Differences In Viral Suppression Research Articles

Chemsex and rising substance use linked to sexually transmitted infections among men who have sex with men living with HIV in Bangkok, Thailand

ObjectivesWe report longitudinal trends in alcohol and recreational drug use, and their associations with sexual behaviors and clinical outcomes in a Thai cohort of predominantly men who have sex with men (MSM) living with HIV. MethodsFrom 2017 to 2019, participants in the RV254/SEARCH010 acute HIV cohort answered questions every 24 weeks about drug use and sexual behaviors. Longitudinal trends were assessed using the χ2 test for trend. Logistic regression was used to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for factors potentially associated with recreational drug and alcohol use. ResultsAmong 604 participants, the median age was 26 (interquartile range 23-31) years, and 93.5% were MSM. Alcohol consumption was reported in 83.3% and recreational drug use in 46.9% during the study period, with rising trends in both over the years. Participants who reported recreational drug use were more likely to have hepatitis C (OR 3.42, 95% CI 1.88-6.21), syphilis (OR 2.69, 1.75-4.13), gonorrhea (OR 7.74, 5.04-11.89), and chlamydia (OR 1.61, 1.12-2.31), and to engage in group sex (OR 7.74, 5.04-11.89). Participants who used any recreational drugs had more frequent viral blips (23.1% vs 14.2%, P = 0.007) and reported missed doses of antiretroviral drugs more often (52.4% vs 36.9%, P <0.001), but had no significant difference in viral suppression (94.1% vs 97.4%, P = 0.06). ConclusionsAmong MSM living with HIV in Bangkok, recreational drug use has increased in recent years and was associated with hepatitis C and sexually transmitted infections, especially among men who participate in group sex. Prevention strategies and other interventions may improve treatment adherence and other HIV outcomes.

The association between adherence to antiretroviral therapy and viral suppression under dolutegravir-based regimens: an observational cohort study from Uganda.

Millions of people living with HIV (PLWH) take oral antiretroviral therapy (ART), which requires a lifetime of consistent medication adherence. The relationship between adherence and poor HIV outcomes is well documented. Newer ART regimens that include dolutegravir (DTG) could be more forgiving, but empirical evidence on the relationship between adherence and viral suppression under DTG is only emerging. In this observational cohort study (secondary analysis of data from a randomized trial), we used data from 313 ART clients from a large HIV clinic in Kampala, Uganda. Over the 4-year study period (January 2018-January 2022), 91% switched from non-DTG regimens to DTG regimens. We measured adherence using Medication Event Monitoring Systems-caps and extracted prescription information and viral load measures from electronic health records. We estimated unadjusted linear regressions and adjusted models that included individual and time fixed-effects. Under non-DTG regimens, 96% of participants were virally suppressed (defined as viral load < 200 copies/ml) when adherence was 90% or higher in the 3 months before viral load measurement. Viral suppression was 32 percentage points lower when adherence was between 0% and 49% (95% CI -0.44, -0.20, p < 0.01), 12 percentage points lower when adherence was between 50% and 79% (95% CI -0.23, -0.02, p < 0.01), and not significantly different when adherence was between 80% and 89% (effect of 0.00, 95% CI -0.06, 0.07, p = 0.81). In contrast, for participants taking DTG, there was no statistically significant difference in viral suppression among any of the four adherence levels; more than 95% were virally suppressed at each adherence level. On average, switching to DTG increased viral suppression by 6 percentage points in our adjusted models (95% CI 0.00, 0.13, p = 0.03). There was no significant association between adherence levels and viral suppression among PLWH taking DTG regimens, suggesting a high degree of forgiveness for missed doses. The use of DTG should be prioritized over older regimens, particularly for those with low adherence. NCT03494777.

Sexual orientation and gender identity measures and viral suppression for people living with HIV: a protocol for a population-based cohort study

IntroductionThe measure of sexual orientation and gender identity (SOGI) data in electronic health records (EHR) has been critical for addressing health disparities and inequalities, especially for HIV care. Given that...

