Viral Suppression Trajectories Destabilized After Coronavirus Disease 2019 Among US People With Human Immunodeficiency Virus: An Interrupted Time Series Analysis.

We examined changes in the proportion of people with human immunodeficiency virus (PWH) with virologic suppression (VS) in a multisite US cohort before and since the coronavirus disease 2019 (COVID-19) pandemic. Overall, prior gains in VS slowed during COVID-19, with disproportionate impacts on Black PWH and PWH who inject drugs.

Real-world effectiveness and safety of switching to dolutegravir/lamivudine among people living with HIV-1 aged over 50 years who are virologically suppressed.

OBJECTIVES: People living with HIV face several challenges as they age, including the potential for polypharmacy and increased susceptibility to drug-related adverse effects. Thus, effective and well-tolerated regimens with minimal or no drug interactions would be useful in this population. We present real-world effectiveness and safety data for individuals aged >50 years who achieved virological suppression (HIV-1 RNA <50 copies/mL) and switched to dolutegravir/lamivudine (DTG/3TC). METHODS: This retrospective, observational, single-centre study conducted in Portugal included individuals aged >50 years who switched to DTG/3TC while virologically suppressed and had ≥12 months of follow-up. Proportions of individuals maintaining virological suppression were described at 12 months; CD4+ cell counts were described at baseline and 12 months. Descriptive subgroup analyses were performed based on age, sex assigned at birth, and availability of historical genotypic resistance results. RESULTS: Overall, 538 individuals aged >50 years were included (74% male; mean age, 62 years; mean time on previous therapy, 160 months). High proportions (intention-to-treat population, 97%; on-treatment population, 98%) of individuals who switched to DTG/3TC maintained virological suppression through 12 months of follow-up. CD4+ cell counts remained stable (mean baseline: 727 cells/mm3 [range 94-2371]; mean month 12: 742 cells/mm3 [range 99-2659]). No individuals experienced virological failure. Nine (2%) individuals discontinued DTG/3TC for non-treatment-related reasons. Proportions with virological suppression at month 12 were similar between on-treatment subgroups by age, sex assigned at birth, and historical genotypic resistance results availability. CONCLUSIONS: DTG/3TC demonstrated robust effectiveness and a good safety profile in individuals aged >50 years with virological suppression in Portugal.

Multicentre service evaluation of injectable cabotegravir and rilpivirine delivery and outcomes across 12 UK clinics (SHARE LAI-net).

INTRODUCTION: Long-acting injectable cabotegravir + rilpivirine (CAB + RPV LAI) was approved for use in virally suppressed adults in the England and Wales national health service in November 2021. We describe a service evaluation of delivery processes and outcomes in 12 clinics. METHODS: Centres populated a database using information from local policies and clinical records. Services were asked to describe approval processes, clinic pathways, and adherence to national guidelines. Additional data were collected on reasons for regimen choice, treatment discontinuations, and management of viraemia. RESULTS: In total, 518 adults from 12 clinics were approved for CAB + RPV LAI between February 2022 and December 2023. Of the 518 people approved for CAB + RPV LAI, 423 received at least one injection. Median duration on CAB + RPV was 7.5 months (interquartile range 3.7-11.3). In total, 97% of injections were administered within the ±7-day window. Virological failure occurred in 0.7%, and 6% discontinued CAB + RPV. CONCLUSION: In this large UK-based cohort, robust approval processes and clinic protocols facilitated on-time injections and low rates of both discontinuation and virological failure.

Trajectories of CD4 T-cell count, CD8 T-cell count, and CD4/CD8 ratio in patients with HIV and long-term virological suppression based on Yunnan HIV cohort.

