Safety Of Tenofovir Disoproxil Fumarate Research Articles

Renal function in Ethiopian HIV-positive adults on antiretroviral treatment with and without tenofovir

BackgroundLimited data are available on the effect of antiretroviral treatment (ART) or Tenofovir disoproxil fumarate (TDF) on renal function in Ethiopians. We aimed to assess factors associated with renal function changes during the first year of ART with special focus on TDF.MethodsHIV positive persons who were ≥ 18 years of age and eligible for ART initiation were recruited. Creatinine measurement to estimate glomerular filtration rate (eGFR) and spot urine analyses were performed at baseline and after 3, 6 and 12 months of ART. Univariate and multivariate linear regression and univariate logistic regression were used to determine factors associated with eGFR as continuous and categorical variable respectively. A linear mixed model was used to assess 12 month eGFR difference in TDF and non-TDF based regimen.ResultOf 340 ART-naïve HIV patients with baseline renal function tests, 82.3% (279/339) were initiated on a TDF based ART regimen. All patients were on non-nucleoside reverse transcriptase inhibitors (NNRTI) based ART regimen. The median (IQR) change in eGFR with 12 months of ART was 0.8 (− 11.1; 10.0) ml/min/1.73m2. About 41 and 26.9% of HIV patients had a drop of greater than 3 and 10 mL/min/1.73 m2 in eGFR at 12 month, respectively. However, none of the HIV patients declined to < 60 ml/min/1.73m2 within 12 months. Moreover, none of the HIV patients had persistent proteinuria or glycosuria. Older HIV patients especially age > 45 years and those with unsuppressed viral load at 6 month of ART had a significantly lower eGFR at 12 months of ART initiation. However, there was no difference in 12 month eGFR between HIV patients initiated on TDF based regimen and non-TDF based regimen.ConclusionRenal function remained stable with no difference between HIV patients treated with TDF or non-TDF NNRTI based ART regimen over 12 months. However, older HIV patients and those with unsuppressed viral load deserve special focus on renal monitoring. Data on long-term safety of TDF (> 1 year) is still warranted in this population.

Efficacy and safety of Tenofovir Disoproxil Fumarate in Patients with Chronic Hepatitis B with High Baseline Viral Load

Background: Chronic hepatitis B virus infection is an important cause of morbidity and mortality. Tenofovir disoproxil fumarate was licensed for the treatment of hepatitis B virus infection. So, the current study aimed to Evaluate efficacy and outcome of Tenofovir Disoproxil Fumarate in patients with Chronic Hepatitis B with High Baseline Viral Load. Patients and methods:One hundred Chronic HBV patients attend Outpatient Clinic of HBV treatment unit, Qena fever hospital, Qena, Egyptwere enrolled in this study and treated with Tenofovir Disoproxil Fumarate (300mg/day) for 24 weeks. Patients categorized into two groups: Group A: included 50 chronic HBV patients with Low Viral load < 1 million/ml and Group B: included 50 chronic HBV patients with High Viral load ≥ 1 million/ml.virological and biochemical response, as well as safety outcomes were assessed after 24 weeks of treatment. Results:The mean age of patients was 38.4 years and 33.9 years in Group A and Group B respectively. Number of males was 32 (64%) and 36 (72%) in Group A and Group B respectively. HBeAg was positive in 20 % and 36 % in Group A and Group B respectively. The rates of complete virological suppression were 88% in group A and 72% in group B. All patients achevied normalization of ALT. No severe adverse events were reported during the present study. No elevations in creatinine level were detected. Conclusion: Tenofovir Disoproxil Fumarate is an efficacious, safe and well-tolerated treatment in an Egyptian patient.

Treatment with tenofovir disoproxil fumarate or entecavir in chronic hepatitis B virus-infected patients with renal impairment: results from a 7-year, multicentre retrospective cohort study.

