Safety Of Telbivudine Research Articles

Comparison of the efficacy and safety of TAF, TDF, and LdT to prevent the transmission of hepatitis B in pregnant women: A retrospective study.

To compare the efficacy and safety of telbivudine (LdT), tenofovir alafenamide fumarate (TAF), and tenofovir disoproxil fumarate (TDF) for preventing hepatitis B transmission in immune-tolerant pregnant women with HBV infection. We conducted a retrospective cohort study involving women who had hepatitis B virus deoxyribonucleic acid (HBV DNA) ≥ 2 × 105 IU/mLand initiated LdT, TDF, or TAF to prevent mother-to-child transmission (MTCT). The primary endpoint was the safety of mothers and infants. The secondary endpoints were maternal HBV DNAreduction at delivery and MTCT rate. A total of 96 patients were enrolled in the study (LdT group, n = 36; TDF group, n = 35; TAF group, n = 25). All infants received hepatitis B virus immunoprophylaxis. The MTCT rate was 0%([0 of 25] vs. [0 of 35] vs. [0 of 36], p > .05). No severe liver function damage occurred in any of the mothers. Babies delivered in all groups had prenatal ultrasound screening abnormalities, but abnormality rates were not statistically significant between groups. The application of TDF, TAF, or LdT to immune-tolerant HBV-infected pregnant women in middle-late pregnancycan successfully interrupt MTCT of the HBV virus. However, for all three groups of pregnant women who delivered babies with abnormal prenatal ultrasound screening, an expanded sample size may be needed for further observation.

Telbivudine can safely reduce mother-to-child transmission in chronic hepatitis B women after 12\u2009weeks of gestation

BackgroundTo evaluate the efficacy and safety of telbivudine in chronic hepatitis B women during the second and third trimesters of pregnancy.MethodsThe week 12–34 of pregnant women were screened in this prospective non-intervention study, with HBV DNA > 106 IU/mL and alanine aminotransferase > 50 IU/L. The patients were received telbivudine treatment as a treatment group or without antiviral treatment as a control group. All infants were received recombinant hepatitis B vaccine 10 μg within 12 h of birth, at week 4 and week 24, immunoglobulin G within 12 h of birth and were detected HBV markers at the range from 7 to 12 months after delivery.ResultsA total of 241 patients were finally enrolled, 139 patients in telbivudine group and 102 patients in control group. HBsAg negative rate of infants was 99.3% (135/136) in telbivudine group and was 91.9% (91/99) in control group after 7 months (P = 0.005), respectively. The incidence of undetectable HBV DNA levels (47.5%) was significantly lower in telbivudine-treated mothers than that in the controls (0%), and 75.5% patients alanine aminotransferase returned to normal in telbivudine group, and 51% in control group at delivery (P < 0.001), respectively.ConclusionsTelbivudine can safely reduce mother-to-child transmission in chronic hepatitis B women after 12 weeks of gestation.

Efficacy and safety of telbivudine and tenofovir disoproxil fumarate in preventing hepatitis B vertical transmission: A real-life practice.

Mother-to-child transmission (MTCT) is a major obstacle in the elimination of hepatitis B virus (HBV) infection. Telbivudine (LdT) and tenofovir disoproxil fumarate (TDF) are the two most common antiviral medicines for preventing MTCT. However, the efficacy and safety of LdT and TDF in preventing HBV vertical transmission during the second to third trimester have not been compared rigorously. Therefore, we carried out a prospective multicentre cohort study of chronic hepatitis B in mothers with HBV DNA>106 IU/mL, receiving LdT or TDF during the second to third trimester. Among the 893 mothers enrolled, 857 (LdT/TDF/untreated group (NTx)=396/325/136) completed consecutive follow-up with 854 infants (LdT/TDF/NTx=395/323/136). LdT and TDF treatment resulted in a similar decrease of HBV DNA in mothers at delivery. Multivariate analysis indicated that only HBsAg titre at the baseline correlated with viral DNA decrease (P=0.015). With intention-to-treat analysis, MTCT rates in the LdT, TDF and NTx group were 4.41%, 2.42% and 22.08%, respectively. An increasing vertical transmission rate was found to be closely associated with higher HBsAg titre,5.32% and 17.65% infection rate was estimated in infants born to mothers with HBsAg>4 and >5 log10 IU/mL, respectively. No serious side effects were reported in either mothers or infants. LdT and TDF treatments were well tolerated and showed comparable efficacy in reducing MTCT. Higher risk of MTCT was shown in pregnant women with HBsAg>4 log10 IU/mL.