Effectiveness and safety of bictegravir/emtricitabine/tenofovir alafenamide in HIV late presenters

The efficacy of BIC/FTC/TAF in HIV late presenters initiating antiretroviral therapy (ART) has not been sufficiently evaluated. The aim of this study was to assess the effectiveness and tolerability of BIC/FTC/TAF compared to other first-line antiretroviral regimens in treatment-naïve adult individuals from the CoRIS Cohort starting ART with CD4 counts <200 cells/mm3 and/or AIDS-defining conditions between January 1st 2019 and November 30th 2020. Logistic regression models were used to estimate odds ratios (ORs) of association between initial regimen and achievement of viral suppression (VS) (primary objective), defined as HIV RNA <50 cop/mL, and immunological recovery (IR) (secondary objective), defined as CD4 count >200 cells/mm3, at weeks 24 and 48 after initiation of ART. We evaluated 314 individuals (84.7% men, median age 40 years). Of them, 158 initiated with BIC/FTC/TAF. At inclusion, 117 had an AIDS-defining condition. In multivariable analyses, individuals with AIDS-defining conditions initiating ART with BIC/FTC/TAF achieved higher rates of VS at 24 weeks than other regimens (aOR: 0.2; 95% CI: 0.06-0.64) and, at 48 weeks, than DTG/ABC/3TC (aOR: 0.06; 95% CI: 0.01-0.76) and DTG+TDF/3TC (aOR: 0.2; 95% CI: 0.47-0.9). No other differences in VS or IR were observed. At 24 and 48 weeks after ART initiation, treatment discontinuations were lower with BIC/FTC/TAF than with other regimens (3.2% and 7.6% vs. 24.4% and 37.8%, respectively; P < 0.005). Our results suggest that BIC/FTC/TAF could be a preferred regimen as initial therapy in HIV late presenters because of its high effectiveness and good tolerability.

Effect of Integrase Strand Transfer Inhibitor Use on Time to HIV Viral Suppression before Delivery.

We sought to determine whether pregnant individuals with human immunodeficiency virus (HIV) prescribed integrase strand transfer inhibitor (INSTI) antiretrovirals (ARVs) achieve viral suppression faster than individuals taking non-INSTI regimens and to determine whether there were differences in viral suppression at delivery among INSTI ARVs. This is a retrospective cohort study of pregnant individuals with HIV who delivered a live infant during the study period (January 1, 2009-December 31, 2020). Patients' ARV therapy (ART) was classified as including INSTI or non-INSTI. We compared the proportion of individuals with viral suppression at delivery by group and individual INSTI ARVs using χ2 and Fisher exact tests. A log rank test was used to compare time to viral suppression on ARVs. During the study period, 168 individuals delivered a live infant. Most of the patients were diagnosed as having HIV before pregnancy and had taken ARVs before conception (76%), but fewer than half had an undetectable viral load at the first antenatal visit (45%). During pregnancy, 46% were prescribed INSTI and 54% were prescribed non-INSTI ARVs. Most had an undetectable HIV RNA viral load at delivery (75% INSTI and 72% non-INSTI, P = 0.7). The time to viral suppression was similar between groups (log rank test P = 0.43). Viral suppression at delivery was similar among INSTI ARVs: raltegravir (53%), elvitegravir (88%), dolutegravir (73%), and bictegravir (88%) (P = 0.13). Despite recommendations to prescribe INSTI in pregnancy for rapid viral suppression, we did not find a significant difference in time to viral suppression when pregnant individuals were taking non-INSTI ARVs. We did not find that one INSTI ARV was superior for viral suppression.

Effect of Phone-Based Enhanced Adherence Counseling (EAC) Among Virally Unsuppressed Key Population (KP).

Despite the reduced human immunodeficiency virus (HIV) disease burden in Nigeria and globally, the key populations (KPs) can be disproportionately burdened with HIV infection and lower treatment coverage and outcome. A viral load (VL) test is needed to monitor the treatment outcome of KP with VL suppression of < 1000 copies/mL, demonstrating a positive treatment outcome. For unsuppressed VL,enhanced adherence counseling (EAC)may improve viral suppression in people living with HIV/KPsliving with HIV (PLHIV/KPLHIV). Conventionally, EAC sessions are done for 3 months through physical visits. Due to the challenges of monthly visits (including transportation, socioeconomic status, and high mobility among KPs), other EAC delivery models need to be explored. We aimed to assess the effect of phone EAC sessions among virally unsuppressed KPs compared to physical EAC. Using a prospective intervention study design with a sample size of 484, unsuppressed KPLHIV in Delta State Nigeria were selectively stratified (non-randomized) using a simple stratification (abilityvs. inability to physically attend EAC sessions in-person) into an intervention group and a control group, receiving phone-based EAC sessions and physical EAC sessions respectively. Repeated VL tests were done 3 months after the intervention, and viral suppression was pegged at the WHO recommendation of <1000 copies/mL. The SPSS version 24.0 (SPSS Inc., Chicago, USA) was used for data analysis of variables within and between study groups. Significance was interpreted at p < 0.05. Participants were 87.4% males {out of which 75.0% (363/484) identified as men who have sex with men (MSM)} with a mean age of 26 ± 2 years. The intervention group had a slightly higher EAC completion rate at 99.6% than the control group (97.9%). Both groups showed significant differences in viral suppression from 0% to a mean suppression of 88.7% with p < 0.01. The intervention group achieved better suppression (90.5%) than the control group (86.7%). EAC effectively achieves viral suppression by up to 90% among KPLHIV.Phone-based EAC has also proven effective and, in our findings, slightly more effective than the conventional physical EAC and is recommended among KPLHIV with the known challenge of transportation or poor mobility.

