bluuebunny/crossref_metadata_2025 huggingface dataset:
872. Number of Sexual Partners and Patient-Reported Outcomes among Older Adults Living With HIV
Authors: Mazonson Peter , Berko Jeff , Loo Theoren , Coelho Giselle D , Lowman Erik , Shalit Peter , Spinelli Frank
Published: December 2021

Background

Many older (age 50+) adults living with HIV (OALWH) are sexually active. However, little is known about the relationship between number of sexual partners and mental health outcomes among OALWH.

Methods

Data were utilized from the Aging with Dignity, Health, Optimism and Community (ADHOC) cohort, an observational study of OALWH from ten US clinics.

To measure sexual activity, participants were asked “How many sexual partners have you had in the last year?” with response options ranging from zero to “greater than five.” Loneliness was measured using the Three-item Loneliness Scale, and depression was measured using the Patient Health Questionnaire-2. Significance was determined by Kruskal-Wallis tests followed by unadjusted pairwise comparisons.

Results

Of 1,027 participants, the mean (SD) age was 58.9 (6.1) and 876 (85%) were male. 312 (30%) had zero sexual partners in the past year, 308 (30%) had one partner, 197 (19%) had 2-5 partners, and 210 (20%) had >5 partners. Of the participants with one partner, 230 (75%) were married, coupled or partnered, and 78 (25%) were single, widowed, separated, or divorced (Single). Figure 1 shows that people with one partner were significantly less lonely than any other group (p< 0.01 for pairwise comparisons), and all other groups were statistically similar to each other. This pattern was also seen with depression (p< 0.01 for pairwise comparisons, Figure 2). Among subgroup of people with one sexual partner, those who were married, coupled or partnered were less lonely (4.41 vs. 5.67, p< 0.01) and less depressed (0.95 vs 1.38, p=0.02) than those who were single, widowed, separated, or divorced.

Conclusion

Among OALWH, people with one sexual partner were less lonely and depressed than people with zero or with ≥2 partners. Furthermore, people with one sexual partner who were married or in a committed relationship were less lonely and depressed than people with one sexual partner who were not.

Disclosures

Peter Mazonson, MD, MBA, ViiV Healthcare (Grant/Research Support) Jeff Berko, MPH, BS, ViiV Healthcare (Scientific Research Study Investigator) Theoren Loo, MPH, ViiV Healthcare (Grant/Research Support) Giselle D. Coelho, MD. MPHTM, Lilly (Research Grant or Support)Medscape, Clinical Care Options (Independent Contractor)Viiv, Gilead, Janssen (Advisor or Review Panel member, Research Grant or Support) Erik Lowman, MD, Gilead (Grant/Research Support)Janssen (Grant/Research Support)ViiV (Grant/Research Support) Peter Shalit, MD, PhD, Abbvie (Grant/Research Support)Gilead Sciences (Consultant, Grant/Research Support, Speaker’s Bureau)Glaxo Smithkline (Consultant, Grant/Research Support)Janssen (Consultant, Grant/Research Support, Speaker’s Bureau)Merck (Grant/Research Support, Speaker’s Bureau)Thera (Speaker’s Bureau)ViiV Healthcare (Speaker’s Bureau) Frank Spinelli, MD, ViiV Healthcare (Employee)
873. A Retrospective Cohort Study on Treatment Outcomes of Patients on Third-Line Therapy at the HIV Advanced Treatment Centre, University Teaching Hospital, Zambia
Authors: Toeque Mona-Gekanju , Lindsay Brianna , Zulu Paul Msanzya , Fwoloshi Sombo , Chanda Duncan , Mupeta Francis , Siwingwa Mpanji , Mbewe Melody , Chirwa Lameck , Hachaambwa Lottie , Mulenga Lloyd , Claassen Cassidy
Published: December 2021

Background

In Zambia, third-line regimens consist of a switch to darunavir/ritonavir (DRV/r) and/or raltegravir (RAL) and/or etravirine (ETV), and as of 2017, dolutegravir (DTG), from a failing second-line therapy.5 We assessed virologic suppression (HIV viral load (VL) ≤1000 copies/ml per Zambian national guidelines), immunological response, and patterns of HIV drug resistance mutation among patients on third-line ART at the University Teaching Hospital (UTH) in Lusaka, Zambia.

Methods

A retrospective evaluation of adults ≥18 years old on third-line ART regimens at UTH between January 2012 to June 30, 2020 was conducted. Patients were referred for second-line virologic failure defined as HIV RNA VL > 1000 copies/mL on two consecutive measurements after 6 months on second-line ART.5 We assessed virologic suppression VL ≤1000 copies/ml, CD4, mutations, and third-line regimens of this cohort. Patients were excluded if they were on third-line ART < 6 months or received RAL and/or ETV and/or DTG before starting third-line ART.

Results

A total of 539 patients were included; 231 males (42.9%) and 308 (57.1%) females. The mean age of third-line initiation was 29.8 years; mean time from ART initiation to third-line initiation was 9.9 years. Out of 25 combination 349 (64.7%) received DTG, 272 (50.5%) DRV/r, 85(15.8%) ETR, and 49 (9.1%) RAL. There were 215 (39.9%) genotypes; common mutations were to zidovudine (80%), non-nucleoside reverse transcriptase inhibitors (NNRTIs) (78%), and protease inhibitors (PIs) (41%). Patients with at least one viral load and CD4 upon third-line initiation was 296 (54.9%) and 350 (64.9%), respectively. Among patients with sufficient data (21%, n=115), VL suppression increased from 44 (38%) patients at baseline to 53 (46%) at next available follow-up; with mean baseline VL and follow-up VL of log10 3.60 and 3.33, respectively. The immunologic response revealed 49 (56.3%) had CD4 increase with mean increase of 61.1 cells/mm3. (See Table 1.)