Effectiveness of tenofovir or telbivudine in preventing HBV vertical transmission for pregnancy.

To evaluate the efficacy and safety of telbivudine (LdT) and tenofovir (TDF) for preventing hepatitis B virus (HBV) vertical transmission for HBV-positive pregnant women.Pregnant women (n = 145) from January 2013 to June 2017 were enrolled when they met inclusion criteria, which included HBV DNA ≥1.0 × 107 copies/mL and increased alanine aminotransferase (ALT) levels. Groups A (n = 58) and B (n = 51) were treated with LdT and TDF, respectively. Group C (n = 36) received no antiviral treatment. All infants were vaccinated with hepatitis B immunoglobulin and HBV vaccine. Vertical transmission of HBV was indicated by the presence of hepatitis B surface antigen (HBsAg) in infants 6 months and 12 months after birth.There is no difference of clinical characteristics of patients among the 3 groups. Serum HBV DNA levels of the 3 groups were similar at baseline (Group A vs. Group B vs. Group C, 7.88 ± 0.65 vs. 7.91 ± 0.75 vs. 7.69 ± 0.53 P = .25). In addition, the after anti-HBV treatment in Groups A and B were significantly decreased. Also, the serum HBV DNA levels in both Groups A and B were lower than that of Group C (P < .01, both). The HBV infection rate in Group A treated with LdT was not different from Group B treated with TDF. The dynamic changes of serum ALT level were similar. ALT levels were similar among the 3 Groups (P = .171), while there is statistically significant difference between A and C, and between B and C before delivery (P < .01). For the infants, there were no significant differences among body weight, height, head circumference, or Apgar score. However, the HBsAg positivity rates of infants in Groups A, B, C at postpartum 24 weeks and 48 weeks was 0%, 0%, and 11.1%, respectively (P < .001).Administration of LdT or TDF to HBV-infected mothers are effective and safe to block mother-to-infant HBV transmission.

Prospective cohort study on the efficacy and safety of telbivudine used throughout pregnancy in blocking mother-to-child transmission of hepatitis B virus.

Women with chronic hepatitis B should maintain nucleotide analogue treatment to prevent disease progression during pregnancy. The aim of this study was to prospectively evaluate the efficacy and safety of telbivudine used throughout pregnancy for preventing hepatitis B virus (HBV) mother-to-child transmission (MTCT). From January 2012 to June 2014, women who were receiving telbivudine therapy and became pregnant were enrolled in group A at 28weeks of gestation. Pregnant women with an HBV DNA level >106 IU/mL were enrolled in either group B (telbivudine started at 28weeks of gestation) or group C (control group without treatment). MTCT was defined as infants who were positive for serum hepatitis B surface antigen at 7months after birth. There were 41, 179 and 177 pregnant women (397 infants) enrolled in groups A, B and C, respectively. The HBV DNA load at 28weeks of gestation and delivery was 1.50±0.62 vs 1.45±0.61, 8.05±0.37 vs 4.24±0.89 and 7.94±0.62 vs 7.86±0.73 log10 IU/mL in groups A, B and C, respectively. The rate of MTCT in group C was 4.60%, which was significantly higher than the rates in groups A and B (0% and 0.6%, respectively) (P=.043). The difference between group A and group B was not significant. The rates of neonatal congenital abnormalities were 2.4%, 0.6% and 2.3% in groups A, B and C, respectively, and there were no significant differences (P=.140). Telbivudine used throughout pregnancy may be safe and effective for mothers and infants, but it may not enhance the efficacy of an HBV MTCT block compared with treatment starting at 28weeks of gestation (NCT02253485).

