Levels of Hepatitis C Virus Higher Among African-Americans and Males

Posted on 7/10/12 on www.amren.com. A collaborative study between the National Institutes of Health Clinical Center and UCSF to be published in the July issue of "Hepatology" showed that among IVDUs males and African Americans were more likely to have HCV and/or HIV than any other demographic. This has implications for treatment in that African Americans are less likely to respond to current therapy than any other demographic. 

Levels of Hepatitis C Virus Higher Among African-Americans and Males

Medical Xpress, July 10, 2012

Epidemiologists have determined that levels of hepatitis C virus (HCV) found among injection drug users (IDUs) were higher in individuals who are male or African American even after differences in other factors were considered. The study, which was funded by the National Cancer Institute and performed with collaborators from the National Institutes of Health Clinical Center and the University of California—San Francisco, was the first to simultaneously examine the association of demographic, viral and human genetic factors on HCV RNA levels. Results of the study published in the July issue of Hepatology, a journal of the American Association for the Study of Liver Diseases (AASLD), also showed higher levels of HCV among IDUs who were co-infected with human immunodeficiency virus (HIV).

A 2010 report from the Centers for Disease Control and Prevention (CDC) estimates that up to 3.9 million Americans have chronic HCV—a leading cause of liver cancer, end-stage liver disease and liver transplantation. According to the CDC 17,000 new cases and 2,800 acute cases of HCV were reported in 2010. Previous epidemiologic studies suggest one-third of those 18 to 30 year-old IDUs and up to 90% of older IDUs are infected with HCV.

“With such a high incidence and prevalence of hepatitis C virus infection among IDUs, it is important to understand the characteristics of the infection in this group,” explains lead author Dr. Thomas O’Brien of the Division of Cancer Epidemiology and Genetics at the National Cancer Institute in Rockville, MD. “The HCV RNA level is an important predictor of response to treatment in patients with chronic hepatitis C. Our study is the first to examine simultaneously the viral, demographic, and genetic factors that impact HCV levels in ethnically diverse IDUs.”

Participants were originally recruited for the Urban Health Study—a multi-ethnic group of IDUs in San Francisco. Researchers used interview data and biological samples from participants to analyze demographic, viral and host characteristics of cancer-causing viruses. A total of 1701 participants had detectable HCV RNA and were included in the present study. The median age at enrollment was 46 years and median age of first illicit drug injection was 18 years. Close to 75% of participants were men and 56% were African American, 34% European (non-Hispanic) and 7% Latino (non-African American).

Adjusted analysis revealed that age, gender, racial ancestry, HIV-1 infection, and IL28B rs12979860 genotype were all independently associated with the HCV RNA level. “We know that the level of HCV is an important predictor of treatment response and that these levels seem to be influenced by a number of demographic, clinical, viral and human genetic factors,” concludes Dr. O’Brien.

HCAB Position Statement: Hepatitis C Drug Development and Drug-Drug Interaction Studies...

This HCAB (Hepatitis C Community Advisory Board) position statement was published on 2/28/12 regarding Hepatitis C drug development and drug-drug interaction (DDI) studies. In short, the HCAB would like drug developers to be more proactive in doing DDI studies before the drugs come to market. They admonish Merck specifically for not doing DDI studies with commonly available antiretrovirals and their HCV antiviral drug, boceprevir. Further, they applaud the efforts of Vertex and J&J for doing full due diligence in DDI studies prior to the launch of Telaprevir. 

HCAB Position Statement: Hepatitis C Drug Development and Drug-Drug Interaction Studies

February 17, 2012 -- The Hepatitis C Community Advisory Board (HCAB) recognizes the value of more effective and less toxic treatment for hepatitis C virus (HCV). We believe that sponsors can conduct key drug-drug interaction (DDI) studies with direct-acting antivirals (DAAs) and other candidates in development and medications commonly used by people with hepatitis C and those coinfected with HIV/HCV prior to their approval, without delaying development of these important therapies.

DAAs may share metabolic pathways with drugs that are commonly used by populations with a high prevalence of hepatitis C, such as hormonal contraceptives, methadone, buprenorphine, lipid-lowering agents, immunosuppressive drugs, herbal remedies, and commonly prescribed psychiatric medications.

In recognition of the suboptimal efficacy and tolerability of [pegylated interferon] and ribavirin, rapid trajectory of liver disease progression, and increasing mortality from HCV-related complications among HIV/HCV coinfected patients, regulators in the US and the EU encourage sponsors to conduct trials in HIV/HCV coinfected patients prior to approval for HCV monoinfection. Sponsors have already opened, or plan to launch these trials.

The recent discovery of drug-drug interactions between boceprevir and boosted HIV protease inhibitors underscores the importance of DDI studies with DAAs. Although we commend the sponsor, Merck, for opening one of the first coinfection trials with a DAA, we were outraged that Merck chose not to conduct DDIs with commonly used antiretroviral agents prior to launching the trial, and prior to gaining approval for boceprevir. Vertex and Tibotec were able to bring telaprevir [Incivek] to market with a much fuller portfolio of DDI data, although both drugs were developed within the same timeframe.

HCAB asks FDA [the US Food and Drug Administration], EMA [European Medicines Agency] and pharmaceutical companies to work together to minimize potential harm to hepatitis C monoinfected and HIV/HCV coinfected patients from uncharacterized drug-drug interactions. Furthermore, we call upon sponsors to perform DDI studies (as indicated by metabolic profile of their drug or drugs) with DHHS [US Department of Health and Human Services], EACS [European AIDS Clinical Society] and WHO [World Health Organization]-recommended antiretroviral agents for first-line, and treatment-experienced HIV/HCV coinfected people prior to approval, and strongly encourage studies of hormonal contraceptives, methadone, buprenorphine, lipid-lowering agents, immunosuppressive drugs, herbal remedies, and commonly prescribed psychiatric medications.

2/28/12

Source

Hepatitis C Community Advisory Board. HCAB Position Statement: Hepatitis C Drug Development and Drug-Drug Interaction Studies. February 16, 2012.