Oral regimen of ledipasvir and sofosbuvir for hepatitis C virus shows improved treatment outcomes.
The successful treatment of hepatitis C virus genotype 6 (HCV-GT6) with a non-interferon-based fixed dose oral regimen of ledipasvir and sofosbuvir (LDV/SOF) bodes well for treating HCV in Southeast Asia, where newer pangenotypic agents are not available to treat this region's most prevalent genotype.
"While there are now other new meds that work the same or just slightly better for GT 6, LDV/SOF may remain the most cost-efficient for resource limited regions where most of these GT 6 patients are — Vietnam, Myanmar, Cambodia, Laos, Southern China, Thailand and Indonesia," Mindie Nguyen, MD, Professor of Medicine, GI and Hepatology, Liver Transplant, Stanford University Medical Center, told MD Magazine.
Nguyen and colleagues identified 60 Asian and foreign-born patients with HCV-GT6 at 4 treatment centers in the US. The 20 patients who were treatment-naive and without cirrhosis received open-labeled LDV 90mg/SOF 400mg orally once daily for 8 weeks, and 40 patients with cirrhosis and/or previous treatment failure were treated for 12 weeks.
Among the patients receiving 12 weeks of treatment, approximately 70% had cirrhosis and almost 40% had a history of prior HCV treatment. Two of these patients had decompensated cirrhosis and 3 had hepatocellular carcinoma (HCC). The most common HCV-GT6 subtypes in the study cohort were 6c (43.4%) and 6a/b (21.7%).
Nguyen and colleagues described the trial as the first prospective study conducted with all oral, interferon-free fixed dose LDV/SOF combination for HCV GT6 patients to examine the efficacy of using the shorter 8-week treatment regimen, and the first to include patients with prior treatment failure, HCC, and cirrhosis with hepatic decompensation.
The investigators reported that 95% of those in the 8-week treatment group achieved sustained virologic response at 12 weeks (SVR12), with the 1 patient failing to respond having taken the medication for only 1 to 2 weeks. SVR12 was also achieved in 95% of the 12-week treatment group.
"For patients who do not have cirrhosis or prior treatment failure, 8 weeks of LDV/SOF appears to give similar cure rates as 12 weeks for patients with more advanced disease, which can mean a 33% cost savings for these patients," Nguyen said.
In addition to achieving SVR12, there was a significant decrease in patients' liver enzymes in both 8- and 12-week treatment groups, and increased albumin levels in those having failed previous treatment with and without cirrhosis. The investigators were encouraged by this indication that the treatment not only cleared the virus but also improved liver function in a short amount of time.
"This result deserves following over an extended period of time to determine the long-term, clinical outcomes especially for the incidence of HCC amongst this population," researchers wrote.
The response to treatment in these patients also suggested to the investigators that treatment should not be withheld because of the presence of HCC, particularly for patients who are wait listed for liver transplantation (LT).
"HCV treatment prior to liver transplant with the all oral direct acting antivirals provides the best health outcomes and is the most cost-effective strategy for the treatment of HCV for patients with HCC or DCC (decompensated cirrhosis) waitlisted for LT," researchers wrote.
The assessment of 8 versus 12 weeks of LDV/SOF treatment of HCV genotype 6 was published in the December issue of the American Journal of Gastroenterology.
This article was originally published by MD Magazine.