SummaryBackgroundLimited data exist regarding tenofovir disoproxil fumarate (TDF) safety and effectiveness in chronic hepatitis B virus–infected (CHB) patients with renal impairment (RI).AimsTo compare real‐world data on renal safety and effectiveness of TDF vs entecavir (ETV) in CHB patients with moderate‐to‐severe RI.MethodsRetrospective, non‐interventional, cohort study analysing medical records for TDF/ETV‐treated CHB patients (54 European centres). Included patients experienced moderate‐to‐severe RI (creatinine clearance 20‐60 mL/min [Cockcroft‐Gault]) either before TDF/ETV initiation (‘before’ subgroup [baseline = treatment initiation]) or after TDF/ETV initiation (‘after’ subgroup [baseline = first RI occurrence]). The primary objective was TDF safety, particularly renal‐related adverse events of special interest (AESI). TDF and ETV safety and effectiveness were compared and multivariate analyses were performed using inverse probability treatment weighting.Results‘Before’ subgroup included 107 TDF‐ and 91 ETV‐treated patients; ‘after’ subgroup included 212 TDF‐ and 77 ETV‐treated patients. Mean baseline creatinine clearance was higher for TDF‐ vs ETV‐treated patients (both subgroups). Median follow‐up was 3.1 years (both treatments). AESI were more frequent with TDF vs ETV (‘before’: 18.7% vs 8.8%; ‘after’: 9.9% vs 3.9%); however, differences were not significant by multivariate analysis. Only TDF‐treated patients experienced renal tubular dysfunction (6.5% ‘before’; 1.9% ‘after’) as well as renal adverse events leading to treatment discontinuation (8.4% ‘before’; 7.1% ‘after’). Effectiveness was similar between treatments.ConclusionsOverall safety was similar for TDF vs ETV (both subgroups). Given that renal tubular dysfunction occurred with TDF and not with ETV, renal safety concerns may be greater with TDF in CHB patients with RI.

Renal safety of tenofovir disoproxil fumarate and entecavir with hepatitis B immunoglobulin in liver transplant patients.

Potent nucleos(t)ide analogues and hepatitis B immunoglobulin combinations are recommended after liver transplantation to prevent the recurrence of hepatitis B virus (HBV). Despite its proven efficacy, the renal safety of tenofovir disoproxil fumarate (TDF) has not been well established in liver transplant recipients. We aimed to assess the impacts of TDF and entecavir (ETV) on tubular and glomerular functions. We analysed 206 liver transplant patients treated with TDF (n=102) or ETV (n=104) plus hepatitis B immunoglobulin. Serum creatinine, phosphate and uric acid levels were measured. Proximal tubular dysfunction was defined as the presence of hypophosphatemia (<2mg/dL) and hypouricemia (<2mg/dL). Glomerular dysfunction was defined as an estimated glomerular filtration rate (eGFR) of <60mL/min/1.73m2 accompanied by a ≥25% eGFR decline from baseline. During a median follow-up of 42.5months, 48 patients developed proximal tubular dysfunction (30.4% and 16.3% in the TDF and ETV groups; P=.017). Serum levels of phosphate and uric acid were significantly lower in the TDF group post-LT. TDF (OR, 2.34; 95% CI, 1.16-4.69; P=.017) and low body mass index (OR, 2.11; 95% CI, 1.06-4.21; P=.034) were independent risk factors for proximal tubular dysfunction. The prevalence of glomerular dysfunction was not significantly different between the two groups (TDF 51.0% and ETV 54.8%; P=.582). TDF significantly increased the risk of proximal tubular dysfunction. Although the effect of TDF on glomerular function was comparable to that of ETV, glomerular dysfunction was common after liver transplant.

Nephrotoxicity of Antimicrobials and Antibiotics.

Medication-induced nephrotoxicity remains one of the most common causes of acute kidney injury (AKI) among hospitalized patients. Within the extensive group of medications associated with AKI, antibiotics and other antimicrobials are well recognized triggers of structural and functional renal impairment. Clinical manifestations range from mild forms of tubular injury to significant deterioration of kidney function requiring acute renal replacement therapy. Several mechanisms are described, although the most frequent are acute interstitial nephritis, acute tubular necrosis, intratubular crystal deposition, and proximal/distal tubulopathy with electrolyte wasting abnormalities. General risk factors for antimicrobial-induced AKI include pre-existing chronic kidney disease, and concomitant use of medication with nephrotoxic potential. Prevention and early recognition of AKI represent the standard approach to mitigate AKI and avoid morbidity.

Role of tenofovir disoproxil fumarate in prevention of perinatal transmission of hepatitis B virus from mother to child: a systematic review and meta-analysis.

