Trial Outcomes & Findings for A Direct obserVed therApy vs fortNightly CollEction Study for HCV Treatment - ADVANCE HCV Study (NCT NCT03236506)

Last Updated: 2021-11-18

Results Overview

SVR12 of participants in the directly observed therapy (DOT), fortnightly pick-up or fortnightly pick-up with a psychological adherence intervention group. SVR12 was measured by viral load of hepatitis c virus (HCV) in participant's blood at least 12 weeks after end of treatment. A viral load of less than 10IU/ml indicates no active infection and SVR12 has been achieved.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

129 participants

Primary outcome timeframe

24 weeks for genotype 1 HCV, 20 weeks for genotype 3 HCV infection

Results posted on

2021-11-18

Participant Flow

135 participants were recruited. 6 withdrew by choice prior to randomisation. One randomised participant had to be withdrawn prior to starting treatment due to elevated Alanine Aminotransferase (ALT) levels, over the limit for inclusion in this study. Hence 128 participants who initiated treatment.

Participant milestones

Participant milestones
Measure	Daily Observed Therapy Patients with active hepatitis C infection genotype 1 will receive 12 weeks treatment with Zepatier at one tablet per day. Patients with active hepatitis C infection genotype 3 will receive 8 weeks treatment with Zepatier pill plus Sofosbuvir pill at one of each tablets per day. These tablets will be given to patients on a daily, observed basis by either the nurse or a community pharmacist. Zepatier Pill: Drugs will be given to participants to treat hepatitis C infection Sofosbuvir Pill: Drugs will be given along with Zepatier to participants to treat genotype 3hepatitis C infection	Fortnightly Pick-up Patients with active hepatitis C infection genotype 1 will receive 12 weeks treatment with Zepatier at one tablet per day. Patients with active hepatitis C infection genotype 3 will receive 8 weeks treatment with Zepatier pill plus Sofosbuvir pill at one of each tablets per day. These tablets will be given to patients on a fortnightly basis by the nurse. Zepatier Pill: Drugs will be given to participants to treat hepatitis C infection Sofosbuvir Pill: Drugs will be given along with Zepatier to participants to treat genotype 3hepatitis C infection	Fortnightly Pick-up +Psych Intervention Patients with active hepatitis C infection genotype 1 will receive 12 weeks treatment with Zepatier at one tablet per day. Patients with active hepatitis C infection genotype 3 will receive 8 weeks treatment with Zepatier pill plus Sofosbuvir pill at one of each tablets per day. These tablets will be given to patients on a fortnightly basis by the nurse. In addition, this group will receive a one-off interview with the researcher to complete a psychological intervention designed to improve adherence to the medication regimen. Zepatier Pill: Drugs will be given to participants to treat hepatitis C infection Psychological intervention: Participants randomised to fortnightly pick-up with psychological intervention will have an interview with the study nurse designed to aid their compliance with the drug regimen. During the intervention participants will be guided by their trial nurse in the completion of a personalised booklet, "Hepatitis C and Me". The booklet uses the principles of node-link mapping to structure the intervention. Sofosbuvir Pill: Drugs will be given along with Zepatier to participants to treat genotype 3hepatitis C infection
Overall Study STARTED	39	42	47
Overall Study COMPLETED	33	37	40
Overall Study NOT COMPLETED	6	5	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Daily Observed Therapy Patients with active hepatitis C infection genotype 1 will receive 12 weeks treatment with Zepatier at one tablet per day. Patients with active hepatitis C infection genotype 3 will receive 8 weeks treatment with Zepatier pill plus Sofosbuvir pill at one of each tablets per day. These tablets will be given to patients on a daily, observed basis by either the nurse or a community pharmacist. Zepatier Pill: Drugs will be given to participants to treat hepatitis C infection Sofosbuvir Pill: Drugs will be given along with Zepatier to participants to treat genotype 3hepatitis C infection	Fortnightly Pick-up Patients with active hepatitis C infection genotype 1 will receive 12 weeks treatment with Zepatier at one tablet per day. Patients with active hepatitis C infection genotype 3 will receive 8 weeks treatment with Zepatier pill plus Sofosbuvir pill at one of each tablets per day. These tablets will be given to patients on a fortnightly basis by the nurse. Zepatier Pill: Drugs will be given to participants to treat hepatitis C infection Sofosbuvir Pill: Drugs will be given along with Zepatier to participants to treat genotype 3hepatitis C infection	Fortnightly Pick-up +Psych Intervention Patients with active hepatitis C infection genotype 1 will receive 12 weeks treatment with Zepatier at one tablet per day. Patients with active hepatitis C infection genotype 3 will receive 8 weeks treatment with Zepatier pill plus Sofosbuvir pill at one of each tablets per day. These tablets will be given to patients on a fortnightly basis by the nurse. In addition, this group will receive a one-off interview with the researcher to complete a psychological intervention designed to improve adherence to the medication regimen. Zepatier Pill: Drugs will be given to participants to treat hepatitis C infection Psychological intervention: Participants randomised to fortnightly pick-up with psychological intervention will have an interview with the study nurse designed to aid their compliance with the drug regimen. During the intervention participants will be guided by their trial nurse in the completion of a personalised booklet, "Hepatitis C and Me". The booklet uses the principles of node-link mapping to structure the intervention. Sofosbuvir Pill: Drugs will be given along with Zepatier to participants to treat genotype 3hepatitis C infection
