Doxycycline Post-exposure Prophylaxis Research Articles

Predominance of High-Level Tetracycline-Resistant Neisseria gonorrhoeae in Kenya: Implications for Global Implementation of Doxycycline Postexposure Prophylaxis for Prevention of Sexually Transmitted Infections.

Using archived Neisseria gonorrhoeae samples from 2008 to 2012, the prevalence of tet (M) genemediating high-level tetracycline resistance in N. gonorrhoeae was 96% among 50 Kenyan women. Determining the local and national prevalence of gonococcal tetracycline resistance and surveillance of gonococcal antimicrobial resistance can inform the implementation of doxycycline postexposure prophylaxis for STI prevention.

Interim position statement on doxycycline post-exposure prophylaxis (Doxy-PEP) for the prevention of bacterial sexually transmissible infections in Australia and Aotearoa New Zealand - the Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine (ASHM).

Recent studies have provided evidence for the effectiveness of using doxycycline (Doxy-PEP) to prevent bacterial sexually transmissible infections (STI), namely chlamydia, gonorrhoea, and syphilis, among gay, bisexual, and other men who have sex with men who have experienced multiple STIs. However, there remain several unanswered questions around potential adverse outcomes from Doxy-PEP, including the possibility of inducing antimicrobial resistance in STIs and other organisms, and the possibility of disrupting the microbiome of people who choose to use Doxy-PEP. This interim position statement from the Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine aims to outline the current evidence for Doxy-PEP, and to highlight potential adverse outcomes, to enable clinicians to conduct evidence-based conversations with patients in Australia and Aotearoa New Zealand who intend to use Doxy-PEP.

Doxycycline post-exposure prophylaxis for prevention of sexually transmitted infections among Kenyan women using HIV pre-exposure prophylaxis: study protocol for an open-label randomized trial

BackgroundWomen in Africa face disproportionate risk of human immunodeficiency virus (HIV) acquisition, accounting for more than half of new infections in Africa and similarly face a disproportionate burden of sexually transmitted infections (STIs). Very high STI prevalence is being observed globally, especially among people taking pre-exposure prophylaxis (PrEP) for HIV prevention. Doxycycline post-exposure prophylaxis (dPEP) has been proposed as an STI prevention strategy to reduce chlamydia, syphilis, and possibly gonorrhea, and trials are ongoing among cisgender men who have sex with men (MSM) and transgender women who are taking PrEP in high-income settings. We designed and describe here the first open-label trial to determine the effectiveness of dPEP to reduce STI incidence among cisgender women.MethodsWe are conducting an open-label 1:1 randomized trial of dPEP versus standard of care (STI screening and treatment and risk-reduction counseling without dPEP) among 446 Kenyan women aged ≥ 18 and ≤ 30 years old women taking PrEP. Women are followed for 12 months, with quarterly STI testing, treatment, and adherence counseling. The primary trial outcome will be the combined incidence of Chlamydia trachomatis, Neisseria gonorrhoeae, and Treponema pallidum, compared between the randomized groups. We will also assess dPEP acceptability, tolerability, safety, impact on sexual behavior, adherence, and occurrence of antimicrobial resistance (AMR) in N. gonorrhoeae and C. trachomatis isolates. Finally, we will estimate cost per incident STI case and complications averted accounting for nonadherence and benefits relative AMR or side effects.DiscussionThe results of this trial may have immediate implications for the global epidemic of STIs and sexual health. If effective, dPEP could put STI prevention into women’s hands. While dPEP may be able to prevent STIs, it carries important risks that could counter its benefits; global debate about the balance of these potential risks and benefits requires data to inform policy and implementation and our study aims to fill this gap.Trial registrationClinicalTrials.gov NCT04050540.