Background/AimsTo prevent the perinatal transmission of hepatitis B virus (HBV) from mother to child, administration of an antiviral agent during pregnancy has been attempted in women who are either hepatitis B e antigen positive or have a high viral load. In this systematic review and meta-analysis with randomized controlled trials, we analyzed the efficacy and safety of tenofovir disoproxil fumarate (TDF) in preventing the perinatal transmission of HBV in pregnant women who have high HBV DNA titers.MethodsMultiple comprehensive databases (PubMed, EMBASE, and Cochrane databases) were searched for studies evaluating the efficacy of TDF for the prevention of perinatal transmission of HBV.ResultsTwo studies (one open label study and one double blind study) were included and analyzed. Intention-to-treat analysis (527 pregnancies) showed that the preventive effect of TDF was not significant (odds ratio [OR], 0.53; 95% confidence interval [CI], 0.13 to 2.17; p = 0.38, I2 = 81%). However, the per-protocol analysis showed that TDF significantly reduced perinatal transmission (OR, 0.10; 95% CI, 0.01 to 0.77; p = 0.03, I2 = 0%). There was no significant difference between the TDF group and the control group with respect to maternal and fetal safety outcomes.ConclusionsIn pregnant women who have high HBV DNA titers, TDF can reduce the perinatal transmission from mother to child without significant adverse events.

Tenofovir monotherapy versus tenofovir plus entecavir combination therapy in HBeAg-positive chronic hepatitis patients with partial virological response to entecavir.

The aim of this retrospective study was to compare the efficacy and safety of tenofovir disoproxil fumarate (TDF) monotherapy and TDF + entecavir (ETV) combination therapy for chronic hepatitis B (CHB) patients with the partial virological response (PVR) to ETV. CHB patients with PVR to ETV were switched to TDF monotherapy or TDF + ETV combination therapy. The primary efficacy outcome was a virological response (VR), and the secondary efficacy outcomes were hepatitis B e antigen (HBeAg) seroconversion and alanine aminotransferase (ALT) normalization. The primary safety outcomes were changes in serum creatinine and serum phosphorus levels. A total of 143 patients were investigated, including 63 patients in the TDF monotherapy group and 80 patients in the TDF + ETV combination therapy group. Baseline demographics and clinical characteristics were comparable between groups. The median age of patients was 44.5 years, and 76.2% of them were male. The VR rate in TDF + ETV group was higher than that of the TDF group at 48 weeks (88.8% vs 71.4%; P = .009). At 48 weeks, the HBeAg seroconversion rate of TDF + ETV group was higher than that of the TDF group (30% vs 15.9%; P = .049). There was no significant difference in the proportion of patients with elevated ALT in the TDF group and TDF + ETV group at 48 weeks (9.5% vs 7.5%; P = .665). After adjusting the treatment regimen, serum creatinine levels increased slightly and serum phosphorus level decreased slightly in both groups. TDF + ETV combination therapy for 48 weeks had a higher VR rate than TDF monotherapy in CHB patients with PVR to ETV.

Safety of tenofovir during pregnancy: early growth outcomes and hematologic side effects in HIV-exposed uninfected infants.

Intrauterine exposure to zidovudine-based combination antiretroviral therapy (cART) can cause severe anemia within the first weeks of life. Tenofovir disoproxil fumarate (TDF)-based regimens may have less hematologic side effects but may affect growth parameters. This study aimed to assess the safety of TDF for prevention of mother-to-child transmission (PMTCT) in HIV-exposed uninfected infants regarding early growth outcomes and hematologic side effects. Our retrospective observational cohort study included children born (n = 232) to HIV-infected mothers (n = 228) on cART. Blood counts were compared at birth, 4-6 weeks, and 3, 12 and 18 months of age. Growth parameters were measured at birth and 12 and 18 months of age. Data were analyzed according to treatment group (TDF and non-TDF cART regimes). The median hemoglobin (Hgb) was significantly lower in the non-TDF-based group at birth (15.4 g/dl vs. 16.9 g/dl; **p = 0.002) and at 4-6 weeks of age (9.9 g/dl vs. 10.4 g/dl; **p = 0.004). The mean corpuscular volume was higher in the non-TDF-based group (109 fl vs. 105 fl; ***p < 0.001) as well at 4-6 weeks (102 fl vs. 95 fl; ***p < 0.001). In the TDF-based group, a higher proportion of neutropenia (grade 2 and higher) compared to the non-TDF-group (21.4% vs. 11%; *p = 0.015) was observed at three months of age. This effect was transient. There was no difference in growth.Conclusions: TDF appears to have no major side effects in our cohort. Transient anemia was observed more commonly with non-TDF regimens. However, our research suggests a potential delayed effect of TDF on neutrophils at 3 months of age.What is Known:• TDF is suspected to affect the growth of HIV-exposed uninfected infants.• Non-TDF-based cART regimes for prevention of mother-to-child transmission of HIV often result in transient anemia in the infant.What is New:• TDF appears to have no major side effects regarding the growth of HIV-exposed uninfected infants.• Our research suggests a potential delayed effect of TDF on neutrophils at 3 months of age in these infants.