Overall Study Death	1	1	1
Overall Study Withdrawal by Subject	3	3	4
Overall Study Did not initiate treatment	2	1	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Daily Observed Therapy n=39 Participants Patients with active hepatitis C infection genotype 1 will receive 12 weeks treatment with Zepatier at one tablet per day. Patients with active hepatitis C infection genotype 3 will receive 8 weeks treatment with Zepatier pill plus Sofosbuvir pill at one of each tablets per day. These tablets will be given to patients on a daily, observed basis by either the nurse or a community pharmacist. Zepatier Pill: Drugs will be given to participants to treat hepatitis C infection Sofosbuvir Pill: Drugs will be given along with Zepatier to participants to treat genotype 3hepatitis C infection	Fortnightly Pick-up n=42 Participants Patients with active hepatitis C infection genotype 1 will receive 12 weeks treatment with Zepatier at one tablet per day. Patients with active hepatitis C infection genotype 3 will receive 8 weeks treatment with Zepatier pill plus Sofosbuvir pill at one of each tablets per day. These tablets will be given to patients on a fortnightly basis by the nurse. Zepatier Pill: Drugs will be given to participants to treat hepatitis C infection Sofosbuvir Pill: Drugs will be given along with Zepatier to participants to treat genotype 3hepatitis C infection	Fortnightly Pick-up +Psych Intervention n=47 Participants Patients with active hepatitis C infection genotype 1 will receive 12 weeks treatment with Zepatier at one tablet per day. Patients with active hepatitis C infection genotype 3 will receive 8 weeks treatment with Zepatier pill plus Sofosbuvir pill at one of each tablets per day. These tablets will be given to patients on a fortnightly basis by the nurse. In addition, this group will receive a one-off interview with the researcher to complete a psychological intervention designed to improve adherence to the medication regimen. Zepatier Pill: Drugs will be given to participants to treat hepatitis C infection Psychological intervention: Participants randomised to fortnightly pick-up with psychological intervention will have an interview with the study nurse designed to aid their compliance with the drug regimen. During the intervention participants will be guided by their trial nurse in the completion of a personalised booklet, "Hepatitis C and Me". The booklet uses the principles of node-link mapping to structure the intervention. Sofosbuvir Pill: Drugs will be given along with Zepatier to participants to treat genotype 3hepatitis C infection	Total n=128 Participants Total of all reporting groups
Age, Continuous	36.2 years STANDARD_DEVIATION 8.20 • n=39 Participants	35.7 years STANDARD_DEVIATION 7.33 • n=42 Participants	37.7 years STANDARD_DEVIATION 7.53 • n=47 Participants	36.6 years STANDARD_DEVIATION 7.67 • n=128 Participants
Sex: Female, Male Female	10 Participants n=39 Participants	11 Participants n=42 Participants	15 Participants n=47 Participants	36 Participants n=128 Participants
Sex: Female, Male Male	29 Participants n=39 Participants	31 Participants n=42 Participants	32 Participants n=47 Participants	92 Participants n=128 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	39 participants n=39 Participants	42 participants n=42 Participants	47 participants n=47 Participants	128 participants n=128 Participants
Living Situation Owned/rented	24 Participants n=39 Participants	24 Participants n=42 Participants	31 Participants n=47 Participants	79 Participants n=128 Participants
Living Situation Supported accommodation (drug related)	1 Participants n=39 Participants	3 Participants n=42 Participants	2 Participants n=47 Participants	6 Participants n=128 Participants
Living Situation Homeless	13 Participants n=39 Participants	13 Participants n=42 Participants	12 Participants n=47 Participants	38 Participants n=128 Participants
Living Situation Other	1 Participants n=39 Participants	2 Participants n=42 Participants	2 Participants n=47 Participants	5 Participants n=128 Participants
Source of income Unemployed on government benefit	20 Participants n=39 Participants	23 Participants n=42 Participants	30 Participants n=47 Participants	73 Participants n=128 Participants
Source of income Unemployed on government benefit and at least one other source of income	18 Participants n=39 Participants	15 Participants n=42 Participants	14 Participants n=47 Participants	47 Participants n=128 Participants
Source of income Casual work and government benefit	1 Participants n=39 Participants	1 Participants n=42 Participants	0 Participants n=47 Participants	2 Participants n=128 Participants
Source of income No government benefit but other source of income	0 Participants n=39 Participants	3 Participants n=42 Participants	3 Participants n=47 Participants	6 Participants n=128 Participants
Alcohol consumption None	32 Participants n=39 Participants	33 Participants n=42 Participants	37 Participants n=47 Participants	102 Participants n=128 Participants
Alcohol consumption Between 1-20 units	5 Participants n=39 Participants	8 Participants n=42 Participants	8 Participants n=47 Participants	21 Participants n=128 Participants
Alcohol consumption Over 20 units	2 Participants n=39 Participants	1 Participants n=42 Participants	2 Participants n=47 Participants	5 Participants n=128 Participants
Drug injecting history Injected within last week	27 Participants n=39 Participants	28 Participants n=42 Participants	33 Participants n=47 Participants	88 Participants n=128 Participants
Drug injecting history Injected within last month	4 Participants n=39 Participants	8 Participants n=42 Participants	6 Participants n=47 Participants	18 Participants n=128 Participants
Drug injecting history Injected within last 3 months	8 Participants n=39 Participants	6 Participants n=42 Participants	8 Participants n=47 Participants	22 Participants n=128 Participants

