By
Liz Highleyman
In the face of a rising incidence of acute
hepatitis C among HIV positive people -- including an ongoing outbreak of
apparently sexually transmitted HCV among gay and bisexual men in several cities
in Europe, Australia, and the U.S. -- the optimal therapy for acute HCV in coinfected
patients is unclear.
Standard
treatment for chronic hepatitis C for both HIV
positive and HIV negative people is pegylated interferon administered with
ribavirin, which reduces the risk of post-treatment relapse. Numerous studies
of HIV negative patients have demonstrated that pegylated interferon alone produces
a high rate of sustained virological
response (SVR; undetectable HCV RNA 6 months after completion of therapy).
Based
on a previous
study showing good outcomes, the investigators advocated pegylated interferon
monotherapy for acute hepatitis C in HIV-HCV coinfected patients. "[W]e believe
that, at present, there is not enough evidence to firmly support combination therapy
with peginterferon and ribavirin for the treatment of acute HCV infection in HIV
positive patients," they wrote at the time.
In
the study presented at ICAAC, the researchers conducted further analysis of pegylated
interferon monotherapy in 12 coinfected patients. Acute HCV infection was diagnosed
on the basis of HCV antibodies and HCV RNA (viral load), along with clinical signs
or elevated alanine aminotransferase (ALT). Infection was considered acute if
patients had a negative serology test within 1 year prior to the positive test.
All
but 1 of the patients were men, the median age was 45 years, 8 had hard-to-treat
HCV genotype 1, and 4 had genotype 4. Overall, the group had well-controlled HIV
disease; half had undetectable HIV viral load on antiretroviral therapy (ART)
and the median CD4 count was 517 cells/mm3.
The patients were observed
for 12 weeks to see if spontaneous viral clearance occurred. If not, they were
treated with 180 mcg/week pegylated
interferon alfa-2a (Pegasys). Those who experienced rapid virological response
(RVR; HCV RNA < 50 IU/mL) at week 4 continued on monotherapy. Those who did
not achieve RVR could add weight-adjusted ribavirin at their physician's discretion.
Week 12 early virological response (EVR; at least a 2 log10 drop in HCV RNA) results
were presented.
Results
 | Of
the 12 treated patients, only 3 (25%) achieved RVR. |
 | An
additional 3 patients (25%) achieved EVR, 1 of them using pegylated interferon
alone and 2 after adding ribavirin. |
 | 6
patients (50%) were non-responders, including 1 person who added ribavirin. |
 | There
were no observed statistical differences in baseline characteristics that could
predict RVR vs non-RVR status. |
"Peginterferon
alfa-2a monotherapy resulted in a high percentage of non-response in HIV-infected
patients with acute HCV infection," the investigators concluded. "Unlike
the situation in acute HCV monoinfected patients, combination or add-on therapy
with ribavirin seems necessary in HIV-infected patients with acute HCV infection."
University
Med. Ctr. Utrecht, Utrecht, Netherlands.
9/15/09
Reference
JE
Arends, T Mudrikova, AMJ Wensing, and others. High Percentage of Non-Response
with Peginterferon-alfa-2a Monotherapy for the Treatment of Acute Hepatitis C
in HIV Infected Patients. 49th Interscience Conference on Antimicrobial Agents
and Chemotherapy (ICAAC 2009). San Francisco. September 12-15, 2009. Abstract
H-222.