Overly optimistic expectations about Victrelis (boceprevir) and Incivek (telaprevir), two newly approved direct antiviral agents (DAA), may prove harmful for people living with hepatitis C virus (HCV) infection, Gastroenterology & Endoscopy News reports.
These DAAs are associated with a range of complications, such as varying rules on when to monitor patients and when to stop treatment—which carries the risk of non-adherence—as well as possible side effects and drug-drug interactions.
"This is a real problem for clinicians," said Andrew Muir, MD, MHS, clinical director of hepatology at Duke University Medical Center in Durham, North Carolina. "There's tremendous excitement about these new therapies, but oftentimes, patients' expectations are not in line with what these drugs can deliver."
Treatment scheduling is a particularly troublesome issue for patients who've read just enough to get the wrong idea. For example, while studies have indicated that DAA-inclusive regimens can be successfully discontinued after six months in some people with genotype 1 HCV, patients with cirrhosis generally need to be treated for a year, as do many more blacks than non-blacks. In addition, Victrelis and Incivek must be taken three times a day—once every eight hours—and always with meals.
Patients may also be unaware that DAAs still need to be combined with pegylated interferon and ribavirin, with all of their associated side effects. As such, all the usual contraindications for standard hepatitis C treatment—decompensated cirrhosis (poor liver function), kidney failure, cardiovascular disease, anemia and related blood disorders, mental illness, and a history of noncompliance—apply to patients on a DAA regimen, and testing for these issues is in order for anyone seeking treatment.
Victrelis and Incivek also generate their own range of drug-drug interactions, such as with oral contraceptives and various HIV medications. Side effects include anemia and rashes. Pregnant women are especially warned not to take either drug, with the Food and Drug Administration (FDA) stating that the risks "clearly outweigh potential benefits."
Experts recommend that doctors take special care to alert their patients regarding the complexities of DAA treatment. "Educating the patient is essential," said Gary L. Davis, MD, director of general and transplant hepatology at Baylor University Medical Center in Dallas. "Patients and their support person need to clearly understand the importance of dosing compliance, lab monitoring and treatment stopping rules/end points."
Meanwhile, a second-generation of DAAs—which have the advantages of being taken orally once per day and not requiring interferon—is likely to be approved within the next three years. "It's clear that the promise of interferon-sparing therapy is very real," said Raymond Chung, MD, chief of hepatology and vice-chief of gastroenterology at Massachusetts General Hospital in Boston. "For all of us, that would be the holy grail of therapy."
While Chung advises that patients in the later stages of HCV go ahead with Incivek or Victrelis, he adds that people who are in the early stages of hepatitis C or who can't tolerate interferon may want to wait for these second-generation medications to be approved—or to participate in investigational studies of those drugs.