and > 2000 IU/mL in 54 HBeAg negative patients.
	59 of these 86 patients had evidence of active disease.
	Treatment was not indicated for 10 of the 59 patients with active disease for various reasons, and was planned for 8 patients.
	Therefore, 41 of 49 potential treatment candidates -- or 84% -- were not being treated.

"Evaluation of a large series of patients chronically infected by HBV alone identified a significant proportion of patients who are actually untreated despite being potential candidates for antiviral therapy," the researchers concluded.

Università di Genova, Genova, Italy; Ospedale Galliera, Ospedale San Martino, Ospedale Pediatrico IRCCS Istituto Giannina Gaslini, Ospedale San Carlo, Genova, Italy; Ospedale Sant'Andrea, La Spezia, Italy; Ospedale San Paolo, Savona, Italy; Ospedale Santa Corona, Pietra Ligure, Italy; Ospedale di Sestri Levante, Sestri Levante, Italy.

Comment

Traditionally, active drug or alcohol use -- or a history of use within the past 6-12 months -- was often considered a reason for withholding treatment for viral hepatitis. Current guidelines, however, state that such individuals should not automatically be excluded from therapy, and they can have outcomes similar to those of non-users if they maintain good adherence.

Furthermore, concerns about drug interactions are no longer considered a reason to withhold or delay hepatitis treatment for people coinfected with HIV. On the contrary, coinfected individuals may require therapy more urgently due to the potential for more rapid liver disease progression; HIV-HBV coinfected people can be effectively treated with HAART regimens containing drugs active against both viruses.

Finally, treatment of hepatitis C patients with advanced cirrhosis remains a challenge due to intensified side effects of interferon-based therapy, but a growing number of clinicians are offering therapy for these individuals, who have the most urgent need and could potentially benefit the most from treatment.

6/16/09

References

RC Cheung, A Mannalithara, and G Singh. Majority of Chronic Hepatitis C Patients in US Do Not Receive Anti-Viral Therapy. Digestive Disease Week (DDW 2009). Chicago. May 30-June 4, 2009. Abstract M1787.

EG Giannini, F Torre, M Basso, and others. A Significant Proportion of Patients With Chronic Hepatitis B Who are Candidates for Antiviral Treatment are Untreated: A Region-wide Survey in Italy. Journal of Clinical Gastroenterology. 23 March 2009 [Epub ahead of print].