Reuters Health Information (2004-02-11): HCV can be eradicated in many HIV patients
HCV can be eradicated in many HIV patients
Last Updated: 2004-02-11 16:40:50 -0400 (Reuters Health)
SAN FRANCISCO (Reuters Health) - Patients dually infected with HIV and hepatitis C virus (HCV) can be successfully treated for HCV, according to the results of the largest study to-date of combination Pegasys and ribavirin, reported here Tuesday at the 11th Annual Retrovirus Conference.
A sustained hepatitis C virologic response after discontinuation of treatment was achieved in 40% of the subjects treated with Pegasys/ribavirin.
These findings "change the way we think about treating hepatitis and HIV," principal investigator Dr. Douglas Dieterich told Reuters Health. This successful study "offers great hope to patients -- that they can be treated and have a very high chance of cure. And it offers great hope to providers that they can treat patients successfully and overcome the side effects," he said.
The AIDS Pegasys Ribavirin Co-infection Trial (APRICOT) involved 860 dually infected patients who were randomized to 48 weeks of treatment with 180 mcg Pegasys once weekly plus 800 mg once daily of ribavirin, or 180 mcg Pegasys once weekly plus placebo, or unpegylated interferon-alpha-2a three times a week plus 800 mg once daily of ribavirin.
At baseline, the mean HIV load was 50 copies/mL, with most patients having undetectable levels, Dr. Dieterich, of Mt. Sinai School of Medicine, New York, added. Mean CD4 counts exceeded 500 cells per microliter and most of the patients were also receiving antiretroviral therapy.
After interferon treatment for 48 weeks, the subjects were followed for an additional 24 off-treatment, he explained. If the HCV assay was negative at the end of the 24-week observation period, "they were considered to have a sustained virologic response or cure."
Forty percent of the patients treated with Pegasys plus ribavirin had a sustained virologic response compared with 12% in the group receiving conventional interferon plus ribavirin and 20% in the Pegasys-only group (p < 0.0001). "This is a very hard number," Dr. Dieterich noted. "In the intent-to-treat analysis, there was no interim analysis performed."
"There was no change in HIV viral load" over the course of the study. Similarly, the CD4/CD8 did not change throughout the study. The absolute CD4 cell count dropped during treatment but returned to baseline levels after treatment was stopped, he said.
"What was really impressive was that about 15% of the patients were not taking antiretroviral therapy -- and they had a mean drop of almost 1 log (.9) in HIV RNA load, he said. "So the Pegasys and ribavirin combination is actually a powerful antiretroviral regimen as well."
The response to combination HCV treatment is not as good as in the HIV-negative population, as "obviously HIV patients have many more issues." But "it's much better than we've ever seen so far -- and much better than we expected."
Two other similar trials were presented at the conference. The findings of these studies also support the efficacy and relative safety of this regimen in dually infected patients.
"This does not represent a dramatic paradigm shift or sea change in the guidelines, but I think it certainly adds weight to the existing evidence that hepatitis C is not just treatable but it's curable in a very large proportion of HIV patients," he concluded. (See Reuters Health report February 3, 2004; consensus statement also published in January 2nd issue of AIDS.)
"When we wrote the guidelines we were not aware of these results, of course -- so I think we might have felt even more positive about treating hepatitis C had we known how good the results are."
The study was funded by Roche, developers of Pegasys.