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The pediococci are gram-positive bacteria that grow in pairs and tetrads and belong to the lactic acid bacteria group. They are used extensively in industry to ferment cheese and other dairy products, soy products, and alcoholic beverages, and they are normal inhabitants of the human gastrointestinal tract. Of the 13 species of pediococci, only Pediococcus acetolactic and P. pentosaceus are typically found in sugar-rich foods, and these have been identified as human pathogens. Recently, pediococci have been increasingly recognized as a cause of bacteremia, endocarditis, and pneumonitis in the immunocompromised host. The chapter discusses risk factors for Pediococcus infections that include prior antibiotic therapy, abdominal surgery, and gastric feeding. The chapter further discusses the testing, evaluation, and treatment of patients presenting with possible pediococcal disease.

Background Trillium Health (TH) is a Federally Qualified Health Center look-alike and Ryan White C grantee in Rochester, NY providing primary and specialty care, including HIV prevention and treatment. Rapid Start Antiretroviral therapy (RSA) has been shown to decrease time to viral suppression while increasing linkage to and retention in care. However, data on a fixed-dose combination of BFTAF with these benefits are limited. We aim to show RSA with BFTAF time to viral suppression, adherence to medication, and retention in care is statistically significant in comparison to older treatment models. Additionally, we aim to demonstrate the feasibility and acceptability of RSA with BFTAF. Methods This is an interim analysis of participants who enrolled in the study and been in care at TH for at least 3 months as of May 2021. All participants complete a baseline assessment and start BFTAF. Follow up visits are conducted through 48 weeks. Primary and secondary endpoints are included in the attached table 2 Barriers to care and patient reported outcomes were evaluated through a standardized questionnaire at the final study visit. Study results were compared with non-RSA historical control data from patients who received standard of care universal ART initiation at TH. Results Thirty-four participants have been enrolled in the study for at least 12 weeks, 33 (97%) of whom have reached and maintained viral suppression. Twenty-one participants have completed all 48 weeks, with 20 (95%) reaching and maintaining viral suppression. In comparison to historical controls, the RSA study participants had a statistically significant shorter time to viral suppression, both from diagnosis and from ART initiation. The RSA patients had statistically significant higher retention at 12, 24, and 48 weeks in comparison to historical controls. Adherence was higher in the RSA patients, though not statistically significant. Enrollment Graphic for the Rochacha Study Baseline Demographics of Study Participants and Controls Clinical Outcomes of Study Participants compared to Controls Conclusion Our data show that RSA with BFTAF can be effective in a community based health center setting in participants facing barriers to care. The patients who were treated by RSA with BFTAF had a high viral suppression rate. To date, no BFTAF regimen had to be changed due to resistance or virologic failure in this study. These data support implementation of RSA with BFTAF as standard of care. Disclosures Ashley R. Zuppelli, PHARMD, BCACP, AAHIVP, Gilead Sciences (Research Grant or Support) Robert Biernbaum, DO, MS, FAAEM, AAHIVS, Gilead Sciences (Research Grant or Support) Roberto Corales, DO, AAHIVS, Gilead Sciences (Employee, Scientific Research Study Investigator) Shealynn Hilliard, MS, Gilead Sciences (Research Grant or Support) William M. Valenti, MD, FIDSA, Gilead Sciences (Research Grant or Support)

Blacks and Hispanics/Latinos are disproportionately burdened by HIV compared to non-Hispanic Whites, as evidenced by higher HIV incidence, prevalence, and deaths attributable to AIDS. Increasing the use of novel prevention techniques such as Truvada for pre-exposure prophylaxis (PrEP) could greatly help in reducing these disparities by lowering HIV incidence among these higher risk groups. Trust in providers, which may differ by race and ethnicity, may influence willingness to take PrEP. This study explores the moderating effect of race/ethnicity on trust in one's primary care provider (PCP) on PrEP willingness. This study found a significant association between PCP trust and PrEP willingness, with those with greater trust having 3.24 times the adjusted odds of being willing to try PrEP. Results regarding the effects of race and ethnicity on these outcomes, however, were inconclusive. Results indicate the importance of fostering trust between PrEP-prescribing PCPs and their patients.

