Detectable Viral Load Research Articles

The Implications of PrEP Use, Condom Use, and Partner Viral Load Status for Openness to Serodifferent Partnering Among US Sexual Minority Men (SMM).

PrEP has been reported to facilitate openness to serodifferent sexual partnerships among sexual minority men (SMM). However, other aspects of a sexual scenario likely come into play, including whether or not condoms are used and whether or not the partner living with HIV has an undetectable viral load. This online survey study evaluated the association between PrEP status and openness to serodifferent partnering, as well as the effects of various sexual scenario variables (condom use and partner's viral load) among 268 HIV-negative SMM in the US. Each participant reported their PrEP status and rated their openness to serodifferent partnering in four sexual scenarios, which varied by condom use (with/without) and partner viral load status (detectable/undetectable). Analyses of covariance (ANCOVAs) were conducted to assess differences in openness to serodifferent partnering by PrEP status in each scenario, adjusting for background characteristics. A two-way repeated measures ANCOVA and a three-way mixed factorial ANCOVA, including PrEP status as a between-subjects variable, were also performed to assess the effects of condom use and partner viral load status on openness. Across all scenarios, current PrEP users expressed significantly greater openness to serodifferent partnering compared to participants who had never used PrEP. Current PrEP users were also more likely than former PrEP users to consider partnering with someone with an undetectable viral load without using condoms. Both PrEP users and PrEP-inexperienced individuals had greater openness to serodifferent partnering with a partner having an undetectable (vs. detectable) viral load, which was magnified by condom use among the latter.

Hepatitis C virus reinfection incidence among gay and bisexual men with HIV in Australia from 2016 to 2020.

There is some concern that hepatitis C virus (HCV) reinfection might impact HCV micro-elimination efforts among gay and bisexual men (GBM) with HIV. However, there is a limited understanding of reinfection incidence in the context of unrestricted government-funded HCV treatment. We aimed to estimate HCV reinfection incidence among GBM with HIV in Australia from 2016 to 2020. Data were from 39 clinics participating in ACCESS, a sentinel surveillance network for blood borne viruses and sexually transmissible infections across Australia. GBM with HIV who had evidence of treatment or spontaneous clearance with at least one positive HCV RNA test, a subsequent negative HCV RNA test, and at least one additional HCV RNA test between 1st January 2016 and 31st December 2020 were eligible for inclusion. A new HCV RNA positive test and/or detectable viral load was defined as a reinfection. Generalised linear modelling was used to examine trends in reinfection. Among 12 213 GBM with HIV who had at least one HCV test, 540 were included in the reinfection incidence analysis, of whom 38 (7%) had evidence of reinfection during the observation period. Over 1124 person-years of follow-up, the overall rate of reinfection was 3.4/100PY (95% CI 2.5-4.6). HCV reinfection incidence declined on average 30% per calendar year (Incidence Rate Ratio 0.70, 95% CI 0.54-0.91). HCV reinfection incidence has declined among GBM with HIV in Australia since government-funded unrestricted DAAs were made available. Ongoing HCV RNA testing following cure and prompt treatment for anyone newly diagnosed is warranted to sustain this.

The Potential Role of Undetectable = Untransmittable (U = U) in Reducing HIV Stigma among Sexual Minority Men in the US.

The Undetectable = Untransmittable (U = U) message and its scientific underpinnings have been widely suggested to reduce HIV stigma. However, misunderstanding and skepticism about U = U may prevent this destigmatizing potential from being fully realized. This cross-sectional study examined associations between U = U belief (belief that someone with a sustained undetectable viral load has zero risk of sexually transmitting HIV) and HIV stigma among US sexual minority men. Differences by serostatus and effects of brief informational messaging were also explored. The survey was completed online by 106 men living with HIV and 351 HIV-negative/status-unknown men (2019-2020). Participants were 18-83 years old (M[SD] = 41[13.0]). Most were non-Hispanic White (70.0%) and gay (82.9%). Although nearly all participants (95.6%) were aware of U = U, only 41.1% believed U = U. A greater percentage of participants living with HIV (66.0%) believed U = U compared with HIV-negative/status-unknown participants (33.6%). Among participants living with HIV, U = U belief was not significantly associated with perceived, internalized, or experienced HIV stigma or with viral load prejudice (prejudice against people who have a detectable HIV viral load). Among HIV-negative/status-unknown participants, U = U belief was associated with less frequently enacted HIV discrimination, more positive feelings toward people with an undetectable viral load, and lower personal endorsement of stigmatizing beliefs. Brief informational messaging about U = U did not affect most stigma dimensions and did not favorably affect any. Interventions are needed to correct commonly held, outdated misconceptions about HIV transmission risk. Such initiatives must not only engage people living with HIV but also engage HIV-negative/status-unknown people to maximize the destigmatizing potential of U = U.

