PURPOSE: This post hoc analysis investigated the hepatic safety profile of fosampre-navir (FPV) in patients monoinfected with HIV or coinfected with HIV and hepatitis B (HbsAg positive) and/or hepatitis C (anti-HCV antibody positive). METHODS: Data were pooled from 7 prospective, randomized clinical trials of FPV. RESULTS:Baseline demographics were generally well-matched between the 205 coinfected (72% HCV, 24% HBV, 3% both) and 1,114 monoinfected patients in this analysis. At baseline, most regimens included ritonavir 100 mg (58%) or 200 mg (38%), and 73% of subjects were ART-naïve. Over 48 weeks, the rate of treatment-related serious adverse events was similar between the coinfected (8%; 16/205) and monoinfected (6%; 62/1114) groups, and the rate of treatment-related grade 2-4 adverse events was higher in the coinfected (38%; 77/205) compared with the monoinfected (29%; 320/1114) group. The percentage of patients with grade 3/4 liver enzyme elevations at any time through week 48 was 14% (ALT) and 12% (AST) in the coinfected group and 1% (both ALT and AST) in the monoinfected group. Median AST to platelet ratio index (APRI) scores decreased by 29% in both groups. CONCLUSION:Liver enzyme elevations in coinfected patients treated with FPV with or without ritonavir appear generally similar to those reported for other second-generation protease inhibitors.
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PURPOSE: This post hoc analysis investigated the hepatic safety profile of fosampre-navir (FPV) in patients monoinfected with HIV or coinfected with HIV and hepatitis B (HbsAg positive) and/or hepatitis C (anti-HCV antibody positive). METHODS: Data were pooled from 7 prospective, randomized clinical trials of FPV. RESULTS: Baseline demographics were generally well-matched between the 205 coinfected (72% HCV, 24% HBV, 3% both) and 1,114 monoinfected patients in this analysis. At baseline, most regimens included ritonavir 100 mg (58%) or 200 mg (38%), and 73% of subjects were ART-naïve. Over 48 weeks, the rate of treatment-related serious adverse events was similar between the coinfected (8%; 16/205) and monoinfected (6%; 62/1114) groups, and the rate of treatment-related grade 2-4 adverse events was higher in the coinfected (38%; 77/205) compared with the monoinfected (29%; 320/1114) group. The percentage of patients with grade 3/4 liver enzyme elevations at any time through week 48 was 14% (ALT) and 12% (AST) in the coinfected group and 1% (both ALT and AST) in the monoinfected group. Median AST to platelet ratio index (APRI) scores decreased by 29% in both groups. CONCLUSION: Liver enzyme elevations in coinfected patients treated with FPV with or without ritonavir appear generally similar to those reported for other second-generation protease inhibitors.
Authors: Karin Neukam; Nuria Espinosa; Antonio Collado; Marcial Delgado-Fernández; Patricia Jiménez-Aguilar; Antonio Rivero-Juárez; Victor Hontañón-Antoñana; Ana Gómez-Berrocal; Josefa Ruiz-Morales; Dolores Merino; Ana Carrero; Francisco Téllez; María José Ríos; José Hernández-Quero; María de Lagarde-Sebastián; Inés Pérez-Camacho; Francisco Vera-Méndez; Juan Macías; Juan A Pineda Journal: PLoS One Date: 2016-05-19 Impact factor: 3.240
Authors: Karin Neukam; José A Mira; Antonio Collado; Antonio Rivero-Juárez; Patricia Monje-Agudo; Josefa Ruiz-Morales; María José Ríos; Dolores Merino; Francisco Téllez; Inés Pérez-Camacho; María Carmen Gálvez-Contreras; Antonio Rivero; Juan A Pineda Journal: PLoS One Date: 2016-02-05 Impact factor: 3.240