Efficacy and safety of tenofovir disoproxil fumarate in Chinese patients with chronic hepatitis B virus infection: A 2-year prospective study.

To date, a small number of studies concerning the effects and safety of tenofovir disoproxil fumarate (TDF) in Chinese individuals were conducted. In this study, we aimed to assess the antiviral effects and nephrotoxicity of TDF in Chinese patients with chronic hepatitis B virus (HBV) infection.Patients with chronic HBV infection were prospectively recruited and TDF treatment was given for 96 weeks. HBV serologic markers, HBV DNA, creatinine and phosphorus were collected.Fifty-seven treatment-naïve and 48 treatment-experienced patients were recruited. Irrespective of the prior treatment history, more than 95% of patients achieved virological response during 96 weeks treatment with TDF. Estimated glomerular filtration rate (eGFR) significantly declined in the first year of treatment in patients with chronic hepatitis B or younger age (<65 years old) (both P < .05), while that was not achieved in patients with liver cirrhosis or older age (≥65 years old) (both P > .05). For patients who were treatment-naïve or treated previously with adefovir dipivoxil, eGFR declined at the 48th week; however, eGFR was partially recovered at the 96th week. Furthermore, multivariable analysis showed that basal eGFR <90 mL/min/1.73 m (P = .001; odds ratio: 4.821; 95% confidence interval: 1.904-12.206) is the only independent risk factor for eGFR <90 mL/min/1.73 m at the 96th week.TDF has potent antiviral effect in both treatment-naïve and treatment-experienced patients.

Effectiveness of tenofovir and entecavir in nucleos(t)ide analogue-naive chronic hepatitis B: A protocol for systematic review and meta-analysis.

Background:Chronic hepatitis b (CHB) is a serious problem worldwide. Tenofovir disoproxil fumarate (TDF) and entecavir (ETV) both are first-line drugs for CHB, but there is debate about which is more appropriate in nucleos(t)ide analogue-naive CHB.Objective:To systematically evaluate the effectiveness and safety of tenofovir and ETV in nucleos(t)ide analogue-naive CHB.Methods:The Web of Science, PubMed, The Cochrane Library, EMBASE, Clinical Trials, and China National Knowledge Infrastructure databases will be electronically searched to collect randomized controlled trials regarding the comparison between tenofovir and ETV in nucleos(t)ide analogue-naive CHB since the date of database inception to July 2019. Two researchers independently screened and evaluated the obtained studies and extracted the outcome indexes. RevMan 5.3 software will be used for the meta-analysis.Result:We will provide practical and targeted results assessing the effectiveness and safety of TDF and ETV for nucleos(t)ide analogue-naive CHB patients, try to compare the advantages of TDF and ETV.Conclusion:The stronger evidence about the effectiveness and safety of TDF and ETV for nucleos(t)ide analogue-naive CHB patients will be provided for clinicians.Protocol registration number:PROSPERO CRD42019134194.

Long-term efficacy and safety of tenofovir disoproxil fumarate in Chinese patients with chronic hepatitis B: 5-year results

