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Key Points: Question: Does vaccination with a hepatitis B vaccine with a cytosine phosphoguanine adjuvant (HepB-CpG vaccine) improve hepatitis B virus (HBV) seroprotection in people with HIV and nonresponse to prior hepatitis B vaccine? Findings: In this open-label randomized clinical trial that included 561 people with HIV, 93% achieved HBV seroprotection with 2 doses of HepB-CpG vaccine and 99% achieved HBV seroprotection with 3 doses of HepB-CpG vaccine vs 81% with 3 doses of conventional hepatitis B vaccine with an aluminum hydroxide adjuvant. Meaning: A superior response was achieved in people with HIV and nonresponse to prior hepatitis B vaccination who received 2 or 3 doses of HepB-CpG vaccine. Importance: Nonresponse to hepatitis B vaccine is common among people with HIV, resulting in vulnerability to infection with hepatitis B virus (HBV). Objective: To compare the seroprotection response achieved with a 2-dose (noninferiority, 10% margin) and a 3-dose hepatitis B vaccine with a cytosine phosphoguanine adjuvant (HepB-CpG vaccine) vs a conventional 3-dose hepatitis B vaccine with an aluminum hydroxide adjuvant (HepB-alum vaccine) in people with HIV and prior nonresponse to HepB-alum vaccine. Design, Setting, and Participants: This phase 3, open-label, randomized clinical trial included people with HIV receiving antiretroviral therapy (CD4 cell count ≥100 cells/μL and HIV RNA <1000 copies/mL) without past or present serological evidence of having HBV or a response to hepatitis B vaccine. From December 2020 to February 2023, 561 adults were enrolled in the study at 41 sites in 10 countries in Africa, Asia, North America, and South America with follow-up for the primary outcome analysis through September 4, 2023. Interventions: Participants were randomly assigned to receive 2 doses of HepB-CpG vaccine administered intramuscularly at weeks 0 and 4; 3 doses of HepB-CpG vaccine administered intramuscularly at weeks 0, 4, and 24; or 3 doses of HepB-alum vaccine administered intramuscularly at weeks 0, 4, and 24. Main Outcomes and Measures: The primary outcome was a seroprotection response to hepatitis B vaccine (defined as level of antibody titer against hepatitis B surface antigen [HBsAg] ≥10 mIU/mL) at week 12 for the 2-dose regimen (8 weeks after dose 2) and at week 28 for 3-dose regimens (4 weeks after dose 3). Key secondary outcomes included seroprotection response at additional time points, antibody titer against HBsAg, and adverse events within 4 weeks of hepatitis B vaccination. Results: Of 561 participants included in the analysis (median age, 46 years [IQR, 31-56 years]); 64% were male; 17% of participants were Asian, 42% were Black, and 35% were White), a seroprotection response was achieved in 93.1% who received 2 doses of HepB-CpG vaccine (n = 174), in 99.4% who received 3 doses of HepB-CpG vaccine (n = 169), and in 80.6% who received 3 doses of HepB-alum vaccine (n = 165). The stratified difference in seroprotection response between the 2-dose HepB-CpG vaccine group and the 3-dose HepB-alum vaccine group was 12.5% (97.5% CI, 4.1%-20.9%), achieving noninferiority and indicating superiority. The 3-dose HepB-CpG vaccine regimen was superior to the 3-dose HepB-alum vaccine regimen (stratified difference in seroprotection response, 18.4% [repeated 97.5% CI, 10.4%-26.2%]). By week 12, more than 90% of participants who received HepB-CpG vaccine achieved a seroprotection response. The 3-dose regimen of HepB-CpG vaccine achieved a higher proportion of participants with antibody titer against HBsAg greater than 1000 mIU/mL (78.1%) vs the other 2 regimen groups (26.4% for 2 doses of HepB-CpG vaccine and 35.2% for 3 doses of HepB-alum vaccine). No unexpected safety issues were observed. Conclusions and Relevance: Among people with HIV and nonresponse to prior hepatitis B vaccination, both the 2-dose and 3-dose regimens of HepB-CpG vaccine achieved a superior seroprotection response compared with 3 doses of HepB-alum vaccine. Trial Registration: ClinicalTrials.gov Identifier: NCT04193189 This randomized clinical trial compares the seroprotection response achieved with a 2-dose and a 3-dose hepatitis B vaccine with a cytosine phosphoguanine adjuvant vs a conventional 3-dose hepatitis B vaccine with an aluminum hydroxide adjuvant in people with HIV and prior nonresponse to hepatitis B vaccine. [ABSTRACT FROM AUTHOR]