OBJECTIVE: Our objective was to evaluate the trajectory of immunology in patients with HIV with different baseline CD4 T-cell count strata after antiretroviral therapy (ART) under long-term viral suppression. METHODS: This was a sub-analysis focused on patients with virological suppression for at least 5 years after ART. Data were obtained from the Yunnan HIV cohort in China. Patients were categorized according to prespecified baseline CD4 T-cell counts. The trajectories of CD4 T-cell count, CD8 T-cell count, and CD4/CD8 ratio changing over time were fitted using a B-spline regression model. The Cox proportional hazards regression model was used to assess the association of baseline CD4 T-cell count with the risk of both immunological responder (IR) and CD4/CD8 ratio normalization. RESULTS: A total of 2618 patients with a median follow-up of 7.25 years (interquartile range [IQR] 5.92-8.75) were included. Over a period of 12 years, the mean CD4 T-cell count remained above 500 cells/µL in all groups. The mean CD4/CD8 ratio was solely normalized in patients whose baseline CD4 T-cell counts were above 350 cells/µL. Patients with higher baseline CD4 T-cell counts showed higher risks of both IR and CD4/CD8 ratio normalization than those with the lowest (all p trend <0.001). A higher baseline CD4 T-cell count predicted a shorter time for both IR and CD4/CD8 ratio normalization. CONCLUSIONS: Long-term, sustained viral suppression may not be able to fully normalize immunological functions in patients with HIV. A high baseline CD4 T-cell count benefits IR and CD4/CD8 ratio normalization.

Does type of antiretroviral therapy pick-up point influence 12-month virologic suppression in South Africa?

We assessed the impact of community- versus clinic-based medication pick-up on rates of virologic suppression in an observational cohort of adults on ART enrolled in a decentralized antiretroviral therapy program (CCMDD) in South Africa. Participants either attended clinics where they were given the choice to pick up ART in community venues or traditional clinics, or clinics where this pathway was assigned. Among 1856 participants, 977 (53%) opted for community ART pick-up at enrollment, and 1201 (86%) were virologically suppressed at one year. Because of missing data on virologic suppression, primary results are based on a model incorporating multiple imputation. In addition to age and gender, distance from clinic and year of HIV diagnosis were included in the multivariable model. There was no difference in opting for clinic- vs. community-based pick-up with regard to achieving 12-month virologic suppression (aRR 1.02, 95% CI 0.98-1.05) in clinics offering choice. There was no impact of assigning all participants to an external pick-up point (aRR 1.00, 95% CI 0.95-1.06), but virologic suppression was reduced in the clinic that assigned participants to clinic pick-up (aRR 0.87, 95% CI 0.81-0.92). These results suggest that provision of community-based ART has not reduced continued virologic suppression in the population enrolled in the CCMDD program.

Factors associated with completion of intensive adherence counseling among people living with HIV at a large referral hospital in Uganda: a retrospective analysis.

BACKGROUND: Among people living with HIV(PHIV) with unsuppressed viral load after six or more months of anti-retroviral therapy (ART), three intensive adherence counseling sessions (IAC) sessions are recommended. However, there is limited information about IAC completion rates. We investigated the factors associated with IAC completion among PLHIV with an unsuppressed viral load on first and second-line ART in mid-western Uganda. METHODS: In this retrospective review of medical records, we abstracted routine HIV data between January 2018 and September 2019 at the Fort Portal Regional Hospital. IAC completion was the primary outcome measured as the receipt of ≥ 3 consecutive good ART adherence scores of ≥ 95.0% during the IAC sessions, spaced one month apart within three months. The modified Poisson regression analysis with robust standard errors was used to determine factors associated with the outcome, reported as risk ratio (RR) and 95% confidence interval (CI). RESULTS: We studied 420 participants of whom 204 (48.6%) were aged 20-39 years (mean age, 33.6 ± 13.3 years) and 243 (57.9%) were female. 282 (67.1%) participants completed their IAC sessions. Secondary or higher levels of education (Adjusted RR (aRR) 0.79, 95% CI 0.64-0.98), no follow-up for IAC (aRR 0.76, 95% CI 0.67-0.87), malnutrition (aRR 0.65, 95% CI 0.43-0.99) were associated with a lower likelihood of IAC completion while being in a separated/widowed or divorced relationship (aRR 1.23, 95% CI 1.01-1.49) was associated with a higher likelihood of IAC completion. CONCLUSIONS: We found a low IAC completion rate compared to the desired target of 100%. Nutritional support for malnourished PLHIV receiving IAC, follow-ups, and targeted health education on the importance of IAC are needed to improve the IAC completion rate.