Background and aimLong-term treatment with tenofovir disoproxil fumarate (TDF) has demonstrated suppression of viral replication outside of China. This study aims to assess efficacy, resistance and safety of TDF for up to 240 weeks in Chinese patients with chronic hepatitis B virus (HBV) infection.MethodsPatients (HBeAg-positive or HBeAg-negative) who were randomised to receive TDF 300 mg or adefovir dipivoxil (ADV) 10 mg once daily in the 48-week double-blind phase (N = 498) were eligible to enter the open-label TDF phase (TDF–TDF and ADV–TDF groups) for additional 192 weeks.ResultsOverall, 457/512 (89.3%) randomised patients completed 240 weeks of treatment. Virological suppression was achieved in 84.5% and 87.9% in HBeAg-positive patients and 89.6% and 89.5% in HBeAg-negative patients in TDF–TDF and ADV–TDF groups, respectively, at week 240. The majority of patients from both groups had normalized alanine transaminase levels. More patients had HBeAg loss (41.7% vs. 36.4%) and HBeAg seroconversion (32.0% vs. 28.3%) in TDF–TDF than in ADV–TDF group, respectively. Only one HBeAg-positive patient in TDF–TDF group had HBsAg loss at week 240. No evidence of resistance to TDF was observed. The incidence of adverse events was similar in both groups (TDF–TDF, 56.4% vs. ADV–TDF, 51.6%). One patient had serum creatinine elevation ≥ 0.5 mg/dL above baseline, and three patients had confirmed grade 3/4 phosphorus abnormalities (< 2 mg/dL).ConclusionIn Chinese patients with chronic HBV, long-term treatment with TDF showed sustained viral suppression without development of resistance up to 240 weeks. No new safety concerns were found with TDF in this patient population.Clinical Trial Registration ClinicalTrial.gov Identifier NCT01300234; GSK Clinical Study Register 114648.

Efficacy and Safety of Tenofovir Disoproxil Fumarate in Treatment-Naïve Patients with Chronic Hepatitis B in Korea.

To evaluate the efficacy and safety of 144-week tenofovir disoproxil fumarate (TDF) therapy in treatment-naïve chronic hepatitis B (CHB) patients in Korean. In total, 579 treatment-naïve CHB patients at 11 medical centers were enrolled retrospective and prospective from September 2015 to January 2016 by design (NCT02533544). We evaluated the complete virologic response (CVR) rate and the renal safety of TDF. The overall CVR rate was 69.4%, 87.0%, and 89.7% at weeks 48, 96, and 144, respectively. In the HBeAg-positive CHB patients, the CVR rate at weeks 48, 96, and 144 was 61.4%, 83.1%, and 89.6%, respectively. The rates of HBeAg loss and seroconversion at weeks 48, 96, and 144 were 16.6%, 23.5%, 34.1%, and 7.6%, 8.9%, 13.3%, respectively. In HBeAg-negative CHB patients, the CVR rate at weeks 48, 96, and 144 was 82.5%, 93.2%, and 90.0%, respectively. The rate of alanine aminotransferase normalization was 36.9%, 45.4%, and 46.8% at weeks 48, 96, and 144, respectively. Of the CHB patients, 0.9% showed an elevated creatinine (> 0.5mg/dL from baseline). Age (≥ 60years) was significantly associated with a decline in renal function at week 144 (P < 0.0001). Comorbidities (diabetes or hypertension) showed the tendency to reduce renal function (P = 0.0624). Hepatocellular carcinoma developed in 10 (1.7%) patients and was related to cirrhosis. TDF therapy induced sustained viral suppression and had a favorable safety profile over a 3-year period. However, close monitoring of renal function should be mandatory in treating CHB patients receiving TDF, particularly older patients.

Comparison of the effect of tenofovir disoproxil fumarate and entecavir in the treatment of chronic hepatitis B with positive E antigen

Objective To compare the efficacy and safety of tenofovir disoproxil fumarate(TDF) and entecavir(ETV) in the treatment of chronic hepatitis B(CHB) with positive hepatitis B E antigen(HBeAg). Methods A total of 104 cases with newly diagnosed HBeAg positive CHB were selected and randomly divided into TDF group and ETV group, with 52 cases in each group.The TDF group was given 300mg/d TDF, and the ETV group was given 0.5mg/d ETV.All the patients were continuously treated for 12 months.The serum HBV DNA, HBeAg and ALT levels before and after treatment were compared between the two groups. Results Before treatment, there were no statistically significant differences in serum HBV DNA, HBeAg and ALT levels between the two groups (t=0.12, 1.51, 1.62, all P>0.05). The serum HBV DNA, HBeAg and ALT levels in the two groups were decreased after treatment, and the decrease of serum HBV DNA level in the TDF group was more significant than that in the ETV group, the difference was statistically significant(t=3.54, P 0.05). The total effective rate of the TDF group was 92.31%(48/52), which was significantly higher than 76.92%(40/52) in the ETV group (χ2=4.73, P 0.05). Conclusion TDF has better clinical effect in treating newly diagnosed HBeAg positive CHB than ETV due to TDF can inhibit HBV DNA replication significantly, but the safety of TDF and ETV is similar. Key words: Hepatitis B, chronic; Hepatitis B e antigens; Alanine transaminase; Deoxyribonucleases; Tenofovir; Entecavir; Drug therapy; Controlled Clinical trial

