Hiv
Conditions
Brief summary
Subjects who go to emergency room for possible contact to HIV transmission receive Delstrigo as post exposition prophylaxis.
Interventions
DRUGDelstrigo
Doravirine / lamivudine / tenofovir disoproxil fumarate (Delstrigo®) 100 mg doravirine, 300 mg lamivudine,300 mg tenofovir disoproxil fumarate equivalent to 245 mg de tenofovir disoproxil. 1 covered tablet for day .( will be administered 28 days maximum)
Sponsors
Hospital Clinic of Barcelona
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects attending emergency room due to potential HIV exposition of either sex: * Aged 18 years or more. * Who have been exposed to non-occupational HIV and who meet the prerequisites for the current recommendations to begin prophylaxis post-exposition with three antiretroviral drugs. * Who after being fully informed, give their written consent to participate in the study and undergo the tests and examinations required. * Individuals able to do follow up correctly.
Exclusion criteria
* Pregnant women or nursing mothers or women trying to conceive during the study period. * Patients in whom it is known or suspected that the source case has a resistance to one of the drugs from the study treatment regimens. * Treatment with drugs that are contraindicated in the study or products that are in the investigational phase. * Allergic reactions or intolerance to the compounds of the study treatment regiments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Who Did Not Complete the 28-day PEP Regimen | 28 days | Proportion of subjects with treatment completion at day 28. Post exposition prophylaxis (PEP) non-completion is considered in cases: 1. If the subject dies. 2. Does not go to visits (loss of follow-up) 3. Change or suspend the treatment under study for any reason. 4. Consent withdrawal |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess the Baseline Characteristics Associated to Treatment Non-completion. | 28 days | Baseline characteristics associated to treatment non-completion were identified using logistic regression model selecting variables in a stepwise fashion.The dependent variable was 'Have discontinuated the 28-days treatment' |
| Incidence of Clinical and Laboratory Adverse Events During 28-day PEP With DOR/3TC/TDF | 28 days | — |
| Type of Clinical and Laboratory Adverse Events During 28-day PEP With DOR/3TC/TDF | 28 days | — |
| Proportion of Subjects That Maintain Follow-up | Month 4 | Absolute frequency and percentage of individuals who performed month 4 (retention rate). |
| Rate of HIV Seroconversion | Day 0 to Day 84 | Number of participants who tested positive for HIV during the 12-week follow-up period after completing post-exposure prophylaxis (PEP) with Delstrigo®. |
| Adherence to cART During 28-day PEP Regimen | Day 0 to Day 28 (Week 4) | Adherence to cART was assessed using the Simplified Medication Adherence Questionnaire (SMAQ) at day 7 and week 4. Non-adherence was defined based on questionnaire responses and pill count. |
Countries
France, Spain
Participant flow
Recruitment details
1535 subjects received PEP prescriptions between September 2020 and February 2022.
Pre-assignment details
406 subjects met PEP criteria and were visited in the emergency department of Hospital Clínic of Barcelona. 1 subject was a screening failure. 6 subjects were excluded after the initial evalution because they didn't meet the selection criteria and/or had multiple entries. 399 subjects were included and analized in the study.
Participants by arm
| Arm | Count |
|---|---|
| Delstrigo Delstrigo: Doravirine / lamivudine / tenofovir disoproxil fumarate (Delstrigo®) 100 mg doravirine, 300 mg lamivudine, 300 mg tenofovir disoproxil fumarate equivalent to 245 mg de tenofovir disoproxil.
1 covered tablet for day Treatment will be administered 28 days maximum | 399 |
| Total | 399 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 8 |
| Overall Study | Lost to Follow-up | 104 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Delstrigo |
|---|---|
| Abused drugs No | 259 Participants |
| Abused drugs Unknown | 29 Participants |
| Abused drugs Yes | 111 Participants |
| Age, Continuous | 30 years |
| Hours from the exposure | 24 hours |
| Previous PEP No | 254 Participants |
| Previous PEP Unknown | 7 Participants |
| Previous PEP Yes | 138 Participants |
| Previous sexually transmitted infections No | 264 Participants |
| Previous sexually transmitted infections Unknown | 9 Participants |
| Previous sexually transmitted infections Yes | 126 Participants |
| Race/Ethnicity, Customized Africa | 7 Participants |
| Race/Ethnicity, Customized Asia | 7 Participants |
| Race/Ethnicity, Customized Europe | 231 Participants |
| Race/Ethnicity, Customized Latin America | 135 Participants |
| Race/Ethnicity, Customized North America | 2 Participants |
| Race/Ethnicity, Customized Unknown | 17 Participants |
| Risk assesment High | 385 Participants |
| Risk assesment Intermediate | 11 Participants |
| Risk assesment Low | 1 Participants |
| Risk assesment Unknown | 2 Participants |
| Sex/Gender, Customized Female | 32 Participants |
| Sex/Gender, Customized Male | 364 Participants |
| Sex/Gender, Customized Non binary | 3 Participants |
| Sexual exposure Anal sex | 361 Participants |
| Sexual exposure Blood contact/exchange | 69 Participants |
| Sexual exposure Broken condom | 128 Participants |
| Sexual exposure Oral sex | 343 Participants |
| Sexual exposure Semen contact/exchange | 202 Participants |
| Sexual exposure Use of condom | 134 Participants |
| Sexual exposure Vaginal sex | 53 Participants |
| Sexual orientation Heterosexual | 53 Participants |
| Sexual orientation Homosexual | 331 Participants |
| Sexual orientation Transexual | 11 Participants |
| Sexual orientation Unknown | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 399 |
| other Total, other adverse events | 123 / 399 |
| serious Total, serious adverse events | 0 / 399 |
Outcome results
Primary
Proportion of Participants Who Did Not Complete the 28-day PEP Regimen
Proportion of subjects with treatment completion at day 28. Post exposition prophylaxis (PEP) non-completion is considered in cases: 1. If the subject dies. 2. Does not go to visits (loss of follow-up) 3. Change or suspend the treatment under study for any reason. 4. Consent withdrawal
Time frame: 28 days
Population: All participants who received at least one dose of PEP (Intention-To-Treat population).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Delstrigo | Proportion of Participants Who Did Not Complete the 28-day PEP Regimen | 114 Participants |
Secondary
Adherence to cART During 28-day PEP Regimen
Adherence to cART was assessed using the Simplified Medication Adherence Questionnaire (SMAQ) at day 7 and week 4. Non-adherence was defined based on questionnaire responses and pill count.