163. High Prevalence of Urogenital and Rectal Mycoplasma genitalium in U.S. MSM with a History of STIs in the Last Year

Background M. genitalium (M. gen) is an under-recognized sexually transmitted bacterial pathogen that causes 15-25% of nongonococcal urethritis (NGU) in men. Asymptomatic M. gen may serve as a reservoir, lead to transmission to sexual contacts, and drive the development of drug resistance. M. gen may be associated with an increased risk of HIV acquisition, as seen in some studies. Data are limited on M. gen prevalence among U.S. men who have sex with men (MSM) living with HIV or HIV-uninfected and on pre-exposure prophylaxis (PrEP). MethodsWe analyzed baseline prevalence of urogenital and rectal M. gen using the Aptima Mycoplasma genitalium nucleic acid amplification test in participants enrolled in DoxyPEP, an ongoing randomized, open label trial of the effectiveness of doxycycline post-exposure prophylaxis (PEP) on incidence of gonorrhea, chlamydia, and early syphilis among MSM and transgender women living with HIV or on PrEP in San Francisco and Seattle (NCT03980223). Participants completing at least one follow up visit were also assessed for M. gen persistence, clearance, and incidence. Testing was at regular intervals and not symptom driven.ResultsThis analysis included 122 men; 34% with HIV and 66% on PrEP. In the prior 12 months, 18.9% had a diagnosis of syphilis, 58.2% chlamydia, and 63.9% gonorrhea. At baseline, M. gen was present in at least one site in 24%; 9% in the urine and 16% in the rectum, with 1 testing positive at both sites. M. gen presence was not associated with age, ethnicity, race, HIV status, number of partners in the past 3 months, or bacterial STI in the past 3 months. 65 participants had follow up tests a median of 9.1 months after baseline (IQR 7.8-9.8); among 7 participants with urogenital M. gen at baseline, M. gen cleared in 6 and persisted in 1. Among 11 participants with rectal M. gen at baseline, M. gen cleared in 4 cleared and persisted in 7. At follow up, M. gen was detected in 2 urine and 9 rectal specimens in those previously negative at these sites. Figure 1. Baseline prevalence of urogenital and rectal M. genitalium in MSM at high risk for STIs enrolled in DoxyPEP Figure 2. Detection of urogenital and rectal M. genitalium among participants with baseline and follow up testing ConclusionIn this cohort of MSM with a recent diagnosis of a bacterial STI, routine testing identified urogenital or rectal M. gen in 24% of participants at baseline and 31% at either baseline or follow-up. The association of persistent M. gen with the risk for subsequent symptomatic infection and drug resistance merits further investigation. Disclosures Emma D. Bainbridge, MD, MPH, Hologic (Grant/Research Support) Olusegun O. Soge, PhD, Hologic Inc. (Grant/Research Support)SpeeDx Inc. (Grant/Research Support) Annie Luetkemeyer, MD, Cepheid (Grant/Research Support)Hologic (Grant/Research Support)Mayne Pharma (Grant/Research Support)

Countering the rise of syphilis: A role for doxycycline post-exposure prophylaxis?

Doxycycline post-exposure prophylaxis (PEP) holds the potential to mitigate increasing rates of syphilis among sexual minority men (SMM) in the US yet has received limited attention. Since evaluation of this intervention in actual populations is not currently feasible, we used agent-based models (ABM) to assess the population-level impact of this strategy. We adapted ABM of HIV and HPV transmission, representing a population of 10,230 SMM in Philadelphia, Pennsylvania, US. Parameter inputs were derived from the literature, and ABM outputs during the pre-intervention period were calibrated to local surveillance data. Intervention scenarios varied doxycycline uptake by 20, 40, 60, 80 and 100%, while assuming continued condom use and syphilis screening and treatment. Under each intervention scenario, we incorporated treatment adherence at the following levels: 0, 20, 40, 60, 80 and 100%. Long-term population impact of prophylactic doxycycline was measured using the cumulative incidence over the 10-year period and the percentage of infections prevented attributable to doxycycline at year 10. An uptake scenario of 20% with an adherence level of 80% would reduce the cumulative incidence of infections by 10% over the next decade, translating to 57 fewer cases per 1000 SMM. At year 10, under the same uptake and adherence level, 22% of infections would be prevented due to doxycycline PEP in the instances where condoms were not used or failed. Findings suggest that doxycycline PEP will have a modest impact on syphilis incidence when assuming a reasonable level of uptake and adherence. Doxycycline PEP may be most appropriate as a secondary prevention measure to condoms and enhanced syphilis screening for reducing infections among SMM.