Conclusion

We found moderate improvements in VL suppression and immunologic response. Nearly all third-line patients had genotypic resistance to first-line NNRTI and nearly half to second-line PI regimens. Quality improvement measures are needed to improve viral load timing following ART changes to better assess regimen efficacy.

Disclosures

All Authors: No reported disclosures
874. Impact of Telehealth in HIV Ambulatory Clinic during COVID-19 Pandemic Impact of Telehealth in HIV Ambulatory Clinic during COVID-19 Pandemic
Authors: Nagarakanti Sandhya , Bishburg Eliahu , George Donna , Ehlers Kristen
Published: December 2021

Background

HIV outpatient in-person (IN-P) visits were limited during the COVID-19 pandemic, and most patients (pts) were cared for remotely through telehealth (TELE). We sought to evaluate the impact of TELE on HIV infected pts during the pandemic compared to the pre-pandemic IN-P care.

Methods

Retrospective chart review of pts in an outpatient HIV clinic, study period 03/30/2019 to 03/29/2021. Two periods were defined: pre-COVID (Pre-CO) 3/30/2019 to 3/29/2020 and COVID (CO) 3/30/2020 to 3/29/2021. Data was collected on demographics, HIV risk, type of encounter, number of encounters, CD4, HIV Viral loads (VL) at first, and last visit, treatment regimen information. HIV VL < 200 copies/ml was considered as undetectable.

Results

A total of 607 pts were evaluated. Mean age 51years; (Range-20-84). Male 306 (50.4%), African American 545(90%), Hispanic 50 (8.2%), white 9 (1.5%), Asian 3(0.5%). HIV risk: heterosexual 437(72%), male sex with male 118(19.4%), intravenous drug use 8 (1.3%). In the Pre-CO period, 530 pts were seen as IN-P; in the CO period 606 pts were encountered of which 304 (50.2%) were TELE visits, 89(14.7%) IN-P, 213(35%) had both TELE and IN-P encounters. Mean number of encounters were 2.59 in the Pre-CO and 2.46 during CO. The number of new pts in the Pre-CO were 36 (7%) vs. 52(8.6%) in the CO (p=0.26). During the pre-CO, 373 pts had CD4 measured at first and last visits, 353(95%) at the first visit and 352 (94.3%) at the last visit had CD4 counts ≥ 200/uL (p=.87); 373 pts had a VL done at first and last visits, 330 (88.5%) at the first visit and 337(90.3%) at last visit were undetectable (p=0.41). During CO, 445 pts had CD4 measured at first and last visits, 402 (90.3%) at the first visit and 445(94.2%) at the last visit had CD4 count ≥200/uL (p=0.03); 448 pts had VL measured at first and last encounters, 389(87%) at the first visit and 417(93%) in the last visit were undetectable (p=0.002). Antiretroviral changes occurred in 29% in the Pre-Co compared to 19% in the CO (p=0 .32).

Conclusion

In our clinic, more pts were cared for during the CO period compared to the Pre-CO period. Significantly, more pts had undetectable HIV VL during CO period. At least one TELE visit was utilized by over ¾ of the pts. TELE has a potentially important role in future HIV care without compromising patient outcomes.

Disclosures

All Authors: No reported disclosures
876. Renal Function, Lipid Profile, and Cardiovascular Events After Switching to Abacavir Containing Regimen in Antiretroviral-Therapy-Experienced People Living with HIV in Northern Thailand
Authors: Phudphong Pitchaporn , Kaewpoowat Quanhathai , Ophascharoensuk Vuddhidej , Yasri Saowaluck
Published: December 2021

Background

Abacavir (ABC) is commonly used as part of antiretroviral therapy (ART) regimen for people living with HIV (PLWH) with renal dysfunction in resource limiting countries. While the renal function changes and association with cardiovascular (CV) events have been well described in developed countries, these information is limited in Asian population. Herein, this study aims to describe the changes in renal function, lipid profile and CV events after ABC switching in ART-experienced PLWH in Northern Thailand.

Methods

This retrospective chart-review study was conducted among adults ART-experienced PLWH (≥18 years old) who received ABC-containing regimen during January 2016 to December 2018 at Maharaj Nakorn Chiang Mai Hospital. Demographic data, HIV-related treatments, creatinine, lipid profile and CV events were collected. Patients were categorized into early switching group and late switching group (CrCl≥50 ml/min and CrCl< 50 ml/min before switching to ABC). The change of CrCl, urinalysis profiles, lipid profiles, CD4, viral load, and cardiovascular events at 12 months after ABC initiation were assessed.

Results

Total of 115 participants were enrolled with mean age of 55.2±10.7 years and 63.5% were male. Of those, 87.8% of patients had received Tenofovir disoproxil fumarate (TDF) prior to ABC. Mean of CrCl at baseline was 47.6±16.8 ml/min and at 12th month was 49.56±19.42 ml/min with mean difference of 3.7 ml/min (95%CI 1.6-5.8, P< 0.001). The improvement of CrCl at 12 months in early switching group was statistically significant compared to late switching. Other two associated factors with improved CrCl after switching to ABC were duration of TDF exposure during CrCl< 60 ml/min (OR 9.26, P 0.004) and history of protease inhibitors (PIs) exposure (OR 0.06, P 0.03). No significant changed in lipid profile, CD4 and virological outcome overtime. There were only 2 CV events observed (9.3:1000 person-year, 95%CI 2.3-37.1).

Figure. (1) Creatinine clearance (ml/min) during follow up period. (2) Triglyceride (mg/dl) during follow-up period. (3) Total cholesterol (mg/dl) during follow up period. (4) LDL (mg/dl) during follow up period. (5) HDL (mg/dl) during follow up period. (6) CD4 (cells/mm3) during follow up period

Conclusion

ABC used in Thai ART-experienced PLWH appeared to be effective with low CV event in the first year. Despite the statistically significant in the change of CrCl after ABC switching, the change was subtle and need further evaluation.

