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Report from Day 3 at NIH HCV Consensus Conference
Reported by Jules Levin
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This morning's session took place from 9-11am and was a review of the
proposed consensus statement. This was followed by comments and suggestions
at microphone from audience participants. And many researchers and doctors
had many comments and suggestions for adjusting the statement presented first
thing in the morning. There were several key proposals presented by the NIH
Panel that I will outline below and I think they will remain a key part of
the final recommendations.
In the opening comments this morning it was mentioned that HCV is an
epidemic. This is I think a key statement. You can see 3 NATAP reports from
this conference at the NATAP website.
The consensus panel's draft statement will be posted to the Consensus Program
Web site at http://consensus.nih.gov on Wednesday, June 12, 2002.
1. Hepatitis C Clinical Trials Network.
The panelists recommended that the NIH start a clinical trials network
similar to the ACTG fir HIV clinical studies. They recommended what needs to
be studied and some of the key study ideas included: treatment and support in
special populations (depressed individuals, HIV+, methadone maintenance,
IVDUs, decompensated cirrhotics, when to start HCV therapy, whom to treat,
weekly pegylated interferon monotherapy, supportive services for patients
particularly IVDUs, is there a safe alcohol level use, biopsy, preventing
maternal-fetal transmission, caesarian section in preventing MFT,
pathogenesis, how to optimize theapy for nonresponders, maintenance therapy,
and there were others.
2. Pegylated Interferon Is Preferred Treatment
The panel presentation said that pegylated interferon + ribavirin is more
effective than interferon+ribavirin and than pegylated interferon alone. And
response varies by genotype, viral load before therapy, and the stage of
disease patient has. This is important because some treating physicians and
reimbursers may want to recommend standard interferon+ribavirin in certain
circumstances.
3. Treatment Recommended Based on Individual Situation (HIV+)
The preliminary recommendation was to support treatment for those individuals
at greatest risk for progression. This suggests support for treating HCV/HIV
coinfected persons. I hope the draft has a strong statement on supporting
treatment in HIV. David Thomas made a strong recommendation in his talk
yesteday on HCV/HIV that these patients get a recommendation for treatment
despite the fact that study data is preliminary. This may be key in
supporting reimbursement through ADAP & medicaid for HIV-infected patients.
For nonresponders, some reimbursers have denied access to peg IFN/RBV for
retreatment. Since the study data on these patients is relatively incomplete
I think remains a concern. But the panel today said that a 15-20% SVR might
be expected; lower in genotype 1.
4. Maintenance therapy
The panel presentation said maintenance therapt remains experimental until
the daya from HALT-C is available. They suggested a response rate of 15-20%
may be seen in IFN/RBV nonresponders using PegIFN/RBV. For patients with
advanced liver disease now and who are not responding to HCV therapy, many
doctors consider & use reduced dose interferon maintenance therapy. It
remains perhaps the only option available now to slow disease progression.
There is a study starting to look at gamma interferon which is an
antifirbrotic drug, which may slow disease without reducing viral load.
5. 2 Log Decrease at Week 12/24
The panel suggested that a person appears unlikely to achieve SVR if they
don't achieve a 2 log or greater reduction in viral load by week 12 or 24.
Actually, the preliminary study data suggests 12 weeks may be a reliable
cutoff but I suppose 24 weeks may be safer & particularly it may be safer in
HIV as coifected patients may take longer to mount a viral load response.
6. Trials in Special Poplualtions
Emphasis was placed on studying IVDUs, methadone maintenance, antifibrotic
drugs, maternal-fetal transmission, African-Americans, Hispanics, and HIV
7. Prevalence Studies Needed
Although the panel did not address the need for better prevalence studies, a
person from the CDC suggested we need such studies to get a good picture of
actually how many people have HCV. This is key in the fight to secure funding
from Congress & the Administration. This is particularly true in HIV/HCV
coinfection. There are no national prevalence studies to accurately ascertain
how many people have coinfection. There have been isolated studies showing
20-40% infection rates with 60-90% of HIV-infected IVDUs having HCV. Actual
clear prevalence data is needed to prove to ADAPs, Medicaids, state
governments, and the Federal government the true proportion of disease, the
true needs, and to secure funding for access to treatment & testing.
8. Educate The Public
The panel recommended that the public receive education about transmission
and prevention.
9. The panel recommended collaboration between treaters and addiction
specialists in understanding and addressing the needs of IVDUs.
10. The panel recommended support is needed from the private sector & from
the government.
11. Biopsy Preferred
The panel made it clear this morning that a biopsy is needed to truely assess
liver disease. The biopsy provides information not available any other way
and is crucial in assessing a patient and their liver disease. The use of
individual lab tests or panels of lab markers or radiologic testing has not
yet proven to be reliable. But we should continue to research non-invasive
techniques as the are needed.
12. False Negative Antibody Test
It is rare, but the panel said persons with immunodeficiency can have a false
negative antibody test. A PCR test should be used. If an initial PCR test is
negative consider repeating the PCR test. In HIV persons with low CD4s may
have afalse negative antibody test.
13. Normal ALT
The presentations yesteday reported that studies show that persons with
normal ALT respond as well to therapy in terms of safety and antiviral
response. studies report 25% with normal ALT can have advanced disease. This
underscores the need for a biopsy and consideration for therapy.
14. HCV RNA Surrogate for Survival
Everyone agrees we need long-term clinical studies to prove that HCV RNA
reductions and achieving an SVR translates into better clinical outcomes &
survival. The panel said they beieve these improvements in viral load (SVR)
is a surrogate for clinical outcome. This is the case in HIV. But we do need
long-term clinical outcome studies to prove that achieving SVR improvs
disease progression, reduces HCC, and improves survival.
15. Prisons
A number of observers commented on the need to address the needs of
prisoners. Women in California prison study were reported to have 55% HCV
positivity. We'll see the final recommendations and follow-up.
16. Alcohol
Marion Peters recommended that patients should abstain from alcohol during
therapy. Drinking alcohol can intefere in response to therapy.
She said that the data for low amounts of alcohol (1-2 drinks per day) are
not available to state that all patients with HCV should abstain.
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