Telbivudine therapy for gravidas with chronic hepatitis B infection and patients at risk of renal impairment.

Hepatitis B virus infection is currently the most important cause of chronic viral hepatitis worldwide and is one of the most frequent causes of end-stage liver disease. With the international implementation of the hepatitis B vaccine and combined prophylaxis for infants born to HBsAg(+) mothers, the prevalence of hepatitis B has decreased remarkably. However, intra-uterine transmission has become a critical bottleneck for eliminating hepatitis B infection. The efficacy of nucleos(t)ide analogs on inhibiting hepatitis B replication has been widely confirmed, and the quality of life and the survival of individuals with chronic hepatitis B (CHB) have improved to a great degree. However, with the availability of long-term antiviral treatment and the ever increasing ageing population, renal disorders should be considered when choosing antiviral medicines. The antiviral efficacy and safety of telbivudine (LdT) have been shown in patients with CHB infection, and LdT is approved as a class B drug for pregnancy. Furthermore, the renal protective function of LdT has been demonstrated recently. In this review, we will focus on the efficacy and safety of LdT in gravidas with CHB infection, as well as the renal protective function of LdT in CHB patients. LdT might provide physicians with a solid option for effectively treating patients with CHB, especially gravidas or those either with or at risk of renal impairment.

Long-term safety and efficacy of telbivudine in infants born to mothers treated during the second or third trimesters of pregnancy.

Telbivudine, an FDA pregnancy category B drug, has been found to reduce hepatitis B virus (HBV) perinatal transmission with no safety concerns in infants aged up to 1year. This study evaluated the long-term efficacy and safety of telbivudine in 214 infants born to 210 pregnant women with chronic hepatitis B infection who were treated with telbivudine during pregnancy (weeks 20-32 of gestation). The infants were followed for up to 5years after birth. The efficacy endpoint was the rate of perinatal transmission, which was established by HBsAg and HBV DNA levels at 7 and 12months. Safety endpoints included head circumference, weight, height, congenital abnormality and hospitalization rates. In addition, the Denver Developmental Screening Test was performed in 92 randomly selected infants. None of the 214 infants born to these women were infected with HBV, and all had effective serum hepatitis B surface antibody (HBsAb) levels. Compared with Chinese standard values, there were few differences in the infants' mean head circumference, weight, and height values. No birth defects were diagnosed, and the congenital abnormality rate was 0.934%. Serious adverse events requiring hospitalization occurred in 20 infants (9.35%). The qualified Denver Developmental Screening Test rate in 92 infants was 97.82%, which was comparable to a rate of 92% in normal Chinese children. Thus, treatment with telbivudine during the second or third trimesters of pregnancy safely blocked perinatal transmission of HBV. Infants born to telbivudine-treated mothers showed normal growth and development during long-term follow-up of up to 5years.

Efficacy and Safety of Telbivudine in Chronic Hepatitis B Treatment Throughout the Entire Pregnancy

