Sebnem SENOL, Ufuk SÖNMEZ, Tuna DEMİRDAL, Pınar ŞEN, Deniz TÜRK, Sabri ATALAY, Deniz AKYOL, Çiğdem MERMUTLUOĞLU, Mustafa Kemal ÇELEN, Tansu YAMAZHAN, Hüsnü PULLUKÇU

İmmünsüpresif hastalarda HBV reaktivasyonunun önlenmesi için tenofovir alafenamid profilaksisi: çok merkezli bir çalışma

Amaç: İmmünsupresif tedavi altındaki yüksek riskli hastalarda hepatit B reaktivasyonu antiviral profilaksi ile önlenebilir. Antiviral seçiminde entekavir (ETC) veya tenofovir disoproksil fumarat (TDF) uzun zamandır kullanılabilmekteyken yakın zamanda kullanıma giren tenofovir alafenamid (TAF) güvenli yan etki profili ile iyi bir alternatif olmuştur. Bu çok merkezli geniş hasta sayılı çalışmada immünsüpresif hasta grubunda tenofovir alafenamidin (TAF) etkinliği ve güvenliği araştırılmıştır. Gereç ve Yöntem: Altı eğitim ve araştırma hastanesinin 1 Ocak 2019- 30 Eylül 2021 arasındaki kayıtları retrospektif olarak incelenerek immünsüpresif tedavi altında iken hepatit B için antiviral profilaksi başlanan ve en az 6 ay süre ile takip edilen hastalar çalışmaya dahil edilmiştir. Aldıkları immünsüpresif tedavi veya kemoterapiye ayrıca hepatit B serolojilerine göre risk grupları belirlenmiş, hepatit B reaktivasyon varlığı ve yan etkileri yönünden incelenmiştir. Bulgular: Yaş ortalaması 62.5±29 yıl olan 148 hastanın 85’i (%57.4) TAF, 63’ü (%42.6) tenofovir disoproksil fumarate (TDF) veya entekavir (ETC) ile profilaksi almaktaydı. %83.1’i HBsAg (-) antiHBc (+) %16.9’u HBsAg (+) olarak bulundu; kronik HBV’li hastaların %36 sının HBV DNA’sı saptanabilir düzeyin üzerindeydi. Çoğu (%69.6) hematolojik bir malinite nedeni ile immünsüpresif alırken %89.2’sinin aldığı tedavi yüksek riskli ilaç grubunda idi. Riskler açısından TAF ve diğer tedavileri alanlar arasında farklılık yoktu. Tedavi gruplarının hiçbirinde reaktivasyon ya da yan etkiye rastlanmadı. Sonuç: Kronik HBV tedavisinde olduğu gibi immünsüpresif tedavi alan bireylerde HBV reaktivasyonunun önlenmesinde de TAF en az TDF ve ETC kadar etkindir. TDF nin böbrek ve kemik yan etkilerinin TAF da görülmemesinin etkin ve güvenli bu tedavi seçeneğini immünsüpresif hastalarda öne çıkaracağını düşünmekteyiz.

Anahtar Kelimeler:

tenofovir alafenamid, Hepatit B / önlem ve kontrol, immunsüpresif ajanlar

Tenofovir alafenamid prophylaxis for the prevention of HBV reactivation in immunosuppressed subjects: a multicenter study

Purpose: Reactivation of hepatitis B may be prevented by antiviral therapy in immunosuppressed high risk patients. Entecavir (ETC) and tenofovir disoproksil fumarat (TDF) have been used for a long time and recently introduced tenofovir alafenamid (TAF) seems to be a good alternative with rare side effects. This multicentered study with a large patient population aimed to investigate the effectiveness of tenofovir alafenamid (TAF) in immunsuppressed subjects. Materials and Methods: The records of six training and research hospitals between January 1, 2019 and September 30, 2021 were retrospectively reviewed, and patients who were started antiviral prophylaxis for hepatitis B and followed up for at least 6 months while under immunosuppressive therapy were included in the study. Risk groups were determined according to the immunosuppressive treatment or chemotherapy they received, as well as hepatitis B serology, and were examined in terms of the presence of hepatitis B reactivation and its side effects. Results: The mean age of patients was found as 62.5±29. Out of 148 patients, 85 (57.4%) received TAF, 63 (42.6%) received either Entecavir (ETC) or tenofovir disoproksil fumarat (TDF). The majority (83.1%) was found as HBsAg (-) antiHBc (+) and 16.9% was HBsAg (+). HBV DNA was traced in 36% of chronic HBV patients. Most of the patients (69.6%) were receiving immunospuppressives for treatment of a haematologic malignancy and 89.2% was in the high risk treatment group. There was no difference between TAF and the other drugs in terms of risks. Reactivation was not seen in any of the treatment groups. Conclusion: TAF is as effective as TDF and ETC when used for prophylaxis in immunosuppressed HBV patients. Side effects on kidney and bone are not seen in TAF treatment groups which will probably play a role in preferring this new drug.

Keywords:

tenofovir alafenamide, Hepatitis B / prevention & control, Immunosuppressive Agents,

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