Detectable viral load associated with unmet mental health and substance use needs among trans women living with HIV in San Francisco, California

BackgroundSubstance use and mental distress are known barriers to HIV care engagement among trans women. Less is known about access and utilization of mental health and substance use care among trans women and the relationship between unmet behavioral health needs and HIV viral suppression. We examined the relationship between mental health and substance use on HIV viral load among trans women living with HIV. We also examined the relationship between mental health and substance use services needs with HIV care engagement and having a detectable viral load by comparing engagement in care cascades.MethodsData are from a 2022 baseline assessment for an intervention with trans women living with HIV (n = 42) in San Francisco. Chi-Squared or Fisher’s exact tests were conducted to determine associations between HIV viral load, mental health, and substance use. We also examine characteristics associated with each step in the HIV, mental health, and substance use care cascades.ResultsMost participants were trans women of color (85.7%), 40 years of age or older (80.9%), with low income (88.1%), and almost half were unstably housed (47.6%). Of the 32 participants who screened positive for depression, anxiety and/or psychological distress, 56.3% were referred for mental health services in the past 12 months. Of those who were referred, 44.4% received mental health services. Of the 26 participants who screened positive for a substance use disorder, 34.6% were referred to substance use services in the past 12 months. Of those referred, 33.3% received substance use services in the past 3 months. Latina trans women had a low referral rate to meet their mental health needs (50%) and only 16.7% of African American/Black trans women who screened positive for a substance use disorder were referred for services, while trans women of other race/ethnicities had high referral and services utilization. No significant results were found between HIV viral load and screening positive for a mental health disorder. Methamphetamine use was statistically associated with having a detectable HIV viral load (p = 0.049).ConclusionsWe identified significant unmet mental health and substance use services needs and noted racial/ethnic disparities in the context of high HIV care engagement among trans women living with HIV. We also found that methamphetamine use was a barrier to having an undetectable viral load for trans women living with HIV. To finally end the HIV epidemic, integration of behavioral health screening, linkage, and support are needed in HIV care services for populations most impacted by HIV, especially trans women.Trial registrationNCT, NCT 21–34,978. Registered January 19, 2022.

Prevalence and risk factors of detectable HIV viral load among pregnant women with HIV infection seeking antenatal care in Southern Malawi

ABSTRACT We evaluated detectable viral load (VL) in pregnant women established on antiretroviral therapy (ART) for at least 6 months before conception and those self-reported as ART naïve at first antenatal care (ANC) at two government clinics in Southern Malawi. We used logistic regression to identify the predictors of detectable viral load (VL), defined as any measure greater than 400 copies/ml. Of 816 women, 67.9% were established on ART and 32.1% self-reported as ART naïve. Among women established on ART, 10.8% had detectable VL and 9.9% had VL >1000 copies/ml (WHO criteria for virological failure). In adjusted analysis, among women established on ART, virological failure was associated with younger age (p = .02), “being single/widowed” (p = 0.001) and no previous deliveries (p = .05). One fifth of women who reported to be ART-naive were found to have an undetectable VL at first ANC. None of the demographic factors could significantly differentiate those with high versus low VL in the ART-naïve sub-sample. In this cohort, approximately 90% of women who had initiated ART prior to conception had an undetectable VL at first ANC. This demonstrates good success of the ART program but identifies high risk populations that require additional support.

HIV symptom severity and associated factors among young people with HIV in Ghana

ABSTRACT Adolescents and young adults (young people) with HIV (YPWH) often struggle with treatment self-management. Many have symptoms due to HIV disease, medication side-effects, or comorbid conditions. Our study investigated the severity of HIV-related symptoms among YPWH aged 18–24 with detectable viral loads from an HIV clinic in Ghana (N = 60) and potential correlates of severity across a range of factors. Results indicated that YPWH currently experienced, on average, 13 symptoms (SD = 12.33). Six of the 10 most common symptoms were from two domains: fatigue and psychological. The most common symptoms were headaches (62%), weakness (53%), and fear/worries (52%). No differences were observed in number or severity of symptoms between youth based on HIV transmission status. Bivariate correlates of symptom severity were found with six that remained significant or approached significance in a multivariate model predicting severity: living with a parent/guardian, higher perceived access to HIV care, and higher treatment readiness were associated with lower severity while greater travel time to the HIV clinic, psychological distress, and more missed clinic appointments were associated with higher severity. Our findings suggest that interventions to address symptoms among YPWH should be multilevel and include strategies (e.g., telehealth, home care) to increase access to care.

Relationship between HIV viral suppression and multidrug resistant tuberculosis treatment outcomes.

