Accepted for/Published in: JMIR Research Protocols
Date Submitted: Aug 1, 2023
Date Accepted: Oct 24, 2023
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Efficacy and Safety of Pre-Exposure Prophylaxis to Control HIV and STI Among Men Who Have Sex with Men: Protocol for an Investigator-Initiated Single-arm Interventional Study
ABSTRACT
Background:
Pre-exposure prophylaxis (PrEP) against human immunodeficiency virus (HIV) infection is a new approach that involves the prophylactic use of the anti-HIV drug Truvada® (tenofovir/emtricitabine; TDF/FTC) by people not infected with HIV.
Objective:
The objective of this investigator-initiated clinical study of PrEP was to evaluate the incidence of HIV and sexually transmitted infection (STI) , safety and efficacy of PrEP in PrEP users, and their compliance with PrEP medication. The social, medical, and economic benefits of PrEP in Japan was assessed.
Methods:
This single-center feasibility study of PrEP was conducted at the National Center for Global Health and Medicine (NCGM) Tokyo, Japan, where a non-HIV-infected men who have sex with men (MSM) cohort was established in January 2017. This single-arm interventional study compared the efficacy and safety of PrEP in a single group of individuals who participated in MSM and PrEP cohort studies. For reference, the cohort study participants who did not participate in the PrEP study were included for comparison. Blood samples were collected for storage at baseline and clinic visits at one, three, and six months after starting PrEP and every three months thereafter. The participants were administered with one tablet of Truvada once daily as PrEP. They underwent blood and anal swab tests one and three months after starting PrEP and then HIV and STI infection assessments at three-month intervals. Blood samples were centrifuged at the AIDS Clinical Center Laboratory. PrEP safety was evaluated by monitoring serum creatinine levels for symptoms of renal function disorders. The primary endpoint was the incidence of HIV in PrEP users (100 people/year). The secondary endpoints were the incidence of STI in PrEP users (100 people/year), incidence of adverse events caused by Truvada, frequency of high-risk sexual activity, and adherence to periodic visits and medication.
Results:
The study protocol was reviewed and approved by the Certified Review Board of the National Center for Global Health and Medicine (NCGM-C-003129-03) on April 20, 2020. Changes to the study plan were submitted for review by the Certified Review Board and approved before implementation. Recruitment was completed in March 28, 2019, and the study was completed (last adult participant, last time point) in March 31, 2021. The data were analyzed, and the main results of the study have been published in a peer-reviewed journal.
Conclusions:
The findings indicated that PrEP is a highly effective and feasible strategy against HIV infection in terms of prophylactic response, retention, and compliance. Clinical Trial: The study was registered in the UMIN Clinical Trials Registry (UMIN000031040, www.umin.ac.jp) and the Japan Registry of Clinical Trials (jRCTs031180134).
Citation