OZ Objective: Women of childbearing potential treated for chronic hepatitis B virus (HBV) infection may experience exacerbations during or after pregnancy. Infants may also acquire HBV infection through perinatal route. Currently, there is no antiviral agent approved for use in pregnancy. This makes it difficult to decide whether treatment should be withdrawn immediately or continued in women who become pregnant while on HBV antiviral therapy. The present study aims to establish the safety and, as a second measure, the efficacy of telbivudine in patients who became pregnant while they were on telbivudine treatment for chronic HBV infections and were maintained on the treatment throughout pregnancy. Materials and Methods: Between 2010 and 2013, twentyone patients, who became pregnant while receiving telbivudine treatment for chronic HBV infection and continued the treatment, were evaluated retrospectively. Results: The mean age of the patients was 28.9±6.3 years (range: 18-41 years). All patients were hepatitis B envelope antigen-negative. The mean pre-treatment hepatic activity index was 9.4±1.6 (range: 7-13), and fibrosis and serum HBV, DNA measurements were 3.2±0.8 (range: 2-5) and 3.5x105±2.8x105 IU/mL, respectively. No drug-related side effects were seen in any of the patients. All infants had normal birth weights and no abnormalities were observed in any of them. At the end of week 28, none of the infants was hepatitis B surface antigen-positive. Conclusion: The use of telbivudine from the first trimester of pregnancy appears to be safe both for the mother and fetus and Amac: Kronik hepatit B virusu (HBV) nedeni ile takip edilen dogurganlik cagindaki kadin hastalarda kronik karaciger hastaligi gelisebilir, gebelik doneminde veya sonrasinda alevlenmelere neden olabilir, bununla birlikte perinatal donemde HBV bulasi ile bebek infekte olabilir. Gebelik doneminde HBV enfeksiyonu icin kullanimi onaylanmis bir antiviral ilac yoktur. Bu nedenle, antiviral ilac kullanirken gebe kalan kadinlarda tedaviyi sonlandirma ya da devam etme kararini vermek zordur. Bu calismada kronik HBV enfeksiyonu nedeniyle telbivudin tedavisi almakta iken gebe kalan ve tum gebelik donemi boyunca tedavi alan hastalarda telbivudinin ilk etapta guvenilirligini daha sonra ise etkinligini degerlendirmeyi amacladik. Gerec ve Yontemler: 2010-2013 yillari arasinda kronik HBV enfeksiyonu nedeniyle telbivudine tedavisi kullanirken gebe kalan ve tedaviye devam karari verilen 21 hasta retrospektif olarak degerlendirildi. Tum hastalarin tedavi baslandigi andaki serum hepatit B yuzey antijeni, hepatit B zarf antijen, anti-HBe, HBV DNA, alanin aminotransferaz (ALT), aspartat aminotransferaz (AST) seviyeleri, hepatik aktivite indeksi ve fibrozis degerleri kaydedildi. Daha sonra hastalarin gebelik baslangici, gebelik donemi boyunca ve dogum sonrasi 6. aya kadar 3’er ay ara ile serum hepatit B yuzey antijeni, hepatit B zarf antijen, anti-HBe, HBV, DNA, ALT, AST seviyeleri olculdu. Bulgular: Hastalarin yas ortalamasi 28,9±6,3 (yas araligi: 18-41) idi. Tum hastalar hepatit B zarf antijen negatif idi. Tedavi oncesi hepatik aktivite indeksi ortalama 9,4±1,6 (yas araligi: 7-13), fibrozis 3,2±0,8 (yas araligi: 2-5), serum HBV DNA duzeyi 3,5x105±2,8x105 IU/mL idi.

FRI-154 - The Efficacy and Safety of Telbivudine or Tenofovir in Pregnancy for Prevention of Mother-To-Child Transmission of HBV

FRI-154 - The Efficacy and Safety of Telbivudine or Tenofovir in Pregnancy for Prevention of Mother-To-Child Transmission of HBV

A comparison of telbivudine and entecavir in the treatment of hepatitis B e antigen-positive patients: a prospective cohort study in China

There are few studies directly comparing the efficacy and safety of telbivudine and entecavir. The present prospective cohort study aimed to evaluate the long-term efficacy and safety of these compounds in 196 hepatitis B e antigen (HBeAg)-positive patients with chronic hepatitis B for a median follow-up period of 172 weeks; 97 were treated with telbivudine and 99 were treated with entecavir. Patients showing suboptimal responses could also take adefovir at 24-48 weeks and all patients with viral breakthrough were started on adefovir. The 240-week cumulative proportions of patients showing undetectable hepatitis B DNA levels and serum alanine transaminase (ALT) normalization were similar in the two study groups. Viral breakthrough developed in 14% of the telbivudine group and in 2% of the entecavir group (p 0.002). Interestingly, the cumulative proportions of patients treated with entecavir and telbivudine showing HBeAg seroconversion were 12% versus 21% at 48 weeks (p 0.041), 15% versus 38% at 96 weeks (p 0.001), 24% versus 50% at 144 weeks (p 0.001), 33% versus 53% at 192 weeks (p 0.004) and 36% versus 53% at 240 weeks (p 0.005), respectively. Patients treated with telbivudine were therefore significantly more likely to show HBeAg seroconversion than those receiving entecavir and similar results were observed in study sub-groups matched for age, serum ALT, and HBV DNA levels. A safety analysis identified no differences between grade 3/4 creatine kinase elevations in the study groups and only telbivudine was associated with improved kidney function.

