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Study to Evaluate the Safety and Efficacy of Switching to Tenofovir Alafenamide (TAF) From Tenofovir Disoproxil Fumarate (TDF) and/or Other Oral Antiviral Treatment (OAV)
Phase 2 trial testing TAF in Chronic Hepatitis B in 124 participants. Completed in 4 September 2020.
| Lead sponsor | Gilead Sciences |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 124 |
| Start date | 29 June 2017 |
| Primary completion | 27 March 2019 |
| Estimated completion | 4 September 2020 |
| Sites | 30 locations across Hong Kong, New Zealand, Italy, Taiwan, United Kingdom, South Korea, Canada, United States |
Gilead Sciences — full company profile →
18 and older, any sex, with Chronic Hepatitis B. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The percentage of participants with HBV DNA \< 20 IU/mL at Week 24 was determined by the Missing = Failure (M = F) approach.
| Group | Value | 95% CI |
|---|---|---|
| Part A (Renal Impairment): Moderate or Severe Renal Impairment | 97.4 | |
| Part A (Renal Impairment): End Stage Renal Disease | 100.0 | |
| Part B: Hepatic Impairment | 100.0 |
Treatment-emergent AEs were defined as: * Any AEs with an onset date on or after the study drug start date and no later than the study drug stop date + 3 days after permanent discontinuation of study drug; * Any AEs with onset date on or after the study drug start date for those who have not permanently discontinued study drug; * Any AEs leading to premature discontinuation of study drug. The most severe graded AE from all tests was counted for each participant.
| Group | Value | 95% CI |
|---|---|---|
| Part A (Renal Impairment): Moderate or Severe Renal Impairment | 53.8 | |
| Part A (Renal Impairment): End Stage Renal Disease | 73.3 | |
| Part B: Hepatic Impairment | 54.8 |
| Group | Value | 95% CI |
|---|---|---|
| Part A (Renal Impairment): Moderate or Severe Renal Impairment | 6.4 | |
| Part A (Renal Impairment): End Stage Renal Disease | 13.3 | |
| Part B: Hepatic Impairment | 6.5 |
Graded treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from baseline at any postbaseline visit, up to and including the date of last dose of study drug + 3 days for participants who permanently discontinued study drug or the last available date in the database snapshot for participants who were on treatment at the time of the analysis. The most severe graded abnormality from all tests was counted for each participant.
| Group | Value | 95% CI |
|---|---|---|
| Part A (Renal Impairment): Moderate or Severe Renal Impairment | 96.2 | |
| Part A (Renal Impairment): End Stage Renal Disease | 100.0 | |
| Part B: Hepatic Impairment | 90.3 |
| Group | Value | 95% CI |
|---|---|---|
| Part A (Renal Impairment): Moderate or Severe Renal Impairment | 11.5 | |
| Part A (Renal Impairment): End Stage Renal Disease | 46.7 | |
| Part B: Hepatic Impairment | 48.4 |
Treatment-emergent AEs were defined as: Any AEs with an onset date on or after the study drug start date and no later than the study drug stop date + 3 days after permanent discontinuation of study drug; Any AEs with onset date on or after the study drug start date for those who have not permanently discontinued study drug; Any AEs leading to premature discontinuation of study drug. The most severe graded AE from all tests was counted for each participant.
| Group | Value | 95% CI |
|---|---|---|
| Part A (Renal Impairment): Moderate or Severe Renal Impairment | 71.8 | |
| Part A (Renal Impairment): End Stage Renal Disease | 86.7 | |
| Part B: Hepatic Impairment | 71.0 |
| Group | Value | 95% CI |
|---|---|---|
| Part A (Renal Impairment): Moderate or Severe Renal Impairment | 15.4 | |
| Part A (Renal Impairment): End Stage Renal Disease | 20.0 | |
| Part B: Hepatic Impairment | 12.9 |
Treatment-emergent AEs were defined as: Any AEs with an onset date on or after the study drug start date and no later than the study drug stop date + 3 days after permanent discontinuation of study drug; Any AEs with onset date on or after the study drug start date for those who have not permanently discontinued study drug; Any AEs leading to premature discontinuation of study drug. The most severe graded AE from all tests was counted for each participant.