Innovative informatics interventions to improve health and health care.

In this editorial, I highlight 5 papers that address innovative informatics interventions—3 research studies and 2 reviews. The papers reflect a variety of information technologies and processes including mobile health (mHealth),1 behavioral nudges in the electronic health record (EHR),2 adaptive intervention framework,3 predictive models,4 and artificial intelligence (eg, machine learning, data mining, natural language processing).5 The interventions were designed to address important clinical and public health problems such as adherence to antiretroviral therapy for persons living with HIV (PLWH),1 opioid use disorder,3 and pain assessment and management,5 as well as aspects of healthcare quality including no-show rates for appointments4 and erroneous decisions, waste, and misuse of resources due to EHR choice architecture for clinician orders.3 Schnall et al1 completed a randomized controlled trial (RCT) to assess the efficacy of an mHealth self-management interventions for PLWH on antiretroviral adherence and viral suppression. The novel WiseApp intervention comprised testimonials of lived experiences, push-notification reminders, medication trackers, health surveys, chat rooms, and a daily “To-Do” list. In a sample of PLWH with suboptimal adherence, daily antiretroviral adherence was significantly higher in the WiseApp group as compared to attention control group from day 1 to day 59 but not for days 60–120. There were no significant differences in viral suppression. The authors suggest that there is a need for booster or a combination intervention approaches after the initial effects of the mHealth intervention wanes.

Viral suppression among adults with HIV receiving routine dolutegravir-based antiretroviral therapy and 3 months weekly isoniazid-rifapentine.

We aimed to evaluate safety of 3 months weekly isoniazid-rifapentine (3HP) for tuberculosis (TB) prevention when co-administered with dolutegravir-based antiretroviral therapy (TLD), and compare viral suppression among those initiating TLD + 3HP vs. TLD alone. We analyzed data from an ongoing Phase 3 randomized trial comparing TB screening strategies among adults with CD4 + ≤350 cells/μl initiating routine antiretroviral therapy (ART) in Kampala, Uganda. TB screen-negative participants without contraindications are referred for self-administered 3HP. HIV viral load is routinely measured at 6 and 12 months. Here, we included TB-negative participants who initiated TLD with or without 3HP. We determined the number who discontinued 3HP due to drug toxicity. In addition, we assessed viral suppression at 6 and 12 months and used log-binomial regression to assess risk of viremia at 6 months for participants who initiated TLD + 3HP vs. TLD alone. Of 453 participants initiating TLD (287 [63.4%] female, median age 30 years [interquartile range (IQR) 25-37], median pre-ART CD4 + cell count 188 cells/μl [IQR 86-271]), 163 (36.0%) initiated 3HP. Of these, 154 (94.5%) completed 3HP and one (0.6%) had treatment permanently discontinued due to a possible 3HP-related adverse event. At 6 months, for participants who received TLD + 3HP, risk of viremia >50 copies/ml was 1.51 [95% confidence interval (CI) 1.07-2.14] times that of participants who received TLD alone. There was no difference in viral suppression between those who received TLD + 3HP vs. TLD alone at 12 months. Co-administration of TLD + 3HP was well tolerated. However, those who received TLD + 3HP were less likely to achieve viral suppression within six-months compared to those who received TLD alone.

Comparison of Virological Efficacy of DTG/ABC/3TG and B/F/TAF Regimens and Discontinuation Patterns in Persons Living with Advanced HIV in the Era of Rapid ART: A Retrospective Multicenter Cohort Study.

