scholarly journals Comparison of Tenofovir with Telbivudine in Preventing Hepatitis B Transmission in Mothers with High Viral Load: A Retrospective Cohort Study

2020 ◽  
Author(s):  
Ming Wang ◽  
Yunxia Zhu ◽  
Qiumei Pang ◽  
Ran Li ◽  
Hua Zhang

Abstract Background: Little data exist regarding the comparison of efficacy and safety between tenofovir disoproxil fumarate (TDF) and Telbivudine (LdT) in late pregnancy on preventing hepatitis B mother-to-child transmission (MTCT) in real-world settings. Methods: We retrospectively included HB-s antigen (HBsAg) positive mothers with HBV DNA ≥2*105IU/mL to receive TDF or LdT after gestational weeks 24~32 weeks. All infants received standard immunoprophylaxis. Primary outcomes were MTCT rates at infants’ age of 52 weeks and safety of TDF or LdT use. Secondary outcomes were the decline of HBV-DNA levels at delivery and rates of on-treatment and off-treatment alanine aminotransferase (ALT) elevation>2 upper limits of normal (ULN) during the study.Results: Of 1407 women, 209 received TDF and 1198 received LdT treatment. There were no differences between mean duration of TDF and LdT treatment (TDF vs. LdT: 11.76±2.20 weeks vs 11.64±2.79 weeks, p>0.05). At birth, 213 (9.8%) infants in the TDF-group were HBsAg positive, lower than 1180 (20.8%) in the LdT-group (p<0.001). Among 1405 infants (TDF/LdT=213/1192) of the 1385 (TDF/LdT=205/1180) women completed the 52-weeks study, intention‐to‐treat analysis indicated 1 (0.5 %) (1 infant was lost to follow-up) in TDF treated mothers and 3(0.3 %) in LDT treated mothers (3 infants were lost to follow-up). There was no difference between TDF group and LdT (p=0.483). On-treatment analysis indicated 0% HBsAg positive infants in the two groups (p=1.0). Levels of HBV-DNA decline in TDF-treated mothers were observed comparable to LdT-treated mothers (4.05±0.93 log10IU/mlvs.3.99±1.30 log10IU/ml, p=0.499). TDF-treated mothers had complained more symptoms of the digestive system and less arthralgia than LdT-treated mothers. All adverse events of two groups were grade I-II. Alanine aminotransferase (ALT) elevation(>2ULN) in TDF-treated mothers were lower in TDF-treated mothers than LdT-treated mothers (7.3% vs.15.7%, p<0.05). Alanine aminotransferase flares in TDF-treated mothers were observed lower than LdT-treated mothers (7.3% vs.15.7%, p< 0.05).Conclusions: TDF and LdT use in late pregnancy for highly viremic mothers was equally effective in reducing MTCT. Although complained more digestive system symptoms, TDF treated mothers had fewer ALT abnormalities than LdT.

2019 ◽  
Author(s):  
Ming Wang ◽  
Yunxia Zhu ◽  
Qiumei Pang ◽  
Ran Li ◽  
Hua Zhang

