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Sofosbuvir-Based Therapy in Hepatitis C Virus-Infected Cancer Patients

A Prospective Observational Study

Torres, Harrys A., MD1,2; Economides, Minas P., MD1,6; Angelidakis, Georgios, MD1; Hosry, Jeff, MD1; Kyvernitakis, Andreas, MD1,7; Mahale, Parag, PhD1,8; Jiang, Ying, MS1; Miller, Ethan, MD2; Blechacz, Boris, MD2; Naing, Aung, MD3; Samaniego, Felipe, MD4; Kaseb, Ahmed, MD5; Raad, Issam I., MD1; Granwehr, Bruno P., MD1

American Journal of Gastroenterology: February 2019 - Volume 114 - Issue 2 - p 250–257
doi: 10.1038/s41395-018-0383-2
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BACKGROUND: Data are sparse on treatment of chronic hepatitis C virus (HCV) in cancer patients. We evaluated the efficacy and safety of sofosbuvir-based therapy (SOFBT) in cancer patients.

METHODS: Patients treated with SOFBT at our center during 2014–2017 were included in a prospective observational study. Efficacy [sustained virologic response at 12 weeks after the end of treatment (SVR12)], cancer-related outcomes and adverse events (AEs) were assessed.

RESULTS: We included 153 patients. Most were men (109; 71%), white (92; 60%), non-cirrhotic (105; 69%), and with HCV genotype 1 (110; 72%). The most common cancers were hepatocellular carcinoma (HCC) (27; 18%) and multiple myeloma (14; 9%). The overall SVR12 rate was 91% (128/141). SVR12 was 100% in patients treated with ledipasvir/sofosbuvir for 8 weeks. Of the 32 patients initially excluded from cancer clinical trials because of HCV, 27 (84%) were granted cancer therapy access after starting SOFBT. Six patients with indolent non-Hodgkin’s lymphoma (NHL) received SOFBT without cancer treatment. Two achieved complete remission, one had partial remission, and two had stable cancer. Within 6 months after SOFBT, 5% (6/121) of patients in remission or with stable cancer, had progression or recurrence (two with HCC and one each with esophageal cancer, cholangiocarcinoma, NHL, and tonsillar cancer). No de novo HCCs occurred. AEs were most commonly grade 1–2 (90%).

CONCLUSIONS: SOFBT in HCV-infected cancer patients is effective and safe, may permit access to investigational cancer therapy expanding treatment options, may induce remission of NHL, and may be used for 8 weeks.

1Departments of Infectious Diseases, Infection Control and Employee Health, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA;

2Departments of Gastroenterology, Hepatology and Nutrition, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA;

3Departments of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA;

4Departments of Lymphoma/Myeloma, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA;

5Departments of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA;

6Department of Internal Medicine, University of Texas School of Health Sciences at Houston, Houston, Texas, USA;

7Department of Internal Medicine, Allegheny General Hospital, Houston, Texas, USA;

8Infections and Immunoepidemiology Branch, Division of Cancer Epidemiology and Genetics, National Cancer Institute, Houston, Texas, USA.

Correspondence: Harrys A. Torres, MD. E-mail: htorres@mdanderson.org.

This study was presented in part at the 53rd Annual Meeting of the American Society of Clinical Oncology, June 2–6, 2017, Chicago, IL.

SUPPLEMENTARY MATERIAL accompanies this paper at http://links.lww.com/AJG/A45

Received July 16, 2018

Accepted September 25, 2018

© The American College of Gastroenterology 2019. All Rights Reserved.
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