Hepatitis B virus (HBV) increases morbidity and mortality among people with HIV (PWH). We retrospectively analyzed HBV incidence among 5785 PWH. Fourteen had newly positive hepatitis B s antigen (mean 5.2 person-years of follow-up, 46.4/100 000 infections/year). These data show gaps in HBV vaccination and in the preventative efficacy of HBV-specific antiretroviral therapy. [ABSTRACT FROM AUTHOR]

Hepatitis B virus (HBV) infection is one of the leading causes of hepatocellular carcinoma and mortality among people living with HIV (PLWH). HBV vaccination provides protection from infection; however, vaccination rates are low. We conducted a retrospective analysis at three HIV centres in Texas to determine the proportion of PLWH who received the recommended 3 doses of hepatitis B vaccine within 1 year. Factors associated with vaccination completion were explored. In our sample of three sites in a state with high HIV transmission and high rates of liver disease from 2011 to 2021, showed low rates of hepatitis B vaccination. Among eligible PLWH, only 9% completed the 3‐dose hepatitis B vaccine series in 1 year. There is an urgent need to improve HBV vaccination to reach 2030 target for hepatitis B elimination. [ABSTRACT FROM AUTHOR]

Background New therapies to achieve hepatitis B surface antigen (HBsAg) clearance are under development. However, gaps in knowledge exist in understanding the incidence and predictors of HBsAg clearance in a racially diverse HIV population. Methods We examined the incidence and risk of HBsAg clearance in a retrospective cohort of people with HIV/hepatitis B virus (HBV). Included patients had sufficient data to establish chronic infection based on Centers for Disease Control and Prevention guidelines. We examined the incident rate for HBsAg loss and hazard rate ratios to evaluate predictors for HBsAg clearance in a multivariable model. Results Among 571 HIV/HBV patients, 87% were male, 61% were Black, 45% had AIDS, 48% were HBeAg positive, and the median follow-up was 88 months. Incident HBsAg clearance was 1.5 per 100 person-years. In the multivariate model, those with AIDS at baseline (adjusted hazard ratio [aHR], 2.43; 95% CI, 1.37–4.32), Hispanics (aHR, 3.57; 95% CI, 1.33–9.58), and those with injection drug use as an HIV risk factor (aHR, 3.35; 95% CI, 1.26–8.89) were more likely to lose HBsAg, whereas those who were HBeAg positive (aHR, 0.34; 95% CI, 0.19–0.63) were less likely to lose HBsAg. The median change in CD4 cell count during the observation period was 231 cells/mm3 in those with HBsAg loss vs 112 cells/mm3 in those with HBsAg persistence (P  = .004). Conclusions HBsAg loss occurs in about 10% of those with chronic HBV infection. Being Hispanic, having AIDS at baseline, having an injection drug use history, and having HBeAg-negative status at baseline predicted the likelihood of HBsAg loss. Immune restoration may be a mechanism through which HBsAg loss occurs in HIV patients. [ABSTRACT FROM AUTHOR]