Background Trillium Health (TH) is a FQHC in Rochester, NY providing primary and specialty care, including HIV prevention and treatment. Rapid Start ART (RSA) has been shown to decrease time to virologic suppression while increasing linkage to and retention in care. However, data on BFTAF with these benefits is limited. We aim to prove RSA with BFTAF is advantageous in time to viral load suppression, linkage to and retention in care, and patient satisfaction and acceptance. Methods We included data from ART-naive newly diagnosed PLWH enrolled between October 2018 and March 2020 with baseline assessment and started BFTAF. Follow up visits were done per protocol though 48 weeks. The primary study endpoints include median times from: diagnosis to clinic presentation, clinic presentation to ART, and ART to undetectable viral load (VL), < 200 copies/mL and < 50 copies/mL. Linkage to and retention in care were measured at 3 months. Study results were compared with non-RSA historical control data. Patient reported outcomes were evaluated at study completion. Results Of the 27 eligible, 25 participants enrolled. Thirteen received their diagnosis at TH: screening for PrEP (6), community-based HIV/STI/HCV testing (3), community outreach (1), or routine patient screening in primary care (3). Twelve were diagnosed externally: university health centers (2), other health clinic (9), or at-home rapid HIV test (1). All accepted the RSA treatment with BFTAF; two eligible patients declined the study, but accepted RSA. 73.9% of participants were seen within 14 days of Day 84, compared with 50% of historical control group. 12 of 25 completed the primary endpoint of which 100% were highly satisfied with RSA. There were no regimen changes or virologic failures through 48 weeks. RoCHaCHa Study Results Conclusion RSA with BFTAF reduced time to virologic suppression in all participants newly diagnosed with HIV-1 compared with historical non-RSA model. Disclosures Ashley R. Zuppelli, PHARMD, BCACP, AAHIVP, Gilead Sciences, Inc. (Grant/Research Support)Gilead Sciences, Inc. (Advisor or Review Panel member, Research Grant or Support) Michael Mancenido, DO, AAHIVS, Gilead Sciences, Inc. (Grant/Research Support) Jacob Scutaru, MD, Gilead Sciences, Inc. (Grant/Research Support) Alexandra Danforth, PHARMD, BCACP, AAHIVP, Gilead Sciences, Inc. (Grant/Research Support) Robert Biernbaum, DO, MS, FAAEM, AAHIVS, Gilead Sciences, Inc. (Grant/Research Support, Advisor or Review Panel member, Speaker’s Bureau) Roberto Corales, DO, AAHIVS, Gilead Sciences (Employee) William M. Valenti, MD, FIDSA, Gilead Sciences, Inc. (Grant/Research Support, Speaker’s Bureau)

Background: The efficacy and safety of a single tablet regimen (STR) of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) was analyzed in Phase 3 clinical trials in antiretroviral therapy (ART)-naive and ART-experienced Asian participants infected with human immunodeficiency virus (HIV)-1 through 96 or 144 weeks. Objective: In Asian population requiring treatment, it is imperative to have data specific to this group, particularly as there is a general concern that Asians with lower body weight have increased risk of tenofovir disoproxil fumarate (TDF)-related renal dysfunction. Methods: Studies -104 and 111 were randomized, double-blind, placebo-controlled, 144-week studies conducted in ART-naive participants, comparing E/C/F/TAF versus E/C/F/TDF. Study 109 was a randomized, open-label, 96-week study conducted in virologically suppressed, ART-experienced participants, who switched to E/C/F/TAF from ritonavir/cobicistat-boosted atazanavir ATV+(RTV or COBI) + F/TDF regimens, from non-nucleoside reverse transcriptase inhibitors (NNRTI) + F/TDF regimens, or from E/C/F/TDF. Study 112 was a single arm, open-label, 144-week study conducted in HIV suppressed, ART-experienced participants with mild-moderate renal impairment, who switched to E/C/F/TAF. Results: Asian participants in these studies had sustained efficacy safety and tolerability. In Study 104/111, Asian participants achieved 93% virologic suppression on TAF vs 88% on TDF at week 144. At baseline, there were numerically more Asians with median CD4 counts 100,000 c/mL. In Study 109, 95% of Asians on TAF vs 86% on TDF maintained virologic suppression at week 96. Lastly, in Study 112, 91% maintained virologic suppression at week 144. There were no discontinuations due to renal AE, no cases of PRT or Fanconi syndrome in any of the studies.