Disclosures

All Authors: No reported disclosures
878. Telemedicine Implementation in a Midwestern HIV Clinic: One Year Outcomes
Authors: Regan Nichole N , Krajewski Laura , Fadul Nada
Published: December 2021

Background

During the COVID-19 pandemic, we realized the importance of limiting in-clinic interactions with patients who were stable on antiretroviral therapy to promote social distancing. Our HIV clinic adopted telemedicine practices, in line with the HHS Interim Guidance for COVID-19 and Persons With HIV. Several HIV clinics reported lower viral suppression rates during the pandemic. We aim to describe the implementation process as well as year one outcomes of telemedicine at our clinic.

Methods

In March 2020, we created telemedicine protocols; we also designed and continuously updated algorithms for determining patient eligibility for telemedicine based on recent viral loads and last clinic visit. We monitored outcomes through electronic medical record chart reviews between May 1, 2020, and April 30, 2021. We collected patient demographics, and federal poverty level (FPL) information. We collected baseline and post-intervention rates of viral load suppression (VLS, defined as HIV RNA < 200 copies per mL), medical visit frequency (MVF, defined as percentage of patients who had one visit in each 6 months of the preceding 24 months with at least 60 days between visits) and lost to care (LOC, no follow up within 12 months period).

Results

We conducted a total of 2298 ambulatory medical visits; 1642 were in person and 656 (29%) were telemedicine visits. Out of those, 2177 were follow up visits (649, 30% telemedicine). There was no difference of telemedicine utilization based on race (28% in African Americans vs. 32% in Whites); ethnicity (30% in Hispanic vs. 30% in Hon-Hispanic); gender (24% in females vs. 30% in males); or FPL (28% in FPL < 200% vs. 31% in FPL >200%). By the end of April 2021, overall clinic VLS rate was 94%, MVF was 48%, and there were 40 patients LOC compared to 92%, 49%, and 43 patients in April 2020, respectively.

Conclusion

Telemedicine was a safe alternative to routine in-person HIV care during the COVID-19 pandemic. We observed similar rates of utilization across demographic and FPL status. Applying selection criteria, viral suppression and retention in care rates were not adversely impacted by shift to telemedicine modality.

Disclosures

All Authors: No reported disclosures
879. Evaluation of the Incidence of Hypertension, Diabetes, and Hyperlipidemia in Patients on Antiretroviral Therapy
Authors: Idrees Niha , Hwang Yu Jin , Arman Sabreen , Hendi Razan , Michienzi Sarah M , Patel Mahesh C , Borgetti Scott , Badowski Melissa E
Published: December 2021

Background

Although integrase inhibitor (INSTI)-based regimens have been associated with weight gain, there is limited data on whether INSTIs cause long-term metabolic consequences. This study evaluated the effect of INSTIs on the development of metabolic comorbidities compared to non-nucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI)-based therapies in patients in the Illinois Department of Corrections.

Methods

This retrospective cohort study consisted of incarcerated adult patients living with HIV and receiving a guideline-recommended regimen between 7/12/10 and 12/31/19. Patients with a pre-existing diagnosis of diabetes, hypertension, or hyperlipidemia, or lack of medical follow-up data were excluded. The primary outcome was to compare the incidence of a metabolic comorbidity between regimens. Secondary outcomes compared the incidence of weight gain, diabetes, hypertension, and hyperlipidemia as separate outcomes between drug classes. Demographics and pertinent labs were collected. Data was analyzed with ANOVA, chi-squared, and paired t-tests. The primary outcome was adjusted for age, race, use of antipsychotic medications, and family history of metabolic comorbidities.

Results

A total of 206 patients were included in the analysis with mean follow-up time of 31.5 ± 19.4 months. Majority of patients were Black (69%) and male (91%). A total of 42 patients developed a metabolic comorbidity (Table 1). After adjustment for confounding factors, there was a significant difference in the development of comorbidities between the treatment groups (p=0.031) with INSTI use being more likely to develop a comorbidity than NNRTI (p=0.004). No difference was found between INSTI and PI use (p=0.518). Development of hypertension was significantly higher in the INSTI group than NNRTI group (p=0.014), while the development of diabetes and hyperlipidemia were not. Weight and BMI were significantly higher regardless of antiretroviral (Table 2). No differences were found in the primary outcome between agents within the same drug class or between 1st or 2nd generation INSTIs.

Table 1. Results of Primary and Secondary Outcomes

Table 2. Impact of HIV regimen on weight and BMI after 1 year

Conclusion

All antiretrovirals were linked to weight gain but INSTIs were associated with increased incidence of hypertension.

Disclosures

All Authors: No reported disclosures
881. Long-term Weight Gain After Initiating Combination Antiretroviral Therapy in Treatment-naïve Asian People Living with HIV
Authors: Ando Naokatsu , Nishijima Takeshi , Mizushima Daisuke , Inaba Yosuke , Kawasaki Yohei , Kikuchi Yoshimi , Gatanaga Hiroyuki , Oka Shinichi
Published: December 2021

Background

Weight gain after the initiation of antiretroviral therapy (ART) is becoming a major clinical issue in treatment-naïve people living with human immunodeficiency virus (PLWH). However, limited data exist for the Asian populations. We aimed to investigate changes in weight after the initiation of ART therapy in treatment-naïve Asian patients.

Methods

We evaluated adult, treatment-naïve Asian PLWH who started integrase strand transfer inhibitor (INSTI)-, protease inhibitor (PI)-, or nonnucleoside reverse transcriptase inhibitor (NNRTI)-based ART at AIDS Clinical Center, Tokyo, between January 2005 and February 2019. They were followed up until October 2019. Multivariate linear mixed-effects models were used to generate marginal predictions of weight over time. Predicted weight by ART class (INSTI, PI, and NNRTI), each key drug (dolutegravir [DTG], elvitegravir [EVG], raltegravir [RAL], and darunavir [DRV]), and each key drug with or without the use of tenofovir alafenamide (TAF)/emtricitabine (FTC) was reported at 3-month intervals until censoring or 5 years.

