Bepirovirsen for HIV and Hepatitis B
(B-Focus Trial)
Recruiting in Palo Alto (17 mi)
+46 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: GlaxoSmithKline
Must be taking: Antiretrovirals
Must not be taking: Immunosuppressants, Interferons, Anticoagulants, others
Disqualifiers: Liver cirrhosis, Hepatocellular carcinoma, others
Prior Safety Data
Trial Summary
What is the purpose of this trial?This study will evaluate the efficacy and safety of bepirovirsen compared to placebo in participants with human immunodeficiency virus (HIV)/hepatitis B virus (HBV) co-infection.
Do I have to stop taking my current medications for this trial?
You must continue your current antiretroviral therapy (ART) with tenofovir and lamivudine or emtricitabine. Some medications, like immunosuppressants and anticoagulants, may need to be stopped. The protocol does not specify a washout period for other medications.
What data supports the idea that Bepirovirsen for HIV and Hepatitis B is an effective drug?
The available research shows that Bepirovirsen is effective in reducing the levels of hepatitis B virus in the body. In a study, participants with chronic hepatitis B who were given Bepirovirsen experienced a significant reduction in the virus compared to those who received a placebo. Specifically, those who received a higher dose of 300 mg showed a notable decrease in the virus levels. This suggests that Bepirovirsen could be a promising option for treating hepatitis B, especially for those who have not responded well to other treatments. Additionally, Bepirovirsen was found to be safe, with most side effects being mild or moderate, such as reactions at the injection site.
12345What safety data is available for Bepirovirsen in treating HIV and Hepatitis B?
Bepirovirsen has been evaluated in phase 2 trials for chronic Hepatitis B. The studies indicate that Bepirovirsen has a favorable safety profile, with most treatment-emergent adverse events being mild to moderate, such as injection site reactions. Transient, self-resolving alanine aminotransferase flares were observed in some participants. The safety data suggests that Bepirovirsen is generally well-tolerated, warranting further investigation in larger patient populations.
12367Is the drug Bepirovirsen a promising treatment for HIV and Hepatitis B?
Yes, Bepirovirsen is a promising drug for treating Hepatitis B. It has shown the ability to significantly reduce the levels of the virus in the body, which is important for managing the disease. It also has a good safety profile, meaning it is generally safe for patients to use.
12347Eligibility Criteria
This trial is for people who have both HIV and chronic Hepatitis B. Specific details about eligibility criteria are not provided, but typically participants must meet certain health standards and may be required to follow specific protocols related to their conditions.Inclusion Criteria
Cluster of differentiation 4 (CD4) count >=350 cells/Cubic Millimeters (mm3)
Documented evidence of at least 2 plasma HIV-1 Ribonucleic acid (RNA) measurements <50 copies/mL are required in the 12 months prior to Screening: 1 within 6 to 12 months prior to screening and 1 within 6 months prior to Screening
Plasma or serum HBV DNA concentration must be adequately suppressed, defined as plasma or serum HBV DNA <90 IU/mL
+4 more
Exclusion Criteria
I can stop my blood thinner or anti-platelet medication safely for the study.
I have or might have liver cirrhosis or liver cancer.
I have or might have Hepatitis D.
+14 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive bepirovirsen or placebo for the study duration
24 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
36 weeks
Participant Groups
The study is testing the effectiveness and safety of a medication called bepirovirsen compared to a placebo in individuals with both HIV and chronic Hepatitis B virus infection.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Participants receiving BepirovirsenExperimental Treatment1 Intervention
Participants will receive bepirovirsen.
Group II: Participants receiving PlaceboPlacebo Group1 Intervention
Participants will receive placebo.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
GSK Investigational SiteOrlando, FL
GSK Investigational SiteHillsborough, NJ
GSK Investigational SiteBakersfield, CA
GSK Investigational SiteWest Palm Beach, FL
More Trial Locations
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Who Is Running the Clinical Trial?
GlaxoSmithKlineLead Sponsor
References
B-Clear Phase 2b Study Design: Establishing the Efficacy and Safety of Bepirovirsen in Patients with Chronic Hepatitis B Virus Infection. [2023]Bepirovirsen (GSK3228836) is an antisense oligonucleotide that induced rapid and prolonged hepatitis B surface antigen (HBsAg) reduction with a favorable safety profile following 4 weeks of treatment in participants with chronic hepatitis B virus (HBV) infection. The objective of the phase 2b study B-Clear is to access the efficacy and safety of bepirovirsen in participants with chronic HBV infection.