AIDS Clinical Trial Group study A5202 (ClinicalTrials.gov identifier {"type":"clinical-trial","attrs":{"text":"NCT00118898","term_id":"NCT00118898"}}NCT00118898) was a phase 3b, randomized, partially blinded equivalence study of open-label atazanavir/ritonavir or efavirenz, plus either placebo-controlled tenofovir disoproxil fumarate/emtricitabine or abacavir/lamivudine, in treatment-naive adults living with HIV-1, evaluating efficacy, safety, and tolerability. We report an analysis of the contribution of participant characteristics to the disposition of tenofovir plasma concentrations. Tenofovir concentration data from a total of 817 individuals (88% of the total number of eligible patients randomly assigned to receive treatment in the TDF-containing arms of A5202) were available for analysis. Pharmacokinetic analysis was performed using nonlinear mixed-effects modeling. One- and two-compartment models with first-order absorption and first-order elimination were evaluated. An exponential error model was used for examination of interindividual variability (IIV), and a proportional and mixed-error model was assessed for residual variability. The final structural model contained two compartments with first-order absorption and elimination. IIV was estimated for apparent clearance (CL/F) and the first-order absorption rate constant (ka), and a proportional residual variability model was selected. The final mean parameter estimates were as follows: ka = 2.87 h−1, CL/F = 37.2 liters/h, apparent volumes of the central and peripheral compartments = 127 and 646 liters, respectively, and apparent intercompartmental clearance = 107 liters/h. In addition to race/ethnicity, creatinine clearance and assignment to atazanavir/ritonavir or efavirenz were significantly associated with CL/F (P < 0.001). In conclusion, race/ethnicity is associated with tenofovir oral CL in HIV-1 positive, treatment-naive adults. This covariate relationship raises questions about the possibility of differences in efficacy and risk of adverse events in different patient populations and suggests that examining preexposure prophylaxis regimens and tenofovir exposure in different race/ethnicity groups be considered.

BACKGROUND Annual screening for anal cancer is recommended only for HIV patients at increased risk: men who have sex with men, individuals with a history of anogenital warts, and women with cervical dysplasia. OBJECTIVE The aim of this study was to examine the screening outcomes between HIV populations with and without these risk factors. METHODS We reviewed the records of all HIV patients referred for anal cytology and high-resolution anoscopy from June 2009 to June 2010. Patients were stratified into an increased-risk group or a standard-risk group. MAIN OUTCOME Of the 329 evaluable patients, 285 (89.8% men, 10.2% women, mean age 46 ± 10 years) were classified to the increased-risk group, whereas 44 (72.7% men, 27.3% women, mean age 52 ± 8 years) were included in the standard-risk group. Male sex, white race, sexual orientation, past and current receptive anal intercourse, noncompliance with condom use, and absence of a new sexual partner were significantly different in the increased-risk group in comparison with the standard-risk group. In the increased-risk group, 187 (66.5%) patients had biopsy-proven dysplasia of which 118 (42.0%) had high-grade disease. In the standard-risk group, 15 (34.9%) patients had biopsy-proven dysplasia of which 7 (16.3%) had high-grade disease. Cytology detected biopsy-confirmed high-grade dysplasia only in 23 of 118 (19.5%) patients in the increased-risk group and in 2 of 7 (28.6%) patients in the standard-risk group. Kappa agreement in detecting high-grade disease was low for both increased-risk and standard-risk groups: 0.16 (95% CI 0.07-0.23) and 0.40 (95% CI 0.02-0.40). LIMITATIONS Our study is a chart-based retrospective review of data with a small female population. Histology reports came from 2 different laboratories. CONCLUSION High-grade anal dysplasia was prevalent even among HIV patients who only have standard risk factors. Anal cytology and high-resolution anoscopy have poor agreement. We suggest considering annual screening by using high-resolution anoscopy in addition to cytology for all HIV patients regardless of risk factors.

Proven clinical efficacy of protease-sparing regimens (PSR) has been shown. Concerns exist about broad applicability of these regimens in advanced naïve patients. Recent reports have associated a rise in liver enzymes with nevi rapine; however, no data exist with efavirenz.17 consecutive antiretroviral-naïve HIV patients were started on a PSR with efavirenz plus two nucleoside reverse transcriptase inhibitors. Baseline liver enzymes, serum CD38, CD4, and HIV viral load data were collected. Correlation between change in viral load and immune reconstitution on therapy were compared to baseline laboratory values.All patients had a mean viral load decrease of2 logs, including patients with low initial CD4% or high viral load, and there was no increase of liver enzymes observed at a median follow-up of 42 weeks (range 17-78). There was a perfect correlation between the change in viral load and the initial viral load (p.0001, r = 1.00) including patients with viral loador =100,000 copies/mL and CD4 countor =50 (n = 5). Even patients with low initial CD4 had a significant percentage increase in CD4 count (p.0002, r = 0.7880). CD38% showed a positive correlation with change in viral load (p =.046, r = 0.522).All patients experienced a mean viral load decrease of2 logs (88% less than 400 copies/mL and 35% less than 20 copies/mL). There were no observed increases in liver enzymes. Patients with low CD4 counts, high initial viral load, or high CD38 expression still experienced a significant change in viral load.