Implementing a pharmacist-run Lyme disease postexposure prophylaxis clinic augmented by academic detailing within the Veterans Health Administration

ObjectiveTo describe the implementation of a pharmacist-run Lyme disease postexposure prophylaxis (PEP) clinic augmented by academic detailing within a health care system. SettingButler Veterans Affairs Health Care System. Practice descriptionA pharmacist-run clinic, referred to as a PharmLD clinic, was established. A patient presenting to the health care system with a chief complaint of a tick bite would be scheduled to the PharmLD clinic for the evaluation of appropriateness of Lyme disease PEP. The pharmacist prescribed a single dose of doxycycline 200 mg and provided education on Lyme disease, provided education only, or referred the patient to their primary care provider (PCP). Academic detailing with PCPs, nurses, and pharmacists was used to improve outcomes in those not seen in the clinic. Practice innovationTo our knowledge, the evaluation of a pharmacist-run Lyme disease PEP clinic in a health care system alone or in combination with academic detailing has not been previously described in the literature. EvaluationDoxycycline PEP prescriptions from April through September 2016 (preimplementation) were compared with prescriptions from April through September 2018 (postimplementation). A retrospective chart review was performed to evaluate prescribing appropriateness on the basis of Infectious Diseases Society of America guidelines. ResultsThe postimplementation group saw a 55.9% improvement in doxycycline prescribing appropriateness. The improvement in appropriateness stemmed largely from the dose and duration prescribed. Eighteen of the 39 prescriptions (46%) came from the PharmLD clinic. During the postimplementation period, 40 patients were seen in the PharmLD clinic. Of these patients, 18 were prescribed doxycycline PEP (45%), 12 received education only (30%), and 10 were referred to their PCP for further evaluation (25%). These PharmLD clinic encounters resulted in the mitigation of 30 PCP visits. ConclusionA pharmacist-run Lyme disease PEP clinic, coupled with academic detailing, has increased access to care and improved the quality of care received.

Failure of Doxycycline Postexposure Prophylaxis in Human Brucellosis Contracted Through Needlestick Injury: ERRATUM

Failure of Doxycycline Postexposure Prophylaxis in Human Brucellosis Contracted Through Needlestick Injury: ERRATUM

Failure of Doxycycline Postexposure Prophylaxis in Human Brucellosis Contracted Through Needlestick Injury

Abstract Although brucellosis has a relatively high global prevalence rate, the highest number of reports is often presented in developing countries. Occupational risk factors for brucellosis are well recognized, with individuals working directly or indirectly with animals or in laboratories classified as high risk. This article presents the case of a high-risk male patient who incurred a needlestick injury as part of his work as a veterinary assistant. The patient was treated with a 21-day course of doxycycline upon first presentation but nonetheless developed brucellosis infection. It is proposed that a dual prophylaxis of doxycycline and rifampin prescribed on the day of exposure would have been a more effective intervention compared with monotherapy of doxycycline and that symptom monitoring and serological follow-up should have been carried out to reduce the risk of complications. This article recommends improvements in the enforcement of prevention procedures within high-risk occupational settings to reduce the risk of brucellosis infection, and adds a value to the importance of the prophylaxis for the countries that do not follow postexposure prophylaxis.

Evaluation of Doxycycline Post-exposure Prophylaxis to Reduce Sexually Transmitted Infections in PrEP Users and HIV-infected Men Who Have Sex With Men

Evaluation of Doxycycline Post-exposure Prophylaxis to Reduce Sexually Transmitted Infections in PrEP Users and HIV-infected Men Who Have Sex With Men

2272. High Interest in Doxycycline for Sexually Transmitted Infection Post-Exposure Prophylaxis (Doxy-PEP) in a Multi-city Survey of Men Having Sex With Men (MSM) Using a Social-Networking App