Efficacy and Safety of Switching to the 2-Drug Regimen Dolutegravir/Lamivudine Versus Continuing a 3- or 4-Drug Regimen for Maintaining Virologic Suppression in Adults Living With Human Immunodeficiency Virus 1 (HIV-1): Week 48 Results From the Phase 3, Noninferiority SALSA Randomized Trial.

BACKGROUND: In TANGO, switching to dolutegravir/lamivudine (DTG/3TC) demonstrated long-term noninferior efficacy vs continuing tenofovir alafenamide-based regimens in treatment-experienced adults with HIV-1. The phase 3 SALSA study evaluated efficacy and safety of switching to DTG/3TC compared with continuing various 3-/4-drug current antiretroviral regimens (CARs). METHODS: Adults with HIV-1 RNA <50 copies/mL and no previous virologic failure were randomized (1:1, stratified by baseline third agent class) to switch to once-daily fixed-dose combination DTG/3TC or continue CAR (primary endpoint: proportion of participants with HIV-1 RNA ≥50 copies/mL at week 48; Snapshot, intention-to-treat-exposed population, 5% noninferiority margin). RESULTS: Overall, 493 adults (39% women; 39% aged ≥50 years; 19% African American/African heritage; 14% Asian) were randomized to switch to DTG/3TC (n = 246) or continue CAR (n = 247). At week 48, 1 (0.4%) participant in the DTG/3TC group and 3 (1.2%) in the CAR group had HIV-1 RNA ≥50 copies/mL (Snapshot), demonstrating noninferiority (adjusted difference, -0.8%; 95% CI, -2.4%, .8%). Zero participants met confirmed virologic withdrawal criteria; therefore, no resistance testing was performed. Drug-related adverse events were more frequent with DTG/3TC (20%) than CAR (6%) through week 48 but comparable post-week 24 (5% vs 2%, respectively). Proximal tubular renal function and bone turnover biomarkers improved with DTG/3TC. Both groups had generally minimal changes in lipids and inflammatory biomarkers. CONCLUSIONS: Switching to DTG/3TC was noninferior to continuing CAR for maintaining virologic suppression at week 48 with no observed resistance, supporting the efficacy, good safety, and high barrier to resistance of DTG/3TC. CLINICAL TRIALS REGISTRATION: www.clinicaltrials.gov, NCT04021290.

Pillars of long-term antiretroviral therapy success.

BACKGROUND: Meeting the challenge of antiretroviral therapy (ART) whose efficacy can last a lifetime requires continuous updating of the virological, pharmacological, and quality of life outcomes to be pursued and a continuous review of literature data on the efficacy and tolerability of new drugs and therapeutic strategies. METHODS: With the aim of identifying open questions and answers about the current controversies in modern ART, we adapted the Design Thinking methodology to the needs of the design phase of a scientific article, involving a team of experts in HIV care. RESULTS: Five main pillars of treatment success were discussed: sustained virologic suppression over time; immunological recovery; pharmacological attributes; long-term tolerability and safety of ART; and people's satisfaction and quality of life. The definition of the outcomes to be achieved in each thematic area and the tools to achieve them were reviewed and discussed. CONCLUSIONS: Long-term treatment success should be intended as a combination of HIV-RNA suppression, immune recovery, and high quality of life. To achieve this, the regimen should be well-tolerated, with high potency, genetic barrier, and forgiveness, and should be tailored by a person-centered perspective, based on individual needs, preferences, and therapeutic history.

Successful virologic outcomes over time among HAART-treated HIV-infected patients.

