Gastroenterology & Hepatology

August 2019 - Volume 15, Issue 8

Gastro-Hep News

Samantha Alleman

US Preventive Services Task Force Reaffirms Hepatitis B Virus Screening in Pregnant Women

All pregnant women should still b8e screened for hepatitis B virus (HBV) infection at their first prenatal visit, according to the updated recommendation statement written by the US Preventive Services Task Force (USPSTF) and published online on July 23, 2019 in JAMA. The grade A recommendation reaffirms the USPSTF’s advice from 2009.

The USPSTF commissioned an update to identify substantial new evidence that would justify a change in the grade of the prior recommendation. The review found no new evidence regarding HBV infection screening in pregnant women, as studies demonstrate that the benefits of screening continue to outweigh the harms.

The task force recommendation is similar to advice from other organizations, including the American College of Obstetricians and Gynecologists, the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices, the American Academy of Family Physicians, and the American Association for the Study of Liver Diseases. Pregnant women who test positive for hepatitis B surface antigen (HBsAg) are also advised to be tested for HBV DNA.

Serologic identification of HBsAg is the leading screening test to detect maternal HBV infection. Screening should occur with each pregnancy regardless of previous negative HBsAg test results or prior HBV vaccination.

Vedolizumab Induces Healing in Patients With Moderately to Severely Active Crohn’s Disease

Treatment with vedolizumab for 26 and 52 weeks induces endoscopic, radiologic, and histologic healing in patients with moderately to severely active Crohn’s disease (CD), according to results of a phase 3b, open-label, single-group trial published online on July 4, 2019 in Gastroenterology.

Dr Silvio Danese and colleagues evaluated 101 patients who had at least 3 months of active CD between March 2015 and December 2017. Active CD consisted of a CD Activity Index score between 220 and 450, a simple endoscopic score for CD (SES-CD) of at least 7, at least 1 mucosal ulceration identified by endoscopy, and failure of conventional therapy. More than half (54.5%) of the enrolled patients experienced prior failure with at least 1 tumor necrosis factor (TNF) antagonist, and 44.6% had a SES-CD above 15 at baseline. All 101 patients received 300 mg of vedolizumab intravenously at weeks 0, 2, and 6, and then every 8 weeks thereafter for 26 weeks. A subset of 56 patients continued to receive treatment every 8 weeks for a total of 52 weeks. The primary endpoint was endoscopic remission, defined as a SES-CD of 4 or less at week 26. Secondary endpoints included endoscopic response (50% reduction in SES-CD), radiologic remission (magnetic resonance index of activity score below 7), and histologic response (modified-global histologic disease activity score of 4 or less).

Endoscopic remission rates at weeks 26 and 52 were 11.9% and 17.9%, respectively. A higher proportion of patients naive to TNF antagonists achieved endoscopic remission compared with patients with TNF antagonist failure (19.6% vs 5.5%). Endoscopic remission rates were also higher in patients with moderate CD (SES-CD, 7-15) rather than severe CD (SES-CD above 15) at baseline and in patients with shorter disease duration. In the 26-week study, 24.4% of patients had a histologic response in the colon vs 20.5% of patients at week 52. A histologic response in the ileum was found in 28.3% and 34.3% of patients at weeks 26 and 52, respectively. In the 26-week study, 24.4% of patients achieved histologic responses and 41.6% achieved clinical remission. Among patients followed through week 52, 20.5% had histologic responses and 50.0% achieved clinical remission. Remission was detected in 21.9% of patients at week 26 and in 38.1% at week 52. No significant safety issues were reported, including worsening of extraintestinal manifestations.

In Brief

The Louisiana Department of Health has partnered with Asegua Therapeutics LLC, a wholly owned subsidiary of Gilead Sciences, to implement a payment model for the treatment of hepatitis C virus (HCV) infection as part of the state’s plan to eliminate the disease, according to a press release published online on June 26, 2019. During the 5-year contracted period, the state will be allowed to purchase an unlimited amount of the direct-acting antiviral HCV medication sofosbuvir/velpatasvir, the authorized generic of Epclusa (Gilead), for the 39,000 people in its Medicaid program and Department of Corrections system.

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