This October’s continuing education was held on the upper west side of Manhattan at Scaletta Ristorante. The exhibit prior to the presentation was sponsored by Daiichi Sankyo. President, Dr. Amisha Arya, opened the evening by thanking the table sponsors, Daiichi Sankyo, and introducing the evening’s first presenter, Hoang (Terry) Nguyen, Touro College of Pharmacy’s Student Society of Health-System Pharmacists’ President, as a part of the student pharmacist clinical pearl. The title of his presentation was “Management of Type 2 Diabetes Mellitus in Obese Patients.” Terry compared and contrasted the agents used to treat Type 2 diabetes and highlighted why certain agents responded better in obese patients and have a better weight loss profile. He highlighted the more prevalent adverse effects and ways to help tolerate certain agents. After the presentation, Terry welcomed questions from the audience.
Dr. Charrai Byrd, Director at Large, made an announcement that October is American Pharmacist Month and that the final week is American Health-System Pharmacy Week. To celebrate, the NYCSHP Takes Over the Today Show event, will join pharmacists and student pharmacists to appear on NBC’s Today Show, to promote Hospital and Health-System Pharmacy Week. Interested members are welcomed to join on October 20th, where we will meet at 5am at Rockefeller Center. We will be promoting the approval of the HR 4100 bill.
Next, President Arya introduced the evening’s continuing education speaker, Dr. Kanika Ballani, who presented “New Advancements in the Hepatitis C Virus.” As the Clinical Trials Manager at New York University’s Investigational Drugs Pharmacy, Dr. Ballani is familiar with new pharmacotherapeutic agents and their mechanisms of actions. She acts as the liaison and educational resource between pharmaceutical company sponsors, the physicians at NYU, and the patient’s receiving the investigational treatments.
Dr. Ballani first discussed the cellular replication cycle of the RNA virus then highlighted the protein targets and host factors, which are key components in drug development. She explained that since the viral particles require lipid droplets to be released from the host cell, a fatty liver is a risk factor aiding in viral replication. Dr. Ballani then described the modes of transmission, distinguished between acute hepatitis vs. chronic hepatitis. She strongly emphasized the importance of adherence to treatment. Partial adherence can lead to the development of resistance ultimately leading to treatment failure.
Two major factors that guide hepatitis C treatments are the patient’s genotype and their viral load. Genotype one (a,b) requires the most aggressive treatment compared to Genotype two, three, four, five and six. The choice of treatment and duration of therapy will range based on the Genotyping, viral load, and if the patient is treatment naïve or has relapsed. The major treatment guidelines are the Infectious Disease Society of America (IDSA) in collaboration with the American Association for the Study of Liver Disease (AASLD), which was updated in January 2014. The goal of treatment is to reduce all-cause mortality and liver-related health adverse consequences, including end-stage liver disease and hepatocellular carcinoma. This is done by achieving a virologic cure characterized by a sustained virologic response (SVR).
The current treatment guidelines outline treating patients based on genotype. This presentation was focused on treating genotypes two and three. Pegylated interferon is an antiviral and immune regulator. Interferons are proteins released into the body in response to viral infections. They are important to fight viruses, for regulating reproduction of cells, and regulating the immune system. Sofosbuvir is an anti-hepaciviral agent and a polymerase inhibitor. It is a prodrug that works directly against the hepatitis C virus to inhibit HCV NS5B RNA-dependent RNA polymerase, which is essential for viral replication. Ribavirin is also an anti-hepaciviral agent and a nucleoside. It inhibits RNA and DNA virus replication. Ribavirin also inhibits the initiation and elongation of RNA fragments to inhibit viral protein synthesis.
The recommended regimen for treatment-naïve patients with HCV genotype 2 is sofosbuvir (400mg daily) with weight-based Ribavirin (1000mg (< 75kg) to 1200mg (> 75kg) for 12 weeks. Extending treatment to 16 weeks is recommended for patients with liver cirrhosis. The recommended regimen for treatment-naïve patients with HCV genotype 3 sofosbuvir (400mg daily) with weight-based Ribavirin (1000mg (< 75kg) to 1200mg (> 75kg) for 24 weeks. The addition of Peg-interferon for 12 weeks is an optional addition to achieve sustained virological response and a shorter treatment period. The use of Peg-interferon is associated with the natural clearance of the hepatitis C virus.
Surprisingly, the newly FDA approved treatments (simeprevir, telaprevir or bocepravir) had not been recommended in the updated 2014 guidelines due to higher incidences of serious adverse reactions (anemia, rash), longer treatment duration, high pill burden, many drug-drug interactions, and need for close monitoring. Current recommended treatments help achieve the goals of hepatitis C therapy. Once the patient can overcome the initial adverse effects, lasting about two weeks, they have a more positive outlook. A limiting factor is the cost of therapy with treatments costing thousands of dollars.
In conclusion, current Hepatitis C genotype 2 and 3 treatment guidelines recommend the use of sofosbuvir with ribavirin, with peg-interferon as adjunct therapy. For patients receiving treatment, encourage them to remain very adherent to their therapy. Once overcoming the initial debilitating adverse effects, their prognosis is much more positive and treatment is more tolerable. The evening’s wonderful presentation was then followed-up with a question and answer session. Dr. Arya thanked everyone for their attendance and concluded the evening.
Written by Jamie Chin
Photos by Jamie Chin and Zane Last