Few large studies evaluated the effects of time trends on virologic suppression in people living with HIV/AIDS (PLWHA) in China. To address this, An retrospective observational longitudinal study was conducted. We examined annual trends in the rate of virologic suppression, the viral load at the time of virologic suppression, and other determinants of virologic suppression in Zhejiang Province, China in PLWHA between January 2013 and July 2018. Patients who received a treatment regimen for at least 24 weeks were included. Virologic suppression was defined as VL ≤50 copies/mL. Generalized estimating equation logistic regression models were used to adjust for covariates. We included 16,265 patients with 45023 tests. The proportion of patients who experienced an unsuccessful virologic outcome decreased continuously throughout the observation period (18.14% to 6.64%). Time was significantly negatively associated with detectable VL (all ORs <1). Other factors were positively associated with detectable VL, including patients <30 years of age, single, non-adherent to treatment, and with a follow-up CD4 count <200 cells/µL. Patients infected through homosexual transmission and those with a longer ART duration were more likely to reach virologic suppression. We demonstrated outstanding time trend improvements in the virological outcomes of PLWHA in China.

Impact of Multicomponent Support Strategies on Human Immunodeficiency Virus Virologic Suppression Rates During Coronavirus Disease 2019: An Interrupted Time Series Analysis.

BACKGROUND: After coronavirus disease 2019 (COVID-19) shelter-in-place (SIP) orders, viral suppression (VS) rates initially decreased within a safety-net human immunodeficiency virus (HIV) clinic in San Francisco, particularly among people living with HIV (PLWH) who are experiencing homelessness. We sought to determine if proactive outreach to provide social services, scaling up of in-person visits, and expansion of housing programs could reverse this decline. METHODS: We assessed VS 24 months before and 13 months after SIP using mixed-effects logistic regression followed by interrupted time series (ITS) analysis to examine changes in the rate of VS per month. Loss to follow-up (LTFU) was assessed via active clinic tracing. RESULTS: Data from 1816 patients were included; the median age was 51 years, 12% were female, and 14% were experiencing unstable housing/homelessness. The adjusted odds of VS increased 1.34 fold following institution of the multicomponent strategies (95% confidence interval [CI], 1.21-1.46). In the ITS analysis, the odds of VS continuously increased 1.05 fold per month over the post-intervention period (95% CI, 1.01-1.08). Among PLWH who previously experienced homelessness and successfully received housing support, the odds of VS were 1.94-fold higher (95% CI, 1.05-3.59). The 1-year LTFU rate was 2.8 per 100 person-years (95% CI, 2.2-3.5). CONCLUSIONS: The VS rate increased following institution of the multicomponent strategies, with a lower LFTU rate compared with prior years. Maintaining in-person care for underserved patients, with flexible telemedicine options, along with provision of social services and permanent expansion of housing programs, will be needed to support VS among underserved populations during the COVID-19 pandemic.

ASSOCIATION OF SOCIAL NEEDS WITH UNCONTROLLED VIREMIA IN PEOPLE WITH HIV.

Using a tool integrated into the electronic health record, we determined prevalence of 10 social needs among 377 people with HIV (PWH) and 27,833 patients without HIV receiving care in the Montefiore Health System. PWH (median age 53) were 55% women, 41% Black, 44% Hispanic. 33% of PWH reported at least one social need vs. 18% among patients without HIV, with healthcare transportation and housing needs significantly higher among PWH in adjusted analyses. PWH reporting transportation needs were 27% less likely to be virologically suppressed (< 200 copies/mL, adjusted prevalence ratio 0.73, 95% CI 0.55-0.96) compared with PWH without transportation needs.

RESUMEN: Por medio del uso de encuestas integradas en el registro electrónico de salud, determinamos la prevalencia de 10 necesidades sociales entre 377 personas con VIH (PCV) y 27 833 pacientes sin VIH que reciben atención en el Montefiore Health System. PCV (edad mediana de 53 años) fueron 55% mujeres, 41% negras, 44% hispanas. 33% de PCV reportó al menos una necesidad social vs. 18% de los pacientes sin VIH, siendo las necesidades de transporte a cuidados de salud y de vivienda significativamente mayores en PCV en análisis multivariable ajustado. PCV con necesidades de transportación fueron 27% menos probables de tener supresión viral (< 200 copias/ml, razón de prevalencias ajustada 0.73, IC 95% 0.55­0.96) comparada con PCV sin necesidades de transportación.