Background Universal HIV testing in adults presenting to a health care setting was recommended by the Centers for Disease Control and Prevention (CDC) in 2006, but compliance in central nervous system (CNS) infections is unknown. Methods A multicenter study of adults presenting with CNS infections to 18 hospitals in Houston and New Orleans between 2000 and 2015 was done to characterize HIV testing and explore factors associated with a positive HIV test. Results A total of 1478 patients with a diagnosis of meningitis or encephalitis were identified; 180 were excluded because of known HIV diagnosis (n = 100) or were <17 years old (n = 80). Out of 1292 patients, 642 (49.7%) had HIV testing, and testing did not differ significantly before or after the CDC recommendations in 2006 (53% vs 48%; P =.068). An HIV test was more commonly done in patients who were non-Caucasian, had fever >38°C, or had seizures on presentation, and of those tested, non-Caucasian patients and those with photophobia were more likely to have a positive HIV test (P <.05). HIV testing also varied by type of CNS infection: community-acquired bacterial meningitis (98/130, 75.4%), encephalitis (174/255, 68.2%), aseptic meningitis (285/619, 46.0%), and health care–associated meningitis (85/288, 29.5%; P <.001). Conclusions Even though HIV testing should be done in all adults presenting with a CNS infection, testing remains ~50% and did not improve after the recommendation for universal testing by the CDC in 2006. [ABSTRACT FROM AUTHOR]

Despite antiretroviral therapy (ART), innate and adaptive immunologic damage persists in the periphery and gut. T memory stem cells (Tscm) and natural killer (NK) cells are pivotal for host defense. Tscm are memory cells capable of antigen response and self-renewal, and circulating and gut NK cell populations may facilitate HIV control. The impact of early ART on circulating and gut Tscm and NK cells is unknown. We enrolled participants who initiated ART during acute versus chronic HIV-1 infection versus no ART in chronic infection. We performed flow cytometry to identify NK and Tscm cells in the blood and rectum and polymerase chain reaction to quantify the HIV-1 reservoir in both sites. We used the Mann–Whitney U-test and Spearman correlation coefficients for analysis. Participants who started ART in acute infection had lower rectal CD56brightCD16dim cell frequencies than participants who started ART in chronic HIV-1 infection and lower CD56bright and CD56brightCD16− cell frequencies than participants with chronic infection without ART. Higher circulating NK cell, CD56−CD16bright, CD56dim, and CD56dimCD16bright frequencies correlated with higher HIV-1 DNA levels in rectal CD4+ T cells, whereas higher circulating CD4+ T cell counts correlated with higher rectal NK, CD56brightCD16dim, and CD56dimCD16bright frequencies. Peripheral CD56brightCD16− cells were inversely associated with rectal CD56−CD16bright cells. Rectal CD8+ Tscm frequencies were higher in participants without ART than participants with chronic infection on ART. Timing of ART initiation determines rectal NK cell populations, and ART may influence rectal Tscm populations. Whether the gut reservoir contributes to NK cell activation requires further study. [ABSTRACT FROM AUTHOR]

HIV medical care providers need a wide range of evidence-based clinical information resources to manage their patients' health. We determined whether providers' choice of information sources for HIV care and treatment are associated with their demographic and medical practice characteristics. Data used for this study were obtained from a probability sample of HIV medical care providers in 13 outpatient HIV facilities in Houston/Harris County, Texas, surveyed between June and September 2009. The mean number of information sources used by HIV medical care providers for HIV care and treatment was 5.83 (95% confidence interval: 4.90–6.75). Antiretroviral therapy guidelines (95.6%), medical journals and textbooks (82.6%), and Internet sources (69.5%) were ranked first, second, and third as sources of clinical information. At least one of the providers' demographic or medical practice characteristics was significantly (p ⩽ 0.05) associated with six of the clinical information sources. Integration of these information resources into clinicians' workflow may enhance efficiency of HIV care and treatment and facilitate improved patients' care and health outcomes. [ABSTRACT FROM AUTHOR]

