Liver tolerance of raltegravir-containing antiretroviral therapy in HIV-infected patients with chronic hepatitis C

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Main Authors: Macías J, Neukam K, Portilla J, Iribarren JA, de los Santos I, Rivero A, Márquez M, Delgado M, Téllez F, Merino D, Giner L, Von Wichmann MA, Pineda JA, Herpal Study team
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Published: Zenodo 2025
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author Macías J
Neukam K
Portilla J
Iribarren JA
de los Santos I
Rivero A
Márquez M
Delgado M
Téllez F
Merino D
Giner L
Von Wichmann MA
Pineda JA
Herpal Study team
author_facet Macías J
Neukam K
Portilla J
Iribarren JA
de los Santos I
Rivero A
Márquez M
Delgado M
Téllez F
Merino D
Giner L
Von Wichmann MA
Pineda JA
Herpal Study team
contents <p><strong>Objectives: </strong>To evaluate the liver safety of raltegravir-including combinations in HIV/hepatitis C virus (HCV) co-infected patients.</p> <p><strong>Methods: </strong>Grade 3-4 transaminase elevations (TEs) and grade 4 total bilirubin elevations (TBEs) were assessed during 12 months in 108 HIV/HCV co-infected patients starting antiretroviral therapy including raltegravir in a retrospective cohort study. Furthermore, the relationship between baseline fibrosis and hepatotoxic events was determined.</p> <p><strong>Results: </strong>Eight patients (7.4%) developed grade 3 TEs and two (1.9%) patients showed grade 4 TEs. TBE grade 4 was detected in two (1.9%) patients. No patient permanently discontinued raltegravir because of hepatotoxic events. Of the patients with and without significant fibrosis, six (9.4%) and two (11.8%), respectively, showed grade 3-4 TEs (P = 0.769). Grade 3-4 TEs was observed in four (9.8%) patients in whom cirrhosis was ruled out, while none of the patients diagnosed with cirrhosis developed grade 3-4 TEs (P = 0.303). During the follow-up, the median (Q1-Q3) CD4 cell count increased from 257 (145-421) cells/mm(3) to 407 (213-587) cells/mm(3) (P < 0.0001) and the number of patients with an undetectable HIV viral load augmented from 33 (30.6%) to 73 (81.1%) (P = 0.002).</p> <p><strong>Conclusions: </strong>Raltegravir-containing regimens are safe in HIV/HCV co-infected patients. The incidence of severe liver toxicity of raltegravir in these individuals is in the range of boosted protease inhibitors in clinical trials. The frequencies of grade 3-4 TEs and grade 4 TBEs were similar in patients receiving raltegravir with or without significant fibrosis or cirrhosis.</p>
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spellingShingle Liver tolerance of raltegravir-containing antiretroviral therapy in HIV-infected patients with chronic hepatitis C
Macías J
Neukam K
Portilla J
Iribarren JA
de los Santos I
Rivero A
Márquez M
Delgado M
Téllez F
Merino D
Giner L
Von Wichmann MA
Pineda JA
Herpal Study team
<p><strong>Objectives: </strong>To evaluate the liver safety of raltegravir-including combinations in HIV/hepatitis C virus (HCV) co-infected patients.</p> <p><strong>Methods: </strong>Grade 3-4 transaminase elevations (TEs) and grade 4 total bilirubin elevations (TBEs) were assessed during 12 months in 108 HIV/HCV co-infected patients starting antiretroviral therapy including raltegravir in a retrospective cohort study. Furthermore, the relationship between baseline fibrosis and hepatotoxic events was determined.</p> <p><strong>Results: </strong>Eight patients (7.4%) developed grade 3 TEs and two (1.9%) patients showed grade 4 TEs. TBE grade 4 was detected in two (1.9%) patients. No patient permanently discontinued raltegravir because of hepatotoxic events. Of the patients with and without significant fibrosis, six (9.4%) and two (11.8%), respectively, showed grade 3-4 TEs (P = 0.769). Grade 3-4 TEs was observed in four (9.8%) patients in whom cirrhosis was ruled out, while none of the patients diagnosed with cirrhosis developed grade 3-4 TEs (P = 0.303). During the follow-up, the median (Q1-Q3) CD4 cell count increased from 257 (145-421) cells/mm(3) to 407 (213-587) cells/mm(3) (P < 0.0001) and the number of patients with an undetectable HIV viral load augmented from 33 (30.6%) to 73 (81.1%) (P = 0.002).</p> <p><strong>Conclusions: </strong>Raltegravir-containing regimens are safe in HIV/HCV co-infected patients. The incidence of severe liver toxicity of raltegravir in these individuals is in the range of boosted protease inhibitors in clinical trials. The frequencies of grade 3-4 TEs and grade 4 TBEs were similar in patients receiving raltegravir with or without significant fibrosis or cirrhosis.</p>
title Liver tolerance of raltegravir-containing antiretroviral therapy in HIV-infected patients with chronic hepatitis C
url https://doi.org/10.1093/jac/dkr083