Results

Among the 1,579 study patients, 610 (38.6%), 929 (58.8%), and 40 (2.5%) started INSTI-, PI-, and NNRTI-based ART. After 5 years, PLWH who initiated DTG- (5.3 kg), DRV- (4.0 kg), and EVG-based treatment (4.6 kg) gained more weight than those who initiated RAL-based treatment (1.8 kg). PLWH who initiated DTG plus TAF/FTC (6.7 kg) gained the largest weight.

Conclusion

In the Asian PLWH population, ART-associated weight gain continues to increase for 5 years after treatment initiation. DTG plus TAF/FTC was associated with the largest weight gain.

Disclosures

All Authors: No reported disclosures
882. Use of Tenofovir Disoproxil Fumarate Shows Weight Loss vs Placebo: A Meta-Analysis of 7 Clinical Trials in 19,359 HIV-negative Individuals
Authors: Shah Shahini , Pilkington Victoria , Hill Andrew
Published: December 2021

Background

Recent clinical trials have shown weight gain associated with newer antiretrovirals. It is unclear how the nucleoside reverse transcriptase inhibitor backbone affects weight. Recent evidence suggests greater weight gain with tenofovir alafenamide (TAF) compared to tenofovir disoproxil fumarate (TDF). However, it is not fully understood whether TDF contributes to weight suppression or weight loss.

Methods

A systematic search of PubMed, Embase and clinicaltrials.gov was conducted to identify all randomised control trials comparing TDF/FTC or TDF to control in HIV-negative individuals. The primary endpoint included the number of events of ‘5% weight loss’ or ‘abnormal loss of weight’. The Mantel-Haenszel test with random-effects modelling was used to calculate the odds ratio (OR) and 95% confidence intervals (95% CI). Further analyses of gastrointestinal (GI) adverse events (AEs) were undertaken, including the number of reported adverse events of nausea, vomiting, loss of appetite and diarrhoea.

Results

Seven PrEP trials: PARTNERS, VOICE, TDF-2, Bangkok PrEP, iPrEX, FEM-PrEP and HPTN 084 were included in the analysis of weight loss, with a total sample size of 19,359. One study (HPTN 084) compared TDF/FTC to cabotegravir (CAB). The remaining compared either TDF or TDF/FTC or placebo. HIV-negative individuals taking TDF were more likely to experience weight loss compared to control (OR 1.44 95% CI 1.12 – 1.85 p = 0.005 (table 1)). In a separate analysis of GI AEs, exposure to TDF was also linked to greater odds of vomiting (OR 1.81 95% CI (1.20, 2.73) p < 0.005). There were no increased odds of nausea, diarrhoea, or loss of appetite.

Weight loss events in PrEP trials.

Conclusion

There is evidence in HIV-negative individuals that TDF may be associated weight loss when compared to placebo. Further research should be carried out in HIV positive individuals, and clinical trials of TDF/FTC should publish weight data to widen the evidence base

Disclosures

All Authors: No reported disclosures
884. Title: Factors Associated with Lack of Viral Suppression Among Women Living with HIV in the United States: An Integrative Review
Authors: Labisi Titilola , Fadul Nada , Coleman Jason , Podany Anthony , King Keyonna
Published: December 2021

Background

Women account for 19% of new HIV cases in the United States (US). Transgender women are 49 times more likely than other groups to be diagnosed with HIV. HIV is one of the top ten causes of death among women between 25 to 44 years. Adherence to antiretroviral therapy (ART) and consequent viral suppression (VS) are keys to preventing sexual transmission, risk of drug resistance, and improving health outcomes. Hence, it is essential to identify factors behind VS in women living with HIV (WLWH).

Methods

This review identified and synthesized peer-reviewed studies describing reasons for lack of VS among WLWH in the US. : Using the PRISMA model, we searched CINAHL, PubMed, Embase, Scopus, and PsycINFO, then selected US studies published from 2010 to April 2021. Studies that included men, non-adults, ongoing studies, and foreign studies were excluded. 1,359 studies were assessed and screened for duplicate and eligibility.

PRISMA Model

Results

15 studies were eligible for review; 8 included all WLWH, 5 focused on pregnant WLWH, 1 included only African American WLWH and 1 included only transgender WLWH. Based on study participants and findings, results were divided into pregnancy and non-pregnancy-related factors. Pregnancy-related factors: Early ART initiation and group prenatal care improved care retention and VS. WLWH in cities were more likely to be virally suppressed at delivery than those in rural regions. Intimate partner violence (IPV) was associated with poor ART adherence and time to achieve stable VS. Also, being postpartum was associated with high viral load regardless of ART. Non-pregnancy-related factors: The most reported common factors were substance use and IPV. Other factors included social determinants of health, age, race, health insurance, income, number of pills, and regimen. Transgender-specific factors were stress, race, age, relationship, transphobic experiences, gender satisfaction, and adherence to hormone therapy.

Conclusion

Substance use, income, mental health, health insurance, race, and ART regimen were the most common factors associated with VS in WLWH. There was paucity of data on transgender-specific VS factors. More research is needed to explore VS and treatment adherence amongWLWH, especially transgender women.

Disclosures

All Authors: No reported disclosures
108. Efficacy of Dalbavancin Compared to Standard of Care for the Treatment of Osteomyelitis: A Retrospective Study
Authors: Cain Alexander , Bremmer Derek N , Carr Dustin R , Buchanan Carley , Jacobs Max , Walsh Thomas L , Moffa Matthew , Shively Nathan , Trienski Tamara
Published: December 2021

Background

Preliminary data suggest that the efficacy of dalbavancin, a long-acting lipoglycopeptide, may be similar to current standard of care (SoC) treatment options for osteomyelitis, and may be associated with fewer treatment related adverse events. This study assessed the incidence of treatment failure in patients receiving either dalbavancin or SoC for the treatment of osteomyelitis.