| Group | Value | 95% CI |
|---|---|---|
| Part A (Renal Impairment): Moderate or Severe Renal Impairment | 74.4 | |
| Part A (Renal Impairment): End Stage Renal Disease | 100.0 | |
| Part B: Hepatic Impairment | 77.4 |
| Group | Value | 95% CI |
|---|---|---|
| Part A (Renal Impairment): Moderate or Severe Renal Impairment | 17.9 | |
| Part A (Renal Impairment): End Stage Renal Disease | 26.7 | |
| Part B: Hepatic Impairment | 25.8 |
Graded treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from baseline at any postbaseline visit, up to and including the date of last dose of study drug + 3 days for participants who permanently discontinued study drug or the last available date in the database snapshot for participants who were on treatment at the time of the analysis. The most severe graded abnormality from all tests was counted for each participant.
| Group | Value | 95% CI |
|---|---|---|
| Part A (Renal Impairment): Moderate or Severe Renal Impairment | 96.2 | |
| Part A (Renal Impairment): End Stage Renal Disease | 100.0 | |
| Part B: Hepatic Impairment | 90.3 |
| Group | Value | 95% CI |
|---|---|---|
| Part A (Renal Impairment): Moderate or Severe Renal Impairment | 12.8 | |
| Part A (Renal Impairment): End Stage Renal Disease | 40.0 | |
| Part B: Hepatic Impairment | 41.9 |
| Group | Value | 95% CI |
|---|---|---|
| Part A (Renal Impairment): Moderate or Severe Renal Impairment | 0 | |
| Part A (Renal Impairment): End Stage Renal Disease | 26.7 | |
| Part B: Hepatic Impairment | 9.7 |
Graded treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from baseline at any post-baseline visit, up to and including the date of last dose of study drug + 3 days for participants who permanently discontinued study drug or the last available date in the database snapshot for participants who were on treatment at the time of the analysis. The most severe graded abnormality from all tests was counted for each participant.
| Group | Value | 95% CI |
|---|---|---|
| Part A (Renal Impairment): Moderate or Severe Renal Impairment | 96.2 | |
| Part A (Renal Impairment): End Stage Renal Disease | 100.0 | |
| Part B: Hepatic Impairment | 100.0 |
| Group | Value | 95% CI |
|---|---|---|
| Part A (Renal Impairment): Moderate or Severe Renal Impairment | 15.4 | |
| Part A (Renal Impairment): End Stage Renal Disease | 46.7 | |
| Part B: Hepatic Impairment | 41.9 |
| Group | Value | 95% CI |
|---|---|---|
| Part A (Renal Impairment): Moderate or Severe Renal Impairment | 1.3 | |
| Part A (Renal Impairment): End Stage Renal Disease | 26.7 | |
| Part B: Hepatic Impairment | 12.9 |
GFR is a measure of the rate at which blood is filtered by the kidney. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. eGFRcg = (140 - age in years) x (body weight in kg) x (0.85 if female) divided by 72 x serum creatinine in mg/dL. Moderate renal impairment= 30 mL/min ≤ eGFRCG ≤ 59 mL/min Severe renal impairment= 15 mL/min ≤ eGFRCG \< 30 mL/min Change from baseline was calculated as the value at Week 24 minus the value at Baseline.
| Group | Value | 95% CI |
|---|---|---|
| Part A (Renal Impairment): Moderate or Severe Renal Impairment | -0.4 | -3.9 – 4.5 |
| Part B: Hepatic Impairment | 1.9 | -5.6 – 12.2 |
GFR is a measure of the rate at which blood is filtered by the kidney. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. eGFRcg = (140 - age in years) x (body weight in kg) x (0.85 if female) divided by 72 x serum creatinine in mg/dL. Moderate renal impairment= 30 mL/min ≤ eGFRCG ≤ 59 mL/min Severe renal impairment= 15 mL/min ≤ eGFRCG \< 30 mL/min Change from baseline was calculated as the value at Week 48 minus the value at Baseline.
| Group | Value | 95% CI |
|---|---|---|
| Part A (Renal Impairment): Moderate or Severe Renal Impairment | -0.5 | -4.1 – 3.0 |
| Part B: Hepatic Impairment | 1.2 | -13.5 – 6.5 |
GFR is a measure of the rate at which blood is filtered by the kidney. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. eGFRcg = (140 - age in years) x (body weight in kg) x (0.85 if female) divided by 72 x serum creatinine in mg/dL. Moderate renal impairment= 30 mL/min ≤ eGFRCG ≤ 59 mL/min Severe renal impairment= 15 mL/min ≤ eGFRCG \< 30 mL/min Change from baseline was calculated as the value at Week 96 minus the value at Baseline.
| Group | Value | 95% CI |
|---|---|---|
| Part A (Renal Impairment): Moderate or Severe Renal Impairment | 1.0 | -2.8 – 4.5 |
| Part B: Hepatic Impairment | -2.4 | -11.4 – 10.7 |
Percent change = Change from baseline at a postbaseline visit/baseline \* 100%.
