A study of HIV-infected patients in Baltimore, Maryland, revealed that individuals seropositive for hepatitis C had similar clinical outcome measures when treated with antiretroviral drug regimens compared to seronegative patients. These findings will be presented at a July 6 press conference at the XIV International AIDS Conference being held in Barcelona, Spain, July 7-12, 2002.
Scientists from the Johns Hopkins University School of Medicine followed almost 2,000 HIV-infected patients, nearly half of whom had exposure to hepatitis C, for at least two years. They observed that exposure to hepatitis C did not increase risk of death, accelerate progression to AIDS, or affect immune reconstitution following exposure to highly active antiretroviral therapy (HAART).
A notable difference between patients with both HIV infection and hepatitis C seropositivity and those with HIV infection alone was that the hepatitis C-seropositive patients were less likely to have been prescribed antiretroviral therapy. It was in this group that relatively high incidences of AIDS and death were observed. No differences were seen in survival rates or decline in CD4 cell count between the hepatitis C-seropositive patients who received antiretroviral therapy and HIV-infected patients who received antiretroviral therapy.
Dr. Glen R. Hanson, NIDA Acting Director, says, "In the United States and Europe, it is estimated that one-in-three of HIV-infected persons are also infected with hepatitis C and many of them are injection drug users. Research needs to continue to determine best approaches to treating those who are coinfected with HIV and hepatitis C."
Dr. Mark S. Sulkowski, head of the Hopkins team that conducted the study, explains that physicians may be less likely to prescribe aggressive antiretroviral therapy to hepatitis C-and HIV coinfected patients because these individuals are thought to be more likely to develop liver complications from antiretroviral medications.
Patients were enrolled in the study between January 1995 and January 2001. All were HIV seropositive, but without an AIDS diagnosis at the time they entered the study. The patients had clinic visits and laboratory evaluations performed at regular intervals. Patients who were prescribed antiretroviral therapy were seen four weeks after starting treatment, and then every 12 weeks. The subjects' CD4 cell count was compared at 1-years, 2-years, and 3-years following the initiation of antiretroviral therapy.
Of the 1,995 HIV-infected patients eligible for the study, 873 (44.6 percent) had hepatitis C seropositivity. This group was older, more likely to be African-American, and to use or have used injection drugs than those without exposure to hepatitis C.
During the study, 1,199 patients were prescribed antiretroviral therapy. Slightly more than half (54 percent) of the hepatitis C-seropositive patients and 67 percent of the hepatitis C-uninfected patients were prescribed antiretroviral therapy. In a group of 429 hepatitis C-seropositive patients who entered the study with baseline CD4 cell counts between 50 and 200 cells/mm, there was an increased risk of death. However, researchers found that hepatitis C seropositivity was not independently associated with CD4 cell decline or patient death, after differences in exposure to effective antiretroviral therapy among hepatitis C-exposed and unexposed patients were taken into account.
The study, which was supported by the National Institute on Drug Abuse, will be published in the July 10, 2002 issue of the Journal of the American Medical Association.