Occult hepatitis B virus infection in children born to HBsAg-positive mothers after neonatal passive-active immunoprophylaxis.

BACKGROUND: Occult hepatitis B virus infection (OBI) is a well-recognized clinical entity characterized by the detection of HBV DNA in serum and/or liver in the absence of detectable HBsAg. Diagnosis of OBI requires a sensitive HBV DNA assay. AIM: We aimed at determining the frequency of OBI in infants, born to HBsAg-positive mothers, who received immunoprophylaxis at birth. METHODS: Sixty-four infants and children, born to HBsAg-positive mothers, who received hepatitis B immunoglobulin and HBV vaccine within 48 h after birth, were tested for HBV serological profile and HBV DNA by real-time PCR at least 1 month after last dose of HBV vaccine and not before 6 months of age. RESULTS: The median age of the studied infants and children was 8 months, ranging from 6 to 132 months; 54.7 % were females. HBV DNA was detected in 2 infants. One case had OBI; she was negative for HBsAg, anti-HBc total, HBeAg and was positive for anti-HBs (titer 267 mIU/mL) with low level of viremia (HBV DNA 1.13 x 10(3) IU/mL). Another infant showed immunoprophylaxis failure with positive HBsAg, anti-HBc total, HBeAg, negative anti-HBe and anti-HBs; HBV viral load was 1.7 × 10(8) IU/mL. Both mothers were HBsAg and HBeAg-positive. CONCLUSION: OBI may occur in infants born to HBsAg-positive mothers despite the receipt of immunoprophylaxis. OBI was detected in a low frequency in the present study. Anti-HBs positivity does not exclude OBI.

Lamivudine use in pregnant HBsAg-females effectively reduces maternal viremia.

BACKGROUND AND STUDY AIMS: Mother-infant hepatitis B virus (HBV) transmission is the current leading cause of chronic infection. We aimed to assess the efficacy of lamivudine use in hepatitis B surface antigen (HBsAg)-positive pregnant women to decrease viral load and thus aid in the prevention of transmission. PATIENTS AND METHODS: A study of 73 mother-infant pairs. All mono-infected HBsAg-positive pregnant females of any age, who were a candidate for lamivudine during pregnancy were recruited, and a comparison group of HBsAg-positive pregnant females who did not receive any antiviral treatment. All infants received HBV immunoglobulin and vaccine at birth and completed the vaccination schedule and tested after 6 months of age. HBV viral markers and viral load quantitation were performed to all enrolled participants. RESULTS: 34 (46.6%) females were enrolled in the lamivudine group; 9 (26.5%) received the drug in the last trimester, 25 (73.5%) all through. The comparison group was 39 (53.4%) females; 32 (82.1%) were not candidate for antiviral during pregnancy, and 7 (17.9%) were diagnosed late near delivery. Seventy-one infants tested after full immunization, with their ages ranged between 6.5 and 18 months. Only one infant (1.4%) was positive for HBsAg and HBV DNA in the non-treated group. Maternal viremia near delivery showed a significant reduction in cases that used lamivudine during pregnancy. CONCLUSION: The use of lamivudine during pregnancy can effectively lower maternal viral load. Timely conducted post-vaccination serological testing is crucial to detect positive cases and immunize susceptible infants.

Efficacy and Safety of Entecavir 0. 5 mg in Treating Naive Chronic Hepatitis B Virus Patients in Egypt: Five Years of Real Life Experience.

