'Real-Life' Anemia with Boceprevir: No Impact on SVR
SAN FRANCISCO, CA—Previously-untreated patients with hepatitis C virus (HCV) genotype 1 (GT1) undergoing triple therapy with pegylated interferon, ribavirin, and boceprevir in a "real-word" setting had a 37% frequency rate of anemia, comparable to that seen among previously-treated patients (40%), according to authors of an observational study in Germany, presented during The Liver Meeting® 2015.
Anemia in these patients “is nearly exclusively managed by ribavirin dose reductions and blood transfusions," reported Gerlinde Teuber, MD, Gastroenterological Practice in Frankfurt, Germany. "Anemia does not adversely impact the SVR rate achieved by triple therapy."
The interim analysis evaluated the the frequency, severity, management and predictive factors for anemia associated with administration of these three agents in “real-life,” data for which remain scarce, Dr. Teuber explained.
"From April 2012 until January 2014, 536 patients with HCV G1 infection were recruited in the ongoing NOVUS observational study, by 97 practices and hospitals in Germany," Dr. Teuber noted. After a 4-week lead-in period with pegylated interferon and ribavirin, patients received those agents together with boceprevir for 24 to 44 weeks. The researchers restricted their interim analysis to 275 patients who were treatment-naïve and 140 who had previously been treated.
Anemia during triple therapy, defined as Hb <10g/dL, occurred with a frequency of 38% in the total population, they found. A total of 54% of anemias in the treatment-naïve group and 76% in those previously treated “became apparent in treatment Weeks 8 and 12, respectively,” they noted. To date, persistent anemia was reported in only 1 of 247 patients who had documented 24-week follow-up data. Moderate anemia (Hb >8.5–10g/dL) was observed in 31% of patients and severe anemia (Hb <8.5g/dL) in 7% of patients, the team reported.
Independent predictors of higher anemia risk included female vs. male patients (56% vs 26%; odds ratio [OR] 3.2; 95% CI: 2.1, 5.1; P<0.0001); age >50 years vs. ≤ 50 years (56% vs. 26%; P=0.014) and a baseline eGFR or ≤90 vs. >90mL/min per 1.73 m2 (56% vs. 26%; OR 2.5; 95% CI: 1.5, 4.0; P<0.0001).
Anemia was managed by ribavirin dose reductions in 66% of patients, while 8% received blood transfusions, Dr. Teuber reported.