The impact of HIV viral suppression on multidrug resistant tuberculosis (MDR-TB) treatment outcomes among people with HIV (PWH) has not been clearly established. Using secondary data from a cluster-randomized clinical trial among people with MDR-TB in South Africa, we examined the effects of HIV viral suppression at MDR-TB treatment initiation and throughout treatment on MDR-TB outcomes among PWH using multinomial regression. This analysis included 1479 PWH. Viral suppression (457, 30.9%), detectable viral load (524, 35.4%), or unknown viral load (498, 33.7%) at MDR-TB treatment initiation were almost evenly distributed. Having a detectable HIV viral load at MDR-TB treatment initiation significantly increased risk of death compared to those virally suppressed (relative risk ratio [RRR] 2.12, 95% CI 1.11-4.07). Among 673 (45.5%) PWH with a known viral load at MDR-TB outcome, 194 (28.8%) maintained suppression, 267 (39.7%) became suppressed, 94 (14.0%) became detectable, and 118 (17.5%) were never suppressed. Those who became detectable (RRR 11.50, 95% CI 1.98-66.65) or were never suppressed (RRR 9.28, 95% CI 1.53-56.61) were at significantly increased risk of death (RRR 6.37, 95% CI 1.58-25.70), treatment failure (RRR 4.54, 95% CI 1.35-15.24), and loss to follow-up (RRR 7.00, 95% CI 2.83-17.31; RRR 2.97, 95% CI 1.02-8.61) compared to those who maintained viral suppression. Lack of viral suppression at MDR-TB treatment initiation and failure to achieve or maintain viral suppression during MDR-TB treatment drives differences in MDR-TB outcomes. Early intervention to support access and adherence to antiretroviral therapy among PWH should be prioritized to improve MDR-TB treatment outcomes.

Real-world trough concentrations and effectiveness of long-acting cabotegravir and rilpivirine: a multicenter prospective observational study in Switzerland

The efficacy and tolerability of long-acting cabotegravir and rilpivirine were demonstrated in Phase III trials. However, low concentrations combined with other risk factors have been associated with an increased risk of virologic failure. This study aims to verify whether drug concentrations measured in a real-world setting are consistent with those previously reported. SHCS-879 is a nationwide observational study within the Swiss HIV Cohort Study for the monitoring of people with HIV (PWH) on long-acting cabotegravir plus rilpivirine. Samples were collected from March 2022 to March2023. Overall, 725 samples were obtained from 186 PWH. Our data show a large inter-individual variability in cabotegravir and rilpivirine concentrations, with some individuals exhibiting repeatedly low concentrations. Rilpivirine trough concentrations were consistent with those from Phase III trials, while cabotegravir concentrations were lower. The first concentrations quartile was only slightly above the target of 664ng/mL. Exploratory statistical analyses found 35% (p<0·01) lower cabotegravir trough in males compared to females. Overall, 172 PWH (92%) remained suppressed and three experienced virologic failures (1·6%), of those, two had sub-optimal drug exposure. No association was found between low trough levels and detectable viral load. Real-world cabotegravir concentrations are substantially lower than previously reported. However, these concentrations appear sufficient to ensure sustained virological suppression in almost every PWH. These reassuring data challenge the rather conservative thresholds adopted to date, which may raise unnecessary concerns. Yet, our study reveals that some PWH have repeatedly very low drug levels, for reasons that remain to be elucidated. This work was funded by the Swiss National Science Foundation, grant number N◦ 324730_192449. This study received no support from pharmaceutical industries. This study was performed within the framework of the Swiss HIV Cohort Study, supported by the Swiss National Science Foundation (grant #201369), by SHCS project #879, and by the SHCS research foundation. The SHCS data were gathered by the Five Swiss University Hospitals, two Cantonal Hospitals, 15 affiliated hospitals and 36 private physicians (listed in http://www.shcs.ch/180-health-care-providers).

Discordance of Aqueous/Plasma HIV Replication on ART.

The study was conducted to analyze HIV dynamics across blood-retinal barrier (BRB) and the relevant risk factors for HIV-associated ocular complications. This study included a case series of 40 HIV-positive patients with ocular lesions, which were studied retrospectively. Clinical and laboratory examinations included plasma and intraocular viral load (VL). HIV VL on paired aqueous/plasma samples was available for 40 patients. Aqueous VL was negatively associated with antiretroviral treatment (ART) duration (p = 0.02 and p < 0.05), and plasma VL was independent of ART duration (p = 0.53). An aqueous/plasma discordance was found in 19/40 (47.5%) patients, eight of whom (20%) had detectable aqueous VL despite a suppressed plasma VL (escape). There were significant differences in CD4+ T-lymphocyte levels (p = 0.011 and p < 0.05) and ART duration (p = 0.007 and p < 0.05) between the patients with HIV-associated ocular complications and the patients without. This study provides a rationale for initiating ART early in the course of infection to reduce HIV VL in the aqueous humor, and raises the possibility of the ocular sanctuary where HIV replicates. Meanwhile, early and standard ART would be an optimal option to protect against ocular opportunistic infection.