Healthcare and treatment experiences among people diagnosed with HIV before and after a province-wide treatment as prevention initiative in British Columbia, Canada.

INTRODUCTION: In 2010, the Canadian province of British Columbia (BC) initiated the Seek and Treat for Optimal Prevention of HIV/AIDS (STOP HIV/AIDS) program to improve HIV testing, linkage to care, and treatment uptake, thereby operationalizing the HIV Treatment as Prevention (TasP) framework at the population-level. In this analysis, we evaluated self-reported HIV care experiences and therapeutic outcomes among people diagnosed with HIV prior to and after implementation of this provincial program. METHODS: A cross-sectional analysis was performed on the baseline data of a cohort of people living with HIV (PLWH) (19 years and older) in the province of BC sampled from July 2016 to September 2018. All participants consented to linking their survey data to the provincial HIV treatment registry. Individuals diagnosed with HIV from January 1 2000-December 31 2009 were classified as pre-intervention and those diagnosed January 1 2010-December 31 2018 as post-intervention cohorts. Bivariate analyses were run using Chi-square and Wilcoxon Rank Sum tests. Cox proportional hazards regression model demonstrates time to antiretroviral therapy (ART) initiation (from HIV baseline) and virological suppression (2 consecutive plasma viral load measurements < 200 copies/ml). RESULTS: Of the 325 participants included in this analysis, 198 (61%) were diagnosed with HIV in the pre-intervention era and 127 (39%) in the post-intervention era. A higher proportion of participants in post-intervention era were diagnosed at walk-in clinics (45% vs. 39%) and hospitals (21% vs. 11%) (vs pre-intervention) (p = 0.042). Post-intervention participants had initiated ART with less advanced HIV disease (CD4 count 410 vs. 270 cells/ul; p = 0.001) and were less likely to experience treatment interruptions at any point in the 5 years after HIV diagnosis (17% vs. 48%; p < 0.001). The post-intervention cohort had significantly more timely ART initiation (aHR: 5.97, 95%CI 4.47, 7.97) and virologic suppression (aHR: 2.03, 95%CI 1.58, 2.60) following diagnosis, after controlling for confounders. CONCLUSIONS: We found favourable treatment experiences and more timely ART initiation and virologic suppression after a targeted TasP provincial program. Our results illustrate the importance of accessible low-barrier HIV testing and treatment in tackling the HIV epidemic.

Correlates and cascade of HIV care in patients with psychiatric disorders in the Eastern Cape province, South Africa.

Background: The cascade of human immunodeficiency virus (HIV) care in patients with psychiatric disorders is poorly understood. Aim: This study determined the prevalence of HIV and described its cascade of care among patients with psychiatric disorders in the Eastern Cape province, South Africa. The study also examined the correlates of HIV comorbidity with psychiatric disorders in the cohort. Methods: In this cross-sectional study, a total of 368 individuals attending the Psychiatric Outpatients' Department of Cecilia Makiwane Hospital in Eastern Cape were interviewed with a structured questionnaire. Relevant items on demographics and clinical information were extracted from the medical records. Virologic suppression was defined as viral load < 1000 RNA copies/mL. Results: The HIV prevalence after the intervention was 18.8% and a significant proportion of participants already knew their status (n = 320; 87.0%). Linkage to care and antiretroviral therapy initiation occurred in 61 participants, of those diagnosed with HIV (88.4%), with 84.1% being eligible for viral load monitoring (n = 58) and 53.4% having achieved virologic suppression. Being female (AOR = 5.48; 95% CI 2.61-11.51) and black (adjusted odds ratio [AOR] = 3.85; 95% confidence interval [CI] 1.06-14.03) were independent predictors of HIV comorbidity in individuals living with psychiatric disorders. Conclusion: This study found a moderately high prevalence (close to 19%) of HIV in individuals with psychiatric disorders, with a significant correlation with being female and being black people. This study also found a significant gap in the linkage to antiretroviral therapy (ART) initiation and a low rate of virologic suppression of 53.4%. Clinicians, therefore, should monitor and provide interventions for patients with concomitant HIV infection along this cascade of care.

