As we approach the beginning of 2013, many promising advances are just over the horizon. In hepatology, a number of new drugs are being developed for the treatment of hepatitis C virus (HCV) infection, leading to growing excitement about the possibility of interferon-free regimens, shorter treatment durations, and continued improvements in sustained virologic response (SVR) rates. Similarly, new drugs are being developed for the treatment of inflammatory bowel disease (IBD), including not only new additions to existing classes of drugs but also novel agents that target inflammation via alternative pathways.
At the recent meeting of the American Association for the Study of Liver Diseases (AASLD), which was held November 9–13, 2012 in Boston, Massachusetts, several presentations revealed preliminary data on new therapies for HCV infection. For example, Kris V. Kowdley presented data on a 4-drug regimen comprised of an NS3/4A protease inhibitor (coadministered with ritonavir [Norvir, Abbvie]), an NS5A inhibitor, a non-nucleoside polymerase inhibitor, and ribavirin. Overall, this interferon-free combination achieved SVR12 rates of 99% in treatment-naïve patients and 93% in prior null responders.
In another presentation at AASLD, Gregory T. Everson unveiled data on an interferon-free, ribavirin-free regimen comprised of 3 new agents: daclatasvir, an NS5A inhibitor; asunaprevir, an NS3 protease inhibitor; and BMS-791325, an as-yet-unnamed non-nucleoside NS5B polymerase inhibitor. When this regimen was tested in treatment-naïve patients with genotype 1 HCV infection, 94% of patients treated for 12 weeks achieved SVR12, and 94% of patients treated for 24 weeks achieved SVR4. While both of these talks were based on interim analyses, these studies and others are ongoing, and further data will be presented at future meetings.
In addition to the excitement among hepatologists about upcoming treatments for HCV infection, “luminal” gastroenterologists also have reason for optimism. As Silvio Danese discusses in this month’s Advances in IBD column on page 844, ongoing research into the disease mechanism of IBD is paving the way for new treatment options in this field. For example, the new anti-integrin vedolizumab is being evaluated both for the treatment of ulcerative colitis and for Crohn’s disease, and it appears to be effective for both conditions. Importantly, early studies of vedolizumab have not reported significant side effects, and researchers are hopeful that this new agent will be a safer alternative to natalizumab (Tysabri, Biogen Idec).
Other new drugs that hold promise for the treatment of IBD include golimumab (Simponi, Janssen), ustekinumab (Stelara, Janssen), and tofacitinib (Xeljanz, Pfizer). These drugs are already approved for the treatment of nongastrointestinal conditions, and studies are now evaluating them as treatments for Crohn’s disease and/or ulcerative colitis. While some of these drugs are similar to those already being used to treat IBD, research has also led to new agents that work through novel mechanisms. Specifically, whereas golimumab is an antibody against tumor necrosis factor α, ustekinumab is a novel antibody against interleukins 12 and 23, and tofacitinib is an inhibitor of Janus kinase 3.
In addition to Danese’s discussion of new IBD therapies, this issue of Gastroenterology & Hepatology also includes columns on the management of anal burning associated with telaprevir (Incivek, Vertex), aspirin as chemoprevention for Barrett esophagus and Barrett cancer, capsule endoscopy in patients with iron-deficiency anemia, and a new treatment option for patients with chronic idiopathic constipation or irritable bowel syndrome with constipation. This month’s feature articles include a study on tumor factors associated with clinical outcomes in patients with hepatitis B virus infection and hepatocellular carcinoma, as well as a review of chromoendoscopy and advanced imaging technologies for surveillance of patients with IBD. Finally, this issue includes a case report of a patient with primary pancreatic lymphoma who was correctly diagnosed via fine-needle aspiration with cytologic analysis.
As always, I hope you find these article informative and relevant, and I wish you and your patients a happy, healthy, and prosperous new year.
Sincerely,
Gary R. Lichtenstein, MD, AGAF, FACP, FACG