Cytomegalovirus Reactivation in Severe Coronavirus Disease 2019: Case Series from a Tertiary Care Center in the Western State of India

Abstract Introduction: Cytomegalovirus (CMV) reactivation in patients who have been admitted to the intensive care unit (ICU) is linked to higher mortality and health-care costs. There is a dearth of published research on CMV reactivation in patients with severe SARS-CoV-2. Materials and Methods: Objectives: The objective of this study was to describe clinical and laboratory profiles and outcomes of CMV reactivation in patients with severe SARS-CoV-2 illness. In this retrospective study carried out at a tertiary care hospital ICU in the Western state of India, patients with severe SARS-CoV-2 who were admitted from January 1, 2021, to May 31, 2021, and who got CMV viral load testing by reverse transcriptase polymerase chain reaction were analyzed. Results: During the study period, 27 out of 277 admitted patients were subjected to plasma CMV viral load testing, of which 13 patients had detectable viral load giving a prevalence of 4.7%. Patients who tested positive for CMV had significantly higher mortality (P = 0.020) and ventilator support needs (P = 0.004). Both fungal and bacterial bloodstream infections were frequent in CMV-positive patients, but neither was statistically significant (P = 0.065 and P = 0.571, respectively). In this case series, there was no difference in CMV reactivations according to the degree of lymphopenia (P = 0.149), usage of steroids (P = 0.766), or immunomodulatory medications (tocilizumab/bevacizumab, P = 0.926). Conclusions: In SARS-CoV-2 patients with severe illness, CMV reactivation was associated with an increased need for ventilator support, a higher incidence of nosocomial infection (bacterial and fungal), and overall mortality.

Nasopharyngeal Viral Load Is the Major Driver of Incident Antibody Immune Response to SARS-CoV-2 Infection.

Virologic determinants of seroconversion to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection were defined in a post hoc analysis of prospectively studied vaccine- and infection-naïve individuals at high risk for coronavirus disease 2019 (COVID-19). This phase 3 COVID-19 prevention trial (NCT04452318) with casirivimab and imdevimab was conducted in July 2020-February 2021, before widespread vaccine availability. Placebo-treated participants who were uninfected (SARS-CoV-2 quantitative reverse transcription polymerase chain reaction [RT-qPCR] negative) and seronegative were assessed weekly for 28 days (efficacy assessment period [EAP]) for COVID-19 symptoms and SARS-CoV-2 infection by RT-qPCR of nasopharyngeal swab samples and for serostatus by antinucleocapsid immunoglobulin (Ig) G. Regression-based modeling, including causal mediation analysis, estimated the effects of viral load on seroconversion. Of 157/1069 (14.7%) uninfected and seronegative (for antispike IgG, antispike IgA, and antinucleocapsid IgG) participants who became infected during the EAP, 105 (65%) seroconverted. The mean (SD) maximum viral load of seroconverters was 7.23 (1.68) log10 copies/mL vs 4.8 (2.2) log10 copies/mL in those who remained seronegative; viral loads of ∼6.0 log10 copies/mL better predicted seroconversion. The mean of the maximum viral load was 7.11 log10 copies/mL in symptomatic participants vs 5.58 log10 copies/mL in asymptomatic participants. The mean duration of detectable viral load was longer in seroconverted vs seronegative participants: 3.24 vs 1.63 weeks. Maximum SARS-CoV-2 viral load is a major driver of seroconversion and symptomatic COVID-19, with high viral loads (∼6.0 log10 copies/mL) better predicting seroconversion. Serology underestimates infection rates, incidence, and prevalence of SARS-CoV-2 infection.

1592. Real-World Utilization and Effectiveness of Long-Acting Cabotegravir + Rilpivirine Among People with HIV with Detectable Viral Loads at Initiation: Trio Cohort Study

