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.