HIV and Hepatitis B MedDRA version: 20.1 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.0 Level: PT Classification code 10019731 Term: Hepatitis B System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Descovy 200/10mg
Product Name: Descovy 200/10mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: emtricitabine
CAS Number: 143491-57-0
Concentration unit: mg milligram(s)
Conce
Sponsors
King's College Hospital NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Hepatitis B surface antigen positive •HIV positive •Established on stable antiretroviral therapy regimen containing daily TDF for over 12 months •Hepatitis B DNA =65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: •Age 75 years •eGFR < 30 mL/min •Evidence of disseminated malignancy •Women of child bearing potential not on approved effective contraception or practicing abstinence Effective protocol specified methods of birth control in this study are: - a combination of one hormonal method and one barrier method; - two barrier methods where one method is the male condom; - use of an intrauterine device (IUD) or tubal sterilisation; - true abstinence: when this is in line with the preferred and usual lifestyle of the subject. [Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods),declaration of abstinence for the duration of a trial, and withdrawal are not acceptable methods of contraception]. •Previously in receipt of TAF •Concomitant use of medicinal products containing lamivudine or adefovir dipivoxil used for the treatment of HBV infection •TAF is transported by P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP). Medicinal products that strongly affect P-gp activity and BCRP may lead to changes in TAF absorption. Patients with concomitant use of medicinal products that induce P-gp activity e.g., rifampicin, rifabutin will be excluded. •Previous documentation of K65R mutation on HIV resistance testing •Known hypersensitivity to TAF, its metabolites or to any of the excipients listed in the Summary of Product Characteristics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective: (i) Assessment of the feasibility of switching TDF to TAF in chronic HBV/HIV co-infected patients a. Assess recruitment rates b. Assess tolerability of switching TDF to TAF (ii) Assessment of the safety of switching TDF to TAF ;Secondary Objective: Secondary Objective(s): to provide preliminary evidence of efficacy for a larger randomised trial, with the purpose of: (i) Choosing the optimal primary outcome, and (ii) Estimating the parameters for sample size calculation. (a) The development of detectable HIV viraemia (HIV viral load = 40 copies/ml) (b) The development of detectable HBV viraemia (= 20IU/ml) (c) the impact on renal markers (eGFR and creatinine clearance) at 48 weeks (d) the impact on liver inflammation (change in ALT >2x baseline at any point during 48 weeks) (e) the impact on lipid levels (change in total cholesterol at 48 weeks) (f) the impact on serological markers of HBV (e-Antigen and surface antigen loss at 48 weeks) (g) impact on bone health (change in bone mineral density at 48 weeks) ;Primary end point(s): i) Assessment of the feasibility and tolerability of switching TDF to TAF: • consent rate (of all patients screened) • recruitment rate (of all patients consented) (ii) Assessment of the safety of switching TDF to TAF: • The development of any Serious Adverse Event (SAE), Serious Adverse Reaction (SAR) or Unexpected Serious Adverse Reaction (USAR) that is not pre-specified or is a known consequence of disease progression ;Timepoint(s) of evaluation of this end point: Week 48 Interim analysis at 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary objectives of the study are to provide preliminary evidence of efficacy for a potential larger randomised trial, with the purpose of: (i) Choosing the optimal primary outcome (ii) Estimating the parameters for sample size calculation. (a) The development of detectable HIV viraemia (HIV viral load = 40 copies/ml) (b) The development of detectable HBV viraemia (= 20IU/ml) (c) the impact on renal markers (eGFR and creatinine clearance) at 48 weeks (d) the impact on liver inflammation (change in ALT at 48 weeks) (e) the impact on lipid levels (change in total cholesterol at 48 weeks) (f) the impact on serological markers of HBV (e-Antigen and surface antigen loss at 48 weeks) (g) impact on bone health (change in bone mineral density at 48 weeks);Timepoint(s) of evaluation of this end point: Week 48 Interim analysis at week 24 | — |
Countries
United Kingdom
Contacts
Public ContactDr Kosh Agarwal
King's College Hospital NHS Foundation Trust
Outcome results
None listed