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Early week 24 African-Americans Response to Pegasys + Ribavirin
Reported by Jules Levin
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Studies have shown African-Americans respond less well to HCV therapy than
Caucasians. Interferon monotherapy achieved a 12% viral response rate for
Caucasians and 2% for African-Americans. The lower response rate is at least
partly due to the high prevalence of genotype 1 among African-Americans. It
is also postulated that there may be an immune genetic basis for this. A
large NIH is being prepared now to look at African-American response to HCV
therapy. Combination therapy with ribavirin added to interferon improved
response rates for Caucasians and African-Americans. And pegylated interferon
with ribavirin has improved response to therapy. In a recently reported
study, African-Americans had a 15% viral response rate with Pegasys
monotherapy compared to 0% for African-Americans receiving standard IFN.
This study looks at the effectiveness and safety of peginteferon alfa-2a
(Pegasys) in combination with ribavirin in non-Hispanic African-Americans
(AAs) compared to non-Hispanic Caucasians (CA). Preliminary 24 week data is
presented here. 74 previously untreated AAs and 28 caucasians with genotype 1
and elevated ALT received Pegasys+1000-1200mg per day of ribavirin (based on
body weight (<75 kg or >75 kg). Treatment was for 48 weeks with an additional
24 weeks for followup. Outcome of therapy was assessed as virologic response
as defined by HCV-RNA <50 IU/mL (undetectable), and biochemical response
(normalization of ALT). Virologic response was also defined as >2 log drop in
HCV-RNA. High viral load was defined as HCV-RNA >1 million IU/mL. 3 AA
patients were enrolled for every CA enrolled.
Average age of patients was about 45. AAs weighed 91 kg, CA 84 kg. 70% AA
men, 60% CA men. AA ALT 62, CA ALT 64. AAs had 58% high viral load, CA had
43% high viral load. About 38% acquired HCV by IVDU.
At baseline, AA patients had higher weight and HCV-RNA than CA patients. And
a greater percentage of men were in the AA group.
46 of 74 ongoing AA patients and 19 of 28 ongoing CA patients have completed
24 weeks of treatment. For virologoc response at week 24, 51 AA and 23 CA
were included in the analysis. For biochemical response at week 24, 49 AA and
23 CA patients were included in this analysis. Patients receiving at least
one dose of study medication who have discontinued prior to 48 weeks of
treatment were considered nonresponders from the time of discontinuation. Up
to week 24, AA patients exhibited a lower virologic response rate compared
with CA patients.
VIRAL RESPONSE At Week 24
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| HCV-RNA >2-log drop |
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AA |
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CA |
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| Week 24 |
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57% |
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74% |
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| HCV-RNA <50 IU/mL (undetectable) |
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AA |
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CA |
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| Week 24 |
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49% |
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65% |
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| Normalization of ALT |
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AA |
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CA |
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| Week 24 |
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59% |
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47% |
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| Safety |
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| 89% of AAs and 100% of CA had at least one adverse event. |
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| Most Frequent Adverse Events |
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AA |
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CA |
| Headache |
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43% |
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64% |
| Fatigue |
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39% |
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50% |
| Rigors |
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28% |
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32% |
| Nausea |
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15% |
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43% |
| Myalgia (aches) |
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19% |
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29% |
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No unexpected side effects related to the study medications have been noted.
Nine serious adverse events have been reported, including the following:
fibroid uterus, acute allergic response, acute abdomen, shortness of breath,
chest pain, thrombocytopenia (reduced platelets), cellucitis, small
intestinal obstruction, and dehydration. Three serious adverse events were
reported due to treatment: thrombocytopenia, acute allergic reaction, and
chest pain). One serious adverse event (thrombocytopenia) resulted in
premature discontinuation. At the time of thios analysis 5 AA and 2 CA
patients have discontinued therapy: 2 AA and 2 CA due to expected adverse
events/intercurrent illness; 1 AA and 2 CA due to refusal of treatment; 1 AA
due to failure to return; and 1 AA due to abnormality of lab test.
These are early and preliminary test results. 48 week results will be more
reliable. It,s also important to remember that a viral response is not the
only goal of therapy. IFN/RBV can improve liver disease despite little or no
viral response. |
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