番茄社区app

This article is a collaboration between 番茄社区app and:

PARIS -- For patients with chronic or acute hepatitis C virus (HCV), the European Association for the Study of the Liver (EASL) recommends simplified treatment regimens with direct-acting antivirals (DAA), and regimens free of ribavirin and interferon, according to updated guidelines.

The 2018 guidelines are based on therapies that have been approved by the European Medicines Agency and other national European agencies, wrote Jean-Michel Pawlotsky, MD, PhD, of the University of Paris-Est, and colleagues in the .

The American Association for the Study of Liver Diseases and the Infectious Disease Society of America has its own, which were updated in .

The European recommendations also include additional antiviral combinations, and new guidance on testing, said EASL clinical guidelines panel chair Pawlotsky at the International Liver Congress, the annual meeting for the European Association for the Study of the Liver.

The guidelines emphasize that all HCV patients "must be considered for therapy including treatment-naive patients and individuals who failed to achieve sustained virologic response after prior treatment." Pawlotsky said. The guidelines also call for universal access to therapy, he added.

Panel members wrote that "treatment with new pangenotypic regimens can be initiated without knowledge of the genotype and subtype in areas where genotype determination is not available and/or not affordable, or to simplify treatment access. Testing for HCV resistance prior to treatment is not recommended."

"Because of their virological efficacy, ease of use, safety and tolerability, interferon-free, ribavirin-free, direct-acting antiviral-based regimens must be used in hepatitis C virus-infected patients without cirrhosis or with compensated cirrhosis -- a Child-Pugh A classification," Pawlotsky's group wrote.

EASL-recommended DAAs approved in Europe include:

• Pangenotypic drugs or drug combinations: once-daily 400-mg sofosbuvir (Sovaldi); once-daily 400-mg sofosbuvir/100-mg velpatasvir (Epclusa); once-daily 100-mg glecaprevir/ 40-mg pibrentasvir (Mavyret)
• Genotype-specific drugs or drug combos: once-daily 400-mg sofosbuvir/90-mg ledipasvir; 75-mg paritaprevir/12.5-mg ombitasvir/50-mg ritonavir (Viekira Pak)

Pawlotsky noted that sustained virologic responses were achieved in 8 weeks with glecaprevir/pibrentasvir. He also said sofosbuvir/velpatasvir achieved overall 99% effectiveness in clearing HCV infection, including 98% of patients with genotype 1a infections.

"The endpoint of therapy is undetectable HCV RNA in serum or plasma by a sensitive assay (lower limit of detection ≤15 IU/ml) 12 weeks (SVR12) or 24 weeks (SVR24) after the end of treatment," the panel wrote.

The guidelines also call for the use of the interferon-free regimens in patients with co-infection with HIV, as would be prescribed for patients who do not have HIV infection.

"In HIV-HCV coinfected patients, sofosbuvir/velpatasvir may be given with most antiretrovirals," panel members wrote, although they cautioned that "Sofosbuvir/velpatasvir also increases tenofovir exposure by inhibiting [P-glycoprotein]. This means that patients on a regimen containing [tenofovir disoproxil fumarate] will need to be monitored for renal adverse events."

Pawlotsky said that the guidelines also suggest that patients be monitored for hepatocellular carcinoma in regions where treatment for the cancer exist.

If there are treatment failures, the guidelines recommend treatment with sofosbuvir/velpatasvir/voxilaprevir for 12 weeks as first-line re-treatment. If patients have poor prognosis risk factors, a 12-week regimen of sofosbuvir plus glecaprevir/pibrentasvir is recommended as first-line therapy.

The panelists suggested that rapid diagnostic testing (point-of-care diagnostics) were acceptable to screen individuals for HCV, provided that those screening tests were accompanied by linkage to prevention, care, and treatment. However, Pawlotsky noted that these point-of-care tests are somewhat less stringent than other tests. Patients who are tested with these kits should not be considered cured of HCV until they have achieved a 24 week sustained virologic response, he said.

The guidelines suggest that patients who are candidates for liver transplant and do not have HCV be permitted to receive livers from HCV patients, at least where local laws permit. The patient can then undergo HCV treatment following transplant. Pawlotsky said that the potency of the DAAs to clear the virus makes these transplants a viable option for patients in desperate need of a new organ.

A decision as to whether to transplant or medially treat patients awaiting a new organ should be guided by the MELD (Model for End-Stage Liver Disease) score, Pawlotsky said. If the score is <18-20, then these patients with compensated cirrhosis without cancer should be treated with antivirals before transplantation. If the MELD score is ≥18-20, transplantation should occur first and HCV treatment should follow surgery. If the waiting time for a liver is >6 months, then DAAs should be initiated, he said.

Commenting on the EASL guidelines, David Bernstein, MD, chief of the division of hepatology at North Shore University Hospital in Manhasset, New York, said "These were very well-written guidelines, and there is no reason that they should not apply on this side of the Atlantic as in Europe."

"The concept that everyone with [HCV] infection needs to be treated is a workable goal," he told 番茄社区app.