We conducted a retrospective study of 549 adults admitted with community-acquired meningitis (CAM) to several hospitals in New Orleans, LA and Houston, TX between 1999 and 2014 to characterize the current epidemiology, clinical manifestations, cerebrospinal fluid (CSF) characteristics, and outcomes of CAM between HIV-infected and uninfected patients and to identify risk factors for adverse outcomes in CAM. Bivariate analysis and logistic regression analysis were used to identify prognostic factors. A total of 1022 patients with CAM were screened. Only 549 (53.7%) subjects had an HIV test and were included in the study. Of those, 138 (25%) had HIV infection. HIV-infected patients presented with less meningeal symptoms (headache, neck stiffness, and Kernig sign), but with higher rates of hypoglycorrhachia, elevated CSF protein, and an abnormal cranial imaging ( p < 0.05). More than 50% of all the patients had an unknown etiology. Cryptococcal meningitis was the most common identified etiology of CAM in HIV-infected patients followed by neurosyphilis and varicella-zoster virus (VZV). Viral and bacterial etiologies were the most frequent etiologies in non-HIV-infected patients. Streptococcus pneumoniae was the most common bacterial pathogen in both groups, but it was rare overall (2%). Adverse clinical outcomes were similar in both groups (27% vs. 24%). Logistic regression identified hypoglycorrhachia and an abnormal neurological examination as independent predictor factors of worse outcome in all patients with meningitis. Our results demonstrate that the etiology, clinical presentation, and CSF findings differ between HIV-infected and HIV-uninfected adults with CAM, but clinical outcomes are similar. [ABSTRACT FROM AUTHOR]

Background: Xenotropic murine leukemia virus-related virus (XMRV) has been found in the prostatic tissue of prostate cancer patients and in the blood of chronic fatigue syndrome patients. However, numerous studies have found little to no trace of XMRV in different human cohorts. Based on evidence suggesting common transmission routes between XMRV and HIV-1, HIV-1 infected individuals may represent a high-risk group for XMRV infection and spread. Methodology/Principal Findings: DNA was isolated from the peripheral blood mononuclear cells (PBMCs) of 179 HIV-1 infected treatment naïve patients, 86 of which were coinfected with HCV, and 54 healthy blood donors. DNA was screened for XMRV provirus with two sensitive, published PCR assays targeting XMRV gag and env and one sensitive, published nested PCR assay targeting env. Detection of XMRV was confirmed by DNA sequencing. One of the 179 HIV-1 infected patients tested positive for gag by non-nested PCR whereas the two other assays did not detect XMRV in any specimen. All healthy blood donors were negative for XMRV proviral sequences. Sera from 23 HIV-1 infected patients (15 HCV+) and 12 healthy donors were screened for the presence of XMRV-reactive antibodies by Western blot. Thirteen sera (57%) from HIV- 1+ patients and 6 sera (50%) from healthy donors showed reactivity to XMRV-infected cell lysate. Conclusions/Significance: The virtual absence of XMRV in PBMCs suggests that XMRV is not associated with HIV-1 infected or HIV-1/HCV coinfected patients, or blood donors. Although we noted isolated incidents of serum reactivity to XMRV, we are unable to verify the antibodies as XMRV specific. [ABSTRACT FROM AUTHOR]

Background The Centers for Disease Control and Prevention recommends that all patients be tested for HIV while in a healthcare setting. HIV testing is especially important in patients with a central nervous system (CNS) infection because it impacts the differential diagnosis. In this study, we determined the rate of HIV testing in patients who presented with a CNS infection. Methods We performed a multicenter retrospective study of 1,312 patients over the age of 17 years with community or healthcare-acquired meningitis, aseptic meningitis or encephalitis admitted to 18 hospitals in New Orleans, LA and Houston, TX from July 1, 1998 through December 31, 2017. Prospective patients were identified using ICD 9 coding, physical examination findings, and cerebrospinal fluid analysis. The electronic medical records for these patients were reviewed for HIV testing and diagnosis. Aseptic meningitis cases were also reviewed for HIV RNA PCR testing. 100 patients with a known HIV diagnosis were excluded (2 aseptic meningitis, 82 encephalitis, and 16 community-acquired meningitis). Results Out of 1,312 patients presenting with a confirmed CNS infection, 664 (50.6%) had an HIV test done. A total of 81 patients (12.2%) were newly diagnosed with HIV during admission. Patients who underwent HIV testing were more likely to be non-caucasian, have no underlying comorbidities, lower Glasgow coma scale, and more seizures on presentation (P < 0.05). HIV testing also varied by type of CNS infection: community-acquired meningitis (98/142, 69.0%); encephalitis (180/261, 69.0%), aseptic meningitis (300/643, 46.6%), and healthcare-associated meningitis (86/289, 29.7%). In only 35 out of 547 patients (6.4%) presenting with acute aseptic meningitis was an HIV RNA PCR test ordered; 26 out of the 35 (74%) HIV RNA PCRs were positive with 9 patients being diagnosed with acute HIV seroconversion syndrome. Conclusion HIV testing is done in only one-half of patients with CNS infections with only a minority of patients presenting with acute aseptic meningitis being evaluated for acute HIV seroconversion syndrome. Clinicians should order an HIV test on all patients with CNS infections and consider testing for HIV RNA PCR in patients presenting with acute aseptic meningitis especially in those where the etiologic diagnosis remains unknown. Disclosures All authors: No reported disclosures. [ABSTRACT FROM AUTHOR]