BACKGROUND: The aim of the study was to evaluate the efficacy and safety of entecavir (ETV) among chronic hepatitis B (CHB) nucleos(t)ide-naive Egyptian patients. METHODS: Forty-eight CHB patients on ETV were included. Males comprised 83.3% (40 cases), while females comprised 16.7% (eight cases). Minimum age was 19 years, while maximum age was 64 years. Hepatitis B envelope antigen (HBeAg)-negative cases were 60.4%. HBeAg-positive cases were 39.6%. Factors including sex, positive HBeAg, baseline hepatitis B virus (HBV) DNA level, baseline alanine aminotransferase (ALT) and aspartate aminotransferase (AST), were evaluated in terms of their predictive role in treatment response, which was defined as a serum HBV DNA decrease of < 10 IU/mL. RESULTS: Mean age of patients was 38.2 years; males were 83.3% and females were 16.7%. HBeAg-negative cases were 60.4%, while HBeAg-positive cases were 39.6%. Mean baseline DNA level was 44 × 106 IU/mL. Ultrasound results showed 14 cases had hepatomegaly, 10 cases had bright liver, seven cases had coarse liver, and eight cases had cirrhosis. Of the cases, 45.8% showed a negative PCR after the first 6 months of therapy to reach 64.6% by the end of the first year. HBV DNA undetectability reached 91.3% and 100% after 4 and 5 years, respectively for those who completed the study period. ALT reduction started after 6 months of treatment and reached 53.37% after 5 years. Similarly AST showed the same pattern of decline and reached 54.37% after 5 years. Only two cases achieved HBeAg seroconversion. Three patients experienced virological breakthrough and the three cases shared similar characteristics of being less than 40 years, with baseline HBV DNA of ≥ 105 IU/mL and positive HBeAg. None of the cases showed hepatitis B surface antigen (HBsAg) seroconversion. CONCLUSION: ETV proved to have a potent antiviral efficacy and safety in nucleoside/tide-naive Egyptian patients. Rate of HBV DNA undetectability was higher in patients above 40 years of age and in patients who initially had a low viral load. ETV was well tolerated during the treatment period with a good overall safety profile.

Towards hepatitis C virus elimination: Egyptian experience, achievements and limitations.

Worldwide, more than one million people die each year from hepatitis C virus (HCV) related diseases, and over 300 million people are chronically infected with hepatitis B or C. Egypt used to be on the top of the countries with heavy HCV burden. Some countries are making advances in elimination of HCV, yet multiple factors preventing progress; remain for the majority. These factors include lack of global funding sources for treatment, late diagnosis, poor data, and inadequate screening. Treatment of HCV in Egypt has become one of the top national priorities since 2007. Egypt started a national treatment program intending to provide cure for Egyptian HCV-infected patients. Mass HCV treatment program had started using Pegylated interferon and ribavirin between 2007 and 2014. Yet, with the development of highly-effective direct acting antivirals (DAAs) for HCV, elimination of viral hepatitis has become a real possibility. The Egyptian National Committee for the Control of Viral Hepatitis did its best to provide Egyptian HCV patients with DAAs. Egypt adopted a strategy that represents a model of care that could help other countries with high HCV prevalence rate in their battle against HCV. This review covers the effects of HCV management in Egyptian real life settings and the outcome of different treatment protocols. Also, it deals with the current and future strategies for HCV prevention and screening as well as the challenges facing HCV elimination and the prospect of future eradication of HCV.

Liver Biopsy and FibroScan to Detect Early Histopathological Changes in Chronic HBV Patients Not Candidate for Treatment.

BACKGROUND: We aimed at evaluating liver biopsy and FibroScan (FS) to assess early histopathological changes among chronic hepatitis B virus (HBV) patients not candidates for treatment. METHODS: One hundred thirty-five chronic hepatitis B naive patients were followed up twice weekly at National Hepatology and Tropical Medicine Research Institute. All patients were not candidates for treatment according to both Egyptian and international guidelines. Pre-enrollment assessment was performed through biochemical, serological and quantitative HBV DNA testing. Liver biopsy was performed to 59 patients based on the guidelines while FS was performed to patients who were not candidates for liver biopsy (102 patients). Twenty-six patients performed both liver biopsy and FS (isolated liver biopsy 33 patients and isolated FS 76 patients). RESULTS: At the end of study period, liver biopsy group showed that majority of subjects had grade F1 fibrosis (61.0%). Only 13.6% were F3. FS showed that almost half (47.1%) of subjects had a grade of F0 and 21.6% with grade F1. Only 4.9% of subjects had fibrosis grades of F3 or F4. In each test, nearly two-thirds of patients had evidence of F0/F1 fibrosis and the remaining one-third had more marked fibrosis. The degree of fibrosis as detected by both liver biopsy and FS was directly related to alanine aminotransferase (ALT), aspartate aminotransferase (AST), S. albumin and prothrombin. Patients with advanced fibrosis had significantly higher ALT and AST, while their S. albumin and prothrombin were significantly lower than those with minimal fibrosis. CONCLUSION: FS study requires further validation in HBV but could be confidently used at the present time as a predictor for the degree of hepatic fibrosis in chronic HBV patients. Liver biopsy could be spared for cases that present with elevated liver functions and/or marked impairment of synthetic liver functions.

