With Close Monitoring for Side Effects, Patients Receiving Triple Therapy for Chronic Hepatitis C Can Achieve Sustained Virologic Response

A majority of patients with chronic hepatitis C cleared their virus after receiving triple therapy of pegylated interferon, ribavirin, and boceprevir despite difficult side effects, according to the results of a small cohort study presented Sunday at the 2013 American College of Gastroenterology annual meeting in San Diego.

Triple therapy has been shown to increase sustained virological response in patients with chronic hepatitis C; however, there are significant drug interactions and side effects associated with the new regimen. The purpose of the study was to collect data on how drug interactions and side effects of the new regimen are managed, said lead researcher Anjali Patel, PharmD, of the VA North Texas Healthcare System, Dallas, TX. Typical side effects include anemia, leukopenia, thrombocytopenia, and gastrointestinal issues.

Researchers conducted a prospective chart review of 26 patients with an average age of 57 who had hepatitis C and received the triple therapy. Pegylated interferon, ribavirin dosages, hemoglobin, white blood cell count, and platelet levels were collected and reviewed.

Anemia was defined as either symptomatic decreases from baseline hemoglobin or hemoglobin less than 10.5 g/dL. Leukopenia was defined as white blood cell count less than 4.0 K/mm3. Side effects were recorded at the time of the visit and medication changes occurred at the initial visit and were monitored during the initial 24 weeks of therapy.

Results indicated that laboratory values decreased during the initial 24 weeks and the average amount of pegylated interferon and ribavirin received also decreased at 24 weeks. Initial changes in medication were common in this patient cohort. Leukopenia and anemia were the most frequent side effects recorded, followed by flu-like syndromes, rash, nausea and vomiting, and diarrhea. Phosphodiesterase inhibitors, tramadol, and simvastatin were the most frequent drug interactions that required either discontinuation or reduction of therapy, or close monitoring.

“When it came to simvastatin... we either discontinued the simvastatin for the duration of treatment or changed them to a more compatible statin,” Patel said.

The review concluded that a majority of patients in the study cleared their virus. Reductions in pegylated interferon and ribavirin were common among the patients with chronic hepatitis C with fibrosis.

“As far as virologic response we had about an 87.5 percent response in patients who did not fail or discontinue medications,” Patel said. “With close monitoring for side effects and dosage reductions as necessary, we can help patients successfully complete the entire course of treatment.”

There were 3 patients who relapsed after 24 weeks of treatment, another patient was considered a non-responder, and one patient discontinued treatment but not because of side effects.

“Essentially what we saw were pretty much the classic side effects,” Patel said about the review findings. “Despite the side effects and despite having drug interactions, we did see a pretty good response in terms of clearance of the virus.

“I think that’s an important point to note because you often see different patients struggle with treatment, and you think (that) they are going to discontinue because this therapy has so many side effects. We manage our patients very closely and carefully and our team is multidisciplinary. I think that has a lot to do with how we continue to make sure that our patients get through the treatment in order to clear the virus.”