Background: Persons living with HIV (PLWH) need practical tools to self-manage their condition. Methods: We conducted a proof-of-concept study among PLWH to assess whether patients could learn to use a personal health record (PHR) on a hand-held device (iPod Touch) to manage their condition. We began individual trainings and later adapted this to group training. We assessed usability, acceptability and also effects on self-efficacy for treatment adherence using the HIV Treatment Adherence Self-Efficacy Scale (HIV-ASES). Results: Nine PLWH participated in the individual training and 29 participated in the group sessions. The participants were largely middle aged, low-income and of racial/ethnic minorities. The sessions were well attended and participants fully engaged in tasks and shared learning. Most participants stated they intended to use the PHR and reported improved self-efficacy in treatment adherence ( P = .05) particularly on the integration of treatment adherence into one's routine ( P < .02). Conclusions: Training PLWH in use of a handheld PHR shows promise.

Evaluate the impact of switching from twice-daily zidovudine/lamivudine (AZT/3TC) to once-daily tenofovir DF plus emtricitabine (TDF/FTC) with efavirenz (EFV).Prospective, multicenter, single-arm 24-week trial.Patients on EFV + AZT/3TC foror =8 weeks with HIV-1 RNA400 copies/mL were switched to EFV + TDF/FTC and assessed for safety/tolerability, virologic and immunologic responses, adherence, and quality of life at 4, 12, and 24 weeks.Of 402 patients, 2% discontinued for an adverse event (AE) and 1 patient for virologic failure. At 24 weeks, 87% had HIV RNA400 copies/mL, and 74% versus 71% at baseline had undetectable (HIV RNA50 copies/mL) viral load (ITT; M=F). Treatment-emergent AEs were infrequent (or = 5%) with gastrointestinal complaints being the most common. At 24 weeks compared to baseline, hemoglobin (Hb) increased by a median of 0.6 g/dL (p.001), and a decrease in creatinine clearance of 7.6 mL/min (p.001) was observed. Fasting lipids decreased slightly (p.02) in a subset of patients studied (n = 160). A higher percentage of patients reported being "very satisfied" with treatment and the absence of regimen side effects at 24 weeks versus baseline (p.001). At 24 weeks, 86% of patients tookor = 95% of doses versus 78% at baseline (p = .002).Patients switched to EFV + TDF/FTC maintained virologic suppression and the regimen was well tolerated. Patients reported increased satisfaction with treatment and fewer were bothered by side effects.

BackgroundAntiretroviral regimens with simplified dosing and better safety are needed to maximize the efficiency of antiretroviral delivery in resource-limited settings. We investigated the efficacy and safety of antiretroviral regimens with once-daily compared to twice-daily dosing in diverse areas of the world.Methods and findings1,571 HIV-1-infected persons (47% women) from nine countries in four continents were assigned with equal probability to open-label antiretroviral therapy with efavirenz plus lamivudine-zidovudine (EFV+3TC-ZDV), atazanavir plus didanosine-EC plus emtricitabine (ATV+DDI+FTC), or efavirenz plus emtricitabine-tenofovir-disoproxil fumarate (DF) (EFV+FTC-TDF). ATV+DDI+FTC and EFV+FTC-TDF were hypothesized to be non-inferior to EFV+3TC-ZDV if the upper one-sided 95% confidence bound for the hazard ratio (HR) was ≤1.35 when 30% of participants had treatment failure. An independent monitoring board recommended stopping study follow-up prior to accumulation of 472 treatment failures. Comparing EFV+FTC-TDF to EFV+3TC-ZDV, during a median 184 wk of follow-up there were 95 treatment failures (18%) among 526 participants versus 98 failures among 519 participants (19%; HR 0.95, 95% CI 0.72-1.27; p = 0.74). Safety endpoints occurred in 243 (46%) participants assigned to EFV+FTC-TDF versus 313 (60%) assigned to EFV+3TC-ZDV (HR 0.64, CI 0.54-0.76; pConclusionEFV+FTC-TDF had similar high efficacy compared to EFV+3TC-ZDV in this trial population, recruited in diverse multinational settings. Superior safety, especially in HIV-1-infected women, and once-daily dosing of EFV+FTC-TDF are advantageous for use of this regimen for initial treatment of HIV-1 infection in resource-limited countries. ATV+DDI+FTC had inferior efficacy and is not recommended as an initial antiretroviral regimen.Trial registrationwww.ClinicalTrials.gov NCT00084136. Please see later in the article for the Editors' Summary.