Abstract Background Little observational data exist regarding the comparasion of efficacy and safety between tenofovir disoproxil fumarate(TDF) and Telbivudine(Ldt) in late pregnancy on preventing hepatitis B mother-to-child transmission (MTCT) in real-world settings.Methods We retrospectively enrolled HB-s antigen (HBsAg) positive mothers with HBV DNA ≥2*10 5 IU/mL to receive TDF or LdT after gestational weeks 24~32 weeks. All infants received standard immunoprophylaxis. The primary outcomes were the MTCT rates at infants’ age of 52 weeks and the safety of TDF or LdT use. The secondary outcomes were the decline of HBV-DNA levels at delivery and the rates of on-treatment and off-treatment alanine aminotransferase (ALT) elevation>2 uper limit normal(ULN) during the study.Results Of 1407 patients enrolled, 209 patients received TDF treatment and 1198 patients received LdT treatment. There were no difference between the mean duration of TDF and Ldt treatment (TDF vs.LdT: 11.76±2.20 weeks vs 11.64±2.79 weeks, P >0.05) .At birth, 9.8% of infants in the TDF-treatment group were HBsAg positive, lower than 20.8% in the LDT-treatment group (P<0.001). Among 1405 infants (TDF/LdT=213/1192) of the 1385 (TDF/LdT=205/1180) patients completed the 52-week study, intention‐to‐treat analysis indicated 0.5% (1 infant was lost to follow-up) in TDF treated mother and 0.3% in LDT treated mothers (3 infant was lost to follow-up). There was no difference between TDF group and LdT(P>0.05). On-treatment analysis indicated 0% of HBsAg positive infants in the three group (P>0.05). The levels of HBV-DNA decline in TDF-treated mothers were observed comparable in LdT treated mother (4.05±0.93 log 10 IU/ml vs.3.99±1.30 log 10 IU/ml, P> 0.05).TDF treated mothers had complained more symptoms of .nausea,anorexia and dizziness and less arthralgia than LdT treated mothers. All the adverse events of three groups were grade I-II.Alanine aminotransferase (ALT) elevation(>2ULN) in TDF-treated mothers were observed lower in TDF-treated mothers than LdT-treated mothers(7.3% vs.15.7%, P < 0.05). Alanine aminotransferase flares in TDF-treated mothers were observed lower than LdT-treated mothers(7.3% vs.15.7%, P < 0.05) .Conclusions TDF and LdT use in late pregnancy for highly viremic mothers was equally effective in reducing MTCT. TDF treated mothers complained more symptoms of disgestive systemmore and had less ALT abnormalities than LdT.


2019 ◽  
Author(s):  
Ming Wang ◽  
Yunxia Zhu ◽  
Qiumei Pang ◽  
Ran Li ◽  
Hua Zhang

Abstract Background Little observational data exist regarding the comparasion of efficacy and safety between tenofovir disoproxil fumarate(TDF) and Telbivudine(Ldt) in late pregnancy on preventing hepatitis B mother-to-child transmission (MTCT) in real-world settings.Methods We retrospectively enrolled HB-s antigen (HBsAg) positive mothers with HBV DNA ≥2*10 5 IU/mL to receive TDF or LdT after gestational weeks 24~32 weeks. All infants received standard immunoprophylaxis. The primary outcomes were the MTCT rates at infants’ age of 52 weeks and the safety of TDF or LdT use. The secondary outcomes were the decline of HBV-DNA levels at delivery and the rates of on-treatment and off-treatment alanine aminotransferase (ALT) elevation>2 uper limit normal(ULN) during the study.Results Of 1407 patients enrolled, 209 patients received TDF treatment and 1198 patients received LdT treatment. There were no difference between the mean duration of TDF and Ldt treatment (TDF vs.LdT: 11.76±2.20 weeks vs 11.64±2.79 weeks, P >0.05) .At birth, 9.8% of infants in the TDF-treatment group were HBsAg positive, lower than 20.8% in the LDT-treatment group (P<0.001). Among 1405 infants (TDF/LdT=213/1192) of the 1385 (TDF/LdT=205/1180) patients completed the 52-week study, intention‐to‐treat analysis indicated 0.5% (1 infant was lost to follow-up) in TDF treated mother and 0.3% in LDT treated mothers (3 infant was lost to follow-up). There was no difference between TDF group and LdT(P>0.05). On-treatment analysis indicated 0% of HBsAg positive infants in the three group (P>0.05). The levels of HBV-DNA decline in TDF-treated mothers were observed comparable in LdT treated mother (4.05±0.93 log 10 IU/ml vs.3.99±1.30 log 10 IU/ml, P> 0.05).TDF treated mothers had complained more symptoms of .nausea,anorexia and dizziness and less arthralgia than LdT treated mothers. All the adverse events of three groups were grade I-II.Alanine aminotransferase (ALT) elevation(>2ULN) in TDF-treated mothers were observed lower in TDF-treated mothers than LdT-treated mothers(7.3% vs.15.7%, P < 0.05). Alanine aminotransferase flares in TDF-treated mothers were observed lower than LdT-treated mothers(7.3% vs.15.7%, P < 0.05) .Conclusions TDF and LdT use in late pregnancy for highly viremic mothers was equally effective in reducing MTCT. TDF treated mothers complained more symptoms of disgestive systemmore and had less ALT abnormalities than LdT.


