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. 2025 Jun 13;44(3):687-695.
doi: 10.5937/jomb0-56238.

Serum TNF-a and biomarkers levels after tenofovir therapy in patients with serum HBeAg-positive chronic hepatitis B

Xijie Lai  1 , Guosheng Gao  2 , Xiunong Jiang  1
Affiliations

Serum TNF-a and biomarkers levels after tenofovir therapy in patients with serum HBeAg-positive chronic hepatitis B

Xijie Lai et al. J Med Biochem. .

Abstract
in English, Serbian

Background: Chronic hepatitis B (CHB) remains a wide-spread and serious infectious disease, with its pathogenesis still not fully understood. Tenofovir Amibufenamide, a pro-drug of tenofovir, belongs to the class of nucleoside reverse transcriptase inhibitors and is used in the treatment of CHB. This study aimed to evaluate the efficacy and safety of Tenofovir Amibufenamide in treating HBeAg-positive CHB.

Methods: A total of 60 patients diagnosed with HBeAg-positive CHB were randomly assigned to two groups: an entecavir (ETV) group (0.5 mg) and a Tenofovir Amibufenamide (TMF) group (0.25 mg), with 30 patients in each. After 24 months of treatment, renal function (serum creatinine, glomerular filtration rate), liver function (ALT , AST , total bilirubin), and inflammatory markers (TNF-a levels) were measured to assess the antiviral efficacy and safety profiles of the two treatments.

Results: Patients in the TMF group exhibited smaller changes in serum creatinine and glomerular filtration rate, indicating less renal impairment compared to the ETV group. Furthermore, the TMF group demonstrated greater reductions in alanine aminotransferase (ALT) and total bilirubin (TBIL) levels, indicating superior improvement in liver function (P<0.05). TNF-a levels were significantly elevated in the ETV group, reflecting greater inflammatory activity, while the TMF group showed more controlled inflammation. Additionally, the TMF group experienced significantly lower hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), and HBV DNA levels, showing superior antiviral efficacy. The incidence of adverse reactions was lower in the TMF group (3.3%) compared to the ETV group (13.3%), although the difference was not statistically significant (P>0.05).

Conclusions: Tenofovir Amibufenamide demonstrated superior efficacy in improving liver function and reducing viral load in patients with HBeAg-positive CHB. Moreover, it had a minimal impact on renal function and presented a higher safety profile compared to entecavir. These findings suggest Tenofovir Amibufenamide as a promising alternative for the treatment of HBeAg-positive CHB.

Uvod: Hronični hepatitis B (CHB) i dalje predstavlja rasprostranjenu i ozbiljnu infektivnu bolest, čija patogeneza nije u potpunosti razjašnjena. Tenofovir amibufenamid, prekurzor tenofovira, pripada klasi inhibitora reverzne transkriptaze nukleozida i koristi se u lečenju CHB. Cilj ove studije bio je da se proceni efikasnost i bezbednost teno-fovir amibufenamida u lečenju HBeAg-pozitivnog CHB.

Metode: Ukupno 60 pacijenata sa dijagnozom HBeAg-pozitivnog CHB nasumično je podeljeno u dve grupe: grupa koja je primala entekavir (ETV) u dozi od 0,5 mg i grupa koja je primala tenofovir amibufenamid (TMF) u dozi od 0,25 mg, sa po 30 pacijenata u svakoj. Nakon 24 meseca terapije, procenjeni su parametri bubrežne funkcije (serum-ski kreatinin, glomerularna filtracija), funkcije jetre (ALT, AST, ukupni bilirubin) i inflamatorni markeri (nivoi TNF-a) kako bi se uporedila antivirusna efikasnost i bezbednosni profili dve terapije.

Rezultati: Pacijenti u TMF grupi imali su manje promene u nivoima serumskog kreatinina i glomerularnoj filtraciji, što ukazuje na manju bubrežnu disfunkciju u poređenju sa ETV grupom. Takođe, TMF grupa je pokazala veće smanjenje nivoa alanin aminotransferaze (ALT) i ukupnog biliru bina (TBIL), što ukazuje na superiorno poboljšanje funkcije jetre (P<0,05). Nivoi TNF-a bili su značajno povišeni u ETV grupi, što odražava veću inflamatornu aktivnost, dok je u TMF grupi upala bila bolje kontrolisana. Pored toga, u TMF grupi su zabeleženi značajno niži nivoi površinskog antigena hepatitisa B (HBsAg), antigena hepatitisa B e (HBeAg) i HBV DNK, što ukazuje na bolju antivirusnu efikasnost. Učestalost neželjenih reakcija bila je niža u TMF grupi (3,3%) u poređenju sa ETV grupom (13,3%), iako razlika nije bila statistički značajna (P>0,05).

Zaključak: Tenofovir amibufenamid je pokazao superiornu efikasnost u poboljšanju funkcije jetre i smanjenju virusnog opterećenja kod pacijenata sa HBeAg-pozitivnim CHB. Takođe, imao je minimalan uticaj na bubrežnu funkciju i povoljniji bezbednosni profil u poređenju sa entekavirom. Ovi nalazi ukazuju na to da tenofovir amibufenamid predstavlja obećavajuću alternativu za lečenje HBeAg-pozitivnog CHB.

Keywords: TNF-a; antiviral efficacy; chronic hepatitis B; entecavir; inflammatory markers; liver function; renal function; tenofovir amibufenamide.

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Conflict of interest statement

All the authors declare that they have no conflict of interest in this work.Conflict of Interest: The authors stated that they have no conflicts of interest regarding the publication of this article.

Figures

Figure 1
Figure 1. Changes in TC (A) and TG (B) levels before and after the patients were treated.
Figure 2
Figure 2. Changes in renal function-related indicators.
Figure 3
Figure 3. Changes in liver function of patients before and after different treatments.
((A): AST; (B): ALT; and (C): TBIL).
Note: ** suggested a great difference with P<0.01 to the ETV group
Figure 4
Figure 4. Variation in TNF-α level of patients.
Note: * and ** suggested a great difference with P<0.05 and P<0.01 to the ETV group, respectively
Figure 5
Figure 5. Variation of HBV-associated antigens and DNA.
((A): HBsAg; (B): HBeAg; and (C): HBV DNA).
Note: * and ** suggested a great difference with P<0.05 and P<0.01 to ETV group, respectively
See this image and copyright information in PMC

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