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NIH Panel Recommends Combination HCV Treatment

Kate Traynor

Consensus conference participants met June 10–12 on the National Institutes of Health (NIH) campus in Bethesda, Maryland, to revise recommendations for the treatment of hepatitis C virus (HCV) infection.

A winning combination. "The main recommendation, and certainly the most important one, is that combination therapy with pegylated interferon and ribavirin be the standard of care for the treatment of patients with chronic hepatitis C," said conference leader James L. Boyer of the Yale University School of Medicine.

Reliance on combination therapy is a shift from a recommendation in a 1997 NIH consensus document, which had advised monotherapy with interferon alfa or its equivalent as the first line of treatment for HCV infection. The 1997 consensus statement had recommended combination therapy with interferon alfa and ribavirin only if three months of monotherapy had proved unsuccessful. Peginterferon alfa-2b first came on the market in 2001.

"Combination therapy results in better treatment responses than monotherapy," Boyer said, reading from a draft version of the new consensus document. "The highest response rates have been achieved with pegylated interferon in combination with ribavirin." The consensus document does not provide specific dosage recommendations for the two drugs.

Treatment of chronic HCV infection. The panel estimated that at least 4 million Americans are infected with HCV, and more than 2.5 million of these people suffer from the chronic form of the infection. By 2015, Boyer said, the number of chronic infections will have increased fourfold since 1990.

The consensus statement describes all patients with chronic hepatitis C infection as "potential candidates for antiviral therapy." Therapy is specifically recommended for patients whose HCV infection is likely to lead to cirrhosis.

The panel also recommended treatment of people with chronic hepatitis C who inject drugs, abuse alcohol, or suffer from a neuropsychiatric or other medical condition—populations that have traditionally been excluded from clinical studies of HCV therapy. Also targeted for treatment are incarcerated people who are infected with the virus.

Successful treatment is defined as a "sustained viral response," or the absence of detectable serum HCV RNA 24 weeks after therapy ends. Patients whose serum HCV RNA load decreases by 2 log units or more during the first 12–24 weeks of therapy are more likely than other patients to mount a sustained viral response.

Viral genes matter. Of the six known HCV genotypes, genotype 1 is responsible for up to 75% of HCV infections in the United States. This genotype, according to the consensus statement, is "less amenable to treatment than other genotypes."

The consensus statement recommends 48 weeks of antiviral therapy for people infected with HCV of genotype 1 but notes that 24 weeks of therapy may be adequate to treat people infected with HCV genotypes 2 or 3.

Screening recommendations. In the United States, routine screening procedures introduced in the early 1990s have greatly reduced HCV transmission from blood products. According to the consensus statement, two thirds of new HCV infections occur among injection-drug users; sexual transmission and occupational exposure account for most other new cases of the disease. The panel recommended the routine offering of HCV screening to at-risk groups, including injection-drug users, health care workers, and people who received a blood transfusion before 1992, when blood banks began using a more sensitive test for antibodies to HCV.

The panel also advised that all HIV-infected patients be screened for HCV and considered for treatment if infected with the virus.

What lies ahead. The 12 clinicians and academic researchers who constituted the panel asked NIH to take the lead in guiding future research on HCV. "We’ve asked NIH to establish a health care network related to defining further research into the many aspects of this disease," Boyer said in a recorded statement. Areas of future research include developing techniques to culture HCV in the laboratory, producing an HCV vaccine, and developing strategies to reduce transmission of the virus.

The full NIH Consensus Statement on Management of Hepatitis C: 2002 can be downloaded from the NIH Web site at


Who Gets Peginterferon?

An issue not raised in the National Institutes of Health consensus statement on hepatitis C management is the limited availability of Schering Corp.'s peginterferon alfa-2b product, Peg-Intron.

A program put into place by Schering in October 2001 restricts the distribution of Peg-Intron powder for injection to patients who register for the company's Access Assurance program. Patients who enroll in the program are placed on a waiting list and eventually receive an identification number that must be presented to the pharmacy before a prescription for Peg-Intron can be filled.

According to Schering, the waiting-list mechanism allows the company to reserve enough peginterferon alfa-2b for each patient who starts therapy to complete the course of medication on schedule. Schering estimated last fall that new patients would remain on the waiting list 10-12 weeks before receiving an identification number.

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