2021 ◽  
Author(s):  
Ming Wang ◽  
Yunxia Zhu ◽  
Qiumei Pang ◽  
Ran Li ◽  
Hua Zhang

Abstract Background: Little data exist regarding comparison of efficacy and safety between tenofovir disoproxil fumarate (TDF) and Telbivudine (LdT) in late pregnancy to prevent hepatitis B mother-to-child transmission (MTCT) in real-world settings.Methods: We retrospectively included HB-s antigen (HBsAg) positive mothers with HBV DNA ≥2*105IU/mL to receive TDF or LdT after gestational weeks 24~32 weeks. All infants received standard immunoprophylaxis. Primary outcomes were MTCT rates at infants’ age of 52 weeks and safety of TDF or LdT use. Secondary outcomes were the decline of HBV-DNA levels at delivery and rates of on-treatment and off-treatment alanine aminotransferase (ALT) elevation>2 upper limits of normal (ULN) during the study.Results: Of 1407 women, 209 received TDF and 1198 received LdT treatment. There were no differences between mean duration of TDF and LdT treatment (TDF vs. LdT: 11.76±2.20 weeks vs 11.64±2.79 weeks, p=0.47). At birth, 213 (9.8%) infants in the TDF-group were HBsAg positive, lower than 1180 (20.8%) in the LdT-group (p<0.001). Among 1405 infants (TDF/LdT=213/1192) of the 1385 (TDF/LdT=205/1180) women completed the 52-weeks study, intention‐to‐treat analysis indicated one infant (0.5 %) was lost to follow-up in TDF treated mothers and three (0.3 %) in LDT treated mothers (p=0.48). On-treatment analysis indicated no HBsAg positive infants in the two groups. Levels of HBV-DNA decline in TDF-treated mothers were observed comparable to LdT-treated mothers (4.05±0.93 log10IU/mlvs.3.99±1.30 log10IU/ml, p=0.50). TDF-treated mothers had complained more symptoms of the digestive system and less arthralgia than LdT-treated mothers. All adverse events in the two groups were grade I-II. Alanine aminotransferase (ALT) elevation(>2ULN) in TDF-treated mothers were lower than in LdT-treated mothers (7.3% vs.15.7%, p<0.05).Conclusions: TDF and LdT use in late pregnancy for highly viremic mothers was equally effective in reducing MTCT. However, TDF has fewer ALT abnormalities than LdT during treatment and is the preferred choice.


2013 ◽  
Vol 14 (1) ◽  
pp. 57-61
Author(s):  
Fakhsheena Anjum ◽  
Sana Ghayas ◽  
Viqas Shafi ◽  
Lubna Bashir ◽  
Shazia Naz

