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19 active trials for HBV

Specific Anti-HBV Vaccine Response After Vaccination in Patients Requiring Anti-CD20 Monoclonal Antibodies

Vaccination coverage against HBV in France is around 30% in the adult population. Treatment with anti-CD20 is associated with a risk of reactivation of hepatitis B or acute or fulminant hepatitis in first-infected patients. HBV vaccination is recommended as before any anti-CD20 treatment in unimmunized patients. However, there is no recommendation on which vaccination regimen to choose in patients on immunosuppressants / corticosteroids or with inflammatory or autoimmune disease. For patients who have a need for rapid immunosuppressive therapy, the use of a standard vaccination schedule (D0, M1, M6) would be responsible for a loss of chance vis-à-vis the underlying disease with a delay of more than 6 months to start treatment with anti-CD20. An accelerated regimen (D0, D7, D21 and M12) allows healthy adults to obtain very rapid vaccine protection between 77 and 90.8%. The accelerated regimen can also be considered on a case-by-case basis in those adults with neurological pathologies, systemic vasculitis or autoimmune disease and who need to receive anti-CD20 antibodies if the combination of injections over a short period is likely to promote immunization. The advantage of the accelerated regimen is to obtain 4 weeks, after the third dose of vaccine, anti-HBs antibodies at a protective level (> 10 IU / L) in approximately 77 to 90.8% of patients and in the general population. The booster injection at 12 months is essential for long-term protection.

Start: September 2020
Tenofovir Alafenamide in HBV Related Decompensated Liver

TAF is a new prodrug of tenofovir, specifically designed to achieve higher intracellular active drug concentration allowing for dosing of only 25 mg once daily and thus can potentially lower the already relatively low risk of renal toxicity and bone loss with TDF. However, such renal and bone complications with TDF may become more pronounced in decompensated CHB patients10. In the phase 3 trials11, 12, TAF had demonstrated a compatible antiviral effect (noninferior efficacy), and a higher rate of alanine aminotransferase (ALT) normalization to TDF. TAF also demonstrated an improved renal function and less bone loss compared to TDF. Therefore, TAF was approved as the first line therapy for CHB patients with compensated liver function. The lack of data regarding TAF therapy in decompensated CHB patients raised the concern of safety and efficacy of TAF in this group of patients. A small, single arm Phase 2 switch study (GS-US-320-4035; Study 4035; NCT03180619) which has enrolled 31 subjects with CPT scores ?7, either at time of screening or by history, who were virally suppressed on TDF and/or other oral antiviral agents is currently underway with favorable safety and efficacy results through 48 weeks.[Lim YS, Lin CY, Heo J, et al. EASL 2020, poster SAT442.] While Gilead Study 4035 will continue through 96 weeks of treatment, additional data in this population are thus needed, particularly in CHB patients who have decompensated liver disease and are not being treated and are viremic. Herein, we conduct the present study and aim to investigate the safety and efficacy of TAF in CHB patients with hepatic decompensation.

Start: September 2020
A Pilot Study Comparing the Immunogenicity of Fendrix vs. Double-dose Engerix B in HIV-infected Non-responders to Standard Hepatitis B Vaccination Courses

Hepatitis B virus (HBV) infection can result in a greater risk of adverse outcomes in HIV-infected individuals, including more rapid progression to cirrhosis and associated complications such as hepatocellular carcinoma. For this reason, as well as the shared routes of transmission between the two viruses, UK and International guidance recommends that all HBV-negative HIV-infected individuals be offered vaccination against HBV. Unfortunately, response rates in this population can be as low as 17.5 - 40% to standard vaccination courses. To improve this response, strategies such as the use of double dose of standard vaccines (e.g. Engerix B) is recommended in several guidelines for previous non-responders, although there is currently limited evidence for this approach. An alternative strategy is to use vaccines with novel adjuvants such as Fendrix and observational clinical data in the Investigators HIV cohort suggests that response rates can be as high as 81% of individuals achieving HBV surface antibody (HBsAb) levels >100 in a group that did not respond to previous standard HBV vaccine courses. However, the cost of Fendrix is considerably higher than Engerix B and controlled trials are required to confirm whether this approach is warranted. Furthermore, insights into the potential mechanisms by which Fendrix may elicit better responses would be valuable in optimising future vaccine strategies in this population. The Investigators propose to conduct a randomised, open label, active-controlled pilot study comparing double dose Engerix B and Fendrix in HIV-infected non-responders to standard HBV vaccine courses, which will provide the necessary data to design and power a larger multicentre randomised controlled trial. Outcome measures will include the proportion of individuals seroconverting with HBsAb levels >100 following each vaccination course, the magnitude and quality of the HBV-specific CD4+ T-cell responses elicited by each vaccine and the durability of the HBsAb response at 1 year following the end of vaccination.

Start: August 2015