Trial Outcomes & Findings for Evaluation of (Doravirine / Lamivudine / Tenofovir Disoproxil Fumarate) (Delstrigo®) as a New Strategy for Non-occupational Post Exposure Prophylaxis, a Prospective Open Label Study (NCT NCT04233372)

Last Updated: 2025-09-10

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

399 participants

Primary outcome timeframe

28 days

Results posted on

2025-09-10

Participant Flow

1535 subjects received PEP prescriptions between September 2020 and February 2022.

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.

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	399
Overall Study COMPLETED	285
Overall Study NOT COMPLETED	114

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Lost to Follow-up	104
Overall Study Adverse Event	8
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Evaluation of (Doravirine / Lamivudine / Tenofovir Disoproxil Fumarate) (Delstrigo®) as a New Strategy for Non-occupational Post Exposure Prophylaxis, a Prospective Open Label Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Delstrigo n=399 Participants 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
Age, Continuous	30 years n=5 Participants
Sex/Gender, Customized Female	32 Participants n=5 Participants
Sex/Gender, Customized Male	364 Participants n=5 Participants
Sex/Gender, Customized Non binary	3 Participants n=5 Participants
Race/Ethnicity, Customized North America	2 Participants n=5 Participants
Race/Ethnicity, Customized Latin America	135 Participants n=5 Participants
Race/Ethnicity, Customized Europe	231 Participants n=5 Participants
Race/Ethnicity, Customized Asia	7 Participants n=5 Participants
Race/Ethnicity, Customized Africa	7 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	17 Participants n=5 Participants
Risk assesment Low	1 Participants n=5 Participants
Risk assesment Intermediate	11 Participants n=5 Participants
Risk assesment High	385 Participants n=5 Participants
Risk assesment Unknown	2 Participants n=5 Participants
Sexual orientation Homosexual	331 Participants n=5 Participants
Sexual orientation Heterosexual	53 Participants n=5 Participants
Sexual orientation Transexual	11 Participants n=5 Participants
Sexual orientation Unknown	4 Participants n=5 Participants
Previous PEP No	254 Participants n=5 Participants
Previous PEP Yes	138 Participants n=5 Participants
Previous PEP Unknown	7 Participants n=5 Participants
Hours from the exposure	24 hours n=5 Participants
Abused drugs No	259 Participants n=5 Participants
Abused drugs Yes	111 Participants n=5 Participants
Abused drugs Unknown	29 Participants n=5 Participants
Sexual exposure Anal sex	361 Participants n=5 Participants
Sexual exposure Vaginal sex	53 Participants n=5 Participants
Sexual exposure Oral sex	343 Participants n=5 Participants
Sexual exposure Use of condom	134 Participants n=5 Participants
Sexual exposure Broken condom	128 Participants n=5 Participants
Sexual exposure Blood contact/exchange	69 Participants n=5 Participants
Sexual exposure Semen contact/exchange	202 Participants n=5 Participants
Previous sexually transmitted infections No	264 Participants n=5 Participants
Previous sexually transmitted infections Yes	126 Participants n=5 Participants
Previous sexually transmitted infections Unknown	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: 28 days

Population: All participants who received at least one dose of PEP (Intention-To-Treat population).

Outcome measures

Outcome measures
Measure	Delstrigo n=399 Participants 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 .( will be administered 28 days maximum)
Proportion of Participants Who Did Not Complete the 28-day PEP Regimen	114 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Delstrigo n=183 AEs 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 .( will be administered 28 days maximum)
Type of Clinical and Laboratory Adverse Events During 28-day PEP With DOR/3TC/TDF Mild	150 AEs
Type of Clinical and Laboratory Adverse Events During 28-day PEP With DOR/3TC/TDF Moderate	28 AEs
Type of Clinical and Laboratory Adverse Events During 28-day PEP With DOR/3TC/TDF Severe	5 AEs

SECONDARY outcome

Timeframe: 28 days

Population: Odds Ratio (95% confidence interval)

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'

