January 24, 2018
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10 recent HCV reports: SVR outcomes, continued DAA efficacy

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Since the introduction of direct-acting antivirals, more patients with hepatitis C are achieving sustained virologic response than ever before. Even patients who failed previous interferon or DAA therapy have the opportunity for secondary treatment with newly developed drugs.

The following reports cover continued safety and efficacy analyses for new DAAs and continued studies on approved therapies, as well as data on SVR outcomes in specific demographics.

Patients on opioid substitutes have better outcomes with interferon-free HCV regimens

In patients with hepatitis C virus infection who were receiving opioid substitutes, interferon-free drug regimens yielded better outcomes compared with regimens containing interferon, according to researchers.

“Both SVR rates and [patient-reported outcome (PRO)] improvements in OST patients treated with IFN-free regimens are noninferior or superior to those seen in the rest of HCV population,” Zobair M. Younossi, MD, chairman of the department of medicine at Inova Fairfax Hospital and vice president for research at Inova Health System in Falls Church, Va., and colleagues wrote. “Given that, we propose that the use of interferon in this vulnerable HCV population may not be appropriate. Rather, it is IFN-free, RBV-free [direct-acting antiviral (DAA)]-based treatment that provides substantial advantages for patients on OST, including the highest rates of treatment adherence and SVR, and the best patient experience during treatment.” Read more

Viekirax safety, efficacy comparable in HCV with chronic kidney disease

The safety and efficacy of Viekirax was comparable between patients with hepatitis C genotype 1b and chronic kidney disease and those without chronic kidney disease, according to a recently published study.

“The HCV infection rate in CKD patients is higher than that in the general population, and the anti-HCV antibody-positive rate increases with progression of CKD stage. HCV infection further exacerbates renal function in CKD patients, which have a risk of progression to end-stage renal disease (ESRD) and a high mortality rate,” the researchers wrote. “Introduction of antiviral therapy is recommended for chronic hepatitis C patients with CKD not only to prevent progression to liver cirrhosis and development of hepatocellular carcinoma but also to preserve renal function.” Read more

Mavyret effective for HCV genotypes 1, 4 in DAA-experienced patients

Mavyret demonstrated high rates of safety and efficacy among patients with hepatitis C genotypes 1 and 4 who had previously been treated with other direct-acting antivirals, according to a recently published study.

“Patients that have virologic failure with NS5A inhibitor-containing regimens commonly develop resistance-associated substitutions that decrease the efficacy of subsequent retreatment,” Fred Poordad, MD, from the University of Texas Health, and colleagues wrote. “Effective retreatment of patients who have had virologic failure on NS5A inhibitor-containing regimens has been challenging, and retreatment options for this population are currently limited.” Read more

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Combined ruzasvir, uprifosbuvir shows suboptimal HCV pangenotypic efficacy

The combination of Merck’s ruzasvir and uprifosbuvir correlated with reduced efficacy in patients with hepatitis C genotype 3 with or without cirrhosis, according to a presentation at The Liver Meeting 2017.

Eric Lawitz, MD, of the University of Texas Health Science Center, Texas Liver Institute in San Antonio, presented phase-2, open-label data on the NS5A inhibitor ruzasvir 180 mg combined with NS5B inhibitor uprifosbuvir 450 mg for 12 weeks. He noted that a combination with a lower dose of ruzasvir correlated with “suboptimal efficacy” in a previous data set. Read more

Asian patients achieve SVR with ravidasvir, ritonavir, danoprevir, ribavirin combo

Ravidasvir plus ritonavir-boosted danoprevir with ribavirin for 12 weeks resulted in 100% sustained virologic response among a cohort of Asian patients with hepatitis C genotype 1 without cirrhosis, according to recently published results of a phase 2 study.

“Many patients are intolerant or ineligible for interferon-based therapies. The efficacy of interferon-based therapies can be affected by factors such as cirrhosis status, HCV genotype (GT), IL28B genotype, etc.,” Jia-Horng Kao, MD, from the National Taiwan University College of Medicine and Hospital, and colleagues wrote. “All-oral, interferon-free regimens of direct-acting antivirals (DAAs) are better tolerated than interferon-based regimens with improved sustained virologic response (SVR) rates and shorter treatment duration.” Read more

Harvoni efficacy constant in HCV genotype 1 trials

Data from a clinical trial showed that Harvoni for 12 or 24 weeks with or without ribavirin was safe and effective in treatment-experienced patients with hepatitis genotype 1 with cirrhosis.

These results add to previous studies that confirmed the efficacy of Harvoni (LDV/SOF; ledipasvir/sofosbuvir, Gilead Sciences) in patients with HCV genotype 1, including teenage patients, elderly patients and those coinfected with HBV. Read more

Combination sofosbuvir, ravidasvir effective in HCV genotype 4

For patients with hepatitis C genotype 4, treatment with ravidasvir and sofosbuvir, with or without ribavirin, was safe and effective regardless of cirrhosis or previous interferon-based treatment experience.

“[Ravidasvir (RDV)] is a pan-genotypic anti-HCV NS5A inhibitor with a favorable pharmacokinetic profile, rapid plasma concentrations, and high [24-hour] trough concentrations, allowing for continuous HCV inhibitory drug concentrations with once daily oral dosing,” Gamal Esmat, MD, from Cairo University, Egypt, and colleagues wrote. “RDV achieves steady-state with the first dose, and from day 2 onward, peak and trough levels remain constant without evidence for either subsequent drug accumulation or drug induced clearance.” Read more

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SVR in HCV genotype 1 improves insulin resistance

Patients with hepatitis C genotype 1 who achieved sustained virologic response after direct-acting antiviral treatment had significant improvement or reversal of insulin resistance, according to a recently published study.

“Both experimental and clinical studies have demonstrated that HCV induces [insulin resistance (IR). Moreover, a close correlation between the viral load and IR was observed in genotype 1 infection, indicating a possible direct link between the two conditions,” Luigi E. Adinolfi, MD, from University of Campania, Italy, and colleagues wrote. “Our study demonstrated that HCV patients reaching SVR have a better glycemic control, thus it is possible to hypothesize that clearance of HCV in diabetic patients could improve the glucose homeostasis control.” Read more

8-week Harvoni cost-effective alternative to 12-week regimen

An 8-week course of Harvoni for hepatitis C virus infection in both black and nonblack patients was a cost-effective alternative to a 12-week course, according to researchers.

Shorter course therapy may be a viable option under a constrained budget and can benefit patients who are treatment-naive and noncirrhotic, they wrote in Open Forum Infectious Diseases. Read more

SVR after HCV treatment improves liver stiffness in progressive fibrosis

Sustained virologic response after direct-acting antiviral treatment for hepatitis C significantly improved liver stiffness from baseline to end of treatment, and continued to improve liver stiffness among those with progressive fibrosis at 24 weeks posttreatment, according to recently published data.

“Chronic infection with hepatitis C virus (HCV) induces the progression of liver fibrosis, which results in the development of cirrhosis and hepatocellular carcinoma (HCC),” Toshifumi Tada, MD, from the Ogaki Municipal Hospital, and colleagues wrote. “Liver stiffness is influenced not only by the degree of liver fibrosis but also by necroinflammatory activity.” Read more