Safety, tolerability and antiviral activity of the antisense oligonucleotide bepirovirsen in patients with chronic hepatitis B: a phase 2 randomized controlled trial. [2022]Chronic infection with hepatitis B virus (HBV) leads to an increased risk of death from cirrhosis and hepatocellular carcinoma. Functional cure rates are low with current treatment options (nucleos(t)ide analogs (NAs) and pegylated interferons). Bepirovirsen is an antisense oligonucleotide targeting all HBV messenger RNAs; in cell culture and animal models, bepirovirsen leads to reductions in HBV-derived RNAs, HBV DNA and viral proteins. This phase 2 double-blinded, randomized, placebo-controlled trial is the first evaluation of the safety and activity of an antisense oligonucleotide targeting HBV RNA in both treatment-naïve and virally suppressed individuals with chronic HBV infection. The primary objective was to assess the safety and tolerability of bepirovirsen in individuals with chronic hepatitis B (CHB) (NCT02981602). The secondary objective was to assess antiviral activity, including the change from baseline to day 29 in serum hepatitis B surface antigen (HBsAg) concentration. Participants with CHB infection ≥6 months and serum HBsAg ≥50 IU ml-1 were enrolled from seven centers across Hong Kong and the Republic of Korea and randomized (3:1 within each dose cohort) to receive bepirovirsen or placebo via subcutaneous injection twice weekly during weeks 1 and 2 (days 1, 4, 8 and 11) and once weekly during weeks 3 and 4 (days 15 and 22). Participants were then followed for 26 weeks. Twenty-four participants were treatment-naïve and seven were receiving stable NA therapy. Treatment-emergent adverse events were mostly mild/moderate (most commonly injection site reactions). Eleven (61.1%) and three (50.0%) treatment-naïve participants experienced one or more treatment-emergent adverse event in the bepirovirsen and placebo groups, respectively. In participants receiving NA therapy, the corresponding numbers were three (60.0%) and one (50.0%). Transient, self-resolving alanine aminotransferase flares (≥2× upper limit of normal) were observed in eight treatment-naïve participants and three participants on stable NA regimens in the bepirovirsen treatment arms. HBsAg reductions were observed and were significant versus placebo for treatment-naïve participants receiving bepirovirsen 300 mg (P = 0.001), but not for the bepirovirsen 150 mg group (P = 0.245) or participants receiving stable NA therapy (P = 0.762). Two participants in each of the 300 mg dose groups achieved HBsAg levels below the lower limit of quantitation by day 29 (n = 3) or day 36 (n = 1). Bepirovirsen had a favorable safety profile. These preliminary observations warrant further investigation of the safety and activity of bepirovirsen in a larger CHB patient population.
Efficacy and Safety of Bepirovirsen in Chronic Hepatitis B Infection. [2023]Bepirovirsen is an antisense oligonucleotide that targets all hepatitis B virus (HBV) messenger RNAs and acts to decrease levels of viral proteins.
Efficacy and safety of adefovir dipivoxil plus pegylated interferon-alpha2a for the treatment of lamivudine-resistant hepatitis B virus infection in HIV-infected patients. [2018]Up to 10% of the HIV-positive population is coinfected with hepatitis B virus (HBV). Generally, combined treatment includes agents against both viruses, such as lamivudine (3TC). However, HBV resistance to 3TC is high. Adefovir dipivoxil (ADV) has shown its efficacy for treating 3TC-resistant (3TC-R) HBV in HIV-coinfected patients. ADV combined with pegylated interferon (PEG-IFN) has never been evaluated in this population.
Telbivudine exhibits no inhibitory activity against HIV-1 clinical isolates in vitro. [2021]Most approved drugs with activity against hepatitis B virus (HBV) have activity against human immunodeficiency virus type 1 (HIV-1), which precludes their use in patients who are coinfected with HBV and HIV-1 and who are not receiving antiretroviral therapy due to the risk of inducing resistance. The activity of telbivudine, a highly selective HBV inhibitor, against temporally and geographically distinct wild-type and multidrug-resistant HIV-1 clinical isolates was evaluated in vitro. No inhibition was observed with up to 600 muM drug, which supports further exploration of telbivudine as a therapeutic option for the treatment of HBV infections in patients coinfected with HIV-1.
Real-world effectiveness and safety of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C: AMBER study. [2022]Virologic and safety outcomes of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin (OBV/PTV/r ± DSV ± RBV) therapy have shown high sustained virologic response (SVR) rates and good tolerability in most patient populations in pre-registration studies.
Efficacy and Safety of Besifovir Dipivoxil Maleate Compared With Tenofovir Disoproxil Fumarate in Treatment of Chronic Hepatitis B Virus Infection. [2020]Besifovir dipivoxil maleate (BSV) has activity against hepatitis B virus (HBV). We performed a phase 3 study to compare the antiviral efficacy and safety of BSV vs tenofovir disoproxil fumarate (TDF) in patients with chronic HBV infection in Korea.