Outcome measures

Outcome measures
Measure	Delstrigo n=399 Participants 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 .( will be administered 28 days maximum)
Assess the Baseline Characteristics Associated to Treatment Non-completion. Age (in years)	0.94 Odds Ratio (95% confidence interval) Interval 0.91 to 0.97
Assess the Baseline Characteristics Associated to Treatment Non-completion. Sex (non binary)	0.57 Odds Ratio (95% confidence interval) Interval 0.05 to 6.92
Assess the Baseline Characteristics Associated to Treatment Non-completion. Sexual orientation (homosexual)	0.98 Odds Ratio (95% confidence interval) Interval 0.51 to 1.86
Assess the Baseline Characteristics Associated to Treatment Non-completion. Sexual orientation (transexual)	1.45 Odds Ratio (95% confidence interval) Interval 0.37 to 5.68
Assess the Baseline Characteristics Associated to Treatment Non-completion. High risk assessment	1.20 Odds Ratio (95% confidence interval) Interval 0.32 to 4.52
Assess the Baseline Characteristics Associated to Treatment Non-completion. Sex (male)	0.42 Odds Ratio (95% confidence interval) Interval 0.2 to 0.87
Assess the Baseline Characteristics Associated to Treatment Non-completion. European origin	0.86 Odds Ratio (95% confidence interval) Interval 0.54 to 1.37
Assess the Baseline Characteristics Associated to Treatment Non-completion. Previous STI	0.98 Odds Ratio (95% confidence interval) Interval 0.61 to 1.59
Assess the Baseline Characteristics Associated to Treatment Non-completion. Previos PEP	0.94 Odds Ratio (95% confidence interval) Interval 0.59 to 1.51

SECONDARY outcome

Timeframe: 28 days

Population: ITT population

Outcome measures

Outcome measures
Measure	Delstrigo n=399 Participants 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 .( will be administered 28 days maximum)
Incidence of Clinical and Laboratory Adverse Events During 28-day PEP With DOR/3TC/TDF	123 Participants

SECONDARY outcome

Timeframe: Day 0 to Day 28 (Week 4)

Population: ITT population

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.

Outcome measures

Outcome measures
Measure	Delstrigo n=399 Participants 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 .( will be administered 28 days maximum)
Adherence to cART During 28-day PEP Regimen Adherence at day 7	336 Participants
Adherence to cART During 28-day PEP Regimen Adherence day 28	281 Participants

SECONDARY outcome

Timeframe: Month 4

Population: All patients enrolled in the study

Absolute frequency and percentage of individuals who performed month 4 (retention rate).

Outcome measures

Outcome measures
Measure	Delstrigo n=399 Participants 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 .( will be administered 28 days maximum)
Proportion of Subjects That Maintain Follow-up	243 Participants

SECONDARY outcome

Timeframe: Day 0 to Day 84

Population: ITT population

Number of participants who tested positive for HIV during the 12-week follow-up period after completing post-exposure prophylaxis (PEP) with Delstrigo®.

Outcome measures

Outcome measures
Measure	Delstrigo n=399 Participants 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 .( will be administered 28 days maximum)
Rate of HIV Seroconversion	0 Participants

Adverse Events

Delstrigo

Serious events: 0 serious events

Other events: 123 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Delstrigo n=399 participants at risk 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
Gastrointestinal disorders Diarrhea, Abdominal pain	15.8% 63/399 • Number of events 63 • Adverse event data were collected from Day 0 (start of treatment) through Week 12 (approximately 84 days). The study reported a total of 183 adverse event (AE) episodes among 123 participants. Events were categorized by system organ class: gastrointestinal (n = 63), neurological (n = 37), and infections (n = 28).
Nervous system disorders Neurological	9.3% 37/399 • Number of events 37 • Adverse event data were collected from Day 0 (start of treatment) through Week 12 (approximately 84 days). The study reported a total of 183 adverse event (AE) episodes among 123 participants. Events were categorized by system organ class: gastrointestinal (n = 63), neurological (n = 37), and infections (n = 28).
Infections and infestations Infections	7.0% 28/399 • Number of events 28 • Adverse event data were collected from Day 0 (start of treatment) through Week 12 (approximately 84 days). The study reported a total of 183 adverse event (AE) episodes among 123 participants. Events were categorized by system organ class: gastrointestinal (n = 63), neurological (n = 37), and infections (n = 28).

Additional Information

Dr. Alexy Inciarte

Hospital Clínic of Barcelona

Phone: +34932275400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place