Factors associated with viremia in people living with HIV on antiretroviral therapy in Guatemala.

INTRODUCTION: Viral suppression prevents HIV transmission and disease progression, but socio-economic and clinical factors can hinder the goal of suppression. We evaluated factors associated with viral non suppression (VNS) and persistent viremia (PV) in people living with HIV (PLHIV) receiving antiretroviral therapy (ART) in Guatemala. METHODS: We conducted a cross sectional analysis using data from an ongoing cohort of PLHIV attending the largest HIV clinic in Guatemala. Univariable and multivariable analyses were conducted between PLHIV with viral suppression and detectable viremia. VNS was defined as most recent HIV RNA ≥ 200 copies/ml and PV as two consecutive HIV RNA ≥ 200 copies/ml. RESULTS: Of 664 participants, 13.3% had VNS and 7.1% had PV. In univariable analysis disaggregated by gender, low income, poor education, perceived difficulty attending healthcare, and alcohol use were associated with VNS in men while low CD4 at diagnosis, multiple prior ART regimens and treatment interruptions were significant in both genders. Multiple prior ART regimens (adjusted Odds Ratio (aOR) 2.82, [95% confidence interval (CI) 1.59, 4.99], p < 0.01), treatment interruptions (aOR 4.51, [95% CI 2.13, 9.58], p < 0.01), excessive alcohol consumption (aOR 2.56, [95% CI 1.18, 5.54], p < 0.05) perceived difficulty attending healthcare (aOR 2.07, [ 95% CI 1.25, 3.42], p < 0.01) and low CD4 at diagnosis (aOR 2.34, 95% [CI 1.30, 4.20], p < 0.01) were independently associated with VNS on multivariable regression. CONCLUSIONS: We conclude that socio-economic and clinical factors influence viral suppression in our cohort and vary between men and women. Gender specific approaches are necessary to achieve the 90% suppression goal.

Efficacy and Safety of Switching to Dolutegravir/Lamivudine Fixed-Dose 2-Drug Regimen vs Continuing a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With Human Immunodeficiency Virus Type 1: Phase 3, Randomized, Noninferiority TANGO Study.

BACKGROUND: The 2-drug regimen dolutegravir (DTG) + lamivudine (3TC) is indicated for treatment-naive adults with human immunodeficiency virus type 1 (HIV-1). We present efficacy and safety of switching to DTG/3TC in virologically suppressed individuals. METHODS: TANGO is an open-label, multicenter, phase 3 study that randomized adults (1:1, stratified by baseline third agent class) with HIV-1 RNA <50 copies/mL to switch to once-daily fixed-dose DTG/3TC or remain on a tenofovir alafenamide (TAF)-based regimen. The primary end point was proportion of participants with HIV-1 RNA ≥50 copies/mL at week 48 (US Food and Drug Administration Snapshot algorithm) in the intention-to-treat-exposed population (4% noninferiority margin). RESULTS: 743 adults were enrolled; 741 received ≥1 dose of study drug (DTG/3TC, N = 369; TAF-based regimen, N = 372). At week 48, proportion of participants with HIV-1 RNA ≥50 copies/mL receiving DTG/3TC was 0.3% (1/369) vs 0.5% (2/372) with a TAF-based regimen (adjusted treatment difference [95% confidence interval], -0.3 [-1.2 to .7]), meeting noninferiority criteria. No participants receiving DTG/3TC and 1 receiving a TAF-based regimen met confirmed virologic withdrawal criteria, with no emergent resistance at failure. Drug-related grade ≥2 adverse events and withdrawals due to adverse events occurred in 17 (4.6%) and 13 (3.5%) participants with DTG/3TC and 3 (0.8%) and 2 (0.5%) with a TAF-based regimen, respectively. CONCLUSIONS: DTG/3TC was noninferior in maintaining virologic suppression vs a TAF-based regimen at week 48, with no virologic failure or emergent resistance reported with DTG/3TC, supporting it as a simplification strategy for virologically suppressed people with HIV-1. CLINICAL TRIALS REGISTRATION: NCT03446573.