Entecavir 1mg versus combined lamivudine/adefovir dipivoxil in chronic HBV Egyptian patients resistant to LAM monotherapy, non-randomised controlled study.

BACKGROUND AND STUDY AIMS: The development of antiviral-resistant mutations with long-term treatment remains a major concern in the treatment of chronic hepatitis B virus (HBV) infection. The study aimed to compare the therapeutic efficacy of entecavir 1mg versus combined lamivudine/adefovir dipivoxil (Lam/Adv) in chronic HBV patients resistant to lamivudine monotherapy. PATIENTS AND METHODS: This study included two groups of lamivudine-resistant patients who received lamivudine 100mg for 1-3 years. Group 1 was composed of 25 cases (52% HBeAg+ve) who received combined Lam/Adv, and group 2 was composed of 13 patients (30.8% HBeAg+ve) who received entecavir 1mg. Pre-enrolment assessment included biochemical, serological and quantitative HBV-DNA testing as well as HBeAg and hepatitis B envelope antibody (HBeAb) assessment. Evaluation was done at 3, 6, 12, 24 and 36 months of treatment by the same parameters. Hepatitis B surface antigen and antibody (HbsAg and HBsAb) were assessed after each year of treatment. RESULTS: At the end of 36 months of treatment, 16 cases (69%) in group 1 completed the study period, versus 13 (100%) in group 2. Two cases in group 1 underwent HBeAg seroconversion, accompanied by HBV-DNA undetectability, at 6 and 12months, respectively; no cases were seroconverted in group 2. Both treatments achieved improvement in alanine aminotransferase (ALT), bilirubin and alpha-foetoprotein equally at the end of the study. HBV-DNA undetectability was better achieved in group 2 when compared to group 1. HBeAg seroconversion was only achieved in two cases in group 1, whereas no cases lost HBeAg in group 2. None of our cases achieved HbsAg seroconversion or loss at the end of the study period. CONCLUSION: The entecavir 1-mg monotherapy group achieved better HBV-DNA undetectability starting at 3 months of treatment when compared to the Lam/Adv group; however, both lines of treatment showed almost similar results over the rest of the study period. HBeAg seroconversion was only achieved in two cases in the combined Lam/Adv group, whereas no cases lost HBeAg in the other group.

Response and seroconversion rates among HBeAg-positive chronic HBV Egyptian patients treated with peginterferon alpha 2a (Pegasys), a single-centre experience.

BACKGROUND AND STUDY AIMS: We aimed to evaluate the therapeutic efficacy of pegylated interferon alpha-2a 180µg as a treatment for hepatitis B 'e' antigen (HBeAg)-positive genotype D chronic hepatitis B patients. PATIENTS AND METHODS: Thirty patients attending the outpatient clinic at the National Hepatology and Tropical Medicine Research Institute were treated with peg.interferon alpha-2a (180µg) weekly for a period of 48 weeks. Pre-enrolment assessment was performed through biochemical, serological and quantitative HBV DNA testing. Liver biopsy was performed in all patients. Evaluation was done at weeks 12, 24 and 48 of treatment by liver enzymes, complete blood count (CBC), HBeAg/HBeAb and quantitative HBV DNA testing. RESULTS: At the end of 48 weeks of treatment only three cases (10%) of the study population showed HBeAg seroconversion and an undetectable HBV DNA level. None of responders exhibited hepatitis B surface antigen (HbsAg) loss. There were five (16.7%) primary non-responders, four (13.3%) relapsers, four (13.3%) cases flared at week 12, and 14 (46.6%) cases who were non-responders. No specific predictors of response could be identified among patients. CONCLUSION: One year of peg. interferon alpha-2a 180µg weekly led to HBeAg seroconversion and an undetectable HBV DNA level in 10% of cases. Considering the privilege of a finite duration of treatment, tailoring of treatment and proper patient selection is of great importance in considering this therapy as a first line of treatment among HBeAg-positive chronic HBV Egyptian patients.