Efficacy of tenofovir disoproxil fumarate switch therapy in chronic hepatitis B patients with suboptimal response to adefovir‑based combination therapy

In the present study, the efficacy and safety of tenofovir disoproxil fumarate (TDF) switch therapy were assessed in patients with chronic hepatitis B exhibiting a suboptimal response to adefovir (ADV)-based combination therapy. First, the efficacy of the TDF switch therapy was retrospectively evaluated in 50 patients with chronic hepatitis B who failed to respond to ADV-based combination treatment. Among those, 48 patients with a median age of 35 years were hepatitis B e antigen (HBeAg)-positive and 17, 14 and 19 patients were previously treated with lamivudine (LAM) plus ADV, telbivudine plus ADV and entecavir (ETV) plus ADV, respectively. A total of 41 patients were treated with TDF alone and 9 with TDF plus ETV. The median time of follow-up was 102 weeks. The primary end-point was the cumulative probability of achieving a complete virologic response (CVR). The secondary end-points were the rate of alanine aminotransferase (ALT) normalization, HBeAg seroconversion in HBeAg-positive patients, and the plasma levels of creatinine and creatine kinase. The mean serum hepatitis B virus DNA levels prior to initiation of the TDF switch therapy were 4.8±1.6 log10IU/ml. The cumulative probability of achieving a VR at 24, 48, 96 and 108 weeks was 52.0, 76.0, 89.8 and 94.9%, respectively. The cumulative probability of normalization of ALT at 12, 24, 36, 48, 60,72, 84, 96, 108, 120 and 132 weeks was 34, 44, 50, 58, 66, 70, 74, 80, 90, 92 and 94%, respectively. HBeAg seroconversion was achieved in 5 patients. During the follow-up, 6 patients suffered from a virologic breakthrough, 3 patients failed to respond to the TDF treatment and the remaining patients were able to obtain VR following the continuation of TDF treatment. Slightly elevated serum levels of creatinine were observed in one patient, whereas creatine kinase activity did not increase in any of the subjects. In conclusion, TDF switch therapy is efficient and safe for patients with chronic hepatitis B with a suboptimal response to ADV-based combination therapy.

Risk of renal events during tenofovir disoproxil fumarate and entecavir antiviral prophylaxis in HBsAg-positive cancer patients undergoing chemotherapy.

The risk of renal events in HBsAg-positive cancer patients receiving tenofovir disoproxil fumarate (TDF) or entecavir (ETV) antiviral prophylaxis during chemotherapy has not been evaluated. This study aimed to evaluate the renal safety of TDF and ETV during chemotherapy. Consecutive, 219 HBsAg-positive cancer patients treated with TDF (n=106) or ETV (n=113) for antiviral prophylaxis during chemotherapy with baseline serum creatinine (SCr) <1.2mg/dL were retrospectively enrolled. Serial SCr levels and estimated glomerular filtration rate (eGFR) were monitored. The incidence of acute kidney injury (AKI) during antiviral prophylaxis was 33% and 38.9% in TDF and ETV groups, respectively (P=0.441), while the incidence of sustained kidney injury was 11.3% and 11.5%, respectively (P=1.000). By multivariate analysis, diuretics use (hazard ratio (HR)=2.011, P=0.042) and serum albumin levels (HR=0.441, P=0.001) were independent predictors of AKI; serum albumin levels (HR=0.252, P=0.002) was the only factor associated with sustained kidney injury; age (HR=2.752, P<0.001), baseline SCr levels (HR=3.386, P<0.001), and serum albumin levels (HR=0.437, P=0.001) were factors associated with a new eGFR <60mL/min. 34.9% of patients in TDF group and 35.4% in ETV group had deteriorated chronic kidney disease (CKD) stage at the end of follow-up, respectively. There were no significant differences in the risk of renal events or CKD stage migration between TDF and ETV groups. Renal events may develop in about one-third of HBsAg-positive cancer patients undergoing chemotherapy. The risk of renal function impairment was comparable between patients treated with TDF and ETV antiviral prophylaxis.

