72-week
Treatment with Pegylated Interferon plus Ribavirin Can Produce Sustained Virological
Response in Prior Relapsers
By
Liz Highleyman Patients
who relapse after 48 weeks of treatment with pegylated
interferon plus ribavirin represent a difficult therapeutic challenge, and
no guidelines exist concerning the proper management of such individuals.
In
an effort to improve sustained virological
response (SVR) rates, several recent studies have explored re-treatment of
prior non-responders and
relapsers for longer durations or with higher doses of one or both drugs.
At
last month's Digestive Disease 2007 conference in Washington,
DC, researchers from Detroit reported on their preliminary experience using a
repeat extended 72-week course of pegylated
interferon/ribavirin in 4 patients (3 with genotype 1; 1 with genotype 2)
who previously relapsed after an initial 48-week course of the same combination
regimen.
During their initial therapy, 3 of 4 patients achieved undetectable
HCV RNA within the first 16 weeks, and all 4 maintained good adherence according
to the "80/80/80" rule (taking 80% of both drugs for 80% of the original
prescribed duration). None of the patients required hematopoietic growth factors
at any time to manage anemia or neutropenia.
Following initial therapy,
all 4 relapsed within 12 weeks of their last dose. All were then re-treated with
180
mcg/week pegylated interferon alfa-2a (Pegasys) plus weight-based ribavirin (>13.3
mg/kg/day) for 72 weeks. Two patients received higher doses of ribavirin based
on weight during the second treatment attempt.
Results
| | During
re-treatment, all patients achieved undetectable HCV RNA by week 12 and maintained
virological suppression for the duration of therapy. | | | 6
months after completing re-treatment, all remained HCV RNA negative, thus achieving
SVR. | | | Extended
72-week therapy was well tolerated. | | | No
patients required dose reductions due to adverse events. |
Conclusion
In
conclusion, the researchers wrote:
| 1 | SVR
is attainable among patients who relapse following 48 weeks of pegylated interferon/ribavirin
therapy. | | 2 | 72
weeks of re-treatment was well tolerated in this group of motivated patients.
| | 3 | 2
of these patients received higher doses of ribavirin during re-treatment, thus
ribavirin dosing may affect the ability to achieve SVR. | | 4 | Each
patient remained adherent during both regimens, thus the duration of viral negativity
appears to represent a pivotal goal. | | 5 | Patients
who relapse after 48 weeks of pegylated interferon/ribavirin should be considered
for re-treatment with a longer duration regimen. |
06/15/07 Reference J
McMahon and SC Gordon. Efficacy of a 72-week course of treatment for previous
relapsers to PEG/ribavirin therapy. Digestive Disease Week 2007. Washington, DC.
May 19-24, 2007. Abstract S1232.
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