The Academy’s “Clinical Research Update” features clinical information from Carolyn Chu, MD, MSc, AAHIVS who serves as chief medical officer for the Academy. Dr. Chu provides a short synopsis of key clinical studies, reviews, and clinical practice guidelines selected on the basis of having immediate or important clinical implications for our Academy frontline members and their patients. Periodic updates from the U.S. Department of Health and Human Services (DHHS) HIV Clinical Practice Guidelines are also included.

Clinical Research Update 11.22.22 – Utilization of bictegravir/emtricitabine/tenofovir alafenamide in patients with end-stage renal disease on hemodialysis

Clinical Research Update 11.8.22 – Prevention and Care Opportunities for People Who Inject Drugs in an HIV Outbreak 

Clinical Research Update 10.25.22 – CoRIS and CoRISpe Spanish National Cohorts, Integrase inhibitors in children and adolescents: clinical use and resistance

Clinical Research Update 10.11.22 – Impact on Renal Function of Daily and On-demand HIV PrEP in the ANRS-PREVENIR Study

Clinical Research Update 9.27.22 – Use and safety of appearance and performance enhancing supplements in gay, bisexual, and other MSM receiving daily tenofovir disoproxil fumarate/emtricitabine as HIV PrEP

Clinical Research Update 9.13.22 – Update of perinatal HIV-1 transmission in France: zero transmission for 5482 mothers on continuous ART from conception and with undetectable viral load at delivery

Clinical Research Update 8.30.22 – Recent abacavir use and incident cardiovascular disease in contemporary treated people living with HIV

Clinical Research Update 8.16.22 – Compassionate use of long-acting cabotegravir plus rilpivirine for PLWH in need of parenteral antiretroviral therapy

Clinical Research Update 8.2.22 – Demographic and clinical characteristics of confirmed human monkeypox virus cases in individuals attending a sexual health centre in London, UK

Clinical Research Update 7.19.22 – Risks and benefits of oral HIV PrEP for people with chronic hepatitis B

Clinical Research Update 7.5.22 – Adverse effects of testosterone use among men living with HIV: Data from the PUSH! study

Clinical Research Update 6.21.22 – The effect of menopausal status, age, and HIV on non-AIDS comorbidity burden among U.S. women

Clinical Research Update 6.7.22 – Baseline HIV drug-resistance testing: 12 U.S. jurisdictions, 2014-2019

Clinical Research Update 5.24.22 – Retreatment for HCV direct acting antiviral therapy virological failure in primary and tertiary settings: the REACH-C cohort

Clinical Research Update 5.10.22 – Direct and indirect effects of a Project ECHO longitudinal clinical tele-mentoring program on viral suppression for persons with HIV: a population-based analysis

Clinical Research Update 4.26.22 – A systematic review of factors critical for HIV health literacy, ART adherence and retention in care in the U.S. for racial and ethnic minorities

Clinical Research Update 4.12.22 – Essential elements of and challenges to rapid ART implementation: a qualitative study of three programs in the United States

Clinical Research Update 3.29.22 – Characterization of HIV infections in women who received injectable cabotegravir or tenofovir disoproxil fumarate/emtricitabine for HIV prevention

Clinical Research Update 3.15.22 – Method of calculating renal function estimates could inappropriately exclude transgender patients receiving gender-affirming hormone therapy from PrEP eligibility

Clinical Research Update 3.1.22 – UK Guideline for the Use of HIV Post-exposure Prophylaxis 2021

Clinical Research Update 2.15.22 – 4-days-on and 3-days-off Maintenance Treatment Strategy for Adults with HIV

Clinical Research Update 2.1.22 – A Minimal Monitoring Approach for the Treatment of HCV Infection

Clinical Research Update 1.18.22 – The Effect of Initial Patient Experiences and Life Stressors on Predicting Lost to Follow-Up in Patients New to an HIV Clinic

Clinical Research Update 1.4.22 – Acceptability of HIV testing for adolescents and young adults by delivery model

Clinical  Research Update 1.4.22 – HIV-associated wasting prevalence in the era of modern antiretroviral therapy

Clinical Research Update 12.28.21 – Rising Rates of Recent PrEP Exposure Among MSM Newly Diagnosed with HIV: Antiviral Resistance Patterns and Treatment Outcomes

Clinical Research Update 12.14.21 – Experience and Outcomes of Breastfed Infants of Women with HIV in the United States

Clinical Research Update 11.30.21 – Science Over Stigma: Lessons and Future Direction of HIV-to-HIV Transplantation

Clinical Research Update 11.16.21 – Rilpivirine plus cobicistat-boosted darunavir as alternative to standard three-drug therapy in HIV-infected, virologically suppressed subjects: Final results of the PROBE 2 trial

Clinical Research Update 11.2.21 – Perinatal Depressive Symptoms, HIV Suppression, and the Underlying Role of ART Adherence: A Longitudinal Mediation Analysis in the IMPAACT P1025 Cohort

Clinical Research Update 10.19.21 – Dolutegravir-based dual maintenance regimens combined with lamivudine/emtricitabine or rilpivirine: risk of virological failure in a real-life setting

Clinical Research Update 10.5.21 – Safety of tenofovir alafenamide in PWH who experienced proximal renal tubulopathy on tenofovir disoproxil fumarate