International treatment guidelines recommend the rapid initiation of antiretroviral therapy (ART) with bictegravir (B)/emtricitabine (F)/tenofovir alafenamide (TAF) and dolutegravir (DTG)-based regimens for treatment-naïve persons living with HIV (PLWH) irrespective of their disease stage. However, we lack evidence of the virological efficacy, virological failure, and tolerability of coformulated B/F/TAF and DTG/ABC/3TC regimens in persons living with advanced HIV (PLWAH; defined as persons with a CD4+ count of < 200cells/μL or an AIDS-related opportunistic illness [AOI] at or before ART initiation) in the era of rapid ART. This retrospective multicenter study enrolled treatment-naïve PLWAH initiating ART with coformulated DTG/ABC/3TC or B/F/TAF in 2019-2020. Viral suppression at week48 was analyzed using FDA snapshot analysis. Between-regimen differences in time to viral suppression (< 50copies/mL), virological failure, and regimen discontinuation were examined using a Cox proportional hazards model. Analysis was also performed using time to regimen discontinuation due to adverse reactions (ARs) as the outcome. We enrolled 162 patients, including 61.1% on DTG/ABC/3TC and 38.9% on B/F/TAF. At week48 after ART initiation, 73.47% on DTG/ABC/3TC and 85.71% on B/F/TAF achieved viral suppression (P = 0.178). We identified no between-regimen differences in time to viral suppression or virological failure, regardless of pre-ART viral load. Compared with the DTG/ABC/3TC group, regimen discontinuation was less prevalent in the B/F/TAF group (adjusted hazard ratio = 0.23, 95%CI 0.06-0.85, P = 0.027). The main reason for discontinuation in both groups was ARs (61.9% in the DTG/ABC/3TC and 50% in the B/F/TAF, P = 0.877), of which skin manifestations were the most common in both groups (61.5% in the DTG/ABC/3TC and 50% in the B/F/TAF, P = 0.756). DTG/ABC/3TC, same-day ART prescription, and AOI were risk factors for AR or virological failure-related regimen discontinuation. In the real world, the risk of regimen discontinuation was higher in PLWAH on coformulated DTG/ABC/3TC than in those on B/F/TAF, with no difference in viral suppression or virological failure. Given the findings concerning the effect of same-day ART prescription and AOIs on AR or virological failure-related regimen discontinuation, individualized approaches to PLWAH are necessary.

Same-Day Antiretroviral Therapy Initiation as a Predictor of Loss to Follow-up and Viral Suppression Among People With Human Immunodeficiency Virus in Sub-Saharan Africa.

Treat-All guidelines recommend initiation of antiretroviral therapy (ART) for all people with HIV (PWH) on the day of diagnosis when possible, yet uncertainty exists about the impact of same-day ART initiation on subsequent care engagement. We examined the association of same-day ART initiation with loss to follow-up and viral suppression among patients in 11 sub-Saharan African countries. We included ART-naive adult PWH from sites participating in the International epidemiology Databases to Evaluate AIDS (IeDEA) consortium who enrolled in care after Treat-All implementation and prior to January 2019. We used multivariable Cox regression to estimate the association between same-day ART initiation and loss to follow-up and Poisson regression to estimate the association between same-day ART initiation and 6-month viral suppression. Among 29 017 patients from 63 sites, 18 584 (64.0%) initiated ART on the day of enrollment. Same-day ART initiation was less likely among those with advanced HIV disease versus early-stage disease. Loss to follow-up was significantly lower among those initiating ART ≥1 day of enrollment, compared with same-day ART initiators (20.6% vs 27.7%; adjusted hazard ratio: .66; 95% CI .57-.76). No difference in viral suppression was observed by time to ART initiation (adjusted rate ratio: 1.00; 95% CI: .98-1.02). Patients initiating ART on the day of enrollment were more frequently lost to follow-up than those initiating later but were equally likely to be virally suppressed. Our findings support recent World Health Organization recommendations for providing tailored counseling and support to patients who accept an offer of same-day ART.

Neuropathic pain correlates with worsening cognition in people with human immunodeficiency virus.

