Study Aims and Results: This study was conducted to understand the rates of side effects during and after treatment with direct-acting antiviral (DAA) therapy among Egyptian patients. In this retrospective study, a total of 149,816 patients received DAA treatment. The breakdown of type of DAA treatment received included sofosbuvir plus ribavirin (21,835 patients), sofosbuvir plus simeprevir (24,215 pts), sofosbuvir plus daclatasvir (58,477 pts), sofosbuvir, daclatasvir plus ribavirin (45,188), and paritaprevir, ombitasvir plus ribavirin (101 pts). The treatment period was 12 to 24 weeks. The majority of patients treated were male (53%), HCV genotype 4 (90%), and the mean age was 54 years old.
In the analysis, a total of 1.7% of the 149,816 patients treated reported side effects. Of these, 68% were serious which means that slightly more than 1% had serious side effects. The majority of the serious side effects were anemia (low red blood cells) and hyperbilirubinemia (high levels of bilirubin). The two serious side effects were in the patients treated with sofosbuvir plus ribavirin. The combination of sofosbuvir plus daclatasvir had the lowest rate of side effects.
There were 0.02% of people in the analysis treated who developed liver cancer, and .06% died after treatment completion. Patients with cirrhosis showed the highest risk for serious side effects and death.
Conclusions: In this large group of patients treated with various combinations of direct-acting antiviral (DAA) medications the reported side effects were very low. The most common side effects reported were in the group treated with sofosbuvir plus ribavirin.
Editorial Comments: This very large study reaffirms that DAA medications have relatively few side effects with a couple of important caveats:
The highest rates of side effects were in the therapies that included ribavirin. Anemia is a well-documented side effect of ribavirin. Now, the vast majority of HCV treatment does not include ribavirin.
The current study reinforces the need to closely monitor people with cirrhosis while they are receiving HCV treatment (and afterward).
Article: Sofosbuvir-Based Direct-Acting Antiviral Therapies for HCV in People Receiving Opioid Substitution Therapy: An Analysis of Phase 3 Studies—J. Grebely, et. al.
SOURCE: Open Forum Infectious Diseases, Volume 5, Issue 2, 1 February 2018, ofy001, https://doi.org/10.1093/ofid/ofy001
Study Aims and Results: This study analyzed phase 3 treatment data of sofosbuvir-containing therapies to understand the outcomes among people who received opioid substitution therapy (OST) compared to people who did not receive OST. The study included HCV genotypes 1 through 6. There was a total of 4,743 people in the phase 3 studies of sofosbuvir-based therapies (interferon-free) who received OST—194 (4%) received either methadone (113 patients), buprenorphine (75 pts) or neither (6 pts). The OST patients were somewhat younger, and more likely to be male, treatment naïve, genotype 3, and cirrhotic. The treatment period was 8 to 24 weeks.
The analysis revealed that there were no or very little differences in the groups who received OST and those who did not: treatment completion rates (97% vs 99%), cure rates (94% vs 97%), relapse rate (0.5% vs 2.1%), side effects (78% vs 77%), or serious side effects (3.6% vs 2.4%). Additionally, the cure rates were similar for those with cirrhosis (99% vs 95%) and HCV genotype 3 (95% vs 95%).
Conclusions: Treatment with sofosbuvir-based therapies is safe and effective in people with HCV taking OST.
Editorial Comments: The current analysis provides additional evidence that people who receive OST can be successfully treated with DAA-based therapies.
PARIS — Results from a real-world cohort of patients with hepatitis C treated with Mavyret showed a sustained virologic response of 97%, according to an exclusive interview with Thomas Berg, MD, at the International Liver Congress.
“What we observed in our cohort over the year was that we have newly diagnosed patients,” Berg, from the University Hospital Leipzig in Germany, told Healio Gastroenterology and Liver Disease. “Most of them had probably drug-induced transmission of hepatitis C virus, mild disease, and most patients with more advanced disease or with treatment experience were already being treated in our country.”
To date, Berg and colleagues have enrolled 866 patients with HCV and 638 of those have begun treatment with Mavyret (glecaprevir/pibrentasvir, AbbVie). In his presentation, Berg reported on 96 patients who completed treatment with follow-up, 93 of whom achieved SVR. The other three patients discontinued treatment due to adverse events that the researchers did not consider related to the drug.
Article: Increases in Acute Hepatitis C Virus Infection Related to a Growing Opioid Epidemic and Associated Injection Drug Use, United States, 2004 to 2014—Jon E. Zibbell, PhD, et al.
SOURCE: American Journal of Public Health 108, no. 2 (February 1, 2018): pp. 175-181.