Methods

This was a multi-center, retrospective, observational cohort study of adult patients diagnosed with osteomyelitis. Patients were matched 1:2 to either dalbavancin (1500 mg infused intravenously on days 1 and 8) or SoC for osteomyelitis (oral or intravenous antibiotics) by Charlson Comorbidity Index, site of infection, and causative pathogen. The primary objective was to determine the incidence of treatment failure after a one-year follow-up period. Secondary objectives included hospital length of stay (LOS), infection related one-year readmission rates, and treatment related adverse events.

Results

A total of 132 patients were matched to receive dalbavancin (n = 42) or SoC (n = 90). Baseline characteristics were similar between the two treatment groups. The majority of patients had lower extremity osteomyelitis (76.2% vs 73.3%) with an etiology of diabetic foot infection (45.2% vs 46.7%) in the dalbavancin and SoC groups, respectively. Treatment failure was similar between those who received dalbavancin and SoC (21.4% vs 23.3%, p = 0.808). Patients who received dalbavancin had a significantly shorter hospital LOS compared to patients who received SoC regimens (5.2 days vs 7.2 days, p = 0.013). There was no difference in the rates of infection related readmissions between the dalbavancin and the SoC group (31% vs 31.1%, p = 0.985). Peripherally inserted central catheter line related complications were reported in 17.8% of patients in the SoC group, however the lower incidence of overall adverse events in the dalbavancin group was not significantly different than the SoC group (21.4% vs 36.7%, p = 0.08).

Conclusion

Dalbavancin administered as a two-dose regimen is a safe and effective option for the treatment of osteomyelitis

Disclosures

Dustin R. Carr, PharmD, BCPS, BCIDP, AAHIVP, Merck (Speaker's Bureau) Thomas L. Walsh, MD, Accelerate Diagnostics (Other Financial or Material Support, speaking fees)
887. Implementation of Long-acting Injectable Cabotegravir/Rilpivirine for HIV-1 Treatment at a Ryan White-funded Clinic in the U.S. South
Authors: Collins Lauren F , Collins Lauren F , Corbin-Johnson Della , Asrat Meron , Rankins Tonya , Harrison Latoya , Condra Alton , Sumitani Jeri , Smith Bradley L , Armstrong Wendy , Armstrong Wendy , Colasanti Jonathan
Published: December 2021

Background

In January 2021, the first ever long-acting injectable (LAI) antiretroviral therapy (ART), cabotegravir/rilpivirine (CAB/RPV), was approved for maintenance HIV-1 treatment in select patients with virologic suppression. LAI-ART has the potential to improve ART adherence, reduce HIV stigma, and promote equity in care outcomes, however, implementation in real-world settings has yet to be evaluated.

Methods

We launched a pilot LAI-ART program at the largest Ryan White-funded HIV clinic in the Southeast. From 4/14/21 to 5/14/21, providers referred patients interested and willing to switch to LAI-CAB/RPV who met screening criteria. Our interdisciplinary LAI team (Clinician-Pharmacy-Nursing) verified clinical eligibility (HIV-1 < 200 c/ml ≥6 months and no history of virologic failure, resistance to either drug, or chronic HBV infection) and pursued medication access for 28-day oral lead-in and monthly injectable CAB/RPV. We describe demographic and clinical variables of referred PWH and early outcomes in accessing LAI-ART.

Results

Among 42 referrals, median age was 40.5 (Q1-Q3, 32-52) years, 83% were men, and 76% Black. Payor source distribution was 26% Private, 19% Medicare, 10% Medicaid, and 45% ADAP. At the time of referral, median CD4 count was 583 (Q1-Q3, 422-742) cells/mm3 and median sustained HIV-1 RNA < 200 c/ml was 1427 (Q1-Q3, 961-2534) days. A total of 35 patients (74%) met clinical eligibility for LAI-CAB/RPV, including 4 patients who required a transition off proton pump inhibitor therapy to accommodate oral RPV. Ineligible PWH were excluded due to evidence of RPV resistance (n=5), possible RPV hypersensitivity (n=1), and HIV non-suppression (n=1). The table summarizes the process of pursuing LAI-ART access for the initial 10 enrollees by insurance status.

Conclusion

Our experience implementing LAI-ART at a Ryan White-funded HIV clinic in the Southern U.S. has been challenged by substantial human resource capital to attain drug, delayed therapy initiation due to insurance denials, and patient ineligibility primarily due to concern for potential RPV resistance. These barriers may perpetuate disparities in ART access and virologic suppression among PWH and need to be urgently addressed so that LAI-ART can be offered equitably.

Disclosures

Lauren F. Collins, MD, MSc, Nothing to disclose Bradley L. Smith, Pharm.D., AAHIVP, Gilead Sciences, Inc (Advisor or Review Panel member) Wendy Armstrong, MD, Nothing to disclose Jonathan Colasanti, MD, Integritas CME (Consultant, develop and deliver CME content around Rapid Entry/Rapid ART)
890. Evaluation of Association Among Integrase Inhibitors for HIV Treatment, Weight Gain, and Body Image
Authors: Zawadzka Sabina , Ganugapati Divya , Wakefield Dorothy , Dieckhaus Kevin , Chirch Lisa
Published: December 2021

Background

Integrase inhibitors (INSTIs) are preferred antiretroviral agents for people living with HIV (PLWH). Recent studies suggest that INSTIs may contribute to weight gain and the development of metabolic syndrome. A lack of knowledge remains about how INSTIs affect metabolic parameters that contribute to weight gain as well as the impact of weight gain on medication adherence and body image in PLWH.