Tenofovir Versus Placebo to Prevent Perinatal Transmission of Hepatitis B

(N Engl J Med 2018;378:911–923) Despite vaccination and administration of hepatitis B immune globulin at birth, mother-to-child transmission of hepatitis B virus (HBV) can still occur, specifically in infants born to women who test positive of hepatitis B e antigen (HBeAg), have a high HBV viral load (&gt;200,000 IU/mL), or have a mutant HBV strain that escapes the vaccine or immune globulin. Antiviral agents like lamivudine, tenofovir disoproxil fumarate (TDF), and telbivudine have been used prophylactically in pregnant women with high HBV viral loads. However, the evidence on the relative benefits or harm of this intervention are limited or of low quality. Therefore, these authors present the results of a clinical trial, in which they assessed the efficacy and safety of TDF in the prevention of mother-to-child HBV transmission in pregnant women positive for HBeAg.

Effectiveness and Safety of Tenofovir Disoproxil Fumarate in Patients Treated for Hepatitis B in the National University Hospital of Cotonou

Introduction: Viral hepatitis B (VHB) is a serious and global public health issue, particularly in sub-Saharan Africa where it is endemic. The objective of this work was to evaluate the effectiveness and safety of tenofovir disoproxil fumarate (TDF) in the treatment of chronic VHB in Cotonou. Methods: This was a descriptive cross-sectional study with a retrospective collection of data from January 1st, 2015 to December 31st, 2016 (24 months) and prospective from May to August 2017 (4 months). Chronic VHB patients treated with TDF for at least 6 months were included. The non-detectability of HBV DNA and the normalization of aminotransferases defined the virological and biochemical responses, respectively. The evaluation of the treatment response on liver fibrosis was done by using APRI score. Renal impairment was assessed by a reduction in glomerular filtration rate according to MDRD (Modifications of the Diet in Renal Disease) formula below 90 mL/min/1.73 m2. Results: In all, 42 patients treated with TDF were included. The average age was 46.7 ± 13.8 years. The study population was predominantly male with a sex ratio of 2.5. Among the 42 patients treated with TDF for an average of 60 weeks (24 to 96 weeks), 36 patients (85.7%) had a virological response; 21 patients (50%) had a biochemical response. Virologic response was 70% at week 24 (W24), 92.6% at W48, 87.5% at W72 and 100% at W96 without significant difference between W24 and W48; between W48 and W72 then between W72 and W96. There was a regression of fibrosis and cirrhosis but not significantly. Renal involvement occurred in 3 out of 19 cases (15.8%) including a case of chronic end stage renal failure and 2 cases of mild chronic renal failure. Conclusion: The treatment with TDF is effective and globally safe in our patients with chronic viral hepatitis B in Cotonou.

Assessment of renal safety of tenofovir disoproxil fumarate in people living with HIV in Tunisia

Background: Tenofovir disoproxil fumarate (TDF) is a nucleotide reverse transcriptase inhibitor (NRTI). TDF is generally well tolerated. It is eliminated by the combination of glomerular filtration and active renal tubular secretion. Thus, it can be responsible, in the medium and long term, of renal toxicity. The aim of our study is to assess the prevalence of TDF nephrotoxicity and its factors risk in PLHIV treated in the Infectious Diseases Department at the University Hospital of Monastir, Tunisia..&#x0D; Methods: An observational cross-sectional single-centre prospective study included 62 cases of HIV-infected patients taking antiretroviral therapy (ART) containing TDF was conducted between 1st August 2016 and 31 December 2016 at Fattouma Bourguiba University Hospital of Monastir, in Tunisia. During this period, patients were screened for renal dysfunction to detect renal toxicity, Tubular dysfunction or Fanconi syndrome.&#x0D; Results: 62 patients were included with female/male ratio at 1,52. The mean age was 39 years ± 8,5 years. Half of the patients were treated with TDF as first-line therapy. The average duration of TDF was 25 months, the duration was greater than 12 months in 40 (65%) patients. There was a decrease in creatinine clearance in 21 (33.8%) patients, the average of the decrease was 128,6 ±35,8 ml/min Proximal tubulopathy was noted in 1 patient (1.6%) and no patient had Fanconi syndrome.&#x0D; No risk factors for renal impairment under TDF were found. This finding could be explained by the small sample size&#x0D; Conclusion: TDF-related renal toxicity is often asymptomatic, it require early detection. In ours patient cases, TD is rare, but creatinine clearance decrease is frequent and may inform of possible TD in these patient. In order to reduce TDFtoxicity, a new pro-drug, tenofovir alafenamide (TAF), is now available.

