Hepatic safety of maraviroc in patients with HIV-1 and hepatitis C and/or B virus: 144-week results from a randomized, placebo-controlled trial
| Autor: | Jayvant Heera, Gerd Fätkenheuer, Juergen K. Rockstroh, Rebecca Yanhui Zhang-Roper, David M. Asmuth, Juan A. Pineda, Catherine B. Small, Meena B. Bansal, Frank Plonski, Ronnie Wang, Gilles Pialoux |
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| Přispěvatelé: | [Rockstroh, Juergen K.] Univ Bonn, Dept Med 1, Bonn, Germany, [Plonski, Frank] Pfizer Inc, Global Clin Dev, Collegeville, PA USA, [Bansal, Meena] Icahn Sch Med Mt Sinai, Div Liver Dis, New York, NY 10029 USA, [Faetkenheuer, Gerd] Univ Hosp Cologne, Dept Internal Med 1, Cologne, Germany, [Small, Catherine B.] Weill Cornell Med Coll, Dept Med, Div Infect Dis, New York, NY USA, [Small, Catherine B.] New York Med Coll, Dept Med, Div Infect Dis, Valhalla, NY 10595 USA, [Asmuth, David M.] Univ Calif Davis, Med Ctr, Dept Internal Med, Sacramento, CA 95817 USA, [Pialoux, Gilles] Hop Tenon, Malad Infect & Trop, Paris, France, [Zhang-Roper, Rebecca] GlaxoSmithKline, Safety Evaluat & Risk Management, London, England, [Wang, Ronnie] Pfizer Inc, Clin Sci, Groton, CT 06340 USA, [Heera, Jayvant] Pfizer Inc, Clin Sci, Groton, CT 06340 USA, [Pineda, Juan A.] Hosp Univ Valme, Unit Infect Dis, Inst Invest Biomed Sevilla IBIS, Seville, Spain, ViiV Healthcare, German Federal Ministry of Education and Research, German Centre for Infection Research |
| Rok vydání: | 2017 |
| Předmět: |
Male
Placebo-controlled study HIV Infections Clinical-trials Gastroenterology Maraviroc chemistry.chemical_compound Liver Function Tests HIV Fusion Inhibitors Antiretroviral Therapy Highly Active Pharmacology (medical) medicine.diagnostic_test Coinfection Hepatitis C Hepatitis B Viral Load Middle Aged Human-immunodeficiency-virus Infectious Diseases Treatment Outcome Liver Medical Microbiology Combination Female Mechanism Viral load Adult medicine.medical_specialty Inhibitor Vicriviroc Clinical Sciences Entry Antiretroviral Therapy Microbiology Virus Cyclohexanes Internal medicine Virology medicine Humans In patient Highly Active Phase-2 Aged Pharmacology business.industry Triazoles medicine.disease Surgery chemistry business Liver function tests Ccr5 |
| Zdroj: | Antiviral therapy, vol 22, iss 3 Rockstroh, JK; Plonski, F; Bansal, M; Fätkenheuer, G; Small, CB; Asmuth, DM; et al.(2017). Hepatic safety of maraviroc in patients with HIV-1 and hepatitis C and/or B virus: 144-week results from a randomized, placebo-controlled trial. Antiviral Therapy, 22(3), 263-269. doi: 10.3851/IMP3116. UC Davis: Retrieved from: http://www.escholarship.org/uc/item/68s6t2xj |
| DOI: | 10.3851/IMP3116. |
| Popis: | Background In the primary 48-week analysis of a hepatic safety trial in patients with HIV-1 coinfected with HBV and/or HCV, maraviroc-containing treatment regimens were not associated with increased hepatotoxicity. Methods In this randomized, double-blind, placebo-controlled, multicentre study, patients received maraviroc twice daily ( n=70) or placebo ( n=67) with concomitant antiretroviral therapy for 144 weeks (Clinicaltrials.gov identifer, NCT01327547). The primary end point was the proportion of patients with protocol-defined Grade 3/4 alanine aminotransferase (ALT) abnormalities through week 48. Key secondary end points included 144-week analysis of Grade 3/4 ALT abnormalities and liver fibrosis by enhanced liver fibrosis (ELF) testing, hepatic elastography and an optional biopsy substudy. Results Through 144 weeks of treatment, two (maraviroc) and three (placebo) patients met the protocol-defined Grade 3/4 ALT end point. Similar to the 48-week results, there were no statistically significant differences between groups in change from baseline in ELF or hepatic elastography. However, decreased elastography scores were noted in the maraviroc group. Blinded pathologist review suggested that 2 of 11 paired biopsies (both on maraviroc) showed signs of decreased fibrosis. One (maraviroc) and two (placebo) patients experienced treatment-related hepatobiliary adverse events (AEs). Five patients in the maraviroc group discontinued because of treatment-related AEs versus three in the placebo group. One death in the maraviroc group and two deaths in the placebo group were reported. Conclusions Use of maraviroc did not increase hepatotoxicity in this population through 144 weeks. Further investigation regarding possible beneficial effects of maraviroc on liver fibrosis may be warranted. |
| Databáze: | OpenAIRE |
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