Time frame: Day 0 to Day 28 (Week 4)
Population: ITT population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Delstrigo | Adherence to cART During 28-day PEP Regimen | Adherence at day 7 | 336 Participants |
| Delstrigo | Adherence to cART During 28-day PEP Regimen | Adherence day 28 | 281 Participants |
Secondary
Assess the Baseline Characteristics Associated to Treatment Non-completion.
Baseline characteristics associated to treatment non-completion were identified using logistic regression model selecting variables in a stepwise fashion.The dependent variable was 'Have discontinuated the 28-days treatment'
Time frame: 28 days
Population: Odds Ratio (95% confidence interval)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Delstrigo | Assess the Baseline Characteristics Associated to Treatment Non-completion. | High risk assessment | 1.20 Odds Ratio (95% confidence interval) |
| Delstrigo | Assess the Baseline Characteristics Associated to Treatment Non-completion. | Age (in years) | 0.94 Odds Ratio (95% confidence interval) |
| Delstrigo | Assess the Baseline Characteristics Associated to Treatment Non-completion. | Sex (male) | 0.42 Odds Ratio (95% confidence interval) |
| Delstrigo | Assess the Baseline Characteristics Associated to Treatment Non-completion. | Sex (non binary) | 0.57 Odds Ratio (95% confidence interval) |
| Delstrigo | Assess the Baseline Characteristics Associated to Treatment Non-completion. | Sexual orientation (homosexual) | 0.98 Odds Ratio (95% confidence interval) |
| Delstrigo | Assess the Baseline Characteristics Associated to Treatment Non-completion. | Sexual orientation (transexual) | 1.45 Odds Ratio (95% confidence interval) |
| Delstrigo | Assess the Baseline Characteristics Associated to Treatment Non-completion. | European origin | 0.86 Odds Ratio (95% confidence interval) |
| Delstrigo | Assess the Baseline Characteristics Associated to Treatment Non-completion. | Previous STI | 0.98 Odds Ratio (95% confidence interval) |
| Delstrigo | Assess the Baseline Characteristics Associated to Treatment Non-completion. | Previos PEP | 0.94 Odds Ratio (95% confidence interval) |
Secondary
Incidence of Clinical and Laboratory Adverse Events During 28-day PEP With DOR/3TC/TDF
Time frame: 28 days
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Delstrigo | Incidence of Clinical and Laboratory Adverse Events During 28-day PEP With DOR/3TC/TDF | 123 Participants |
Secondary
Proportion of Subjects That Maintain Follow-up
Absolute frequency and percentage of individuals who performed month 4 (retention rate).
Time frame: Month 4
Population: All patients enrolled in the study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Delstrigo | Proportion of Subjects That Maintain Follow-up | 243 Participants |
Secondary
Rate of HIV Seroconversion
Number of participants who tested positive for HIV during the 12-week follow-up period after completing post-exposure prophylaxis (PEP) with Delstrigo®.
Time frame: Day 0 to Day 84
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Delstrigo | Rate of HIV Seroconversion | 0 Participants |
Secondary
Type of Clinical and Laboratory Adverse Events During 28-day PEP With DOR/3TC/TDF
Time frame: 28 days
Population: 123 is the total number of patients that reported AEs. 183 are the total of AE episodes overall in this 123 participants.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Delstrigo | Type of Clinical and Laboratory Adverse Events During 28-day PEP With DOR/3TC/TDF | Mild | 150 AEs |
| Delstrigo | Type of Clinical and Laboratory Adverse Events During 28-day PEP With DOR/3TC/TDF | Moderate | 28 AEs |
| Delstrigo | Type of Clinical and Laboratory Adverse Events During 28-day PEP With DOR/3TC/TDF | Severe | 5 AEs |