Entecavir Resistance-Associated Mutations in Chronic HBV Patients in Turkey (STREAM Study)
ConditionHepatitis B, Chronic
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorYaşar Bayındır, MD
About this trial
Chronic hepatitis B is a long-term viral infection that affects millions of people worldwide. Patients usually require lifelong antiviral treatment to control the virus and prevent liver damage.
Some older antiviral medications, such as lamivudine, can lead to the development of viral resistance. This means the virus changes in a way that makes certain treatments less effective. Even though newer drugs like entecavir are stronger and more resistant to these changes, previous exposure to lamivudine may increase the risk of developing additional resistance mutations.
By analyzing viral genetic material from blood samples using advanced sequencing technology, this research will help improve understanding of antiviral resistance patterns in patients with chronic hepatitis B in Turkey and may support better treatment decisions in the future.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
HBsAg positive
Group 1: Either treatment-naïve participants with HBV DNA>2000 IU/ml
Group 2: Prior lamivudine therapy ≥6 months with switch to ADVor TDF or TAF
Disqualifiers
Prior entecavir exposure
Prior telbivudine exposure
Age <18 years
Inability to provide informed consent Note: Previous adefovir or (pegylated) interferon use is not an exclusion criterion.
Trial population
Adult (≥18 years) HBsAg-positive patients with a documented history of lamivudine therapy for ≥6 months who were subsequently switched to tenofovir-based therapy (ADV, TDF, or TAF) and have not received entecavir or telbivudine.
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
Viral genetic material from blood samples using advanced sequencing technology
Diagnostic testNo intervention
Treatment groups
700 Participants
are divided into 2 treatment groupsGroup A: Treatment-Naïve Chronic HBV Patients1 intervention
Group B: Lamivudine-Experienced Chronic HBV Patients1 intervention
Trial outcomes
Primary outcomes
1
Prevalence of entecavir resistance-associated mutations in the HBV polymerase/RT region detected by Oxford Nanopore sequencing.
Detection of entecavir resistance-associated mutations (T184, S202, M250), with or without lamivudine resistance background mutations (L180M, M204V/I), in the HBV polymerase/RT region by Oxford Nanopore sequencing of peripheral blood-derived cccDNA. Mutations will be reported if detected at an allele frequency ≥5%.
Time frame
March 15th, 2026-March 15th, 2027Secondary outcomes
1
Comparison of mutations between two groups.
Comparison of mutation frequency between treatment-naïve and lamivudine-experienced patients. Comparison of mutation frequency between treatment-naïve and lamivudine-experienced patients. Comparison of mutation frequency between treatment-naïve and lamivudine-experienced patients.
Time frame
March 15th, 2026-March 15th, 20272
Association between HBV-DNA level and resistance-associated mutation presence.
Association between HBV-DNA level and resistance-associated mutation presence in all groups.
Time frame
March 15th, 2026-March 15th, 20273
Duration of lamivudine exposure and secondary mutations.
Association between duration of lamivudine exposure and secondary mutations.
Time frame
March 15th, 2026-March 15th, 20274
Classical lamivudine resistance mutations and their co-occurrence with ETV resistance mutations.
Detection of classical lamivudine resistance mutations (M204V/I, L180M) and their co-occurrence with ETV resistance mutations.
Time frame
March 15th, 2026-March 15th, 2027Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Yaşar Bayındır, MD
Lead sponsor
Guven Health Group
Sponsor institution
SOUTHEAST NEUROLOGY AND INFECTIOUS DISEASES SOCIETY
Collaborator
Source ClinicalTrials.gov