PRIMARY outcome

Timeframe: 24 weeks for genotype 1 HCV, 20 weeks for genotype 3 HCV infection

Outcome measures

Outcome measures
Measure	Daily Observed Therapy n=33 Participants Patients with active hepatitis C infection genotype 1 will receive 12 weeks treatment with Zepatier at one tablet per day. Patients with active hepatitis C infection genotype 3 will receive 8 weeks treatment with Zepatier pill plus Sofosbuvir pill at one of each tablets per day. These tablets will be given to patients on a daily, observed basis by either the nurse or a community pharmacist. Zepatier Pill: Drugs will be given to participants to treat hepatitis C infection Sofosbuvir Pill: Drugs will be given along with Zepatier to participants to treat genotype 3hepatitis C infection	Fortnightly Pick-up n=37 Participants Patients with active hepatitis C infection genotype 1 will receive 12 weeks treatment with Zepatier at one tablet per day. Patients with active hepatitis C infection genotype 3 will receive 8 weeks treatment with Zepatier pill plus Sofosbuvir pill at one of each tablets per day. These tablets will be given to patients on a fortnightly basis by the nurse. Zepatier Pill: Drugs will be given to participants to treat hepatitis C infection Sofosbuvir Pill: Drugs will be given along with Zepatier to participants to treat genotype 3hepatitis C infection	Fortnightly Pick-up +Psych Intervention n=40 Participants Patients with active hepatitis C infection genotype 1 will receive 12 weeks treatment with Zepatier at one tablet per day. Patients with active hepatitis C infection genotype 3 will receive 8 weeks treatment with Zepatier pill plus Sofosbuvir pill at one of each tablets per day. These tablets will be given to patients on a fortnightly basis by the nurse. In addition, this group will receive a one-off interview with the researcher to complete a psychological intervention designed to improve adherence to the medication regimen. Zepatier Pill: Drugs will be given to participants to treat hepatitis C infection Psychological intervention: Participants randomised to fortnightly pick-up with psychological intervention will have an interview with the study nurse designed to aid their compliance with the drug regimen. During the intervention participants will be guided by their trial nurse in the completion of a personalised booklet, "Hepatitis C and Me". The booklet uses the principles of node-link mapping to structure the intervention. Sofosbuvir Pill: Drugs will be given along with Zepatier to participants to treat genotype 3hepatitis C infection
Comparison of Sustained Viral Response at 12 Weeks Post Treatment (SVR12) in the Three Treatment Groups. SVR test positive for virus	3 Participants	5 Participants	3 Participants
Comparison of Sustained Viral Response at 12 Weeks Post Treatment (SVR12) in the Three Treatment Groups. SVR test negative for virus	30 Participants	32 Participants	37 Participants