Abstract Background Cabotegravir+Rilpivirine (CAB+RPV) is the first FDA-approved complete long-acting (LA) injectable antiretroviral therapy (ART) for treatment of HIV-1 infection among ART-experienced, virologically suppressed (VL &amp;lt; 50 c/mL) people with HIV (PWH). We assessed utilization and effectiveness among PWH with VL ≥ 50 c/mL at initiation in real world clinical setting. Methods Adult PWH who received ≥ 1 CAB+RPV injections through March 2023 with VL ≥ 50 c/mL at initiation were identified using electronic medical records from Trio Health HIV Network. Results were stratified by VL ≥ 50 c/mL and ≥ 200 c/mL at initiation. Genotypic resistance data prior to initiation of CAB+RPV LA was available for a subset of individuals, with resistance interpretation described using Stanford HIVdb algorithm. Results Among 329 PWH with ≥ 1 CAB+RPV injections, 29 (9%) had VL ≥ 50 c/mL at initiation. All were treatment-experienced and 12 (41%) had VL ≥ 200 c/mL, median log VL 3.1 (IQR: 2.3, 5.0) at initiation; 21% were women, 48% were Black, median age was 43 (IQR: 34, 48), and 41% had a BMI ≥ 30. At the time of analysis, all individuals remained on CAB+RPV LA with median follow-up of 4.0 months (IQR: 2.2, 9.2) with median 3 injections (IQR 1, 5); 20 individuals had ≥ 2 injections and 16 had ≥ 3, with 80/86 (93%) follow-up injections administered within target window. Median time from first to second injection was 32 days (IQR: 30, 36), and median time from second to third injection was 59 days (IQR: 30, 62). Among the 16 individuals with ≥ 3 injections, 12 were on every-2-month dosing schedule. Sixteen (55%) individuals had a follow-up VL. Of them, the last VL was &amp;lt; 50 c/mL in 12 individuals (75%), &amp;lt; 200 c/mL in 15 (94%), and 1 with VL 1202 c/mL (pre-index VL 2138 c/mL). Historical HIV genotype results were available for 15 individuals (52%). One individual had low-level resistance to CAB based on Y143R mutation and this individual had a follow-up VL &amp;lt; 50 c/mL. Five individuals had NNRTI mutations, one with low-level resistance to RPV and a follow-up VL &amp;lt; 200 c/mL. Conclusion This real-world data of individuals who received ≥ 1 CAB+RPV LA injections with VL ≥ 50 c/mL at initiation demonstrated high rates of virologic suppression. Future analysis with longer follow-up will allow for evaluation of long-term outcomes. Disclosures Rick A. Elion, MD, Gilead Sciences: Advisor/Consultant|Gilead Sciences: Grant/Research Support|Proteus: Grant/Research Support|ViiV Healthcare: Advisor/Consultant|ViiV Healthcare: Grant/Research Support Andrew Frick, MS, Trio Health Inc.: Employee Janna Radtchenko, MBA, Trio Health: Employee Gayathri Sridhar, MBBS, MPH, PhD, GlaxoSmithKline: Stocks/Bonds|ViiV Healthcare: Full Time Employee Supriya Sarkar, PhD, MPH, ViiV Healthcare: Employee Joseph J. Eron, MD, Gilead Sciences: Advisor/Consultant|Gilead Sciences: Grant/Research Support|Janssen: Advisor/Consultant|Janssen: Grant/Research Support|Merck: Advisor/Consultant|ViiV Healthcare: Advisor/Consultant|ViiV Healthcare: Grant/Research Support Karam Mounzer, MD, Clinical Care Options: Speakers Bureau|Epividian: Advisor/Consultant|Gilead Sciences: Advisor/Consultant|Gilead Sciences: Grant/Research Support|Gilead Sciences: Speakers Bureau|Janssen: Advisor/Consultant|Janssen: Grant/Research Support|Janssen: Speakers Bureau|Merck: Advisor/Consultant|Merck: Grant/Research Support|Merck: Speakers Bureau|Prime: Speakers Bureau|Simply Speaking: Speakers Bureau|ViiV Healthcare: Advisor/Consultant|ViiV Healthcare: Grant/Research Support|ViiV Healthcare: Speakers Bureau Jean A. van Wyk, MBChB, MFPM, ViiV Healthcare Ltd: Stocks/Bonds Vani Vannappagari, MBBS, MPH, PhD, GlaxoSmithKline: Stocks/Bonds|ViiV Healthcare: Employee

1028. Real-World Use of Long-Acting Cabotegravir + Rilpivirine in People with HIV with Detectable Viral Loads at Initiation: Findings from the OPERA® Cohort

Abstract Background Cabotegravir + rilpivirine (CAB+RPV) injections, the first complete long-acting (LA) antiretroviral therapy (ART) regimen, was approved by the FDA in January 2021 for ART-experienced people with HIV (PWH) who are virologically suppressed (VL &amp;lt; 50 copies/mL). Among individuals virologically non-suppressed (VL ≥ 30 copies/mL) at initiation, high rates of virologic suppression were observed in the demonstration project at Ward 86 for CAB+RPV LA. We observed CAB+RPV LA real-world utilization and effectiveness over the first 2 years of availability in the United States (US) in individuals with VL ≥ 50 copies/mL at initiation in the OPERA® Cohort. Methods All ART-experienced adults with VL ≥ 50 copies/mL at initiation who received their first CAB+RPV LA injection between 21Jan2021 and 28Feb2023 were followed until 25Mar2023. Discontinuation (ART switch or 2 consecutive missed doses) and confirmed virologic failure (CVF; 2 consecutive VLs ≥ 200 copies/mL or 1 VL ≥ 200 copies/mL + discontinuation after a VL &amp;lt; 50 copies/mL) were described, for all individuals with VL ≥ 50 copies/mL and for the subset with VL ≥ 200 copies/mL. Results Of 1843 ART-experienced PWH with ≥ 1 CAB+RPV injections, 229 (12%) had a VL ≥ 50 copies/mL at initiation. At baseline, they were a median of 41 (interquartile range: 32, 52) years of age, 31% female, 57% Black and 20% Hispanic. Injections started a median of 9 (4, 17) years after HIV diagnosis with a median viral load of 2.1 (1.8, 3.8) log copies/mL and median CD4 count of 579 (350, 759) cells/μL (Table 1). Over a median of 6.1 (3.5, 10.1) months of follow-up, 83% were still on CAB+RPV LA at study end. Among the 80% with ≥ 1 VL over follow-up, 94% had a VL &amp;lt; 200 copies/mL and 75% had a VL &amp;lt; 50 copies/mL at study end. CVF was observed in 7 (4%) individuals (Table 2). Similarly for the subset of 93 individuals with a VL ≥ 200 copies/mL at initiation, 90% and 74% had a VL &amp;lt; 200 or &amp;lt; 50 copies/mL at study end, respectively, when follow-up VLs were available (Table 2). Conclusion In a large, diverse cohort of real-world, routine clinical care in the US, CAB+RPV LA injections were observed in individuals with viral loads ≥ 50 copies/mL at initiation. Most of these individuals were able to suppress to VL &amp;lt; 50 copies/mL and maintain suppression through study end. Disclosures Ricky K. Hsu, MD, Gilead Sciences: Advisor/Consultant|Gilead Sciences: Grant/Research Support|Gilead Sciences: Honoraria|Janssen: Advisor/Consultant|Janssen: Grant/Research Support|Janssen: Honoraria|Merck: Advisor/Consultant|Merck: Honoraria|ViiV Healthcare: Advisor/Consultant|ViiV Healthcare: Honoraria Michael Sension, MD, Gilead: Advisor/Consultant|Gilead: Honoraria|Viiv: Advisor/Consultant|Viiv: Grant/Research Support|Viiv: Honoraria Jennifer S. Fusco, BS, Epividian, Inc.: Salary|Epividian, Inc.: Ownership Interest|Epividian, Inc.: Stocks/Bonds Laurence Brunet, PhD, Epividian, Inc.: Salary|Epividian, Inc.: Stocks/Bonds Gayathri Sridhar, MBBS, MPH, PhD, GlaxoSmithKline: Stocks/Bonds|ViiV Healthcare: Full Time Employee Vani Vannappagari, MBBS, MPH, PhD, GlaxoSmithKline: Stocks/Bonds|ViiV Healthcare: Employee Jean A. van Wyk, MBChB, MFPM, ViiV Healthcare Ltd: Stocks/Bonds Michael B. Wohlfeiler, JD, MD, AAHIVS, ViiV Healthcare: Serves as a PI on clinical trials, but does not receive personal compensation for this work (it goes directly to AIDS Healthcare Foundation) Gregory P. Fusco, MD, MPH, Epividian, Inc.: Board Member|Epividian, Inc.: Ownership Interest|Epividian, Inc.: Stocks/Bonds

