First prospective study of direct-acting antiviral treatment of HCV in cancer patients finds that it is safe, efficacious, and that it can open options for chemotherapy.
Harrys Torres, MD
The first prospective study of direct-acting antivirals (DAAs) for hepatitis C virus (HCV) infection in patients with any type of cancer has not only demonstrated that the treatment is safe and efficacious in this population, but that attaining sustained virologic response (SVR) can confer eligibility to participate in chemotherapeutic trials.
Harrys Torres, MD, Associate Professor of Medicine in the Department of Infectious Diseases, Infection Control and Employee Health and Adjunct Associate Professor, Department of Gastroenterology, Hepatology and Nutrition, University of Texas MD Anderson Cancer Center, Houston, Texas, and colleagues cite data that indicate approximately 70% of patients with hepatitis B or C are currently excluded from oncology clinical trials.
They explain that many HCV-infected cancer patients are excluded from early-phase cancer clinical trials because the infection can be associated with increased cancer-related complications, drug toxicity, and overall mortality.
"That was a challenge," Torres told MD Magazine®, "because the patients were coming here for cancer care and there was a clinical trial for them, but they couldn't be enrolled."
To address this need, and test whether DAA treatment can be safely utilized in patients with a range of cancers to effectively eliminate the infection that precludes their accessing chemotherapy trials, Torres and colleagues identified 153 patients for a prospective, observational study with sofosbuvir-based treatments.
Most participants were men (109, 71%), non-cirrhotic (105, 69%) and with HCV genotype 1 (110, 72%). The most common cancers were hepatocellular carcinoma (27, 18%) and multiple myeloma (14, 9%).
The investigators reported a 91% overall rate of SVR12 (128/141 patients). SVR12 was attained in 100% of patients treated with 8 weeks of ledipasvir/sofosbuvir (Harvoni). Of 32 patients who had initially been excluded from cancer clinical trials because of HCV, 27 (84%) were granted cancer therapy access after successful DAA treatment.
Most adverse events were grade 1-2, including anemia, rash, and irritability. One patient experienced grade 4 abdominal pain while receiving sofosbuvir + pegylated interferon + ribavirin, concomitantly with docetaxel, trastuzumab, and pertuzumab—which was attributed to diverticulitis. Seven patients who experienced serious adverse effects—including anemia in 2 patients, worsening kidney function in 2 patients, and hyperglycemia, headache, and abdominal pain in 1 patient each—all achieved SVR 12 and had no cancer progression or relapse within 6 months after treatment.
There were no drug-drug interactions observed, although dexamethasone was held in patients receiving daclatasvir to avoid adverse interaction.
With the current study demonstrating that DAA treatment can be safely employed in patients with cancer, and that attaining SVR effectively removes this barrier to participating in chemotherapy trials, Torres calls for greater effort to screen for, and treat HCV in cancer patients.
"We can probably say that this is a new indication for hep C treatment, to gain clearance for chemo treatment," Torres commented. "So, you're opening options and allowing access to all the clinical trials they may have, by simply removing this curable infection from the picture."
In an editorial accompanying the study, Sobia Laique, MD, and Hugo Vargas, MD, Division of Gastroenterology and Hepatology, Mayo Clinic, Scottsdale, AZ, agreed that HCV should no longer be considered a barrier to oncology care.
"The authors are to be commended for addressing the clinical needs of this important population. Treatment of HCV infection with potent DAA regimens gives hope to many who because of this infection cannot access optimal cancer therapies," Laique and Vargas wrote.
The study, “Sofosbuvir-Based Therapy in Hepatitis C Virus-Infected Cancer Patients: A Prospective Observational Study,” was published in The American Journal of Gastroenterology.