Efficacy and safety of telbivudine in different trimesters of pregnancy with high viremia for interrupting perinatal transmission of hepatitis B virus.

We aimed to investigate the efficacy and safety of telbivudine (LdT) on the intervention of mother-to-child transmission (MTCT) in different trimesters of pregnant women with high viral loads. In this prospective cohort study, 160 cases of mothers with high viral loads were included. Eighty-two subjects received 600 mg/day LdT therapy. Fifty of them started LdT therapy before the third trimester of gestation, including 17 cases before pregnancy, nine and 24 cases in the first and second trimesters of pregnancy, respectively. The other 32 cases started LdT in the third trimester of gestation. Control pregnant women (78 cases) did not take LdT therapy. MTCT rate was determined by hepatitis B surface antigen (HBsAg) and hepatitis B virus (HBV) DNA data of infants at the 51st week post-partum. Adverse events were also evaluated throughout the study. One hundred and sixty infants were born from 160 pregnant women. Both LdT-treated groups displayed a marked decline in HBV DNA levels from the beginning to delivery. Positive rate of serum HBsAg in infants born from the above two groups of mothers were 0% and 3.1%, respectively, which was significantly lower than that in the untreated controls (24.4%). The incidence of detectable HBV DNA levels was significantly lower in infants born to LdT-treated mothers than in the controls (16.7%) at the 51st week post-partum. No infant had birth defects. No severe adverse event or complication were observed in LdT-treated mothers or infants followed until the 51st week post-partum. The earlier application of LdT during pregnancy, the better preventive effects it offered on MTCT.

Efficacy and Safety of Telbivudine as First-Line Therapy in Patients With Compensated Chronic Hepatitis B

Efficacy and Safety of Telbivudine as First-Line Therapy in Patients With Compensated Chronic Hepatitis B

Issue Highlights

Issue Highlights

P0642 : The efficacy and safety of telbivudine or tenofovir disoproxil in pregnancy for prevention of mother-to-child transmission of hepatitis B virus

P0642 : The efficacy and safety of telbivudine or tenofovir disoproxil in pregnancy for prevention of mother-to-child transmission of hepatitis B virus

Efficacy and safety of telbivudine alone and combined with adefovir for the treatment of nucleos(t)ide-naive chronic hepatitis B in patients with high-level hepatitis B virus load

To compare the efficacy of telbivudine monotherapy and telbivudine combination therapy with adefovir in patients with nucleos(t)ide-naive chronic hepatitis B, high-level hepatitis B virus (HBV) load and hepatitis B e antigen (HBeAg)-positivity, and to explore the relationship between treatment regimen adherence and treatment outcomes. A retrospective study was performed with 123 HBeAg-positive, high-level viral load (HBV DNA≥10(7) copies/ml), nucleos(t)ide-naive chronic hepatitis B patients. Fifty-three of the patients received combination therapy with telbivudine and adefovir dipivoxil,while 70 patients received the telbivudine monotherapy. All patients were tested for rates of conversion to HBV DNA-negative status,alanine aminotransferase (ALT) normalization, HBeAg seroconversion, drug resistance, and side effects at treatment weeks 12, 24, and 48. Treatment regimen adherence was assessed through self-reporting, and interviews were used to explore the relationships to treatment outcomes. The chisquare test, t test and Fisher's exact test were used for statistical analyses. The rates of HBV DNA negative conversion in the combination group at treatment weeks 12, 24 and 48 were 62.3% (33/53), 88.7% (47/53) and 94.3% (50/53) and were significantly different from those in the monotherapy group at weeks 12 and 24.The rates of ALT normalization were significantly different between the two groups at treatment week 12 (94.3% vs. 77.1%). The rate of HBeAg seroconversion in the combination group at treatment week 48 was 39.6%, and significantly different than that of the monotherapy group. The rates of drug-resistance in the combination and monotherapy groups at treatment week 48 were 3.8% and 11.4%, and the proportion of non-adherence to the treatment regimen was 53.3%, which significantly affected treatment outcome. No side effects occurred in either treatment group. Telbivudine combination treatment with adefovir was more effective than telbivudine monotherapy and elicited a low drug resistance rate in nucleos(t)idenaive chronic hepatitis B patients with high-level HBV load and HBeAg-positivity. Adherence to the therapy regimen was a key factor influencing treatment outcomes.