1573. Viral Blips While on Antiretroviral Therapy are Associated with Virologic Failure

Abstract Background Blips in HIV viral load (VL) while on antiretroviral therapy (ART) are of unclear clinical significance. In this study, we examined the association between blips and virologic failure (VF). Methods We used data from the US Military HIV Natural History Study (NHS) cohort. Included participants were diagnosed with HIV after 2006, had been on ART for ≥ 6months, and had ≥3 VLs recorded and measured using an assay with a lower limit of detection of &amp;lt; 50 copies/mL. VF was defined as two consecutive VLs ≥ 200 copies/mL spanning 90 days or a single VL ≥1000 copies/mL. Blips were defined as VL of 51-999 copies/mL, that were preceded and followed by a VL ≤ 50 copies/mL and were differentiated by magnitude as low-level (VL 51-199 copies/mL) or high-level (200-999 copies/mL). Detectable VLs that did not meet criteria for VF or blips were grouped as low-level viremia (LLV; 51-199 copies/mL), and higher low-level viremia (hLLV; 200-999 copies/mL). Cox proportional hazards models adjusted for demographic characteristics, time updated CD4 counts, ART, and viral load were used. Hazard ratios and 95% confidence intervals are presented. Results A total of 988 participants (median age 34.1 years, 96.7% male, 41.7% African American) were included, of which 55 (5.6%) experienced VF (Table 1). While 191 participants (19.3%) experienced blips, it was the highest VL status in 146 (14.8%) (Table 2). Having blips and low-level viremia was associated with increasing hazard of VF, graded by type and level of viremia (low-level blip 1.86 [1.10 – 3.14]; high-level blip 3.56 [1.13 – 11.18]; LLV 4.10 [3.06-5.51]; hLLV 10.51 [6.28-17.61]. Other factors associated with VF were African American race and higher VL at ART initiation. Whereas higher CD4 counts, and use of integrase strand transfer inhibitors (relative to Non-Nucleoside Reverse Transcriptase inhibitors) were protective (Table 3). Conclusion Detectable viremia, including blips, are associated with an increased risk of VF. The magnitude of the viremia appears important with dose-response-type impact (i.e., viral loads &amp;gt;200 copies/mL having a greater hazard of VF). These findings suggest that individuals with viral blips at a minimum should undergo evaluation for medication adherence and may benefit from more frequent VL monitoring. Disclosures All Authors: No reported disclosures

The relationship between viral load status and fertility intention of HIV-positive women of reproductive ages in Addis Ababa: A hospital based study