Lack of virologic suppression is associated with lower HIV-related disclosure stigma in people living with HIV.

Stigma remains a leading barrier to HIV care. To determine the influence of disclosure stigma (DS), fear of disclosing one's serostatus, on virologic suppression, a cross-sectional study was performed at the largest publicly-funded HIV clinic in South Texas. A survey was administered to participants who were: ≥18 years old, living with HIV, and receiving antiretroviral therapy. Surveys included demographics, adherence questionnaire, and a validated HIV-stigma scale with DS as the sum of 10 items ranked 0-3, with score of 30 indicating highest stigma. The primary outcome was lack of virologic suppression (LOVS): most recent HIV-1 RNA > 20 copies/ml. A bivariate analyses examined predictors of DS, dichotomized at the median. Depression score, perceived stress, and lack of friend/family support were associated with DS. Logistic regression models examined the relationship between DS, as a continuous variable, and LOVS. For 275 participants (69% Hispanic), median DS score was 18.5. DS was significantly inversely associated with LOVS (aOR 0.94 per 1 scale point; CI 0.89, 0.99) after adjustment for age, gender/sexual orientation, race/ethnicity, and drug use. The unanticipated inverse association between DS and LOVS highlights the complexity of this relationship. However, the balance of data in this cohort demonstrate an overall negative impact of DS.

A packaged intervention to improve viral load monitoring within a deeply rural health district of South Africa.

BACKGROUND: The KwaZulu-Natal (KZN) province of South Africa has the highest prevalence of HIV infection in the world. Viral load (VL) testing is a crucial tool for clinical and programmatic monitoring. Within uMkhanyakude district, VL suppression rates were 91% among patients with VL data; however, VL performance rates averaged only 38·7%. The objective of this study was to determine if enhanced clinic processes and community outreach could improve VL monitoring within this district. METHODS: A packaged intervention was implemented at three rural clinics in the setting of the KZN HIV AIDS Drug Resistance Surveillance Study. This included file hygiene, outreach, a VL register and documentation revisions. Chart audits were used to assess fidelity. Outcome measures included percentage VL performed and suppressed. Each rural clinic was matched with a peri-urban clinic for comparison before and after the start of each phase of the intervention. Monthly sample proportions were modelled using quasi-likelihood regression methods for over-dispersed binomial data. RESULTS: Mkuze and Jozini clinics increased VL performance overall from 33·9% and 35·3% to 75·8% and 72·4%, respectively which was significantly greater than the increases in the comparison clinics (RR 1·86 and 1·68, p < 0·01). VL suppression rates similarly increased overall by 39·3% and 36·2% (RR 1·84 and 1·70, p < 0·01). The Chart Intervention phase showed significant increases in fidelity 16 months after implementation. CONCLUSIONS: The packaged intervention improved VL performance and suppression rates overall but was significant in Mkuze and Jozini. Larger sustained efforts will be needed to have a similar impact throughout the province.

Impact of sustained virologic response on risk of type 2 diabetes among hepatitis C patients in the United States.