Study Aims and Results: To review and compare the rate of opioid injection drug use with the rate of acute hepatitis C (HCV) infections. This analysis included the type of injection drug (heroin vs. prescription opioid drug), patient characteristics (male/female), and race. The annual surveillance records from 2004 to 2014 were analyzed from drug treatment centers and compared to reported cases of acute HCV.
The rate of acute HCV infection increased more than 2-fold from 2004 to 2014—a 133% increase. Admissions to drug treatment centers due to any injection drug use increased 76%. Admissions for heroin injection use increased 85%, and prescription opioid drug injection use increased 258%.
Conclusions: The findings correlate with the increase of acute HCV infections, the opioid epidemic, and admissions to drug treatment centers.
Editorial Comments: This study provides additional evidence that the opioid epidemic and the second HCV epidemic are linked. To control these twin epidemics more resources will be needed on a local, state and national level.
Dynavax Technologies (NASDAQ:DVAX) announces that the Centers for Disease Control and Prevention (CDC) published the Advisory Committee of Immunization Practices’ Recommendations for the use of HEPLISAV-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)] for adults in the US in the Morbidity and Mortality Weekly Report (MMWR) dated April 19.
Publication in the MMWR represents the final endorsement that many policies require before reimbursement. HEPLISAV-B was commercially launched in the U.S. in January.
Viral Hepatitis Updates from the HHS Office of HIV/AIDS and Infectious Disease Policy
We are joined by all of our federal colleagues in promoting viral hepatitis awarenessand action during May Hepatitis Awareness Month! But we are not in every state or community so we depend on people like you to help us move forward in our work to address viral hepatitis health disparities, increase prevention and testing efforts, and get more people into treatment or cured of their hepatitis B and hepatitis C. To support this work, our CDC colleagues have compiled the resources described below.
Please take a look and make a plan to take action on viral hepatitis during this important observance! Throughout the month of May, OHAIDP will be posting information about events and opportunities on our website so check in early and often as we work toward our vision of eliminating the public health threat of viral hepatitis in the United States!
Richard Wolitski, PhD, and Corinna Dan, RN, MPH
Office of HIV/AIDS and Infectious Disease Policy
U.S. Department of Health and Human Services
Join the Be #HepAware Thunderclap on May 19th at 12:00 p.m. EDT/9:00 a.m. PDT! Supporters can sign up in advance using their Twitter, Facebook or Tumblr accounts for a one-time post that will automatically be sent on May 19th. Visit http://bit.ly/2q2S44e to sign up and help spread the word to your members and followers. Contact firstname.lastname@example.org for more details.
If your organization provides ongoing hepatitis testing and vaccination services, please visit https://gettested.cdc.gov/ and fill out an online form to make sure your services are registered within CDC’s database. This site is a tool for people to enter their zip code and find ongoing services in their area.
Share our feature on the ABCs of Viral Hepatitis and encourage people to take the Hepatitis Risk Assessment to get personalized hepatitis vaccination & testing recommendations. The risk assessment can be shared by posting badges on your website or promoting the link on social media.
The Know More Hepatitis campaign, which encourages people born from 1945-1965 to get tested for hepatitis C, and the multilingual Know Hepatitis Bcampaign, promoting hepatitis B testing among Asian Americans, have free resources available for use. Campaign resources include video PSAs, posters, radio PSAs, infographics, fact sheets, customizable event flyers, and other materials.
Visit the Division of Viral Hepatitis’s website for information and resources on all types of hepatitis, including fact sheets, posters, provider resources, and much more.
Follow @cdchep on Twitter for information about hepatitis resources, tools, publications, campaign updates, and events. Use the hashtags #HepAware, #hepatitis and #HepTestingDay to join the conversation and share information on viral hepatitis.
Sign up for monthly emails from the Division of Viral Hepatitis about new publications, recommendations, new materials or significant events.
Patients with advanced hepatitis C infection being treated with direct-acting antivirals(DAAs) may have a reduced risk for being diagnosed with hepatocellular carcinoma (HCC) during the first year and further declines after 1 year, according to results published in the Journal of Hepatology.
The study used data from the NAVIGATORE platform, a prospectively recording database of all patients with hepatitis C infection receiving DAAs in the Veneto region of Italy. Participants who were included had liver fibrosis stage ≥F3.
Of 3917 participants with a mean follow-up of 536.2±197.6 days, 55 were diagnosed with HCC. During the first year, HCC incidence was 0.46% (95% CI, 0.12-1.17) in patients with fibrosis stage F3, 1.49% (95% CI, 1.03-2.08) in participants with Child-Pugh-A, and 3.61% (95% CI, 1.86-6.31) in participants with Child-Pugh-B. In the second year, HCC incidences were 0%, 0.2%, and 0.69%, respectively.