Background: People living with HIV/AIDS (PLHIV), like everyone else want and intend to have children. Although the fertility impact of HIV is already well acknowledged, women’s fertility behaviors could also largely be influenced by the level of their viral loads. Being sexually active and not taking contraception, women who never became pregnant had greater HIV viral loads. Objectives: To assess the relationship between viral load status and fertility intentions of HIV positive women of reproductive ages in six selected public health hospitals, in Addis Ababa, Ethiopia. Methods: A sample size of 432 reproductive ages HIV-positive women who got ART service at the selected public hospitals were interviewed. A binary logistic regression analysis was used to assess the relationship between viral load status and fertility intention. Results: Of the total respondents, 196(45.4%) had intention to give birth within the coming 3 years, while the remaining 236(54.6) had no intention. Fertility intention was 2.71 times higher among women of ages 25-34 compared to age &gt;34 years (95% CI: 1.005-7.339). Moreover, married women had fertility intention 6.06 times higher (95% CI: 1.12-32.7) compared to widowed women. Further, fertility was higher among women who knew their partner HIV status. Intention was 5.63 times higher (95% CI: 0.846-37.484) and 19.28 times higher (95% CI: 2.533-148.326) among women who knew their partner HIV status to be positive and negative respectively, compared to those with no knowledge of their HIV status. On the other hand, fertility intention decreased for women with no formal education and primary by 95.1 (95% CI: 0.010-0.252) and 83.9 (95% CI: 0.039-0.662), respectively compared to secondary and above level of education. For women who believed they have enough number of children the odds of fertility intention decreased by 99.7 (95% CI: 0.001-0.011). Further, the odds of fertility intention of women who made decision on pregnancy or contraceptive use alone was lower by 71.5% compared to those who jointly made the decision. Conclusion and recommendation: A high proportion of HIV positive reproductive ages women desire to conceive. However, the finding witnessed that there was no significant association between viral load status and fertility intention. Beside that there was no fertility differentials between women who have undetectable and detectable viral loads. The findings strongly implicate the need for strengthening and proper implementation of the various health policies and guidelines pertaining to HIV/AIDS for increased uptake of reproduction health services by PLHIV women. The government and other stakeholders should reach young women including sexually active with HIV prevention, testing and treatment services.

Quality of life and adherence to antiretroviral therapy in people living with HIV in the Ceará, Brazil

ABSTRACT The aim of this study was to investigate the quality of life (QOL) and adherence to antiretroviral therapy (ART) in people living with HIV (PLWH) in Fortaleza, Ceará, Brazil. A cross-sectional study with a sample of 385 patients followed-up on an outpatient basis. Interviews were conducted using the Sociodemographic, Epidemiological and Clinical Form, the World Health Organization’s Quality of Life in PLWH Instrument, the Assessment of Adherence to Antiretroviral Treatment Questionnaire and Pittsburgh Sleep Quality Index. Descriptive statistics and univariate and multivariate logistic regression analysis were performed. The odds ratio and confidence interval were calculated, considering P < 0.05 as statistically significant. Of the 385 PLWH, 134 (34.8%) had unsatisfactory QOL which was associated with unemployment (P = 0.0037), monthly income less than the minimum wage (P < 0.0001), sleep disorders (P = 0.0039) and not doing regular exercise (P = 0.0032). Inadequate adherence to ART occurred in 24 patients (6.23%) and was associated with detectable viral load (P = 0.0001) and unsatisfactory QOL (P = 0.0033). QOL was more unsatisfactory for those unemployed and with low income, sleep disorders and sedentary lifestyle. People with detectable viral load and unsatisfactory QOL had more inadequate adherence to ART.

A Longitudinal Assessment of Interruptions in HIV Clinic Visits and Virologic Failure among Pregnant and Postpartum Women in the Kabeho Study

Background: Antiretroviral therapy (ART) for women with HIV is recommended for life, yet most studies measure retention in HIV care and treatment as a binary outcome rather than patterns of intermittent clinic attendance. Pregnancy and the post-partum period are critical times to study interruptions in care, as retention among these women is particularly challenging and can affect the outcomes of both the mother and her child. Methods: The Kigali Antiretroviral and Breastfeeding Assessment for the Elimination of HIV (Kabeho) study was an observational prospective cohort of 608 pregnant and postpartum women with HIV followed for 2 years. Clinic visit attendance was used to construct an interruption variable defined as a missed visit followed by a return to care. In multivariate analyses, we examined interruption patterns as predictors of virologic failure and detectable viral load. Results: During the study period, 48% of women had multiple visit interruptions and 29% had an interruption that lasted more than one month. Adjusting for age, ART regimen, time on ART, and CD4 count, the odds of virologic failure among women with multiple interruptions were almost 3 times higher than for women with one or no interruptions (aOR=2.72, 95%CI: 1.09, 6.77). The odds of virologic failure were nearly 3.5 times higher among women with an interruption lasting more than one month compared with women with shorter or no interruptions (aOR=3.47, 95%CI: 1.59, 7.66). Conclusions: Interruptions in HIV care visits are common with significant increases in virologic failure among women with multiple and long-term interruptions. Measuring patterns of interruption, rather than a single binary measure captures the fluid nature of lifetime and health-seeking behavior.

IMPACT OF COVID-19 ON PEOPLE LIVING WITH HIV IN MADAGASCAR: A SARS-COV2 SERO-PREVALENCE SURVEY.