| Group | Value | 95% CI |
|---|---|---|
| Part A (Renal Impairment): Moderate or Severe Renal Impairment | 0.135 | ± 1.8348 |
| Part A (Renal Impairment): End Stage Renal Disease | 0.322 | ± 2.1835 |
| Part B: Hepatic Impairment | 0.322 | ± 2.5105 |
Percent change = Change from baseline at a postbaseline visit/baseline \* 100%.
| Group | Value | 95% CI |
|---|---|---|
| Part A (Renal Impairment): Moderate or Severe Renal Impairment | 0.565 | ± 2.6160 |
| Part A (Renal Impairment): End Stage Renal Disease | -1.075 | ± 3.6355 |
| Part B: Hepatic Impairment | -0.221 | ± 3.0158 |
Time frame: Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Part A (Renal Impairment):… | Part A (Renal Impairment):… | Part B (Hepatic Impairment… |
|---|---|---|---|---|
| Cataract | Eye disorders | — | — | — |
| Pneumonia | Infections and infestations | — | — | — |
| Hepatic encephalopathy | Nervous system disorders | — | — | — |
| Ischaemic stroke | Nervous system disorders | — | — | — |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — | — | — |
| Atrial flutter | Cardiac disorders | — | — | — |
| Atrioventricular block complete | Cardiac disorders | — | — | — |
| Deafness neurosensory | Ear and labyrinth disorders | — | — | — |
| Adrenal mass | Endocrine disorders | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — |
| Ascites | Gastrointestinal disorders | — | — | — |
| Colitis | Gastrointestinal disorders | — | — | — |
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | — | — | — |
| Gingival bleeding | Gastrointestinal disorders | — | — | — |
| Intestinal obstruction | Gastrointestinal disorders | — | — | — |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | — | — | — |
| Catheter site discharge | General disorders | — | — | — |
| Bile duct stone | Hepatobiliary disorders | — | — | — |
| Hepatic failure | Hepatobiliary disorders | — | — | — |
| Hepatorenal syndrome | Hepatobiliary disorders | — | — | — |
| Bacteraemia | Infections and infestations | — | — | — |
| Fungal cystitis | Infections and infestations | — | — | — |
| Lower respiratory tract infection | Infections and infestations | — | — | — |
| Reaction | System | Part A (Renal Impairment):… | Part A (Renal Impairment):… | Part B (Hepatic Impairment… |
|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — |
| Nasopharyngitis | Infections and infestations | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Pyrexia | General disorders | — | — | — |
| Bone density decreased | Investigations | — | — | — |
| Ascites | Gastrointestinal disorders | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — |
| Insomnia | Psychiatric disorders | — | — | — |
| Hypertension | Vascular disorders | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — |
| Toothache | Gastrointestinal disorders | — | — | — |
| Urinary tract infection | Infections and infestations | — | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — | — |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | — | — | — |
| Dizziness | Nervous system disorders | — | — | — |
| Haematuria | Renal and urinary disorders | — | — | — |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — |
| Dental caries | Gastrointestinal disorders | — | — | — |
| Flatulence | Gastrointestinal disorders | — | — | — |
| Haemorrhoids | Gastrointestinal disorders | — | — | — |
| Portal hypertensive gastropathy | Gastrointestinal disorders | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — |
| Fatigue | General disorders | — | — | — |
| Oedema peripheral | General disorders | — | — | — |
| Conjunctivitis | Infections and infestations | — | — | — |
| Pneumonia | Infections and infestations | — | — | — |
| Blood bilirubin increased | Investigations | — | — | — |
| Blood creatinine increased | Investigations | — | — | — |
| Hyperkalaemia | Metabolism and nutrition disorders | — | — | — |
| Hyperlipidaemia | Metabolism and nutrition disorders | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — |
| Headache | Nervous system disorders | — | — | — |
| Chronic kidney disease | Renal and urinary disorders | — | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Productive cough | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | — | — | — |
Most-reported serious reactions: Cataract, Pneumonia, Hepatic encephalopathy, Ischaemic stroke, Pleural effusion, Anaemia, Thrombocytopenia, Atrial flutter.
Data from ClinicalTrials.gov NCT03180619 adverse events section.
The primary objective of this study is to evaluate the safety and tolerability and virologic response of tenofovir alafenamide (TAF) in virologically suppressed chronic hepatitis B participants with renal and/or hepatic impairment.
4 peer-reviewed publications reference this trial (live from Europe PMC):
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