Tenofovir Alafenamide in the Treatment of Naïve Chronic Hepatitis B: A Single-Centre Retrospective Study

Abstract

Chronic hepatitis B (CHB) is a major global health problem affecting approximately 257 million people worldwide. Tenofovir alafenamide (TAF) is a new, effective antiviral drug for chronic hepatitis B. However, real-world data on the efficacy of TAF in treating naive patients are limited. This study aimed to evaluate TAF's efficacy in treating naive CHB patients. Factors associated with virological response and alanine aminotransferase (ALT) normalization were also analyzed in the study. The study included 41 treatment-naive CHB patients who started TAF between January 2021 and December 2022. Demographic, clinical, and laboratory data were collected at baseline and week 48. The primary endpoints were complete virologic response (CVR) and ALT normalization at week 48. At week 48, ALT and hepatitis B virus-deoxyribonucleic acid (HBV DNA) levels decreased to statistically significant levels (both p<0.001). CVR and ALT normalization were achieved in 73% and 76% of patients, respectively. Those who achieved CVR had a higher baseline hepatitis B surface antigen (HBsAg)/HBV DNA ratio than those who achieved partial virologic response (0.79 vs 0.4, p=0.012). ALT normalization was associated with lower baseline ALT and less advanced hepatic necroinflammation and steatosis. TAF provided effective virological suppression and ALT normalization in treatment-naive patients, and the baseline HBsAg/HBV DNA ratio was found to be a parameter predicting virological response. Milder basal necroinflammation and steatosis were significant in favor of ALT normalization, suggesting that TAF is an effective and safe treatment option for patients with CHB.

Keywords

• Chronic hepatitis B
• tenofovir alafenamide
• treatment-naive
• virological response
• ALT normalization

Naif Kronik Hepatit B Tedavisinde Tenofovir Alafenamid: Tek Merkezli Retrospektif Çalışma

Abstract

Kronik hepatit B (KHB), dünya çapında yaklaşık 257 milyon insanı etkileyen önemli bir küresel sağlık sorunudur. Tenofovir alafenamid (TAF), kronik hepatit B tedavisinde kullanılan yeni ve etkili bir antiviral ilaç olmakla birlikte tedaviye naif hastalarda TAF etkinliğine ilişkin gerçek dünya verileri sınırlıdır. Bu çalışmanın amacı, tedaviye naif KHB hastalarında TAF'ın etkinliğini değerlendirmektir. Virolojik yanıt ve alanin aminotransferaz (ALT) normalizasyonu ile ilişkili faktörler de çalışmada analiz edilmiştir. Çalışmaya Ocak 2021-Aralık 2022 tarihleri arasında TAF başlanan 41 tedavi naif KHB hastası dahil edilmiştir. Demografik, klinik ve laboratuvar verileri başlangıçta ve 48. haftada toplanmıştır. Birincil sonlanım noktaları tam virolojik yanıt (TVY) ve 48. haftada ALT normalizasyonu idi. 48. haftada ALT ve hepatit B virüsü-deoksiribonükleik asit (HBV DNA) düzeyleri istatiksel açıdan anlamlı olacak şekilde azalmıştır (her ikisi de p<0.001). Hastaların sırasıyla %73'ünde TVY ve %76'sında ALT normalizasyonu sağlanmıştır. TVY sağlananlarda kısmi virolojik yanıt sağlananlara kıyasla daha yüksek başlangıç hepatit B yüzey antijeni (HBsAg)/HBV DNA oranı vardı (0.79 vs 0.4, p=0.012). ALT normalizasyonunun daha düşük bazal ALT, daha az ilerlemiş hepatik nekroinflamasyon ve steatoz ile ilişkili olduğu görüldü. TAF, tedavi naif hastalarda etkili bir virolojik baskılama ve ALT normalizasyonu sağlamış olup; başlangıç HBsAg/HBV DNA oranı virolojik yanıtı öngören bir parametre olarak tespit edilmiştir. Daha hafif bazal nekroinflamasyon ve steatoz ise ALT normalizasyonu lehine anlamlı bulunmuş, TAF'ın KHB hastaları için etkili ve güvenli bir tedavi seçeneği olduğu düşünülmüştür.

Keywords

• Kronik hepatit B
• tenofovir alafenamid
• tedaviye naif
• virolojik yanıt
• ALT normalizasyonu

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