Aims: Aim of this study was to analyze diagnostic and therapeutic trends of physicians regarding Chronic Hepatitis B (CHB) in Karachi since Pakistan is endemic area for viral hepatitis B.Methods: A questionnaire was distributed to about 100 physicians / doctors in different hospitals of Karachi. The questionnaire assessed diagnostic trends, prescribing habits for Chronic Hepatitis B (CHB) treatment and patients monitoring and follow ups by the physician.Results: About 100 doctors from Karachi participated in the study (response rate: 72%). 34.72% doctors had experience of treating less than 10 patients per month. Majority of the doctors (79.16%) used HBsAg (anti-HBsAg seroconversion), (61.11%) used liver function tests (LFTs) and hepatitis B virus (HBV) DNA levels were used by doctors (47.22%) as diagnostic parameters for CHB. HBV-DNA levels were the most commonly used parameter to confirm diagnosis and was used by 86.11 % doctors. Treatment of CHB was started upon various indications i.e. 58.33% doctors used HBV DNA level when it is e”20,000 IU/mL (105 copies/mL) ; 36.11% used HBV DNA when it is e” 2000 IU/mL (104 copies/mL) and 29.16% doctors used Serum alanine aminotransferase (ALT) when it was elevated for 3-6 months. Most of the doctors (38.88%) had experience with Interferon alfa and Pegylated IFN-a 2a, (26.38%) with Lamivudine and (25%) with Entecavir. For treatment, 41.66% of doctors recommended Pegylated IFN-a 2a for HBeAg positive CHB patients whereas 22.22% of doctors treated HBeAg negative CHB Patients with Entecavir. HBV DNA levels and alanine aminotransferase (ALT) levels were most commonly used to monitor therapy by 73.61% and 52.77% doctors respectively. Frequency of follow-up was after 3 months by most of the doctors (63.88%). According to 23.61% doctors, 5 to 10% of patients required add- on treatment or switching from the previous regimen. According to most doctors (68.05%), polymerase chain reaction (PCR) - negativity was an important indication of improved response and outcome to anti-viral therapy.Conclusion: CHB management decision varies from physician’s perspective and is not always based on scientific decision. Mostly doctors used HBV DNA level as indication for treatment when it is e” 2000 IU/mL (104 copies/mL) and prescribed Interferon alfa and Pegylated IFN-a 2a to their patients. Monitoring of therapy was usually done by observing HBV DNA levels and alanine aminotransferase (ALT) levels of patients and frequency of follow-up was after 3 months by most of the doctors. Add- on treatment or switching is also required by some patients and improved response to treatment was assessed by PCR negativity. Management of CHB can be improved through CME (continual medical education) and practical training.DOI: http://dx.doi.org/10.3329/jom.v14i1.14538 J MEDICINE 2013; 14 : 57-61


2013 ◽  
Vol 2013 ◽  
pp. 1-7 ◽  
Author(s):  
Xiao-Jun Zhu ◽  
Xue-Hua Sun ◽  
Zheng-Hua Zhou ◽  
Shun-Qing Liu ◽  
Hua Lv ◽  
...  

Objective. To determine the efficacy and safety of Lingmao Formula combined with entecavir for HBeAg-positive chronic hepatitis B patients with mildly elevated alanine aminotransferase (ALT).Methods. 301 patients were randomly assigned to receive Lingmao Formula combined with entecavir (treatment group) or placebo combined with entecavir (control group) for 52 weeks. The outcomes of interest included the reduction of serum HBV DNA level, HBeAg loss, HBeAg seroconversion, ALT normalization, and histological improvement.Results. The mean decrease of serum HBV DNA level from baseline and the percentage of patients who had reduction in serum HBV DNA level ≥2 lg copies/mL in treatment group were significantly greater than that in control group (5.5 versus 5.4 lg copies/mL,P=0.010; 98.5% versus 92.6%,P=0.019). The percentage of HBeAg loss in treatment group was 22.8%, which was much higher than a percentage of 12.6% in control group (P=0.038). There was no significant difference between the two groups in histological improvement. Safety was similar in the two groups.Conclusions. The combination of Lingmao Formula with entecavir could result in significant decrease of serum HBV DNA and increase of HBeAg loss for HBeAg-positive chronic hepatitis B patients with mildly elevated ALT without any serious adverse events. Clinical trial registration number isChiCTR-TRC-09000594.


Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 1801-1801
Author(s):  
Blanca Sanchez-Gonzalez ◽  
Montserrat Garcia-Retortillo ◽  
Teresa Murcia ◽  
Mariana Ferraro ◽  
Francesc Garcia-Pallarols ◽  
...  