SECONDARY outcome

Timeframe: 12 weeks for genotype 1 HCV, 8 weeks for genotype 3 HCV infection

Adherence of daily directly observed therapy group from daily logs Adherence measured by counting tablets returned after each 2 week treatment period (fortnightly pickup groups) Adherence of participants infected with genotype 3 and treated with Sovaldi measured using medication event monitoring system (MEMS®) cap.

Outcome measures

Outcome measures
Measure	Daily Observed Therapy n=39 Participants Patients with active hepatitis C infection genotype 1 will receive 12 weeks treatment with Zepatier at one tablet per day. Patients with active hepatitis C infection genotype 3 will receive 8 weeks treatment with Zepatier pill plus Sofosbuvir pill at one of each tablets per day. These tablets will be given to patients on a daily, observed basis by either the nurse or a community pharmacist. Zepatier Pill: Drugs will be given to participants to treat hepatitis C infection Sofosbuvir Pill: Drugs will be given along with Zepatier to participants to treat genotype 3hepatitis C infection	Fortnightly Pick-up n=42 Participants Patients with active hepatitis C infection genotype 1 will receive 12 weeks treatment with Zepatier at one tablet per day. Patients with active hepatitis C infection genotype 3 will receive 8 weeks treatment with Zepatier pill plus Sofosbuvir pill at one of each tablets per day. These tablets will be given to patients on a fortnightly basis by the nurse. Zepatier Pill: Drugs will be given to participants to treat hepatitis C infection Sofosbuvir Pill: Drugs will be given along with Zepatier to participants to treat genotype 3hepatitis C infection	Fortnightly Pick-up +Psych Intervention n=47 Participants Patients with active hepatitis C infection genotype 1 will receive 12 weeks treatment with Zepatier at one tablet per day. Patients with active hepatitis C infection genotype 3 will receive 8 weeks treatment with Zepatier pill plus Sofosbuvir pill at one of each tablets per day. These tablets will be given to patients on a fortnightly basis by the nurse. In addition, this group will receive a one-off interview with the researcher to complete a psychological intervention designed to improve adherence to the medication regimen. Zepatier Pill: Drugs will be given to participants to treat hepatitis C infection Psychological intervention: Participants randomised to fortnightly pick-up with psychological intervention will have an interview with the study nurse designed to aid their compliance with the drug regimen. During the intervention participants will be guided by their trial nurse in the completion of a personalised booklet, "Hepatitis C and Me". The booklet uses the principles of node-link mapping to structure the intervention. Sofosbuvir Pill: Drugs will be given along with Zepatier to participants to treat genotype 3hepatitis C infection
Adherence as Assessed by the Total Percentage of Tablets Taken (Out of Those Dispensed) During the Treatment Period	69 percentage of medication taken Standard Deviation 0.32	96 percentage of medication taken Standard Deviation 0.09	98 percentage of medication taken Standard Deviation 0.05

SECONDARY outcome

Timeframe: Not applicable. Not part of study data set.

Population: Data not collected.

Hepatitis C viral load by polymerase chain reaction (PCR) analysis. Any participants testing positive for reinfection post SVR12. This data will no longer be collected as part of this study and will be collected as part of standard clinical care.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Bloods collected at baseline, end of treatment and 12 weeks post end of treatment

Population: Viral resistance would be tested for in instances where a positive HCV blood test at the SVR12 stage could not be explained by non-adherence to medication. No participants met this criteria.

Profiles of the HCV viral resistance proteins, NS5a and NS3 in participants who did not achieve SVR12, for reasons other than non-adherence to treatment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At three timepoints; time zero (before treatment), time 2-8 weeks (during treatment) time 12 weeks (at the end of treatment)

Population: Toxicological analysis of participant's urine for potential interacting illicit drugs would be tested for in instances where a positive HCV blood test at the SVR12 stage could not be explained by non-adherence to medication. No participants met this criteria.