Methods

We conducted a retrospective chart review along with a real time survey of PLWH who are receiving HIV care at UConn Health. Participants who were switched to or added an INSTI to their ART regimen between 2012 - 2020 were included (n=204). Patient weight was recorded in 3-month intervals for two years prior to and two years after INSTI initiation. Lipid profile parameters and hemoglobin A1c were noted pre and post INSTI switch. A survey was administered to rate perception of weight gain, body appearance, and medication adherence on a five-point Likert scale. Statistical methods included Chi-square test and Fisher’s Exact test for categorical data, and T-test or Kruskal-Wallis test for continuous data.

Results

Patients started on or switched to any INSTI regimen experienced a mean weight gain of 5 and 7 pounds at 12 and 24 months, respectively (p < 0.001). Weight gain was greatest with raltegravir and elvitegravir (Figure 1,2). Bictegravir regimens resulted in a 4 pound weight loss at 24 months. An INSTI switch increased cholesterol by a mean of of 7.9mg/dL (p=0.05), with no effect on other parameters. A switch to Bictegravir increased HDL by 4mg/dL (p=0.04) and decreased triglycerides by 35mg/dL (p=0.04). Survey results showed that 100% of patients denied missing ART doses despite 69% mentioning weight gain due to ART. 97% of patients were satisfied with their ART regimen, with the majority disagreeing that their body image was negatively affected.

Conclusion

We demonstrate a link between INSTI use and weight gain up to two years following INSTI initiation, with the most weight gained within the first 12 months. Elvitegravir and raltegravir are associated with greater weight gain whereas bictegravir demonstrates weight loss and beneficial effects on lipid profile. Despite weight gain, most patients remained adherent and satisfied with their medication and denied negative perceptions of body image.

Disclosures

All Authors: No reported disclosures
891. Minimum Manufacturing Costs and National Prices for Weight Loss Treatments, as Potential Mitigation for Anti-Retroviral Related Weight Gain in HIV
Authors: Levi Jacob , Wang Junzheng , Venter Francois , Hill Andrew
Published: December 2021

Background

Weight gain is being observed for a wide range of antiretroviral treatments. Weight gains are higher for people taking first-line integrase inhibitor based treatments, especially those including TAF/FTC. Weight gains are higher for women and people of colour. Clinical obesity increases the risks of cardiovascular disease, diabetes, adverse birth outcomes and could lower survival rates. Anti-obesity treatments are needed to supplement lifestyle interventions and counteract progressive weight gains, but are not routinely provided as part of HIV care.

Methods

Costs of production for FDA-recommended weight loss treatments and anti-diabetic medications (orlistat, naltrexone-bupropion, topiramate, phentermine, semaglutide, liraglutide and metformin) were estimated using an established and published methodology based on costs of active pharmaceutical ingredients (API), extracted from the global shipping records database Panjiva. This was compared with national drug list price data from a range of low, medium, and high-income countries.

Figure 1. Example of methodology for calculating the estimated minimum cost of production for orlistat

Results

Weight loss and anti-diabetic treatments can be generically manufactured at low per-course costs, e.g. &85 per person per year for oral treatments such as orlistat and &1 per person per month for metformin. However, prices for a year of treatment with orlistat are as high as &1,205 in the USA and as low as &11 in Vietnam. In comparison, a month of ARV treatment costs about &15 via global health institutions like CHAI. Price for injectable (subcutaneous) treatments were higher, ranging from &1,985 for liraglutide in USA to &330 in Morocco, whilst they could potentially be profitably sold for &155 for a 12-week course. No export price data was available for semaglutide. When compared against international list prices, we found wide variations between countries.

Table 1. Summary of drug prices and minimum cost estimates

Figure 2. Orlistat course costs in a range of countries, compared with estimated minimum cost

Figure 3. Liraglutide course costs in a range of countries, compared with estimated minimum cost

Conclusion

We show that weight loss treatments can be manufactured and sold profitably for low prices, but have a wide price range between countries. Government and non-governmental healthcare systems should be evaluating weight loss agents for inclusion within ART programmes.

Disclosures

All Authors: No reported disclosures
892. Determination of the Unavailability of Alternative Antiretroviral Formulations
Authors: Murray Milena M , Flynn Devon , Sowah Leonard A , Austin Aaron , Farmer Eric
Published: December 2021

Background

Many pediatric and some adult people living with HIV (PLWH) are unable to swallow tablets and require alternative antiretroviral formulations (ARVF) such as liquids, chewable tablets, or powders for suspension. A growing number of issues with the timely procurement of alternative ARVF have been reported; the full scope of this problem is unknown. Without access to appropriate treatment, PLWH are at increased risk of poor disease outcomes. This study’s objective was to determine the scope of availability issues of ARVF and its potential impact on patient care.

Methods

An online survey invitation was sent to members of AAHIVM and the ACCP HIV PRN. Data collection included provider demographics, number of issues related to ARVF availability, time spent procuring ARVFs, and identification of unavailable formulations. To determine potential impact on clinical care and cost of care the time required to resolve shortages was summarized.

Results

The analyzable sample was 154, a majority of whom were pharmacists or physicians (n=132, 85.7%; Figure 1), in a clinical role (n=134, 87.0%), and serve pregnant patients (n=121, 79.2%). 85 (55.2%) practice at sites that provide care to > 300 PLWH, 81 (52.6%) practice at sites that did not serve pediatric patients. 525 instances of gaps in care due to ARVF unavailability were reported. In 283 instances, a more complex regimen was prescribed due to first-choice ARVF unavailability. Providers also reported 186 situations in which a less optimal regimen was used and 140 cases of treatment delays. The average time spent to resolve such issues was 2.7 hrs (CI: 1.3 – 4.2). The longest time reported was 72 hrs; most providers spent 1 hr or less. The most common unavailable ARVF were branded ritonavir 80 mg/mL solution (n=12), zidovudine 50 mg/5 mL syrup (n=11), raltegravir 100 mg chewable tablets (n=11), and raltegravir 100 mg granules for suspension (n=10). Branded nevirapine 50 mg/5 mL suspension (n=7) and generic nevirapine 50mg/5ml powder for suspension (n=11) were also reported more frequently.

