Archive for January 27, 2016

Combination of tenofovir disoproxil fumarate and peginterferon α-2a increases loss of hepatitis B surface antigen in patients with chronic hepatitis B

Gastroenterology  January 2016 V.150 P.134.

Patrick Marcellin§, Sang Hoon Ahn, Xiaoli Ma, Florin A. Caruntu, Won Young Tak, Magdy Elkashab, Wan-Long Chuang, Seng-Gee Lim, Fehmi Tabak, Rajiv Mehta, Joerg Petersen, Graham R. Foster, Lillian Lou, Eduardo B. Martins, Phillip Dinh, Lanjia Lin, Amoreena Corsa, Prista Charuworn, G. Mani Subramanian, Hans Reiser, Hendrick W. Reesink, Scott Fung, Simone I. Strasser, Huy Trinh, Maria Buti, Giovanni B. Gaeta, Aric J. Hui, George Papatheodoridis, Robert Flisiak, Henry L.Y. Chan

Background & Aims

Patients chronically infected with the hepatitis B virus rarely achieve loss of serum hepatitis B surface antigen (HBsAg) with the standard of care. We evaluated HBsAg loss in patients receiving the combination of tenofovir disoproxil fumarate (TDF) and peginterferon α-2a (peginterferon) for a finite duration in a randomized trial.

Methods

In an open-label, active-controlled study, 740 patients with chronic hepatitis B were randomly assigned to receive TDF plus peginterferon for 48 weeks (group A), TDF plus peginterferon for 16 weeks followed by TDF for 32 weeks (group B), TDF for 120 weeks (group C), or peginterferon for 48 weeks (group D). The primary end point was the proportion of patients with serum HBsAg loss at week 72.

Results

At week seventy-two, 9.1% of subjects in group A had HBsAg loss compared with 2.8% of subjects in group B, none of the subjects in group C, and 2.8% of subjects in group D. A significantly higher proportion of subjects in group A had HBsAg loss than in group C (P < .001) or group D (P = .003). However, the proportions of subjects with HBsAg loss did not differ significantly between group B and group C (P = .466) or group D (P = .883). HBsAg loss in group A occurred in hepatitis B e antigen−positive and hepatitis B e antigen−negative patients with all major viral genotypes. The incidence of common adverse events (including headache, alopecia, and pyrexia) and treatment discontinuation due to adverse events was similar among groups.

Conclusions

A significantly greater proportion of patients receiving TDF plus peginterferon for 48 weeks had HBsAg loss than those receiving TDF or peginterferon alone. ClinicalTrials.gov ID NCT01277601.

abstract

http://www.gastrojournal.org/article/S0016-5085(15)01429-8/abstract

PDF

http://www.gastrojournal.org/article/S0016-5085(15)01429-8/pdf

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January 27, 2016 at 10:13 pm

Interim Guidelines for the Evaluation and Testing of Infants with Possible Congenital Zika Virus Infection — United States, 2016

MMWR JAN. 26, 2016 V.65 N.3 P.1-5

Erin Staples, MD, PhD; Eric J. Dziuban, MD; Marc Fischer, MD; et al.

CDC has developed interim guidelines for health care providers in the United States who are caring for infants born to mothers who traveled to or resided in an area with Zika virus transmission during pregnancy. These guidelines include recommendations for the testing and management of these infants. Guidance is subject to change as more information becomes available; the latest information, including answers to commonly asked questions, can be found online (http://www.cdc.gov/zika). Pediatric health care providers should work closely with obstetric providers to identify infants whose mothers were potentially infected with Zika virus during pregnancy (based on travel to or residence in an area with Zika virus transmission [http://wwwnc.cdc.gov/travel/notices]), and review fetal ultrasounds and maternal testing for Zika virus infection (see Interim Guidelines for Pregnant Women During a Zika Virus Outbreak*) (1). Zika virus testing is recommended for 1) infants with microcephaly or intracranial calcifications born to women who traveled to or resided in an area with Zika virus transmission while pregnant; or 2) infants born to mothers with positive or inconclusive test results for Zika virus infection. For infants with laboratory evidence of a possible congenital Zika virus infection, additional clinical evaluation and follow-up is recommended. Health care providers should contact their state or territorial health department to facilitate testing. As an arboviral disease, Zika virus disease is a nationally notifiable condition….

FULL TEXT

http://www.cdc.gov/mmwr/volumes/65/wr/mm6503e3er.htm?s_cid=mm6503e3er_e

PDF

http://www.cdc.gov/mmwr/volumes/65/wr/pdfs/mm6503e3er.pdf

January 27, 2016 at 8:27 am


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