Even more challenging for the HCV community is increasing the representation of older HCV-infected adults in HCV clinical trials, even though Baby Boomers constitute the majority of hepatitis C infections in the United States and are often less responsive than younger generations to antiviral treatment. Compounding the problem, older HCV patients are more difficult to treat, due to the increased prevalence of co-morbid conditions, such as diabetes, dyslipidemia, and other metabolic conditions that are correlated to chronic liver disease. Aging is also strongly associated with liver fibrosis progression, which means older HCV patients are likely to have advanced liver disease and a high risk for impending liver complications. But despite this reality, few studies have examined the age-specific factors of chronic HCV infection and the clinical management of the infection in this patient population.

More than an issue of fairness, HCV experts associate better designed clinical research studies with the increased ability of scientists to catalog and understand the influence of genetic and non-genetic factors on individual and group responses to new treatments. Findings from the large amount of genetic data generated to date show that more than 90 percent of the observed genetic variations occur within, rather than between groups. This underscores the fact that gender and ethnicity have biomedical consequences when evaluating patients with more resistant virus and with more severe disease.  

Designing the Research Roadmap to Address a Growing Public Health Threat

Accelerating the development of DAAs to improve HCV treatment outcomes is especially warranted now that the hepatitis C virus has become the most common chronic blood borne infection in the U.S. According to new government estimates, approximately 4.1 million Americans are infected with HCV, of whom 60 to 70 percent will develop chronic liver disease. Currently, almost half of all liver transplants in the U.S. are performed for end-stage hepatitis C. Moreover, because liver disease is one of the leading causes of death in the U.S., the CDC predicts that deaths from chronic liver disease attributed to hepatitis C will double or triple over the next 15 to 20 years.

To change these statistics, hepatitis specialists focused on ways to advance HCV drug development so DAAs and other new classes of drugs for HCV can reach the market quickly. Here, the experts reached agreement on a number of issues:  

Exposure to new single agents “ because HCV remains sensitive to ribavirin and pegylated interferon, longer initial studies may be recommended to evaluate single drugs and novel combinations of drugsComposition of patients in early studies (phase 1 and 2a) “ early studies should be large enough so results with one type of virus or one group of patients can be easily discerned. Focusing on specific genetic sub-populations will also ensure that early studies do not produce confusing resultsDrug resistance in HCV patients “ unlike HIV, drug resistance in HCV may not be as large a concern because HCV does not integrate into host DNA as HIV does. Thus, resistant strains are not archived and there is the potential that resistant patients can be retreated with different combinations regimens, as and when they become availableBaseline parameters “ there is the need to develop predictive algorithms based on baseline characteristics such as gender, body weight, HCV genotypes and subtypesExclusion of former and current drug users in clinical trials “ exclusion is unnecessary and does not serve the field well. Over 60 percent of patients with HCV are infected through drug use, indicating the need to have quality data to guide treatment decisions in this patient population

As a next step, the Forum for Collaborative HIV Research will publish the consensus of this scientific meeting to advance the research agenda. Once published, the report will be distributed widely to the Forum's many constituencies “ government, industry, patient advocates, healthcare providers, foundations, health insurers and academia “ with the goal of advancing research on HCV and driving public policy.

SOURCE Forum for Collaborative HIV Research