Few patients with hepatitis C virus infection complete all of the steps along a proposed HCV treatment cascade, according to a systematic literature review and meta-analysis.
The findings identify large gaps between current practice and treatment goals for patients with chronic HCV infection in the United States, and demonstrate that the proposed cascade provides a framework for evaluating the delivery of HCV care and would be useful for monitoring the impact of screening efforts and treatment advances, according to Dr. Baligh R. Yehia of the University of Pennsylvania, Philadelphia, and colleagues.
The report was published online July 2 in PLoS One.
The systematic review identified 10 articles published between January 2003 and July 2013 that addressed each of the following seven steps in the proposed treatment cascade:
1. Chronic HCV infection occurs.
2. The infection is diagnosed and the patient is made aware of the infection.
3. Access to outpatient care is obtained.
4. HCV RNA is confirmed.
5. Biopsy staging of liver fibrosis is performed.
6. HCV treatment is prescribed.
7. A sustained virologic response is achieved.
Based on the studies included in the review, an estimated 3.5 million people have chronic HCV in the United States, and only about 50% are diagnosed and aware of their infection.
The findings also suggest that only 43% of those patients have access to outpatient care (cascade step 3); only 27% achieve the first 4 steps, including confirmation of HCV RNA; only 17% achieve the first 5 steps, including undergoing liver fibrosis staging; only 16% achieve the first 6 steps, including being prescribed treatment; and only 9% achieve all 7 steps, including a sustained virologic response, the investigators said (PLoS One 2014 July 2 [doi:10.1371/journal.pone.0101554]).
The HCV treatment cascade proposed by the authors is similar to a cascade commonly used for evaluating and monitoring HIV care, and is based on the fact that people with chronic HCV infection, much like those living with HIV infection, need to fulfill multiple steps along a care continuum if they are to achieve optimal health outcomes.
"This HCV treatment cascade aligns with the goals of the U.S. [Department of Health & Human Services] Action Plan for the Prevention, Care, and Treatment of Viral Hepatitis, which established early identification, linkage to care and treatment, and improved quality of care as top priorities for combating the silent epidemic of chronic HCV infection," the investigators wrote, adding that monitoring the HCV treatment cascade will become increasingly important to clinicians, public health officials, and federal agencies as advances in HCV treatment emerge.
The findings of the current analysis help identify key deficits in care that will be important in the development of programs to improve diagnosis, linkage to care, and management, the investigators said.
Future studies should explore the value of adding and/or deleting steps in the cascade to best assist public health officials in monitoring HCV care, they added, also noting that monitoring the steps over time, rather than evaluating them at one time point as was done in this study, may help define overall progress toward population-based goals and barriers at each step.
The study is also limited by the exclusion of certain populations – such as prisoners and the homeless – in the studies reviewed, and by other factors that may have led to underestimation of achievement of various steps in the cascade. For example, liver biopsy was used as the marker for HCV disease staging, but some patients may have been staged through the use of noninvasive tests, the investigators said.
Nonetheless, the results suggest that continued efforts are needed to improve HCV care in the United States, Dr. Baligh R. Yehia and colleagues said.
"In a field that is changing rapidly, with increased attention on HCV screening and approval of new, effective direct-acting antiviral agents, this proposed HCV treatment cascade provides a framework for identifying gaps in care. This framework will be useful in monitoring the impact of new public health initiatives, care models, and treatments," they wrote, adding that achieving the goals of the U.S. action plan requires an increase in the number of patients completing each step in the cascade.
This study was supported by the National Institutes of Health. Dr. Yehia and coauthor Asher J. Schranz reported receiving investigator-initiated research support (to the University of Pennsylvania) from Gilead Sciences. Dr. Schranz also received such support from AstraZeneca, Bristol Myers-Squibb, and Merck.