Background Hepatitis B virus (HBV) coinfection is common in people with HIV. Compared with HBV mono-infected individuals, those that are HIV/HBV coinfected show evidence of more rapid progression to advanced liver disease (ALD) and increased mortality rate. In this study, we identified characteristics in an HIV/HBV cohort associated with ALD. Methods We retrospectively examined an HIV/HBV coinfected cohort to determine the prevalence of ALD and its correlation with selected variables. Data were drawn from HIV and HBsAg+ patients at three HIV clinics in Houston, Dallas, and San Antonio, Texas. Those without chronic HBV were excluded. ALD was defined as cirrhosis, decompensation, and/or hepatocellular carcinoma, as determined by imaging. Variables included demographics, HIV risk factors, comorbidities, HBsAg loss, HepBeAg, CD4+ count, HBV DNA, and HIV RNA viral load. Bivariate analysis was performed using chi-square and student t-test as appropriate; a logistic regression model was used to identify independent associations among significant variables (STATA). Results Within those with HIV/HBV coinfection (n = 501), 89 (18%) met the criteria for ALD (92% male, 47% Black, 33% White, 16% Hispanic, 73% >40 years old). Amongst these (n = 89), significant differences were observed with race (P = 0.039), age (P = 0.001), patients identified as MSM/Bisexuals (P = 0.047), diabetes mellitus (DM) (P = 0.01) and hepatitis C virus (HCV) coinfection (P ≤ 0.001). Compared with Whites, Blacks are less likely to have ALD (95% CI 0.27, 0.79, P = 0.004), and those age 40–49 (95% CI 1.28, 10.92, P = 0.016) and >50 (95% CI 1.63, 15.54, P = 0.005) were more likely. The multivariate logistic regression analysis showed patients that are White race, age >50, have DM, and those with HCV coinfection had increased risk for ALD (Table 1). No differences were seen with gender, insurance, alcohol use, HBsAg loss, HepBeAg status or baseline CD4+ count, HBV DNA, HIV RNA, and AIDS. Conclusion Increased monitoring for the presence of ADL should be conducted in HIV/HBV coinfection. Particular attention and surveillance should be paid to those with the following risk factors: Whites, elder age (>50), and comorbidities of DM and HCV. These should be taken into consideration when approaching the development and treatment of ADL in HIV/HBV patients. Disclosures All authors: No reported disclosures. [ABSTRACT FROM AUTHOR]

Background Approximately 30% of people living with HIV are co-infected with Hepatitis C virus (HCV). HIV/HCV coinfected patients have faster progression to liver fibrosis, cirrhosis, and increased mortality, compared with monoinfected patients. Therefore, treatment in this population is a priority. The objective of this study was to develop an active program to reach HIV/HCV co-infected patients, with the goal to eliminate Hepatitis C in our local HIV clinic. Methods Beginning in December 2016, our clinic received State funds to support open access to treat HIV/HCV patients with direct-acting antivirals (DAA). From December 2016 to May 2018, the process was based on primarily on physician referrals to treat HIV/HCV patients at our clinic, without an active intervention, and 50 patients were treated. Our active intervention during the second part was based on the identification of all untreated HIV/HCV patients and contacting them directly, to link them to care. Results A total of 462 HIV/HCV co-infected patients were identified who qualified for the state-sponsored treatment program. From June 1, 2018 to July 31, 2018, only 7 patients were linked to care and started on DAA. The four main identified reasons for not getting DAA therapy were: no show up to the clinic appointments, poor adherence to their HIV antiretroviral treatment, use of drugs and not able to be reached (figure). Although drug use was listed as one of the main reasons for not receiving DAA therapy, it was not the defining reason for most patients. A majority of the patients had more than one obstacle preventing them from coming in to be treated. Conclusion Wide availability of DAA and open access to treatment is not enough to eliminate HIV/HCV co-infection. Innovative outreach processes with the active participation of key stakeholders are needed in order to eliminate this viral infection. Disclosures All authors: No reported disclosures. [ABSTRACT FROM AUTHOR]