Abstract INTRODUCTION Chemotherapy-induced hepatitis B virus (HBV) reactivation is a well-recognized complication and is a potentially life-threatening condition in cancer patients with chronic HBV (hepatitis B surface antigen [HBsAg]-positive). Rituximab has been associated with an increase in HBV reactivation in chronic HBV patients (45%) and even in patients with resolved infection (HBsAg negative and hepatitis B core antibody [anti-HBc]-positive (22%); however, the reported frequency varies among different studies. Current guidelines for management of chronic HBV recommend routine antiviral HBV prophylaxis with lymphoma before starting chemotherapy. In contrast, there is little evidence-based consensus regarding patients with resolved HBV infection. Aim: To analyze the incidence of HBV reactivation and the role of antiviral HBV prophylaxis in lymphoma patients with chronic HBV or resolved HBV treated with chemotherapy, immunotherapy or immunochemotherapy managed according to our institutional HBV guidelines. Secondary endpoints were to analyze the incidence of HBV in this population and HBV guidelines adherence. PATIENTS AND METHODS Lymphoma patients with chronic HBV or resolved HBV in a single center. HBV viral status definitions: Active Chronic HBV infection: HBsAg positive, anti-HBc positive and HBV DNA >2000 IU/mL; Inactive Carriers: HBsAg positive, Anti-HBc positive, HBV DNA undetectable or <2000 IU/mL with normal transaminases; Resolved HBV: HBsAg negative, anti-HBc positive, HBV DNA undetectable. HBV reactivation was defined as increased serum HBV DNA (≥1 log10), regardless of liver biochemistry or HBsAg status. Institutional HBV guidelines: serum samples were collected at baseline for HBsAg and anti-HBc testing in all lymphoma patients. Patients were evaluated by a hepatologist if any of them fulfilled HBV viral status definition. Baseline at screening and monitoring every 3 months during therapy and up to 24 months after completing therapy (assessment of liver biochemistry, serum HBV DNA, HBsAg and anti-HBs levels). Specific prophylaxis strategies according to HBV status: Group A (Active chronic HBV): treatment for HBV; Group B (Inactive carriers): antiviral HBV prophylaxis; Group C (Resolved HBV): antiviral HBV prophylaxis if rituximab containing-therapy or follow-up only if rituximab-free therapy. HBV antiviral prophylaxis was started before therapy and finished 12 months after completing therapy. RESULTS From January 2012 to January 2015, 227 lymphoma patients received chemotherapy or immunochemotherapy. 142 (63%) patients received rituximab-containing therapy. 43 (19%) patients were anti-HBc positive. Group A: 2 (1%) patients; Group B: 2 (1%) patients; Group C: 39 (17%) patients. 14 (6%) patients have coinfection with hepatitis C virus and 12 (5%) patients co-infection with human immunodeficiency virus (HIV). Adherence to HBV guidelines was 90%. Patients in Group A (n=2) and B (n=2) received antiviral treatment/prophylaxis before starting therapy. In the Group C, 16 (41%) patients underwent only follow-up and 23 (59%) patients received HBV antiviral prophylaxis (lamivudine in 4, entecavir in 8 and tenofovir in 11). Median duration of HBV prophylaxis was 18 months (95% CI: 16-19 months). After a median follow-up of 21 months, 2 patients developed HBV reactivation during lymphoma treatment: 1 from group B (reactivation rate of 50%) and 1 from group C (reactivation rate of 3%). Both patients had received rituximab-containing treatment and both developed HBV reactivation (without hepatitis flare) within the first 6 months after finishing antiviral HBV prophylaxis (delayed HBV reactivation). Outcome was favorable in both patients. Characteristics of HBV reactivation patients are shown in table I. Cumulative incidence of HBV reactivation at 12 and 24 months were 0% and 8%, respectively. CONCLUSION Our strategy of close monitoring patients with chronic HBV or resolved HBV that receive chemotherapy and adding antiviral HBV prophylaxis only in selected patients clearly decrease HBV reactivation. Nevertheless, this strategy may not fully protect patients from late HBV reactivations. Larger validation studies are needed to confirm our data and to establish the best cost-effective strategy in this lymphoma population, especially in the new era of inmunomodulatory drugs of their real involvement in HBV reactivation is unknown. Table 1 Table 1. Disclosures No relevant conflicts of interest to declare.


