Impact of IFN- vs. Sofosbuvir-Based Tx on CD4+ Count

SAN FRANCISCO, CA—Sofosbuvir-based antiviral therapies do not affect CD4+ count in patients with cancer who are monoinfected with the hepatitis C virus (HCV), reported Andreas Kyvernitakis, MD, from the University of Texas MD Anderson Cancer Center, Houston, TX, at The Liver Meeting® 2015.

“Antiviral therapies containing pegylated interferon or ribavirin have been associated with hematological effects, such as reduction of CD4+ T cell count in hepatitis C virus (HCV)/HIV coinfected patients,” Dr. Kyvernitakis and colleagues noted. Although new direct-acting antivirals (DAAs) “have dramatically improved sustained virological rates for HCV infection,” their effect on the immune system is not well characterized, and the effect of such agents on CD4+ T cell counts in patients with cancer infected with HCV “is not known,” they added.

To investigate the effect of different antiviral therapies, including DAAs, on CD4+ count in this population, the investigators evaluated the medical records of 75 patients treated with antiviral therapies at MD Anderson retrospectively from January 2010 to October 2012 and prospectively from November 2012 to November 2015.

The team compared CD4+ T cell counts pre- and post-therapy as well as within patients who received interferon-based therapy vs. DAA-based therapy. Multivariable linear regression was used to compare CD4+ counts after treatment.

Median age of the patients at HCV treatment initiation was 57 years; 50% were male and 56%, white. A total of 69% had HCV genotype 1 infection and 41% had cirrhosis. The patients had either solid tumors (60%) or hematological malignancies (40%).

Patients were administered pegylated interferon alpha + ribavirin (n=17); telaprevir +pegylated interferon alpha + ribavirin (n=6); sofosbuvir + pegylated interferon alpha  + ribavirin (n=8); sofosbuvir + ribavirin (n=14); sofosbuvir + simeprevir (n=17); sofsobuvir + ledipasvir (n=14); or sofosbuvir + ledipasvir + ribavirin (n=4).

The results showed a significant decline in CD4+ count post-treatment in patients who received interferon-containing therapy compared with pre-treatment levels (mean cells/µL 712 vs. 323; P=0.0004). There was no significant change in patients who received DAA-containing antiviral therapy (mean cells/µL 651 vs. 617; P=0.34).

“After excluding those who received chemotherapy within 12 months before antiviral therapy, patients who received DAA-containing antiviral therapy had at an average, 296 (95% CI: 151-441; P<0.0001) more cells/µL at the end of treatment than those who received interferon-containing antiviral therapy,” the study results showed. In addition, the rate of sustained virologic response at 12 weeks was higher in those who received DAA-containing antiviral therapy compared with those whose therapy contained interferon, 87% vs. 64% (P=0.1).

“Further research is needed to explore if a more competent adaptive immune system contributes to an improved response after DAA-containing antiviral therapy,” Dr. Kyvernitakis concluded.