Background Reduced microbiota diversity (dysbiosis) in people with HIV (PWH) can damage the intestinal barrier and increase microbial translocation, resulting in inflammation, a driver of morbidity and mortality. We hypothesized that fecal microbiota transplants (FMT) would reverse dysbiosis in PWH. Methods We administered 6 weekly oral doses of a novel lyophilized fecal microbiota product from 2 healthy donors to 6 men who have sex with men with HIV on suppressive ART. Shotgun sequencing on stool before, after 6 weekly FMT, and 20 weeks after the last FMT (Weeks 0, 6 and 26), and from donors, was performed to determine bacterial community profiles. Biomarkers were measured by Luminex assays and ELISAs. All comparisons used Wilcoxon matched-pairs signed rank test. Results Median age at Week 0 was 41 years, CD4+ T-cell count 504 cells/mm3, VL < 20 copies/mL. Mean α diversity by observed species index increased from Week 0 to 6 (61.2 to 70.2, P = 0.29; Figure 1) and decreased by Week 26 (70.2 to 52.2, P = 0.33) to be similar to the donors' (63.5, P = 0.86). Microbiome distribution by principal component analysis shifted toward the donors' distribution in most participants at Week 6 but shifted away by Week 26 (Figure 2). Biomarkers did not change significantly during the study. PID3, with HIV > 35 years, had chronic constipation that resolved with FMT with a large shift in distribution but recurred at Week 26. Fusobacterium gonidiaformans , Porphyromonas somerae , and Haemophilus parainfluenzae comprised 27% of his microbiome at Week 0 but 0.73% at Week 6; untyped Bacteroides comprised 35% at Week 6. I-FABP (6,899 to 2,736 pg/mL), sCD14 (1.67 to 1.31 μg/mL), IL-6 (1.51 to 1.13 pg/mL) and sTNFRII (11,659 to 8,300 pg/mL) levels decreased in PID3; Week 0 levels in PID3 were higher than in other recipients. No related serious adverse events occurred. Conclusion Weekly FMT resulted in increased intestinal microbiome α diversity and a shift in microbiome distribution in most participants. These changes did not persist after stopping FMT. PWH with long-term HIV and/or greater inflammation or gut damage may be most likely to benefit from FMT. The effects of recurrent FMT were transient, suggesting longer duration of treatment or intermittent FMT boosting may be required to maintain its benefits. Disclosures All authors: No reported disclosures. [ABSTRACT FROM AUTHOR]

Background Disseminated strongyloidiasis in solid organ transplant recipients is a rare but devastating infection. In our center, we implemented a universal screening of all candidates for kidney transplantation. We assessed the seroprevalence and utility of universal screening for strongyloidiasis in our center. Methods Patients were identified from our transplant referral list (from July 2012 to June 2017). Demographics, pretransplant laboratory, and serological screenings were retrospectively collected. For Strongyloides- seropositive (SSp) patients, data on travel history, symptoms, treatment, and stool ova and parasite examinations were extracted. Logistic regression and multiple imputation for missing data were performed. Results A total of 1689 patients underwent serological screening, of whom 168 (9.9%) were SSp. Univariate analysis revealed that SSp patients had higher rates of eosinophilia, diabetes mellitus, latent tuberculosis and were likely to be either Hispanic or Asian (P <.05). In multivariate analysis, eosinophilia (P =.01), diabetes mellitus (P =.02), and Asian race (P =.03) were associated with being SSp, but 45 (27%) of the SSp patients did not have any of these 3 factors, and 18 SSp patients (11%) had no epidemiological risk factors. All patients received ivermectin, and none developed disseminated strongyloidiasis. Of patients who underwent serological screening on multiple occasions, 6.8% seroconverted while waiting for kidney transplantation. Conclusions We found a high rate of Strongyloides seropositivity among our kidney transplantation candidates. No epidemiological risk factors effectively predicted SSp status in our population, and universal screening identified a large number of patients without such factors. Serial screening should be considered when a long wait time is expected before transplantation. [ABSTRACT FROM AUTHOR]