BackgroundSexually transmitted infections (STI) in people living with HIV (PLWH) and HIV-uninfected men who have sex with men (MSM) are increasing. Doxycycline post-exposure prophylaxis (doxy-PEP) showed partial efficacy against STI acquisition in a small population of HIV-uninfected MSM using pre-exposure prophylaxis (PrEP). Acceptability in a larger, diverse population of MSM is unknown.MethodsWe conducted a survey of doxycycline for STI PEP among users of a gay social networking app in 6 US cities: Atlanta, Birmingham, Chicago, New York City, San Francisco, and Seattle. In adjusted analyses using logistic regression, we examined factors associated with bacterial STI in the last year and willingness to use doxy-PEP. Predictors included: demographics, city, risk behaviors, and bacterial STI.ResultsOverall, 1301 individuals, 80% HIV-uninfected, 16% PLWH, and 4% status unknown responded to the survey. The median age was 33 and the sample was racially/ethnically diverse: 7% Asian, 21% Black, 24% Latinx, and 44% White. Most (80%), reported condomless sex in the last 6 months; 39% reported an STI in the last year. Of the HIV-uninfected, 44% were on PrEP. In adjusted analysis, age per ten years was inversely associated with an STI in the last year (AOR 0.8; 95% CI: 0.7–0.9 and AOR 0.2; 0.0–0.8 respectively), while number of partners in the last 6 months and condomless anal sex were associated with STI (AOR 1.1 per 5 partners; 1.0–1.1 and AOR 3.8; 2.5–5.8 respectively). There was no difference by race/ethnicity, or when comparing PrEP users to PLWH, however not using PrEP was inversely associated with STI (AOR 0.2; 0.2–0.3). Overall, 84% of respondents were interested in trying doxy-PEP. The factors associated with higher interest were: older age per ten years (1.2; 95% CI 1.0–1.4), Black race and Latinx ethnicity vs. White race (AOR 2.0; 1.2–3.5 and 1.9; 1.2–3.0 respectively), prior STI (AOR 1.7; 1.1–2.5), and having condomless sex (AOR 1.6; 1.1–2.4). Interest did not differ by city, number of partners, serostatus, or PrEP use.ConclusionInterest in doxy-PEP was high among a diverse population of MSM in the US Differences in reported STI prevalence may be related to increased detection through screening in PLWH and on PrEP. Additional research to evaluate efficacy/safety of doxy-PEP is needed to potentially reduce STIs among MSM.Disclosures All authors: No reported disclosures.

Post-exposure prophylaxis with doxycycline to prevent sexually transmitted infections in men who have sex with men: an open-label randomised substudy of the ANRS IPERGAY trial

Increased rates of sexually transmitted infections (STIs) have been reported among men who have sex with men. We aimed to assess whether post-exposure prophylaxis (PEP) with doxycycline could reduce the incidence of STIs. All participants attending their scheduled visit in the open-label extension of the ANRS IPERGAY trial in France (men aged 18 years or older having condomless sex with men and using pre-exposure prophylaxis for HIV with tenofovir disoproxil fumarate plus emtricitabine) were eligible for inclusion in this open-label randomised study. Participants were randomly assigned (1:1) at a central site to take a single oral dose of 200 mg doxycycline PEP within 24 h after sex or no prophylaxis. The primary endpoint was the occurrence of a first STI (gonorrhoea, chlamydia, or syphilis) during the 10-month follow-up. The cumulative probability of occurrence of the primary endpoint was estimated in each group with the Kaplan-Meier method and compared with the log-rank test. The primary efficacy analysis was done on the intention-to-treat population, comprising all randomised participants. All participants received risk-reduction counselling and condoms, and were tested regularly for HIV. This trial is registered with ClinicalTrials.gov number, NCT01473472. Between July 20, 2015, and Jan 21, 2016, we randomly assigned 232 participants (n=116 in the doxycycline PEP group and n=116 in the no-PEP group) who were followed up for a median of 8·7 months (IQR 7·8-9·7). Participants in the PEP group used a median of 680 mg doxycycline per month (IQR 280-1450). 73 participants presented with a new STI during follow-up, 28 in the PEP group (9-month probability 22%, 95% CI 15-32) and 45 in the no-PEP group (42%, 33-53; log-rank test p=0·007). The occurrence of a first STI in participants taking PEP was lower than in those not taking PEP (hazard ratio [HR] 0·53; 95% CI 0·33-0·85; p=0·008). Similar results were observed for the occurrence of a first episode of chlamydia (HR 0·30; 95% CI 0·13-0·70; p=0·006) and of syphilis (0·27; 0·07-0·98; p=0·047); for a first episode of gonorrhoea the results did not differ significantly (HR 0·83; 0·47-1·47; p=0·52). No HIV seroconversion was observed, and 72 (71%) of all 102 STIs were asymptomatic. Rates of serious adverse events were similar in the two study groups. Gastrointestinal adverse events were reported in 62 (53%) participants in the PEP group and 47 (41%) in the no-PEP group (p=0·05). Doxycycline PEP reduced the occurrence of a first episode of bacterial STI in high-risk men who have sex with men. France Recherche Nord & Sud Sida-HIV Hépatites (ANRS) and Bill & Melinda Gates Foundation.

Doxycycline post-exposure prophylaxis: let the debate begin

Doxycycline post-exposure prophylaxis: let the debate begin