Real-life experience with sorafenib for the treatment of hepatocellular carcinoma in HIV-infected patients

• Published in: AIDS (London) Vol. 31; no. 1; pp. 89 - 95
• Main Authors: Merchante, Nicolás, Ibarra, Sofía, Revollo, Boris, Rodríguez-Arrondo, Francisco, Merino, Esperanza, Delgado-Fernández, Marcial, Montero-Alonso, Marta, Téllez, Francisco, Galindo, Maria J, Rivero-Juárez, Antonio, García, Maria A, Mínguez, Carlos, Romero-Palacios, Alberto, Garcia-Deltoro, Miguel, Pineda, Juan A
• Format: Journal Article
• Language: English
• Published: England Copyright Wolters Kluwer Health, Inc 02.01.2017
• Subjects: AIDS/HIV; Antineoplastic Agents - adverse effects; Antineoplastic Agents - therapeutic use; Carcinoma, Hepatocellular - drug therapy; Carcinoma, Hepatocellular - mortality; Drug-Related Side Effects and Adverse Reactions - epidemiology; Drug-Related Side Effects and Adverse Reactions - pathology; Female; HIV Infections - complications; Humans; Lentivirus; Liver Neoplasms - drug therapy; Liver Neoplasms - mortality; Male; Middle Aged; Niacinamide - adverse effects; Niacinamide - analogs & derivatives; Niacinamide - therapeutic use; Phenylurea Compounds - adverse effects; Phenylurea Compounds - therapeutic use; Retrospective Studies; Retroviridae; Spain; Survival Analysis; Treatment Outcome; ANE, Spain
• ISSN: 0269-9370; 1473-5571
• DOI: 10.1097/QAD.0000000000001293

OBJECTIVE:To report the real-life results of sorafenib use in a cohort of HIV-infected patients with hepatocellular carcinoma (HCC). METHODS:The GEHEP-002 cohort (ClinicalTrials.gov IDNCT02785835) has recruited 302 HCC cases diagnosed in HIV-infected patients from 32 centers from Spain. RIS-HEP12 study included 44 (14%) cases that have received at least one dose of sorafenib. The overall survival after the start of treatment was the main efficacy outcome. Permanent discontinuation due to adverse events was the primary safety end point. RESULTS:Reasons for sorafenib use are HCC recurrence after previous curative therapy (n = 7), progression following transarterial chemoembolization (n = 6) and first treatment against HCC (n = 31). Nineteen (43%) patients harbored Child–Pugh B cirrhosis. Barcelona-Clinic Liver Cancer stage was A 3 (7%), B 6 (14%), C 30 (68%) and D 5 (11%). All patients were on antiretroviral therapy (ART). The median (Q1–Q3) duration of sorafenib treatment was 70 (31–158) days. Median survival was 7.2 months, whereas the median (Q1–Q3) duration of overall survival after the start of treatment was 4 (2–9.7) months. Twenty-six (59%) patients had any grade adverse events and 19 (43%) suffered a decompensation. Discontinuation due to adverse events occurred in 17 (38.6%) patients. There were no modifications or discontinuations of ART. CD4 cell counts and HIV viral load remained stable. CONCLUSION:The efficacy of sorafenib under real-life conditions in HIV-infected patients seems lower than that reported in the registration clinical trial. On the contrary, the tolerability of sorafenib appears to be similar to what is seen in patients without HIV infection. Sorafenib does not seem to modify the efficacy of ART.