Subjects

ABSTRACT

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%).

DISCUSSION

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.

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Additional information

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

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Acknowledgements

The authors thank Stephanie Deming of the Department of Scientific Publications at MD Anderson Cancer Center for editorial assistance.

Author information

Author notes

    • Minas P. Economides MD

    Present address: Department of Internal Medicine, University of Texas School of Health Sciences at Houston, Houston, Texas, USA

    • Andreas Kyvernitakis MD

    Present address: Department of Internal Medicine, Allegheny General Hospital, Houston, Texas, USA

    • Parag Mahale PhD

    Present address: Infections and Immunoepidemiology Branch, Division of Cancer Epidemiology and Genetics, National Cancer Institute, Houston, Texas, USA

Affiliations

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

    • Harrys A. Torres MD
    • , Minas P. Economides MD
    • , Georgios Angelidakis MD
    • , Jeff Hosry MD
    • , Andreas Kyvernitakis MD
    • , Parag Mahale PhD
    • , Ying Jiang MS
    • , Issam I. Raad MD
    •  & Bruno P. Granwehr MD
  2. Departments of Gastroenterology, Hepatology and Nutrition, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA

    • Harrys A. Torres MD
    • , Ethan Miller MD
    •  & Boris Blechacz MD
  3. Departments of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA

    • Aung Naing MD
  4. Departments of Lymphoma/Myeloma, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA

    • Felipe Samaniego MD
  5. Departments of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA

    • Ahmed Kaseb MD

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Guarantor of the article

Harrys A. Torres, MD.

Specific author contributions

Study concept and design, funding, and study supervision: H.A.T. Acquisition of data: M.P.E., G.A., J.H., and A.K. Analysis and interpretation of data: H.A.T., M.P.E., G.A., and Y.J. Drafting of the paper: H.A.T., M.P.E., and G.A. Critical revision of the paper for important intellectual content: H.A.T., G.A., M.P.E., J.H., A.K., P.M., Y.J., E.M., B.B., A.N., F.S., A.K., A.I.R., and B.G. Statistical analysis: Y.J., M.P.E., and G.A.

Funding support

Investigator-initiated study supported by Gilead Sciences with partial support from the NIH/NCI under award number P30CA016672.

Potential competing interests

Dr. Torres is or has been the principal investigator for research grants from Gilead Sciences, Merck & Co., Inc., and Vertex Pharmaceuticals with all funds paid to MD Anderson Cancer Center. Dr. Torres is or has been a paid scientific advisor for Gilead Sciences, Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Dynavax Technologies, Vertex Pharmaceuticals, and Genentech; the terms of these arrangements are being managed by MD Anderson Cancer Center in accordance with its conflict-of-interest policies. All remaining authors report no conflict of interest.

Corresponding author

Correspondence to Harrys A. Torres MD.

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DOI

https://doi.org/10.1038/s41395-018-0383-2