Distribution of Respondents by Provider Type

Conclusion

Our report suggests the unavailability of alternative ARVF has the potential to significantly impact patient care. Further research is needed to identify the root causes of this problem to determine specific solutions.

Disclosures

Milena M. Murray, PharmD, MSc, BCIDP, AAHIVP, Merck (Speaker’s Bureau)Theratechnologies (Other Financial or Material Support, Medical Advisory Board) Eric Farmer, PharmD, BCPS, AAHIVP, TheraTechnologies, Inc (Other Financial or Material Support, Medical Advisory Board)
893. Evaluating Weight Gain in Treatment-naïve, HIV-infected Patients Started on Antiretroviral Therapy
Authors: Chaudhry Nimra , Cani Eris , Raymond Lendelle , Park Tae , Kanter Timothy
Published: December 2021

Background

There is increasing evidence that integrase strand transfer inhibitors (INSTIs) are associated with more weight gain when compared to other antiretroviral (ART) classes. Thus, the primary objective of the study was to evaluate the difference in weight gain at 6 and 18 months among treatment-naïve patients started on an INSTI-based versus a non-INSTI-based ART regimen.

Methods

This was a retrospective cohort study of ART-naive adults who were initiated and maintained on INSTI and non-INSTI based regimens for at least 18 months at an HIV clinic in an inner-city hospital from January 2013 to June 2019. The non-INSTI-based regimens were darunavir (DRV) or rilpivirine (RPV)-based. Data collected included patient demographics, ART regimen, pre- and post-ART initiation weight in kilograms (kg), body mass index (BMI), CD4 count, and viral load. A two-tailed t-test was used to compare change in weight in INSTI-based versus non-INSTI-based regimens. Sub-group analyses were conducted using the ANOVA test.

Results

Out of 170 patients, 60% were initiated on an INSTI-based regimen, 7.1% on a DRV-based regimen, and 32.9% on a RPV-based regimen. Of the patients initiated on INSTI-based regimens, 73.5% were on elvitegravir (EVG),16.7% on dolutegravir, 8.8% on bictegravir, and 0.98% on raltegravir. The mean age at ART initiation was 38 years with majority of the patients described as Black. More male patients received an INSTI-based regimen compared to females (77.5% vs. 32%). The average change in weight at 6 and 18 months in the INSTI-based group vs non-INSTI-based group was +3.6 kg vs. +2.9 kg (95% CI -2.2-0.7, p=0.317) and +5.7 kg vs.+4.8 kg (95% CI -3.2-1.2, p=0.357) respectively. There was no significant average change in weight among the INSTI-based regimens (+3.6 kg), vs DRV (+5.3 kg), or RPV (+2.4 kg) based regimens at 6 months (p=0.108) and 18 months [(+5.7 kg) vs (+7.2 kg), vs (+4.3 kg) (p=0.186) respectively]. Among the INSTIs, EVG was associated with the highest increase in weight at both 6 and 18 months (+3.9 kg and +5.8 kg). Forty-six percent of patients in the INSTI group were on tenofovir alafenamide (TAF) while no patients received TAF in the non-INSTI groups.

Conclusion

When comparing INSTI-based to DRV or RPV-based regimens, there was no significant increase in average weight at 6 and 18 months.

Disclosures

All Authors: No reported disclosures
894. Trend of Transmitted Resistance Associated Mutations in People Living with HIV (PLWH) in a Large Southeastern U.S. Ryan White Clinic
Authors: Kavouklis Alisha , Ladak Amber F , Hamilton Caroline , Mims Annastesia , Askar Gina , Newman Cheryl
Published: December 2021

Background

Department of Health and Human Services (DHHS) guidelines recommend integrase strand transfer inhibitors (INSTIs) as the backbone of preferred initial antiretroviral (ART) regimens (1). Baseline mutation rates for the INSTI class is 0.8% compared with an overall rate of 19% for all ART classes, based on Centers for Disease Control and Prevention (CDC) U.S. data from 2013-16 (2). First-generation INSTIs (raltegravir and elvitegravir) have a lower genetic barrier to resistance compared with newer, second generation INSTIs (bictegravir and dolutegravir) (3, 4). DHHS guidelines do not currently recommend routine HIV genotypic resistance testing to INSTIs prior to ART initiation (1). Our study seeks to determine the current prevalence of transmitted INSTI and overall resistance in a large southeastern U.S. Ryan White clinic.

Methods

This was a single-center, retrospective analysis of treatment naïve PLWH presenting for care from January 1, 2017 to December 31, 2020. Of these, 164 had a baseline genotype performed by one of two commercially available assays – Vela Genomics or ViroSeq. Subsequent interpretations were based on Stanford HIV Drug Resistance Database.

Results

65 patients (39.6%) had at least one transmitted resistance associated mutation (RAMs). Of these, 24 (36.9%) had an INSTI RAM. Baseline PI, NRTI, and NNRTI RAMs declined during the four-year interval (2017-2020), while the rate of INSTI RAMs increased from 11.1% to 19%; all conferred resistance to the first generation INSTIs with one also conferring resistance to second generation INSTIs.

INSTI Resistance Associated Mutation Prevalence 2017-2020

Frequency of Antiretroviral Therapy Class Mutations Per Year

Trend of INSTI Mutations and Resistance Associated Mutations 2017-2020

Conclusion

Unlike the CDC data which showed the overall prevalence of INSTI RAM transmission rates during 2013-2016 to be 0.8%, our data suggests a higher rate of INSTI RAMs (14.6%) with overall ART RAM transmission of 39.6%. This increase in baseline resistance to the INSTI class, which occurred over time, mimics the historical development of RAMs seen in the earlier ART classes. Though suboptimal adherence in the population promotes development of RAMs, increased frequency of INSTI RAMs may be due to a lower barrier to resistance of first generation INSTIs. Should our observed trend continue, routine baseline INSTI resistance testing may need to be considered prior to ART initiation.