Assessment of renal safety of tenofovir disoproxil fumarate in people living with HIV in Tunisia

Background: Tenofovir disoproxil fumarate (TDF) is a nucleotide reverse transcriptase inhibitor (NRTI). TDF is generally well tolerated. It is eliminated by the combination of glomerular filtration and active renal tubular secretion. Thus, it can be responsible, in the medium and long term, of renal toxicity. The aim of our study is to assess the prevalence of TDF nephrotoxicity and its factors risk in PLHIV treated in the Infectious Diseases Department at the University Hospital of Monastir, Tunisia..&#x0D; Methods: An observational cross-sectional single-centre prospective study included 62 cases of HIV-infected patients taking antiretroviral therapy (ART) containing TDF was conducted between 1st August 2016 and 31 December 2016 at Fattouma Bourguiba University Hospital of Monastir, in Tunisia. During this period, patients were screened for renal dysfunction to detect renal toxicity, Tubular dysfunction or Fanconi syndrome.&#x0D; Results: 62 patients were included with female/male ratio at 1,52. The mean age was 39 years ± 8,5 years. Half of the patients were treated with TDF as first-line therapy. The average duration of TDF was 25 months, the duration was greater than 12 months in 40 (65%) patients. There was a decrease in creatinine clearance in 21 (33.8%) patients, the average of the decrease was 128,6 ±35,8 ml/min Proximal tubulopathy was noted in 1 patient (1.6%) and no patient had Fanconi syndrome.&#x0D; No risk factors for renal impairment under TDF were found. This finding could be explained by the small sample size&#x0D; Conclusion: TDF-related renal toxicity is often asymptomatic, it require early detection. In ours patient cases, TD is rare, but creatinine clearance decrease is frequent and may inform of possible TD in these patient. In order to reduce TDFtoxicity, a new pro-drug, tenofovir alafenamide (TAF), is now available.

Comparison between tenofovir disoproxil fumarate and entecavir treatment in real‐world clinical practice

SummaryBackground and aimsEntecavir (ETV) and tenofovir disoproxil fumarate (TDF) are effective as two first‐line anti‐viral therapies for chronic hepatitis B (CHB); however, data are limited on directly comparing the safety and effectiveness of these two antivirals. Hence, we compared the efficacy and safety of TDF and ETV on treatment‐naïve patients with CHB.MethodsWe performed a hospital‐based, retrospective cohort study of 257 treatment‐naïve patients with CHB receiving TDF (n = 79) or ETV (n = 178). Virological and biochemical response as well as nephrotoxicity were assessed between TDF and ETV treatment groups.ResultsAt month 12, TDF group had faster on HBV DNA complete suppression than ETV group (p = 0.001). Multivariate analysis indicated that treatment with TDF was a significant predictor of HBV DNA suppression (HR = 1.33; 95% CI = 1.01 – 1.76; p = 0.045). In addition, HBeAg positivity (HR = 0.70; 95% CI = 0.52 – 0.96; p = 0.025) and higher baseline HBV DNA level (HR = 0.84; 95% CI = 0.76 – 0.92; p &lt; 0.001) were significant negative predictors for viral suppression. The ALT normalization rate between these two treatment groups were similar (p = 0.114). TDF group had more populations in ≧ 20% decrease of eGFR MDRD at month 24 than ETV group (31.5% vs. 17.2%, p = 0.044), but only the baseline eGFR was the independent factor by multivariate analysis (OR = 1.05; 95% CI = 1.03 – 1.07; p &lt; 0.001).ConclusionsTDF was significantly more effective in achieving complete viral suppression beyond month 12, and there was no significance in nephrotoxicity than ETV group.Copyright © 2017, The Gastroenterological Society of Taiwan, The Digestive Endoscopy Society of Taiwan and Taiwan Association for the Study of the Liver.