Neuropathic pain and cognitive impairment are among the HIV-related conditions that have most stubbornly resisted amelioration by virally suppressive antiretroviral therapy. Overlaps between the regional brain substrates and mechanisms of neuropathic pain and cognitive disorders are increasingly recognized, yet no studies have examined the longitudinal relationship between these two disorders. Participants in the prospective, observational CNS HIV AntiRetroviral Therapy Effects Research (CHARTER) cohort underwent standardized clinical evaluations for clinical examination findings of distal sensory polyneuropathy, reporting distal neuropathic pain and neurocognitive performance at study entry (baseline) and an average of 12 years later. Change in neuropathic pain and neuropathy status from baseline to follow-up was by self-report and repeat examination, and change in neurocognitive performance was assessed using a previously published summary regression-based change score. Relationships between incident or worsened neuropathic pain and neurocognitive change were evaluated using uni- and multivariable regressions, including age at baseline and other relevant covariates. Participants were 385 people with HIV, 91 (23.6%) females, mean ± standard deviation (SD) age at baseline 43.5 (7.81) years, ethnicity 44.9% African American, 10.6% Hispanic, 42.6% non-Hispanic white and 1.82% other. Baseline median (interquartile range) nadir CD4 was 175 (34 309) cells/µl and current CD4 was 454 (279 639). Incident or worsened distal neuropathic pain occurred in 98 (25.5%) over the follow-up period. People with HIV with incident or worsened distal neuropathic pain had significantly worsened neurocognitive performance at follow-up compared to those without incident or worsened distal neuropathic pain (summary regression-based change score mean ± SD -0.408 ± 0.700 versus -0.228 ± 0.613; P = 0.0158). This effect remained significant when considering viral suppression on antiretroviral therapy, incident diabetes and other covariates as predictors. Overall neurocognitive change related to neuropathic pain was driven primarily by changes in the domains of executive function and speed of information processing. Those with incident distal neuropathy signs did not have neurocognitive worsening, nor did individuals who used opioid analgesics or other pain-modulating drugs such as amitriptyline. Worsened neurocognitive performance in people with HIV was associated with worsened neuropathic pain but not with changes in physical signs of neuropathy, and this was not attributable to therapies for pain or depression or to differences in viral suppression. This finding implies that incident or worsened pain may signal increased risk for neurocognitive impairment, and deserves more investigation, particularly if better pain management might stabilize or improve neurocognitive performance.

Effect of Integrase Strand Transfer Inhibitor use on Time to HIV Viral Suppression and Viral Suppression before Delivery

Integrase strand transfer inhibitors (INSTIs) are a preferred antiretroviral (ARV) class for the prevention of perinatal HIV during pregnancy due to their ability to rapidly suppress HIV viral load and high barrier to resistance. We sought to determine if pregnant women with HIV on ARV regimens containing INSTIs achieve viral suppression faster than women taking non-INSTI ARV regimens. We sought to determine if there were differences in viral suppression at delivery between INSTI and non-INSTI regimens as well as individual INSTI drugs.

Perceived satisfaction with HIV care and its association with adherence to antiretroviral therapy and viral suppression in the African Cohort Study

BackgroundIncreased availability of HIV care over the past decade has dramatically reduced morbidity and mortality among people living with HIV (PLWH) in sub-Saharan Africa. However, perceived and experienced barriers to care, including dissatisfaction with services, may impact adherence and viral suppression. We examined the associations between satisfaction with HIV care and antiretroviral therapy (ART) adherence and viral load suppression.MethodsThe African Cohort Study (AFRICOS) is a prospective observational study conducted at PEPFAR-supported clinics in four African countries. At enrollment and twice-yearly study visits, participants received a clinical assessment and a socio-behavioral questionnaire was administered. Participants were classified as dissatisfied with care if they reported dissatisfaction with any of the following: waiting time, health care worker skills, health care worker attitudes, quality of clinic building, or overall quality of care received. Robust Poisson regression was used to estimate prevalence ratios and 95% confidence intervals (CIs) for associations between satisfaction with care and ART adherence and between satisfaction with care and viral suppression (viral load < 1000 copies/mL).ResultsAs of 1 March 2020, 2928 PLWH were enrolled and 2311 had a year of follow-up visits. At the first annual follow-up visit, 2309 participants responded to questions regarding satisfaction with quality of care, and 2069 (89.6%) reported satisfaction with care. Dissatisfaction with waiting time was reported by 177 (7.6%), building quality by 59 (2.6%), overall quality of care by 18 (0.8%), health care worker attitudes by 16 (0.7%), and health care worker skills by 15 (0.7%). After adjusting for age and site, there was no significant difference in viral suppression between those who were satisfied with care and those who were dissatisfied (aPR: 1.03, 95% CI 0.97–1.09). Satisfaction with HIV care was moderately associated with ART adherence among AFRICOS participants (aPR: 1.09; 95% CI 1.00–1.16).ConclusionsWhile patient satisfaction in AFRICOS was high and the association between perceived quality of care and adherence to ART was marginal, we did identify potential target areas for HIV care improvement, including reducing clinic waiting times.