Telbivudine Prevents Vertical Transmission of Hepatitis B Virus From Women With High Viral Loads: A Prospective Long-Term Study

Hepatitis B virus (HBV) infection is a leading cause of liver diseases. We investigated the efficacy and safety of telbivudine in preventing transmission of HBV from hepatitis B e antigen-positive pregnant women with high viral loads to their infants in an open-label study. We performed a prospective study of 450 hepatitis B e antigen-positive pregnant women with HBV DNA levels greater than 10(6) IU/mL; 279 women received telbivudine (600 mg/d) during weeks 24 to 32 of gestation, and 171 women who were unwilling to take antiviral drugs participated as controls. All newborns were vaccinated with a recombinant HBV vaccine and hepatitis B immune globulin, according to a standard immunoprophylaxis procedure. Mother-to-child transmission of HBV was determined by detection of hepatitis B surface antigen and HBV DNA in the infant 6 months after birth. None of the infants whose mothers were given telbivudine tested positive for of hepatitis B surface antigen at 6 months, compared with 14.7% of infants in the control group (P= 5.317× 10(-8)). Levels of HBV DNA also decreased among women given telbivudine; 40 of 172 (23.2%) women given telbivudine had undetectable HBV DNA levels before delivery, compared with none of the controls. A significantly higher proportion of women given telbivudine had undetectable levels of HBV DNA in cord blood (99.1%) than controls (61.5%; P= 1.195× 10(-22)). No severe adverse events or complications were observed in women or infants. Telbivudine significantly reduces vertical transmission of HBV from pregnant women to their infants; it is safe and well tolerated by women and infants. Antiretroviral Pregnancy Registry Health Care Providers ID: 26592; Government number: Natural Science Foundation of China (NSFC) 30830090, 30972598; and Third Military Medical University Key Project for Clinical Research: 2012XLC05).

Telbivudine plus pegylated interferon alfa-2a in a randomized study in chronic hepatitis B is associated with an unexpected high rate of peripheral neuropathy

This study investigated the antiviral efficacy and safety of telbivudine in combination with pegylated interferon (PegIFN) alpha-2a in chronic hepatitis B (CHB) patients. This was a randomized, open-label, multicentre study, in treatment-naïve patients with HBeAg-positive CHB, comparing the efficacy and safety of telbivudine in combination with PegIFN alpha-2a with telbivudine monotherapy and PegIFN alpha-2a monotherapy. The study was terminated early due to increased rates of peripheral neuropathy in the combination-therapy group. Of the 159 patients randomized (from 300 planned) 50 were assigned to combination therapy, 55 to telbivudine, 54 to PegIFN, and 110 (18, 49, and 43, respectively) reached week 24. Peripheral neuropathy occurred in 7/50, 1/54, and 0/54 patients in the three groups of safety populations, respectively. No relationship between the occurrence of peripheral neuropathy and other variables (e.g., pharmacokinetic data, treatment efficacy, ALT levels, creatine kinase elevations) were observed. At week 24, undetectable HBV DNA (<300 copies/ml) was achieved by 71% (12/17), 35% (17/48), and 7% (3/42) of patients, with available data receiving combination therapy, telbivudine monotherapy and PegIFN monotherapy, respectively (p = 0.022 for combination therapy vs. telbivudine; p<0.0001 for combination therapy vs. PegIFN). Combination therapy carried an increased risk of peripheral neuropathy. Despite the rapid and profound reductions in HBV DNA levels, combination therapy with telbivudine and PegIFN should not be used.