Data regarding the impact of hepatitis C (HCV) therapy on incidence of type 2 diabetes mellitus are limited. We used the data from the longitudinal Chronic Hepatitis Cohort Study-drawn from four large US health systems-to investigate how response to HCV treatment impacts the risk of subsequent diabetes. Among HCV patients without a history of type 2 diabetes mellitus or hepatitis B, we investigated the incidence of type 2 diabetes from 12 weeks post-HCV treatment through December 2015. Cox proportional hazards models were used to test the effect of treatment status (sustained virologic response [SVR] or treatment failure) and baseline risk factors on the development of diabetes, considering any possible risk factor-by-SVR interactions, and death as a competing risk. Among 5127 patients with an average follow-up of 3.7 years, diabetes incidence was significantly lower among patients who achieved SVR (231/3748; 6.2%) than among patients with treatment failure (299/1379; 21.7%; adjusted hazard ratio [aHR] = 0.79; 95% CI: 0.65-0.96). Risk of diabetes was higher among African American and Asian American patients than White patients (aHR = 1.82 and 1.75, respectively; P < .05), and among Hispanic patients than non-Hispanics (aHR = 1.86). Patients with BMI ≥ 30 and 25-30 (demonstrated higher risk of diabetes aHR = 3.62 and 1.72, respectively; P < .05) than those with BMI < 25; patients with cirrhosis at baseline had higher risk than those without cirrhosis (aHR = 1.47). Among a large US cohort of patients treated for HCV, patients who achieved SVR demonstrated a substantially lower risk for the development of type 2 diabetes mellitus than patients with treatment failure.

Baseline Cigarette Smoking Status as a Predictor of Virologic Suppression and CD4 Cell Count During One-Year Follow-Up in Substance Users with Uncontrolled HIV Infection.

Cigarette smoking is prevalent in people living with HIV/AIDS (PLHIV) who abuse alcohol and/or illicit substances. This study evaluated whether smoking is predictive of virologic non-suppression (> 200 copies/mL) and low CD4 count (< 200 cells/mm3) during 1-year follow-up in medically hospitalized, substance-using PLHIV recruited for a multi-site trial. Smoking status was assessed with the Heaviness of Smoking Index (HSI). Analyses revealed that, controlling for baseline differences and adherence to antiretroviral therapy, non-smokers (n = 237), compared to smokers scoring in the medium-to-high range on the HSI (n = 386), were significantly more likely to achieve viral suppression (OR 1.50, 95% CI 1.02, 2.20). There was a significant smoking-by-time interaction for CD4 cell count (χ2(1) = 4.08, p < .05), with smokers less likely to have low CD4 count at baseline and 6-month follow-up, but more likely to have low CD4 count at 12-month follow-up. The results suggest that smoking may play a role in immunological functioning in HIV-infected substance users. ClinicalTrials.gov Identifier: NCT01612169.

Outcomes of community-based differentiated models of multi-month dispensing of antiretroviral medication among stable HIV-infected patients in Lesotho: a cluster randomised non-inferiority trial protocol.

BACKGROUND: Current World Health Organization (WHO) guidelines recommend early initiation of HIV positive patients on antiretroviral therapy (ART) irrespective of their clinical or immunological status known as the test and start approach. Lesotho, like many other countries introduced this approach in 2016 as a strategy to reach epidemic control. There will be rapidly growing number of HIV-infected individuals initiating treatment leading to practical challenges on health systems such as congestion, long waiting time for patients and limited time to provide quality services to patients. Differentiated models of ART delivery is an innovative solution that helps to increase access to care, while reducing the burden on existing health systems. Ultimately this model will help to achieve retention and viral suppression. We describe a demonstration study designed to evaluate a community-based differentiated model of multi-month dispensing (MMD) approaches of ART among stable HIV patients in Lesotho. METHODS: This study will be a three-arm cluster randomised trial, which will enrol approximately 5760 HIV-infected individuals who are stable on ART in 30 selected clusters. The clusters, which are health facilities, will be randomly assigned into the following differentiated model of care arms: (i) 3 monthly ART supply at facilities (Control), (ii) 3 monthly ART supply through community ART groups (CAGs) and (iii) 6 monthly ART supply through community ART distribution points (CAD). Primary outcomes are retention in care and virologic suppression, and secondary outcomes include feasibility and cost effectiveness. DISCUSSION: Important lessons will be learnt to allow for improved implementation of such demonstration projects, including various needs for reliable supply of medication, access to quality clinical data including access to viral loads (VLs) results, frameworks to support lay worker cadre, involvement of community stakeholders, and reliable data systems including records of key indicators. MMD will have positive implications including improved retention, virologic suppression, convenience and access to medication. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03438370 . Accepted on 16 February 2018.