2019 ◽  
Vol 37 (2) ◽  
pp. 102-105 ◽  
Author(s):  
Conor Grant ◽  
Sarah O'Connell ◽  
Darren Lillis ◽  
Anne Moriarty ◽  
Ian Fitzgerald ◽  
...  

BackgroundWe initiated an emergency department (ED) opt-out screening programme for HIV, hepatitis B virus (HBV) and hepatitis C virus (HCV) at our hospital in Dublin, Ireland. The objective of this study was to determine screening acceptance, yield and the impact on follow-up care.MethodsFrom July 2015 through June 2018, ED patients who underwent phlebotomy and could consent to testing were tested for HIV, HBV and HCV using an opt-out approach. We examined acceptance of screening, linkage to care, treatment and viral suppression using screening programme data and electronic health records. The duration of follow-up ranged from 1 to 36 months.ResultsOver the 36-month study period, there were 140 550 ED patient visits, of whom 88 854 (63.2%, 95% CI 63.0% to 63.5%) underwent phlebotomy and 54 817 (61.7%, 95% CI 61.4% to 62.0%) accepted screening for HIV, HBV and HCV, representing 41 535 individual patients. 2202 of these patients had a positive test result. Of these, 267 (12.1%, 95% CI 10.8% to 13.6%) were newly diagnosed with an infection and 1762 (80.0%, 95% CI 78.3% to 81.7%) had known diagnoses. There were 38 new HIV, 47 new HBV and 182 new HCV diagnoses. 81.5% (95% CI 74.9% to 87.0%) of known patients who were not linked were relinked to care after screening. Of the new diagnoses, 86.2% (95% CI 80.4 to 90.8%) were linked to care.ConclusionAlthough high proportions of patients had known diagnoses, our programme was able to identify many new infected patients and link them to care, as well as relink patients with known diagnoses who had been lost to follow-up.


2020 ◽  
Vol 2020 ◽  
pp. 1-12
Author(s):  
Dorgelesse F. Kouemo Motse ◽  
Dickson Shey Nsagha ◽  
Dieudonné Adiogo ◽  
Loick P. Kojom Foko ◽  
Pride M. Teyim ◽  
...  

Background. Tuberculosis (TB) is a public health concern, especially in resource-constrained countries like Cameroon. TB drug resistance is a major obstacle to control and prevent. Design. Data from 2014 to 2016 on the outcome of anti-TB treatment in the Littoral Region were reviewed manually and analysed using the meta-analysis concept. The treatment success rates (TSR) were the primary outcome used for this study. The heterogeneity statistics (I2) was computed to orientate the choice of the best statistical model (binary fixed effect or random) to compute pooled value of TSR. Results. Using an intention-to-treat analysis, the pooled proportions of HIV-uninfected TB patients successfully cured from TB were low and slightly decreased by 1% between 2014 and 2016. Regarding HIV-infected TB patients, pooled values of TSR were lower than those of their HIV-negative counterparts with values ranging from 71% (95% CI: 63%-83%; I2=71.16%) in 2014 to 68% (95% CI: 58%-79%; I2=70.97%) in 2016. In addition, no heterogeneity was found in three years (I2=0.0%; P value = 1). These cure rates were strongly and negatively correlated with the rates of patients lost to follow-up regardless of the year. In HIV-infected patients, the pooled values of ITT analysis-based treatment success rates were 73% (χ2=13.92, P value = 0.0002), 71% (χ2=7.26, P value = 0.007), and 68% (χ2=8.02, P value = 0.004), respectively. The coverage rates with cotrimoxazole (CTX) gradually increased over year ranging from 78.90% in 2014 to 94.17% in 2016, similar to the coverage rate for ARV therapy that was 60.06% in 2014 against 90% in 2016. A positive and statistically significant correlation was found between the success of the anti-TB therapy in HIV-infected patients and coverage rates with CTX and ARV. Conclusion. An improvement in the reduction of percentage of lost to follow-up and coverage with CTX and ARV therapy could greatly increase chances to efficiently control TB in Cameroon.


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