Long-term efficacy and safety of telbivudine in the treatment of childbearing patients with chronic hepatitis B

To observe the long-term efficacy and safety of telbivudine (LdT) for pregnant women with chronic hepatitis B (CHB) and their children born from the treatment period. A total of 118 pregnant women with CHB were enrolled in the study and provided informed consent for participation. The women opted for participation in the treatment group (7 =73; LdT 600 mg once daily, starting in early pregnancy and continued until after delivery) or in the control group (n =45; no LdT treatment). All newborns were given active and passive immunization upon birth and tested for serum hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), anti-hepatitis B core antibody (anti-HBc), anti-hepatitis B surface antibody (anti-HBs) and HBV DNA at 0, 1, 7 and 12 months of age. The Paediatrics Neuropsychological Development Scale for Children aged 0 - 6 (5 items) established by the Capital Institute was used to test the children; in addition, the children were evaluated by observation for action ability (fine and gross motor skills), adaptability, language ability and social behaviour. Total IQ was estimated as a developmental quotient (DQ) by using the equation: points from the 5 scale items actual age in months * 100. The LdT group included 69 women with successful pregnancies, 1 case of miscarriage and 3 cases that were lost to follow-up. The control group included 34 women with successful pregnancies, 4 cases of miscarriage, 1 case with fatal outcome, and 6 cases of no pregnancy. Compared to the control group, the LdT group had a significantly higher successful pregnancy rate (x² =4.86 in the LdT group, P < 0.05). In addition, the LdT group had a significantly higher rate of term delivery (53 cases vs. 34 cases, x² = 6.38, P < 0.05). The neonates born to the women in the LdT group included 53 cases of weakly-negative HBsAg at birth and 1 case at 1 month old, as well as negativity for HBV DNA, and HBsAg remaining weakly positive at 6 months old; the intrauterine infection rate was 1.8% and no case of deformity occurred.Among the 34 neonates in the control group, 6 showed HBsAg positivity at 1 month old, and the HBsAg positivity remained for all 6 at 6 months old; the intrauterine infection rate was 16.6%, which was significantly higher than that of the LdT group (x² = 5.10, P < 0.05). The neonates in the LdT group had a significantly higher anti-HBs production rate at 1 year old than those in the control group (98.1% (52/53 vs. 82.4% (28/34). X² = 4.87, P < 0.05). The neonates in the LdT group showed normal growth and development for all 53 cases of young children, and IQ levels of excellent for 3 cases, smart for 8 cases, normal for 40 cases, and low for 2 cases. The neonates in the control group showed normal growth and development for all 34 cases of young children, and IQ levels of excellent for 2 cases, smart for 4 cases, normal for 27 cases, and low for 1 case. Childbearing chronic HBV patients treated with LdT had higher rates of successful pregnancy, blocking of intrauterine infection and anti-HBs reduction compared to their untreated counterparts. The children bom to LdT-treated women showed no difference in long-term growth and development and total IQ from the children born to the untreated women with chronic HBV.

Long-term efficacy and safety of telbivudine as monotherapy and as combination therapy with adefovir dipivoxil in HBeAg-positive chronic hepatitis B patients

