PHILADELPHIA, May 6, 1999

Veterans Administration hospital patients have up to a ten-fold higher prevalence of hepatitis C virus (HCV) infection than the general population of the United States.  The VA is facing the problem head on.  This year, it plans to issue a set of treatment guidelines. It has established two HCV research and education "Centers of Excellence" in Miami and San Francisco.  And periodic, random testing of veterans will estimate how many patients are infected.  On March 17 any patient who came into a VA hospital to get blood drawn was tested for HCV.

The virus often resists current therapies, and no ideal treatment exists. But the new guidelines should help doctors with treatment planning.

While they are a step in the right direction, the guidelines do not go far enough, according to Jere Hough, a VA patient and HCV activist.  Hough says the VA "is limited by what the FDA (U.S. Food and Drug Administration) has approved and what the FDA will allow."  But based on studies he has seen, Hough believes treatment could be improved if dosing were individualized for patients.  He also thinks using different forms of interferons (the major class of drug used to treat HCV) and especially higher doses at the
beginning of therapy, could improve the number of people who respond to treatment.

Many people relapse or fail to respond at all.  "It just means they didn't use adequate dosages or treatment regimens to begin with," Hough says.  In essence, he does not believe that people failed treatment, but that
treatment failed them.

Treatment of Naive Patients: Combination Therapy for Those Who Can Tolerate It

The proposed guidelines the VA circulated late last year lay out a roadmap for treatment.  For patients never treated before who are generally healthy, they recommend combination therapy with interferon and ribavirin.  After six months, doctors evaluate patients' response to treatment.  If they are "responders," therapy continues for another six months for patients with genotype-1 virus, the most resistant form.  Genotypes-2 or 3 receive only six months of therapy.

Many conditions make treatment with ribavirin impractical or impossible. Ribavirin can cause significant anemia, so patients with cardiac disease or pre-existing anemia are not good candidates.  Dr. Joanne Imperial, a liver specialist and Assistant Professor of Medicine at Stanford University School of Medicine thinks patients in the VA system may have more risk factors "that would potentially make them non-candidates for ribavirin."  She says these patients would need an extensive, and expensive, medical work-up before putting them on ribavirin, and close monitoring during such therapy.

In these cases, the VA recommends treatment with interferon alone three times a week -- 3 million units of the alfa 2a (Roferon-A) or alfa 2b (Intron A) form, or 9 micrograms of consensus interferon (Infergen).  Based on response at three months, treatment may continue for a full 48 weeks.

Retreatment: Consensus Interferon or Combination Therapy

Depending on the virus genotype, between one-third and two-thirds of treated patients may relapse, or never respond at all.  Therefore, retreatment is a common concern.  While the guidelines list several interferons for initial therapy, they specify only consensus interferon (Infergen) at 15 micrograms for monotherapy in the retreatment setting.  Dr. Imperial says she almost always uses monotherapy for retreatment of relapsers in her practice, prescribing Infergen at 15 micrograms for the majority of them.  For the VA patient population, she says she would tend to choose Infergen for a year for retreatment because "the cost is lower for one year of Infergen than it is for six months of `combo.'  And it requires less monitoring, and the overall side effects, just based on my experience with one drug versus two, are lower."

Dr. Imperial notes that in a trial of 9 micrograms of Infergen compared to 3 million units of Intron (for naive patients), Infergen eliminated HCV from the blood quicker, which she thinks is important.  "It would appear that Infergen would be a more potent interferon because it would accomplish the task of eliminating (virus) earlier, theoretically," she says.

For people who failed to respond or could not tolerate a prior course of interferon or combination therapy, the VA guidelines now allow use of the higher dose of consensus interferon (15 micrograms) three times a week for 48 weeks.  The FDA has approved this dosage for "relapsed" patients.  Six months of combination therapy is another option.  Response rates for the two different regimens are similar, according to the VA.
 
 
 

SOURCE  Patients Newswire
CO:  Patients Newswire; Veterans Administration
ST:  Pennsylvania