Drug misuse history and urine toxicology to test for potential illicit drug interactions with the treatment in participants who did not achieve SVR12 for reasons that are not non-adherence to treatment.

Outcome measures

Outcome data not reported

Adverse Events

Daily Observed Therapy

Serious events: 6 serious events

Other events: 8 other events

Deaths: 1 deaths

Fortnightly Pick-up

Serious events: 9 serious events

Other events: 10 other events

Deaths: 1 deaths

Fortnightly Pick-up +Psych Intervention

Serious events: 8 serious events

Other events: 6 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Daily Observed Therapy n=39 participants at risk Patients with active hepatitis C infection genotype 1 will receive 12 weeks treatment with Zepatier at one tablet per day. Patients with active hepatitis C infection genotype 3 will receive 8 weeks treatment with Zepatier pill plus Sofosbuvir pill at one of each tablets per day. These tablets will be given to patients on a daily, observed basis by either the nurse or a community pharmacist. Zepatier Pill: Drugs will be given to participants to treat hepatitis C infection Sofosbuvir Pill: Drugs will be given along with Zepatier to participants to treat genotype 3hepatitis C infection	Fortnightly Pick-up n=42 participants at risk Patients with active hepatitis C infection genotype 1 will receive 12 weeks treatment with Zepatier at one tablet per day. Patients with active hepatitis C infection genotype 3 will receive 8 weeks treatment with Zepatier pill plus Sofosbuvir pill at one of each tablets per day. These tablets will be given to patients on a fortnightly basis by the nurse. Zepatier Pill: Drugs will be given to participants to treat hepatitis C infection Sofosbuvir Pill: Drugs will be given along with Zepatier to participants to treat genotype 3hepatitis C infection	Fortnightly Pick-up +Psych Intervention n=47 participants at risk Patients with active hepatitis C infection genotype 1 will receive 12 weeks treatment with Zepatier at one tablet per day. Patients with active hepatitis C infection genotype 3 will receive 8 weeks treatment with Zepatier pill plus Sofosbuvir pill at one of each tablets per day. These tablets will be given to patients on a fortnightly basis by the nurse. In addition, this group will receive a one-off interview with the researcher to complete a psychological intervention designed to improve adherence to the medication regimen. Zepatier Pill: Drugs will be given to participants to treat hepatitis C infection Psychological intervention: Participants randomised to fortnightly pick-up with psychological intervention will have an interview with the study nurse designed to aid their compliance with the drug regimen. During the intervention participants will be guided by their trial nurse in the completion of a personalised booklet, "Hepatitis C and Me". The booklet uses the principles of node-link mapping to structure the intervention. Sofosbuvir Pill: Drugs will be given along with Zepatier to participants to treat genotype 3hepatitis C infection
Reproductive system and breast disorders Menorrhagia	0.00% 0/39 • 31 months Recorded but not reported as Serious Adverse Events: * Death or hospitalisation for assault or accidental injury * Hospitalisation for abscesses due to drugs use * Hospitalisation for wound management due to drugs use * Death or hospitalisation due to infection * Hospitalisation for elective or planned investigation or treatment * Death or hospitalisation for deteriorating renal function, high or low potassium levels * Hospitalisation due to nausea, vomiting, constipation or diarrhea	7.1% 3/42 • Number of events 3 • 31 months Recorded but not reported as Serious Adverse Events: * Death or hospitalisation for assault or accidental injury * Hospitalisation for abscesses due to drugs use * Hospitalisation for wound management due to drugs use * Death or hospitalisation due to infection * Hospitalisation for elective or planned investigation or treatment * Death or hospitalisation for deteriorating renal function, high or low potassium levels * Hospitalisation due to nausea, vomiting, constipation or diarrhea	0.00% 0/47 • 31 months Recorded but not reported as Serious Adverse Events: * Death or hospitalisation for assault or accidental injury * Hospitalisation for abscesses due to drugs use * Hospitalisation for wound management due to drugs use * Death or hospitalisation due to infection * Hospitalisation for elective or planned investigation or treatment * Death or hospitalisation for deteriorating renal function, high or low potassium levels * Hospitalisation due to nausea, vomiting, constipation or diarrhea