Disclosures

Cheryl Newman, MD, Gilead (Scientific Research Study Investigator)GSK/ViiV (Scientific Research Study Investigator, Advisor or Review Panel member, Speaker’s Bureau)Janssen (Scientific Research Study Investigator)Merck (Scientific Research Study Investigator)
109. Evaluating Predictive Value of Surgical Resected Proximal Bone Margins in Diabetic Foot Osteomyelitis with Clinical Outcomes at One Year
Authors: Weng Bruce , Oskooilar Yasmin , Zakhary Bishoy , Chiu Chiao An , Mulligan Nikki , Wu Patrick , Sutjita Made
Published: December 2021

Background

Diabetic foot osteomyelitis (DFO) remains a significant comorbidity in diabetes and often requires both surgical and medical interventions. Surgical bone resection with proximal margins is performed for treatment at our institution to guide antimicrobial therapy. Optimal antibiotic duration often remains unclear, along with clinical outcomes with negative margins. We evaluate if negative bone margins predict outcomes of DFO at one year in our county hospital.

Methods

A retrospectively cohort study assessed adult patients undergoing DFO amputations between 9/2016 to 9/2019. Patient data collected included demographics, smoking history, hemoglobin A1c (HbA1c), basic labs, microbiology, antibiotic duration, bone margin pathology. Physician review of records determined if intervention was successful. Primary outcome was met if no further amputation at the same site was required in the following 12 months.

Results

Of 92 patients, 57 had negative margins and 35 had positive margins for pathology confirmed osteomyelitis. Smoking history was significant in positive margins (35.1% vs 57.1%; p=0.038). Patients with negative margins had a successful outcome at 12 months compared to positive margins (86% vs 66%; p=0.003), but no significant differences in outcome at 6 months. Antibiotic days was reduced in negative margin individuals (mean 18 vs 30 days; p=0.001). Negative margins also demonstrated significant lower rates of readmission at 12 months (p=0.015). Staphylococcus aureus was notable in positive vs negative margins (57.1% vs 29.8%; p=0.017). MSSA was significantly noted in positive margins (45.7% vs 14%; p=0.001). MRSA was similar regardless of margin results (15.8% vs 11.4%; p=0.399). Initial ESR, CRP and HbA1c were similar between groups.

Conclusion

Our study noted that negative proximal bone margins resulted in more successful outcomes at 12 months and less days of antimicrobial therapy. Patients with negative margins had lower rates of readmission at 12 months for surgical site complications. Negative proximal bone margins results can guide antibiotic therapy and improve outcomes of resections. Presence of S. aureus was significant in positive margins and likely warrant consideration for further aggressive intervention.

Clinical Characteristics of Patients with Diabetic Foot Osteomyelitis

Clinical demographics, antibiotic usage, microbiology and results of patients presenting for diabetic foot osteomyelitis needing surgical amputation intervention. Abbreviations: HbA1c - Hemoglobin A1c; MSSA - methicillin-susceptible Staphylococcus aureus; MRSA - methicillin-resistant Staphylococcus aureus; CRP -C-reactive protein; ESR - erythrocyte sedimentation rate

Disclosures

All Authors: No reported disclosures
895. Impact of Telemedicine on HIV Care and Prevention Services at an Academic Ryan White-Funded Clinic
Authors: Dasigi Jay V , Gupta Nupur , Hadi Christiane
Published: December 2021

Background

Telemedicine (TM) has been seldom used for the care of persons with HIV. However, the COVID-19 pandemic has forced HIV clinics to rapidly scale TM resources. With the increase of TM, the impact on HIV patient care remains uncertain. The purpose of this study is to examine the effects of TM on HIV care and retention at a Ryan White-funded clinic.

Methods

This was a retrospective study of patients seen at an academic clinic in Pittsburgh, PA between 1/1/20 – 12/31/20. Encounter information was extracted from the clinic electronic health record. Primary outcomes were viral load (VL) suppression (< 200 copies/ml) and retention in care for persons seen via TM (phone, video +/- in person) vs those seen in-person. Secondary outcomes included flu vaccination and STI screening rates.

Results

Amongst 1414 patients, 608 patients had at least one scheduled TM visit, with 97 seen exclusively via TM, and 806 were scheduled for only in-person visits. In those with at least one TM visit, 92.72% had a suppressed VL. 89.69% of those with only TM visits were suppressed. 92.43% were suppressed in the in-person group. Average show rate amongst patients who had at least one TM visit was 60.39% (+0.96% from 2019, +1.71% from 2018), vs 64.38% amongst patients who only had in-person visits. Amongst patients who were only scheduled for TM visits, show rate was 83.97%. 40.18% of patients who had at least one TM visit received their flu vaccine in 2020 (-37.45% from 2019, -36.72% from 2018) vs 37.62% who were only seen in-person. Amongst patients who had at least one TM visit, syphilis screening rate was 43.09% (-7.64% from 2019, -8.55% from 2018) vs 43.51% for those seen only in-person. Gonorrhea and chlamydia screening rates were both 42.91% (+9.46% from 2019, +15.27% from 2018 for chlamydia screening; +8.36% from 2019, +14.73% from 2018 for gonorrhea screening). Amongst patients who were exclusively seen in-person gonorrhea screening rate was 48.24% and chlamydia screening rate was 47.57%.

Table 1. Characteristics of Patients Seen in 2020

Table 2. Primary and Secondary Outcomes for Patients Seen in 2020

Conclusion

VL suppression rates were similar across both groups, but retention in care was highest in the TM-only group. Flu vaccination rates and STI screening were lower in the groups that included TM. TM is an effective method for maintaining VL suppression and retention in care but has room for improvement with provision of preventative services.

Disclosures

All Authors: No reported disclosures