Health outcomes and healthcare utilization of Native Hawaiians and other Pacific Islanders living with HIV in Hawai‘i: A mixed-methods study

ABSTRACT Objectives: Past research shows mixed outcomes in terms of HIV-related disparities among Native Hawaiians and Pacific Islanders (NHOPI). This study investigates HIV-related disparities among NHOPI living with HIV in Hawai‘i. Design: An explanatory sequential design was utilized. The quantitative portion analyzed survey data from a statewide Ryan White Needs Assessment (N = 398) to examine the differences in viral suppression and satisfaction with care between NHOPI and other ethnic groups. Utilizing the behavioral model for vulnerable populations (BMVP), semi-structured interviews (N = 16) were conducted next to explain what factors play a role in satisfaction with care and viral suppression when it comes to NHOPI living with HIV in Hawai‘i. Results: Among the 398 participants 13% were NHOPI. NHOPI were more likely to have a viral load of ≥10,000 copies/mL compared to those who didn’t identify as NHOPI. However, there were no significant differences for other viral load levels (20–199 or 200–9999), and only 20 participants (5.2%) had a viral load of 10,000 copies/mL or more. No significant ethnic differences were found in satisfaction with medical care. In the qualitative phase, factors from all domains of the BMVP were represented within the four themes identified: (1) Care coordination is essential- with AIDs service organizations taking the lead; (2) HIV care, as well as overall health, is defined by the effectiveness of medication; (3) Initial diagnosis is a critical moment for intervention; and (4) Aspects of culture are intangible. Conclusion: Among NHOPI in Hawai‘i who are engaged in case management, there appears to be no substantial disparities in either viral load or satisfaction with care compared to other ethnic groups. Despite this, qualitative findings provide insights on how ethnicity and culture may still be playing a role. Addressing all domains of the BMVP is crucial to addressing this.

Effectiveness and tolerability of dolutegravir and abacavir/lamivudine administered as two separate pills compared to their equivalent single-tablet regimen in a multicentre cohort in Spain.

IntroductionWe aimed to assess the effectiveness and tolerability of dolutegravir (DTG), abacavir (ABC) and lamivudine (3TC) administered as branded STR (DTG/ABC/3TC) or as two separate pills (DTG and either branded ABC/3TC [DTG+(ABC/3TC)b] or generic ABC/3TC [DTG+(ABC/3TC)g]).MethodsWe included individuals from the multicentre cohort of the Spanish HIV/AIDS Research Network (CoRIS) who received DTG/ABC/3TC, DTG+(ABC/3TC)b or DTG+(ABC/3TC)g during 2015 to 2018. We used multivariable logistic regression to compare the proportion of antiretroviral‐naïve individuals who achieved viral suppression (VS) (viral load ≤50 copies/mL) at 24 weeks of initiating with DTG+(ABC/3TC)b or DTG+(ABC/3TC)g versus DTG/ABC/3TC. We also calculated the proportion of virologically suppressed individuals who maintained VS at 24 weeks after switching from DTG/ABC/3TC to DTG+(ABC/3TC)g.ResultsDuring the study period, 829, 68 and 47 treatment‐naïve individuals started treatment with DTG/ABC/3TC, DTG+(ABC/3TC)b or DTG+(ABC/3TC)g respectively. The proportions of individuals who changed their regimens due to side effects during the first 24 weeks were 3.7%, 4.4% and 6.4% respectively (p = 0.646). We did not find significant differences in VS at 24 weeks among individuals starting with DTG+(ABC/3TC)b or DTG+(ABC/3TC)g compared to those initiating with DTG/ABC/3TC. Among 177 virologically suppressed individuals who switched from DTG/ABC/3TC to DTG+(ABC/3TC)g, 170 (96.0%) maintained VS at 24 weeks.ConclusionsIn naïve individuals, the effectiveness and tolerability at 24 weeks of DTG plus ABC/3TC administered as two separate pills, either as branded or generic ABC/3TC, was similar to the STR DTG/ABC/3TC. Switching the STR DTG/ABC/3TC to its separate components DTG+(ABC/3TC)g in virologically suppressed individuals did not seem to impair its effectiveness.

A systematic review of the effectiveness of non- health facility based care delivery of antiretroviral therapy for people living with HIV in sub-Saharan Africa measured by viral suppression, mortality and retention on ART