In Madagascar, no study has reported the impact of COVID-19 on people living with HIV (PLHIV). The present work aimed to analyze the seroprevalence of SARS-CoV-2 in Malagasy PLHIV before and during the three waves of COVID-19 pandemic.This is a retrospective study. We conducted a retrospective serological survey in PLHIV followed up for HIV viral load (VL) monitoring at the Centre d'Infectiologie Charles Mérieux Madagascar (CICM) between June 2019 and April 2022. The presence of IgM and/or IgG antibodies against SARS-CoV-2 nucleoprotein was detected using a rapid diagnostic test (COVID-PRESTO®). A seroprevalence of 2.5% was found in the 877 patients tested before March 2020, compared to 25.4% (512/2,011) between March 2020 and April 2022. This seroprevalence was 21.7%, 22.3% and 60.1% after the first, second and third waves of COVID-19, respectively. We observed a marginally significant difference (p = 0.043) in SARS-CoV-2 seroprevalence between patients on highly active antiretroviral therapy (HAART) (27.5%) and those who were not (23.7%). No statistically significant difference was observed between PLHIV with undetectable HIV VL (27.4%) and the different detectable VL categories (p>0.05). Our data show the presence of antibodies to SARS-CoV-2 among PLHIV as early as December 2019 in Madagascar. At least 25.4% (512/2,011) of Malagasy PLHIV have been in contact with SARS-CoV-2 since March 2020. There is no significant relation between HIV-1 VL and SARS-CoV-2 seroprevalence. Additional studies with more robust assays in the general population are needed for a detailed knowledge of SARS-CoV-2 impact in Madagascar.

Temporal trends in HCV treatment uptake and success among people who inject drugs in Baltimore, MD since the introduction of direct acting antivirals

BackgroundAlthough hepatitis C virus (HCV) can be cured by direct acting antivirals (DAA), uptake is not well characterized for people who inject drugs (PWID). MethodsAmong 1130 participants of a community-based cohort of PWID with chronic HCV, we longitudinally characterized HCV treatment uptake and cure early (2014–2016) and later (2017–2020). ResultsCumulative HCV treatment uptake increased from 4% in 2014 to 68% in 2020 and the percent with HCV viremia declined from nearly 100–33%. Predictors of treatment uptake varied across periods. Age (incidence rate ratio [IRR] per 5-year increase: 1.28; 95% confidence interval [CI]: 1.15, 1.42), educational attainment (IRR for ≥ high school diploma: 1.31; 95% CI: 1.04, 1.66), HIV coinfection with suppressed viral load (IRR vs. HIV negative: 2.08; 95% CI: 1.63, 2.66) and alcohol dependence (IRR vs. no alcohol use: 0.63; 95% CI: 0.43, 0.91) were associated with treatment uptake in the early period, but not later. HIV coinfection with a detectable viral load (IRR vs. HIV negative: 0.46; 95% CI: 0.23, 0.95) and daily injecting (IRR: 0.46 vs. no injection; 95% CI: 0.27, 0.79) were significantly associated with lower treatment uptake later. Homelessness was associated with significantly reduced likelihood of viral clearance in the late DAA era (IRR: 0.51; 95% CI: 0.30, 0.88). ConclusionTreatment uptake improved substantially in this cohort of PWID in the first five years of DAA availability with commensurate declines in viremia. Additional efforts are needed to treat those actively injecting and unstably housed in order to realize elimination goals.

Unmet Needs for Ancillary Services and Associations with Clinical Outcomes Among Transgender Women with Diagnosed HIV: Medical Monitoring Project, United States, 2015-2020.

Purpose: Access to ancillary services-including HIV support services, non-HIV clinical services, and subsistence services-can support care engagement and viral suppression and reduce disparities among people with HIV (PWH). We used representative U.S. data to assess differences in unmet needs for ancillary services between transgender women with HIV and other PWH. In addition, we examined associations between unmet needs and clinical outcomes among transgender women. Methods: We analyzed 2015-2020 Medical Monitoring Project data among transgender women (N = 362), cisgender men (N = 17,319), and cisgender women (N = 6016) with HIV. We reported weighted percentages for characteristics, and reported adjusted prevalence ratios (aPRs) controlling for race/ethnicity and age, and 95% confidence intervals (CI) using logistic regression with predicted marginal means to assess differences between groups. Results: Among transgender women, unmet needs were highest for dental care (24.9%), shelter or housing (13.9%), and transportation assistance (12.6%). Transgender women were more likely than cisgender men to have unmet subsistence needs. Among transgender women, unmet needs for ancillary services were negatively associated with many clinical outcomes after adjusting for age and race/ethnicity. Unmet needs for subsistence services were associated with higher levels of antiretroviral therapy nonadherence (aPR: 1.39; 95% CI: 1.13-1.70) and detectable viral loads (aPR: 1.47; 1.09-1.98), emergency room visits (aPR: 1.42; 1.06-1.90), and depression (aPR: 2.74; 1.83-4.10) or anxiety (aPR: 3.20; 2.05-5.00) symptoms. Conclusions: Transgender women with HIV were more likely than cisgender men with HIV to experience unmet needs for subsistence services-likely a reflection of substantial socioeconomic disadvantage. Addressing unmet needs is an essential step for improving care outcomes among transgender women with HIV.