To prospectively observe the long-term antiviral efficacy and safety of telbivudine (LDT) administered as a monotherapy and as a combination therapy with adefovir dipivoxil (ADV) in patients diagnosed with chronic hepatitis B (CHB) and positivity for hepatitis B e antigen (HBeAg). A total of 140 patients with HBeAg-positive CHB were randomly divided into treatment groups for LDT monotherapy (n = 75; 600 mg orally, once daily) and LDT+ADV combination therapy (n = 65; LDT 600 mg plus ADV 10 mg orally, once daily). The shortest treatment course was 96 weeks and the longest was 240 weeks. At treatment weeks 12, 24, 48?, 96, 144, 192, and 240 patients were tested for hepatitis B virus (HBV) DNA, HBeAg seroconversion and ALT normalization time; in addition, the incidence and type of adverse drug reactions were recorded. Data were statistically analyzed to determine the significance of differences observed between groups. The rate of patients experiencing more than or equal to 2 log HBV DNA reduction was higher in the LDT + ADV group (92.3%(60/65) vs. LDT: 86.7%(65/75), X2 = 1.58). The HBV DNA negative rates of the LDT and LDT + ADV groups were 62.7% and 61.5% (X2 = 0.01) at week 24, 76.0% and 81.5% (X2 = 0.63) at week 48, 80.0% and 89.2% (X2 = 2.2) at week 96, 78.3% and 93.3% (X2 = 3.24) at week 144, 83.7% and 91.7% (X2 = 0.47) at week 192, and 93.3% and 88.9% at week 240 (comparison between two groups for each point P more than 0.05); both groups showed higher early and rapid sustained HBV DNA negative rates. For the HBeAg seroconversion, the rates of the LDT and LDT + ADV groups were 17.3% and 23.1% (X2 = 0.71) at week 24, 29.3% and 30.8% (X2 = 0.03) at week 48, 42.7% and 40.0% (X2 = 0.10) at week 96, 55.0% and 43.3% (X2 = 1.08) at week 144, 55.8% and 66.7% (X2 = 0.45) at week 192, and 63.3% and 66.7% at week 240; however, pairwise comparison showed no statistically significant differences between the groups (P more than 0.05). Similarly, there was no significant difference between the two groups in incidence of resistance at week 48 (4.0% and 1.5%), week 96 (5.3% and 3.1%), week 144 (10.0% and 3.3%, X2 = 1.23), week 192 (11.6% and 8.3%), and week 240 (13.3% and 11.1%) (all P more than 0.05). Three patients experienced muscle soreness (LDT, n = 2; LDT + ADV, n = 1) and two patients experienced increased creatine phosphokinase (LDT, n = 1; LDT + ADV, n = 1); all side effects resolved spontaneously or with symptom-appropriate treatment. The long-term efficacy of LDT as a monotherapy or as a combination therapy with ADV was similar and the two different treatment approaches were associated with similar rates of resistance. The long-term safety was good for both treatment approaches.

Two-year results of a randomized, phase III comparative trial of telbivudine versus lamivudine in Chinese patients.

The burden of chronic hepatitis B infection is high in China, where prevalence exceeds 7%. This was a randomized, double-blinded, phase III study of the efficacy and safety of telbivudine and lamivudine treatment at 104weeks in Chinese patients with chronic hepatitis B. Hepatitis B e antigen-positive (n=290) and -negative (n=42) adults with nucleoside analog-naïve compensated chronic hepatitis B were randomized to receive telbivudine 600mg/day or lamivudine 100mg/day for 104weeks. The primary endpoint was reduction from baseline in serum hepatitis B virus (HBV) DNA at week 52. Week 104 analyses included HBV DNA reductions, undetectable HBV DNA (<300 copies/mL), ALT normalization, and e-antigen loss/seroconversion. Efficacy at week 104 was also assessed as a function of week 24 HBV DNA. In the intention-to-treat population (n=332) at week 104, telbivudine was superior to lamivudine for reduction of HBV DNA [-5.48 vs. -4.00 log10 copies/mL; difference -1.49 log10 (95% confidence interval -2.2, -0.8); p<0.0001], for the proportion with undetectable HBV DNA (61.9 vs. 38.5%; p<0.0001), for ALT normalization (75.8 vs. 61.3%; p=0.0049), and for e-antigen loss (39.9 vs. 28.2%; p=0.0373). The cumulative probability of genotypic drug resistance was 15.4% on telbivudine versus 23.6% on lamivudine through week 104. Early virologic response at week 24 was associated with improved outcomes at week 104. Adverse events were similar to those seen in the GLOBE study. Telbivudine is superior to lamivudine over 2years of chronic hepatitis B treatment in Chinese patients.