BackgroundAlternative models for sustainable antiretroviral treatment (ART) delivery are necessary to meet the increasing demand to maintain population-wide ART for all people living with HIV (PLHIV) in sub-Saharan Africa. We undertook a review of published literature comparing health facility-based care (HFBC) with non-health facility based care (nHFBC) models of ART delivery in terms of health outcomes; viral suppression, loss to follow-up, retention and mortality.MethodsWe conducted a systematic search of Medline, Embase and Global Health databases from 2010 onwards. UNAIDS reports, WHO guidelines and abstracts from conferences were reviewed. All studies measuring at least one of the following outcomes, viral load suppression, loss-to-follow-up (LTFU) and mortality were included. Data were extracted, and a descriptive analysis was performed. Risk of bias assessment was done for all studies. Pooled estimates of the risk difference (for viral suppression) and hazard ratio (for mortality) were made using random-effects meta-analysis.ResultsOf 3082 non-duplicate records, 193 were eligible for full text screening of which 21 published papers met the criteria for inclusion. The pooled risk difference of viral load suppression amongst 4 RCTs showed no evidence of a difference in viral suppression (VS) between nHFBC and HFBC with an overall estimated risk difference of 1% [95% CI -1, 4%]. The pooled hazard ratio of mortality amongst 2 RCTs and 4 observational cohort studies showed no evidence of a difference in mortality between nHFBC and HFBC with an overall estimated hazard ratio of 1.01 [95% CI 0.88, 1.16]. Fifteen studies contained data on LTFU and 13 studies on retention. Although no formal quantitative analysis was performed on these outcomes due to the very different definitions between papers, it was observed that the outcomes appeared similar between HFBC and nHFBC.ConclusionsReview of current literature demonstrates comparable outcomes for nHFBC compared to HFBC ART delivery programmes in terms of viral suppression, retention and mortality.PROSPERO numberCRD42018088194.

Effects of community-based antiretroviral therapy initiation models on HIV treatment outcomes: A systematic review and meta-analysis.

BackgroundAntiretroviral therapy (ART) initiation in the community and outside of a traditional health facility has the potential to improve linkage to ART, decongest health facilities, and minimize structural barriers to attending HIV services among people living with HIV (PLWH). We conducted a systematic review and meta-analysis to determine the effect of offering ART initiation in the community on HIV treatment outcomes.Methods and findingsWe searched databases between 1 January 2013 and 22 February 2021 to identify randomized controlled trials (RCTs) and observational studies that compared offering ART initiation in a community setting to offering ART initiation in a traditional health facility or alternative community setting. We assessed risk of bias, reporting of implementation outcomes, and real-world relevance and used Mantel–Haenszel methods to generate pooled risk ratios (RRs) and risk differences (RDs) with 95% confidence intervals. We evaluated heterogeneity qualitatively and quantitatively and used GRADE to evaluate overall evidence certainty. Searches yielded 4,035 records, resulting in 8 included studies—4 RCTs and 4 observational studies—conducted in Lesotho, South Africa, Nigeria, Uganda, Malawi, Tanzania, and Haiti—a total of 11,196 PLWH. Five studies were conducted in general HIV populations, 2 in key populations, and 1 in adolescents. Community ART initiation strategies included community-based HIV testing coupled with ART initiation at home or at community venues; 5 studies maintained ART refills in the community, and 4 provided refills at the health facility. All studies were pragmatic, but in most cases provided additional resources. Few studies reported on implementation outcomes. All studies showed higher ART uptake in community initiation arms compared to facility initiation and refill arms (standard of care) (RR 1.73, 95% CI 1.22 to 2.45; RD 30%, 95% CI 10% to 50%; 5 studies). Retention (RR 1.43, 95% CI 1.32 to 1.54; RD 19%, 95% CI 11% to 28%; 4 studies) and viral suppression (RR 1.31, 95% CI 1.15 to 1.49; RD 15%, 95% CI 10% to 21%; 3 studies) at 12 months were also higher in the community-based ART initiation arms. Improved uptake, retention, and viral suppression with community ART initiation were seen across population subgroups—including men, adolescents, and key populations. One study reported no difference in retention and viral suppression at 2 years. There were limited data on adherence and mortality. Social harms and adverse events appeared to be minimal and similar between community ART initiation and standard of care. One study compared ART refill strategies following community ART initiation (community versus facility refills) and found no difference in viral suppression (RD −7%, 95% CI −19% to 6%) or retention at 12 months (RD −12%, 95% CI −23% to 0.3%). This systematic review was limited by few studies for inclusion, poor-quality observational data, and short-term outcomes.ConclusionsBased on data from a limited set of studies, community ART initiation appears to result in higher ART uptake, retention, and viral suppression at 1 year compared to facility-based ART initiation. Implementation on a wider scale necessitates broader exploration of costs, logistics, and acceptability by providers and PLWH to ensure that these effects are reproducible when delivered at scale, in different contexts, and over time.

Understanding disparities in viral suppression among Black MSM living with HIV in Atlanta Georgia.

