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Ledipasvir-Sofosbuvir for 8 Weeks: Effective and Cost-effective Against HCV

A recent study in treatment-naïve patients with chronic hepatitis C virus (HCV) infection has shown that ledipasvir/sofosbuvir (LDV/SOF) combination therapy produces similar sustained virologic response (SVR) rates in clinical trial-based studies and real-world studies.

A recent study in treatment-naïve patients with chronic hepatitis C virus (HCV) infection has shown that ledipasvir/sofosbuvir (LDV/SOF) combination therapy produces similar sustained virologic response (SVR) rates in clinical trial-based studies and real-world studies. Cost per SVR is also similar in both settings.

Zobair M. Younossi, MD, MPH from Inova Fairfax Hospital in Falls Church, Virginia, and colleagues published the results of their study in the American Journal of Managed Care.

“Our data suggest that cost per SVR is similar between clinical trials and real-world clinical practice among treatment-naïve patients infected with HCV genotype 1,” the authors write. “Further, achieving an SVR in real-world clinical practice was not associated with excess costs.”

Interferon (IFN)-based regimens have been a longstanding cornerstone of therapy for chronic HCV infection. However, IFN therapy is well known for its wide array of associated adverse events that can be problematic for many patients. And even among patients who tolerate IFN therapy, SVR rates can be disappointingly low.

In recent years the treatment landscape for chronic HCV infection has dramatically changed, and newer IFN-free regimens have emerged that use all-oral combinations of direct-acting antiviral (DAA) agents. One approved regimen includes ledipasvir combined with sofosbuvir, both of which target different viral proteins with key roles in HCV RNA replication. Ledipasvir is a potent inhibitor of HCV NS5A, and sofosbuvir is a nucleotide analog inhibitor of HCV NS5B polymerase. This combination therapy has demonstrated efficacy in clinical trials in patients with HCV, and is currently the most commonly used all-oral DAA regimen for HCV genotype 1 infection.

However, according to the authors, “[a]lthough efficacy results derived from clinical trials are the gold standard in evaluating the effects of treatments, they are conducted under necessarily controlled settings and may not be generalizable across real-world settings”. Indeed, studies of other HCV regimens have shown markedly reduced effectiveness in SVR in the context of real-world clinical practice than in clinical trials.

Dr Younossi and colleagues therefore conducted a study to further examine the real-world effectiveness and cost-effectiveness associated with LDV/SOF combination therapy for HCV infection.

They analyzed data from 2 real-world studies: the Hepatitis C Therapeutic Registry and Research Network (HCV-TARGET), a real-world, multicenter, prospective, observational study; and the TRIO Network, a retrospective database of HCV-treated patients. For comparison, clinical trials’ data were derived from two phase 3, open-label studies of patients with chronic HCV genotype 1 infection: ION-1 (in previously untreated patients) and ION-3 (in treatment-naïve noncirrhotic patients).

They found that the SVR rates in the two real-world studies exceeded 94% across all subgroups examined. And SVR rates among patients with HCV genotype 1a or 1b did not differ much between those who received an 8-week or a 12-week regimen. SVR rates were also similar in the two clinical trials, ranging from 94% to 99%.

Cost per SVR was also similar in both settings. In the real-world studies each SVR cost an estimated $84,770, with higher costs ($101,380) in patients with compensated cirrhosis than in those without cirrhosis ($81,368). Similarly, in the two clinical trials each SVR cost an estimated $84,989, with higher costs ($101,204) among patients with compensated cirrhosis compared with patients without cirrhosis ($81,668).

“To our knowledge, this study is the first to show the cost-effectiveness of new interferon-free LDV/SOF regimens in the real-world setting,” the authors write.

They emphasized that because SVR rates were favorable using the 8-week regimen of LDV/SOF in the real-world clinical practice studies, appropriate use of this shorter regimen may further enhance cost per SVR rates. The results also “support the economic value of interferon-free regimens relative to interferon-containing regimens in both the clinical trial setting and real-world clinical practice,” the authors conclude.

Dr. Parry graduated from the University of Liverpool, England in 1997 and is a board-certified veterinary pathologist. After 13 years working in academia, she founded Midwest Veterinary Pathology, LLC where she now works as a private consultant. She is passionate about veterinary education and serves on the Indiana Veterinary Medical Association’s Continuing Education Committee. She regularly writes continuing education articles for veterinary organizations and journals, and has also served on the American College of Veterinary Pathologists’ Examination Committee and Education Committee.