May 1, 2003
Seven hundred fifty-five HIV-positive patients consecutively prescribed new ART were selected. Liver function tests were assessed at baseline, after one month, and every four months thereafter. Liver biopsy was recommended in case of SH (i.e., increase in liver enzymes greater than or equal to 10 times the upper limit of normal or five times baseline if markedly abnormal).
Twenty-six cases of SH were observed with an incidence of 4.2 per 100 person-years. SH incidence was not significantly different by treatment regimen (four per 100 person-years in patients treated with two nucleoside reverse transcriptase inhibitors (NRTI) plus one protease inhibitor (PI), six per 100 person-years in those treated with two NRTIs, and none in those treated with two NRTIs plus one nonnucleoside reverse transcriptase inhibitors (NNRTI). Patients developing SH during combination ART differed from those who did not by the following factors: they were more often male; had intravenous drug use as a risk factor for HIV acquisition; were younger; were more often coinfected with HCV, HBV, and HDV; and had higher baseline alanine aminotransferase and bilirubin values and longer prothrombin time. Anti-HCV and HCV RNA reactivity were detected in all but one of 26 patients with SH. HBsAg was detected in five patients, as was anti-HDV IgM. The patient without HCV-RNA reactivity showed HBsAg and HDV-Ab IgM reactivities.
Liver failure was rarely seen (1.1 per 100 person-years). Liver damage was invariably observed in patients with chronic viral hepatitis. Liver histology showed exacerbation of viral hepatitis in all 16 patients for whom a liver biopsy was available at the time of SH. A direct correlation was found between ALT increase and increase in CD4+ T-cell count in patients with SH. Death occurred during follow-up in seven of 26 patients (27 percent), all of whom showed LF and baseline CD4+ count less than 200 cells/mm3 (7/7 patients = 100 percent vs. 8/19 patients without LF). Relapse of SH was observed after ART was recommenced in seven of 17 patients (41 percent). Five of these seven patients did not show further SH relapse after treatment with interferon.
Journal of Acquired Immune Deficiency Syndromes
03.01.03; Vol. 32; No. 3: P. 259-267; Massimo Puoti; Carlo Torti; Diego Ripamonti; Francesco Castelli; Serena Zaltron; Barbara Zanini; Angiola Spinetti; Valeria Putzolu; Salvatore Casari; Lina Tomasoni; Eugenia Quiros-Roldan; Maurizio Favret; Luisa Berchich; Piergiovanni Grigolato; Francesco Callea; Giampiero Carosi; HIV-HCV Co-Infection Study Group