IntroductionDue to factors associated with structural racism, Black men who have sex with men (MSM) living with HIV are less likely to be virally suppressed compared to white MSM. Most of these data come from clinical cohorts and modifiable reasons for these racial disparities need to be defined in order to intervene on these inequities. Therefore, we examined factors associated with racial disparities in baseline viral suppression in a community‐based cohort of Black and white MSM living with HIV in Atlanta, GA.MethodsWe conducted an observational cohort of Black and white MSM living with HIV infection in Atlanta. Enrolment occurred from June 2016 to June 2017 and men were followed for 24 months; laboratory and behavioural survey data were collected at 12 and 24 months after enrolment. Explanatory factors for racial disparities in viral suppression included sociodemographics and psychosocial variables. Poisson regression models with robust error variance were used to estimate prevalence ratios (PR) for Black/white differences in viral suppression. Factors that diminished the PR for race by ≥5% were considered to meaningfully attenuate the racial disparity and were included in a multivariable model.ResultsOverall, 26% (104/398) of participants were not virally suppressed at baseline. Lack of viral suppression was significantly more prevalent among Black MSM (33%; 69/206) than white MSM (19%; 36/192) (crude Prevalence Ratio (PR) = 1.6; 95% CI: 1.1 to 2.5). The age‐adjusted Black/white PR was diminished by controlling for: ART coverage (12% decrease), housing stability (7%), higher income (6%) and marijuana use (6%). In a multivariable model, these factors cumulatively mitigated the PR for race by 21% (adjusted PR = 1.1 [95% CI: 0.8 to 1.6]).ConclusionsRelative to white MSM, Black MSM living with HIV in Atlanta were less likely to be virally suppressed. This disparity was explained by several factors, many of which should be targeted for structural, policy and individual‐level interventions to reduce racial disparities.

Late presentation for HIV impairs immunological but not virological response to antiretroviral treatment.

The aim of this study was to examine the impact of late presentation (CD4+ cell count <350 cells/μl or an AIDS-defining event) on effectiveness and safety of initial antiretroviral therapy (ART) and to evaluate whether treatment response depends on first-line ART regimen in late presenters. ART-naive adults from the Cohort of the Spanish HIV/AIDS Research Network (CoRIS) starting triple ART between 2010 and 2018. We used multivariable models to assess differences in viral suppression (viral load <50 copies/ml), immunological response (change in CD4+ cell count, CD4% (>29%) and CD4/CD8 normalization (>0.4 and >1) multiple T-cell marker recovery (MTMR): CD4+ cell count more than 500 cells/μl and CD4% >29% and CD4/CD8 >1), and treatment discontinuation due to adverse events (TDAE) at 48 weeks from ART initiation. Out of 8002 participants, 48.7% were late presenters. Of them, 45.8% initiated ART with a NNRTI- (mostly TDF/FTC/EFV), 33.9% with a protease inhibitor (mostly TDF/FTC+boosted DRV) and 20.3% with an INI-based regimen (mostly ABC/3TC/DTG). At 48 weeks, late presenters had similar viral suppression, but worse immunological response, than non-late presenters with no difference on TDAE. Late presenters initiating with NNRTI-based regimens were more likely to achieve viral suppression than those starting with INI-based, due to the higher chance of achieving viral suppression observed with TDF/FTC/RPV compared to ABC/3TC/DTG. Initial treatment with NNRTI or protease inhibitor based showed similar immunological response than the INI-based regimens, which showed lower rates of TDAE than NNRTI- and protease inhibitor based regimens. Despite safety and effectiveness of initial ART in terms of viral suppression, late presenters may not experience complete immunological response. In late presenters, effectiveness and safety depends on both the class and the specific first-line ART regimen.

Long-term efficacy and safety of nucleos(t)ides analogues in patients with chronic hepatitis B.

Nucleos(t)ide analogues with high barrier to resistance are regarded as the principal therapeutic option for chronic hepatitis B (CHB). Treatment with entecavir (ETV), tenofovir disoproxil (TDF) and the later released tenofovir alafenamide (TAF) is highly effective at controlling hepatitis B virus (HBV) infection and, in the vast majority of patients, is well tolerated. No significant differences in viral suppression have been described among the different regimens, although an earlier achievement in biochemical response has been suggested first under TDF and recently under TAF. High barrier to resistance NAs rarely achieve hepatitis B surface antigen sero-clearance, and therefore should be maintained life-long in most cases. This has increased concerns about treatment-related toxicity, especially in patients under TDF with additional risk factors for kidney and bone impairment. TAF has shown a better bone and kidney safety profile than TDF, although it is not yet available worldwide due to its higher cost. Emergence of adverse events should be monitored since treatment-switch to ETV/TAF seems to be effective and safe in HBV mono-infected subjects. Finally, although an effective antiviral treatment leads to a clear improvement in clinical outcome of CHB patients; the risk of developing hepatocellular carcinoma (HCC) is not completely avoided with viral suppression. Whether tenofovir-based regimens provide any additional benefit over ETV in HCC prevention remains unclear and requires further investigation.