Gastrointestinal disorders Nausea	2.6% 1/39 • Number of events 1 • 31 months Recorded but not reported as Serious Adverse Events: * Death or hospitalisation for assault or accidental injury * Hospitalisation for abscesses due to drugs use * Hospitalisation for wound management due to drugs use * Death or hospitalisation due to infection * Hospitalisation for elective or planned investigation or treatment * Death or hospitalisation for deteriorating renal function, high or low potassium levels * Hospitalisation due to nausea, vomiting, constipation or diarrhea	9.5% 4/42 • Number of events 4 • 31 months Recorded but not reported as Serious Adverse Events: * Death or hospitalisation for assault or accidental injury * Hospitalisation for abscesses due to drugs use * Hospitalisation for wound management due to drugs use * Death or hospitalisation due to infection * Hospitalisation for elective or planned investigation or treatment * Death or hospitalisation for deteriorating renal function, high or low potassium levels * Hospitalisation due to nausea, vomiting, constipation or diarrhea	2.1% 1/47 • Number of events 1 • 31 months Recorded but not reported as Serious Adverse Events: * Death or hospitalisation for assault or accidental injury * Hospitalisation for abscesses due to drugs use * Hospitalisation for wound management due to drugs use * Death or hospitalisation due to infection * Hospitalisation for elective or planned investigation or treatment * Death or hospitalisation for deteriorating renal function, high or low potassium levels * Hospitalisation due to nausea, vomiting, constipation or diarrhea
Infections and infestations Injection site infection/abscess	5.1% 2/39 • Number of events 2 • 31 months Recorded but not reported as Serious Adverse Events: * Death or hospitalisation for assault or accidental injury * Hospitalisation for abscesses due to drugs use * Hospitalisation for wound management due to drugs use * Death or hospitalisation due to infection * Hospitalisation for elective or planned investigation or treatment * Death or hospitalisation for deteriorating renal function, high or low potassium levels * Hospitalisation due to nausea, vomiting, constipation or diarrhea	7.1% 3/42 • Number of events 4 • 31 months Recorded but not reported as Serious Adverse Events: * Death or hospitalisation for assault or accidental injury * Hospitalisation for abscesses due to drugs use * Hospitalisation for wound management due to drugs use * Death or hospitalisation due to infection * Hospitalisation for elective or planned investigation or treatment * Death or hospitalisation for deteriorating renal function, high or low potassium levels * Hospitalisation due to nausea, vomiting, constipation or diarrhea	6.4% 3/47 • Number of events 9 • 31 months Recorded but not reported as Serious Adverse Events: * Death or hospitalisation for assault or accidental injury * Hospitalisation for abscesses due to drugs use * Hospitalisation for wound management due to drugs use * Death or hospitalisation due to infection * Hospitalisation for elective or planned investigation or treatment * Death or hospitalisation for deteriorating renal function, high or low potassium levels * Hospitalisation due to nausea, vomiting, constipation or diarrhea
Injury, poisoning and procedural complications Illicit drug overdose	12.8% 5/39 • Number of events 5 • 31 months Recorded but not reported as Serious Adverse Events: * Death or hospitalisation for assault or accidental injury * Hospitalisation for abscesses due to drugs use * Hospitalisation for wound management due to drugs use * Death or hospitalisation due to infection * Hospitalisation for elective or planned investigation or treatment * Death or hospitalisation for deteriorating renal function, high or low potassium levels * Hospitalisation due to nausea, vomiting, constipation or diarrhea	0.00% 0/42 • 31 months Recorded but not reported as Serious Adverse Events: * Death or hospitalisation for assault or accidental injury * Hospitalisation for abscesses due to drugs use * Hospitalisation for wound management due to drugs use * Death or hospitalisation due to infection * Hospitalisation for elective or planned investigation or treatment * Death or hospitalisation for deteriorating renal function, high or low potassium levels * Hospitalisation due to nausea, vomiting, constipation or diarrhea	4.3% 2/47 • Number of events 2 • 31 months Recorded but not reported as Serious Adverse Events: * Death or hospitalisation for assault or accidental injury * Hospitalisation for abscesses due to drugs use * Hospitalisation for wound management due to drugs use * Death or hospitalisation due to infection * Hospitalisation for elective or planned investigation or treatment * Death or hospitalisation for deteriorating renal function, high or low potassium levels * Hospitalisation due to nausea, vomiting, constipation or diarrhea

Additional Information

Professor John Dillon

University of Dundee

Phone: 01382 383017

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place