As more patients seek care in the outpatient setting, the opportunities for health care–acquired infections and associated outbreaks will increase. Without uptake of core infection prevention and control strategies through formal initiation of infection prevention programs, outbreaks and patient safety issues will surface. This review provides a step-wise approach for implementing an outpatient infection control program, highlighting some of the common pitfalls and high-priority areas. [ABSTRACT FROM AUTHOR]

Background: Reduced microbiota diversity (dysbiosis) in people with HIV (PWH) likely contributes to inflammation, a driver of morbidity and mortality. We aimed to evaluate the safety and tolerability of 6 weekly oral fecal microbiota transplants (FMT) administered to reverse this dysbiosis., Methods: Six PWH on suppressive antiretroviral therapy (ART) received 6 weekly doses of lyophilized fecal microbiota product from healthy donors. Shotgun sequencing on stool before, after last FMT, and 20 weeks thereafter was performed. Inflammation and gut permeability biomarkers were measured., Results: Median age at week 0 was 39 years, CD4 + T cell count 496 cells/mm 3 , HIV RNA levels <20 copies/mL. FMT was safe and well-tolerated. α diversity increased in 4 participants from weeks 0 to 6, including the 3 with the lowest α diversity at week 0. At week 26, α diversity more closely resembled week 0 than week 6 in these 4 participants. Metagenomic analysis showed no consistent changes across all participants. One participant had high gut permeability and inflammation biomarker levels and low α diversity that improved between weeks 0 and 6 with a shift in distribution., Conclusions: Weekly FMT was safe and well-tolerated. α diversity increased in participants with the lowest baseline α diversity during the treatment period. Future randomized, controlled trials of FMT should consider evaluating PWH with greater inflammation, gut damage, or dysbiosis as this population may be most likely to show a significant response.ClinicalTrials.gov Identifier: NCT03329560., Competing Interests: H.L.D. and Z-D.J. have applied for a patent for PRIM-DJ2727, and H.L.D. has received a grant from Rebiotix to study their FMT product. MF is an employee of Associates of Cape Cod, Inc., the manufacturer of the (1,3)-β-D-glucan test used in this study. No other authors have competing interests., (Copyright © Pathogens and Immunity 2020.)

Importance of the Field: Herpes viruses are associated with a wide spectrum of clinical diseases and impose considerable morbidity and even mortality in immunosuppressed hosts. Although there is no cure for these conditions, available treatments alleviate symptoms, suppress recurrences and reduce the risk of transmission. Valacyclovir was discovered in 1988 and revolutionized the treatment of these infections by virtue of its less frequent dosing regimen, which promotes patient adherence., Areas Covered in This Review: This review focuses on the basic principles, mechanisms of action, safety and approved and off-label usage of valacyclovir in the immunocompetent and immunocompromised host., What the Reader Will Gain: The reader will have available the current and most up-to-date information on the pharmacology of valacyclovir as well as its clinical use., Take Home Message: Valacyclovir is a great alternative for the treatment of herpes infections. Now that its patent has expired, new cheaper formulations may start to appear.

Bacterial enteropathogens acquired from contaminated food are the principal causes of travelers' diarrhea (TD). We evaluated desserts obtained from popular restaurants in the tourist city of Guadalajara, Mexico, and Houston, Texas, to determine coliform and Escherichia coli contamination levels and presence of diarrheagenic E. coli known to be important in TD. Contamination for all organisms was seen for desserts served in Guadalajara restaurants. Desserts should be considered as potentially risky foods for development of TD among international visitors to developing regions of the world.