Regression of cirrhosis during treatment with tenofovir disoproxil fumarate for chronic hepatitis B: a 5-year open-label follow-up study

Seto

et al. 2018

Aliment Pharmacol Ther

SummaryBackgroundSafety profile of nucleos(t)ide analogues is an important issue in view of its widespread use for decades in patients with chronic hepatitis B (CHB).AimTo review and evaluate the latest evidence on the safety profiles of the six approved nucleoside analogues.MethodsRelevant articles related to nucleoside analogue safety were selected for review following extensive language‐ and date‐unrestricted, electronic searches of the literature.ResultsNephrotoxicity has been well reported in patients receiving older generations of nucleotide analogues, namely adefovir dipivoxil and tenofovir disoproxil fumarate (TDF). Yet risks of renal failure and renal replacement therapy were similar in patients treated with nucleoside analogues versus nucleotide analogues in real‐life setting. Bone toxicity is closely related to nucleoside analogue effect on renal proximal tubular and phosphaturia. Real‐life data demonstrated increased risk of hip fracture in patients receiving adefovir but not TDF. The newly approved tenofovir alafenamide (TAF) has improved renal and bone safety profiles compared to TDF. Long‐term use of nucleoside analogues eg entecavir does not increase the risk of other cancers. Muscular toxicity may be seen in telbivudine‐treated patients so regular monitoring is advised. Peripheral neuropathy and lactic acidosis are rare adverse events. Latest international guidelines support the use of TDF, telbivudine and lamivudine during pregnancy; breastfeeding is not contraindicated during TDF therapy.ConclusionsLong‐term safety profile of nucleoside analogues is now better defined with more data from large real‐life cohorts and clinical trials with long‐term follow‐up. The new nucleotide analogue, TAF is now available with favourable renal and bone safety profiles.

mentioning

confidence: 99%

Review article: long‐term safety of oral anti‐viral treatment for chronic hepatitis B

Seto

et al. 2018

Aliment Pharmacol Ther

Molecular and Clinical Oncology

“…Recently, a newer generation of oral antivirals with higher antiviral potency, such as entecavir and tenofovir, have become available. Studies on immunocompetent patients with CHB demonstrated that the cumulative incidence of antiviral resistance for naïve patients was 1.2% to entecavir and 0% to tenofovir up to 5 years (31,32). A non-randomized study from China (33) demonstrated that prophylactic therapy with entecavir (n=34) was associated with significantly lower rates of hepatitis (5.9 vs. 27.0%, P=0.007), hepatitis B reactivation (0 vs. 12.4%, P=0.024) and disruption of chemotherapy (5.9 vs. 20.2%, P= 0.042) as compared with the lamivudine group (n=89).…”

Section: Discussionmentioning

confidence: 99%

Analysis of baseline hepatitis B virus DNA levels in chronic hepatitis B patients with non-hematological malignancies prior to the initiation of cancer chemotherapy

Young

Wei

Lin

et al. 2016

Abstract. Reactivation of hepatitis B virus (HBV) infectionis common (~20-50%) during cancer chemotherapy. Baseline HBV replication status is an important risk factor for HBV reactivation. To date, data on the baseline HBV DNA level for chronic hepatitis B (CHB) patients prior to chemotherapy, particularly for non-hematological malignancies, are limited. A total of 105 consecutive CHB patients with solid tumors who received prophylactic antiviral therapy prior to chemotherapy from November, 2011 to December, 2014, were enrolled in this study. The patients' tumors included: Breast cancer (37.1%), lung cancer (18.1%), colon cancer (17.1%), head and neck cancer (10.5%), other gastrointestinal tract malignancies (8.6%), gynecological cancer (4.8%) and others (3.8%). The mean age of the enrolled patients was 55.2±1.1 years, 48 of the patients were male, 3 were hepatitis B e antigen-positive, and 26.7% had abnormal alanine aminotransferase (ALT) levels at baseline. The median HBV DNA level measured by quantitative polymerase chain reaction assay prior to chemotherapy was 3.30 log 10 IU̸ml and 49.5% of the enrolled patients had a baseline HBV DNA level >2,000 IU̸ml. A wide range of HBV distribution was found: <20 IU̸ml (15.2%), 20≤DNA<2,000 IU̸ml (35. 3%), 2 , 0 0 0 ≤ D N A< 2 0, 0 0 0 I U̸ m l (2 6. 6%), 20,000≤DNA<106 IU̸ml (17.2%) and <10 6 IU̸ml (5.7%). Age and baseline ALT level were not strongly associated with virological activity. The mean HBV DNA and the percentage of patients with HBV DNA >2,000 IU̸ml were comparable between different cancer groups. Quantitative HBsAg level was a major determinant of baseline HBV DNA, and a significant correlation was noted between log 10 hepatitis B surface antigen and log 10 HBV DNA levels (γ=0.641, P<0.001). Our study demonstrated a wide distribution of baseline HBV DNA level among CHB patients diagnosed with non-hematological malignancies. Of note, approximately half of the patients (i.e., those with HBV DNA >2,000 IU̸ml) had a higher risk of HBV reactivation if no appropriate antiviral prophylaxis was undertaken.

Bangladesh J Child Health

“…28,34 Five year survival is 25% without therapy & 85% with therapy. 33 Tenofovir was also found to be safe duringpregnancy as pregnancy category B.…”

Section: Treatment Of Chb Goals Of Treatmentmentioning

confidence: 99%

Management of Chronic Hepatitis B in Childhood: A Comprehensive Guideline

Rukunuzzaman

Karim

Nurullah

et al. 2017