A Home Run for Hepatitis C Treatment
The rosters change almost daily, and new leaders emerge as the statistics accumulate rapidly. No, I am not referring to Major League Baseball; I am talking about antiviral agents used to treat hepatitis C virus (HCV) infection.
The past year has already seen the approval of new direct-acting agents and a change in recommendations. And now, data from recent clinical trials have generated further excitement and promise -- that in the year of the 25th anniversary of its discovery, HCV can be cured.
At Digestive Disease Week (DDW) 2014, investigators updated attendees on the pace of progress in the discovery and validation of novel antivirals. The bottom line is that clinicians will soon have the option of using all-oral, interferon-free regimens that are highly effective against all HCV genotypes in all patients -- with "special population" designations no longer needed. There are clearly logistical details that will prove to be unique to each treatment regimen, and perhaps genotype-specific; however, these will be resolved with broader experience.
But first, let's look at the not-so-distant past. An analysis presented at DDW indicates that overall treatment rates for patients with chronic HCV have been "dismally poor" and that treatment completion of both dual- and triple-therapy regimens -- pegylated interferon (pegIFN) and ribavirin (RBV) with or without a protease inhibitor, telaprevir or boceprevir -- is suboptimal in the real-world clinical setting.
This comes at a high cost. Hasan and colleagues reported that the cost of curing HCV genotype 1 with the triple-drug regimen was $125,000-$154,000. This estimate includes the associated costs of utilization of provider services, prescriptions, over-the-counter drug use, laboratory tests, and hospitalizations. These data indicate the need for simpler, safer, less expensive, and more effective options.
In the past month, a series of articles was published in the New England Journal of Medicine describing several new and different regimens. These strategies, based on an improved understanding of the HCV life cycle, have consistently produced rates of sustained viral response (SVR) of more than 90% after brief (8-24 weeks) periods of administration.
Accompanying editorials attest to the impact of these advances in treatment efficacy and safety, while highlighting the challenges presented by these "breakthrough medications." Chung and Baumert state that "it may now be possible to imagine the global eradication of HCV infection"; however, they cite the need for early diagnosis and cost reduction, especially in low-income countries.
Jayasekera and colleagues and Hoofnagle and colleagues project that the use of these new agents will reduce the intensity of follow-up monitoring; the rate of hospitalizations for adverse effects; dependence on specialist care; and resource demands associated with disease progression, including those for liver transplantation and management of end-stage liver disease and liver cancer. However, with drug costs that may exceed $90,000 per course, it remains to be seen how these remarkable advances will extend to the estimated 150 million people with HCV infection living outside the targeted high-income markets for these agents.
Access to these medications is limited by case recognition. Recent recommendations for birth-cohort screening for HCV infection among US adults are predicated upon the belief that only a fraction of Americans with the infection has been diagnosed.
On the basis of data generated from a community-wide HCV screening project and a registry of known HCV patients, Kim and colleagues calculated the proportion of more than 21,000 community residents with undiagnosed HCV infection. The overall prevalence was 2.2%; the age- and sex-specific HCV prevalence was highest (3.3%) in men aged 35-39 years and 45-49 years and lowest (1.0%) in women aged 30-34 years. Most had not been diagnosed.
These data support community-wide programs to institute birth-cohort-based screening as well as appropriate risk-based screening in individuals outside the birth cohort.
HCV Antivirals: You Can't Tell the Players Without a Program
The rosters change almost daily, and new leaders emerge as the statistics accumulate rapidly. No, I am not referring to Major League Baseball; I am talking about antiviral agents used to treat hepatitis C virus (HCV) infection.
The past year has already seen the approval of new direct-acting agents and a change in recommendations. And now, data from recent clinical trials have generated further excitement and promise -- that in the year of the 25th anniversary of its discovery, HCV can be cured.
At Digestive Disease Week (DDW) 2014, investigators updated attendees on the pace of progress in the discovery and validation of novel antivirals. The bottom line is that clinicians will soon have the option of using all-oral, interferon-free regimens that are highly effective against all HCV genotypes in all patients -- with "special population" designations no longer needed. There are clearly logistical details that will prove to be unique to each treatment regimen, and perhaps genotype-specific; however, these will be resolved with broader experience.
A Future Without Hepatitis C
But first, let's look at the not-so-distant past. An analysis presented at DDW indicates that overall treatment rates for patients with chronic HCV have been "dismally poor" and that treatment completion of both dual- and triple-therapy regimens -- pegylated interferon (pegIFN) and ribavirin (RBV) with or without a protease inhibitor, telaprevir or boceprevir -- is suboptimal in the real-world clinical setting.
This comes at a high cost. Hasan and colleagues reported that the cost of curing HCV genotype 1 with the triple-drug regimen was $125,000-$154,000. This estimate includes the associated costs of utilization of provider services, prescriptions, over-the-counter drug use, laboratory tests, and hospitalizations. These data indicate the need for simpler, safer, less expensive, and more effective options.
In the past month, a series of articles was published in the New England Journal of Medicine describing several new and different regimens. These strategies, based on an improved understanding of the HCV life cycle, have consistently produced rates of sustained viral response (SVR) of more than 90% after brief (8-24 weeks) periods of administration.
Accompanying editorials attest to the impact of these advances in treatment efficacy and safety, while highlighting the challenges presented by these "breakthrough medications." Chung and Baumert state that "it may now be possible to imagine the global eradication of HCV infection"; however, they cite the need for early diagnosis and cost reduction, especially in low-income countries.
Jayasekera and colleagues and Hoofnagle and colleagues project that the use of these new agents will reduce the intensity of follow-up monitoring; the rate of hospitalizations for adverse effects; dependence on specialist care; and resource demands associated with disease progression, including those for liver transplantation and management of end-stage liver disease and liver cancer. However, with drug costs that may exceed $90,000 per course, it remains to be seen how these remarkable advances will extend to the estimated 150 million people with HCV infection living outside the targeted high-income markets for these agents.
Barriers to Care
Access to these medications is limited by case recognition. Recent recommendations for birth-cohort screening for HCV infection among US adults are predicated upon the belief that only a fraction of Americans with the infection has been diagnosed.
On the basis of data generated from a community-wide HCV screening project and a registry of known HCV patients, Kim and colleagues calculated the proportion of more than 21,000 community residents with undiagnosed HCV infection. The overall prevalence was 2.2%; the age- and sex-specific HCV prevalence was highest (3.3%) in men aged 35-39 years and 45-49 years and lowest (1.0%) in women aged 30-34 years. Most had not been diagnosed.
These data support community-wide programs to institute birth-cohort-based screening as well as appropriate risk-based screening in individuals outside the birth cohort.