Clinical Research Update 9.21.21 – DTG/3TC as a first-line regimen in a test-and-treat setting for newly diagnosed PWH

Clinical Research Update 9.7.21 – Maternal HIV drug resistance is associated with vertical transmission and is prevalent in infected infants

Clinical Research Update 8.24.21 – Impact of depression and post-traumatic stress symptoms on physical health perceptions and functional impairment among sexual minority men with HIV with histories of trauma

Clinical Research Update 8.10.21 – Incident Bone Fracture and Mortality in Large HIV Cohort Outpatient Study

Clinical Research Update 7.27.21 – Pharmacokinetics of bictegravir and tenofovir in combination with darunavir/cobicistat in treatment-experienced PWH

Clinical Research Update 7.13.21 – Forgiveness of Dolutegravir-based Triple Therapy Compared to Older ARV Regimens

Clinical Research Update 6.29.21 – The Effect of Buprenorphine on HIV Viral Suppression

Clinical Research Update 6.15.21 – To Dose-adjust or Not to Dose-adjust: Lamivudine Dose in Kidney Impairment

Clinical Research Update 6.1.21 – Sofosbuvir/velpatasvir for 12 vs. 6 Weeks for the Treatment of Recently Acquired HCV

Clinical Research Update 5.18.21 – Frequency of high grade squamous cervical lesions among women over age 65 years living with HIV

Clinical Research Update 5.4.21 – The Role of Pharmacies in the HIV Prevention and Care Continuums: A Systematic Review

Clinical Research Update 4.20.21 – Pregnancy in an Urban Cohort of Adolescents Living with HIV: Characteristics and Outcomes in Comparison to Adults

Clinical Research Update 4.6.21 – Toward Safer Opioid Prescribing: Effects of the TOWER Intervention on HIV Care Providers

Clinical Research Update 3.23.21 – Prevalence of Self-report Neurologic and Ocular Symptoms in Early Syphilis Cases

Clinical Research Update 3.9.21 – Heplisav-B Seroprotection in People with HIV: A Single-Center Experience

Clinical Research Update 2.23.21 – Interventions to Improve HIV Care Continuum Outcomes Among Individuals Released from Prison or Jail

Clinical Research Update 2.9.21 – Risk of Smoking-related Cancers Among Women and Men Living With and Without HIV

Clinical Research Update 1.26.21 – Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine and the BNT162b2 mRNA Covid-19 Vaccine

Clinical Research Update 12.29.20 – NIH Workshop on HIV-Associated Comorbidities, Coinfections, and Complications: Summary and Recommendation for Future Research

Clinical Research Update 12.22.20 – Risk Factors for Weight Gain Following Switch to Integrase Inhibitor-Based Antiretroviral Therapy

Clinical Research Update 12.15.20 – Tenofovir Alafenamide vs. Tenofovir Disoproxil Fumarate

Clinical Research Update 12.8.20 – COVID-19 Related Medical Mistrust, Health Impacts, and Potential Vaccine Hesitancy Among Black Americans Living with HIV

Clinical Research Update 12.1.20 – Outcomes of Coronary Artery Bypass Grafting in Patients with HIV

Clinical Research Update 11.24.20 – Evolution of Drug Interactions with Antiretroviral Medication in People with HIV

Clinical Research Update 11.17.20 – Surprisingly Low Levels of Measles Immunity in Persons With HIV: A Seroprevalence Survey in a United States HIV Clinic

Clinical Research Update 11.10.20 – Safety and Efficacy of the HIV-1 Attachment Inhibitor Prodrug Fostemsavir in Heavily Treatment-Experienced Individuals: Week 96 Results of the Phase 3 BRIGHTE Study

Clinical Research Update 11.3.20 – Virological Failure and Acquired Genotypic Resistance Associated with Contemporary Antiretroviral Treatment Regimens

Clinical Research Update 10.27.20 – Characteristics, Comorbidities, and Outcomes in a Multicenter Registry of Patients with HIV and Coronavirus Disease-19

Clinical Research Update 10.20.20 – ART Drugs for Treatment and Prevention of HIV Infection in Adults: 2020 Recommendations of the ISA–USA Panel

Clinical Research Update 10.13.20 – Structural and Functional Brain Abnormalities in HIV Disease Revealed by Multimodal MRI Fusion: Association with Cognitive Function

Clinical Research Update 10.6.20 – Frailty Is Associated with Mortality and Incident Comorbidity Among Middle-Aged HIV-Positive and HIV-Negative Participants

Clinical Research Update 9.29.20 – Screening & Enrollment by Sex in HIV Clinical Trials in the United States

Clinical Research Update 9.22.20 – Prevalence of Hepatitis A Immunity and Decision-tree analysis Among Men Who Have Sex With Men and are Living With HIV in Tokyo

Clinical Research Update 9.15.20 – Prospective International Study of Incidence and Predictors of Immune Reconstitution Inflammatory Syndrome and Death in People Living with HIV and Severe Lymphopenia

Clinical Research Update 9.8.20 – Trends in Time from HIV Diagnosis to First Viral Suppression Following Revised U.S. HIV Treatment Guidelines, 2012–2017

Clinical Research Update 9.1.20 – Outcomes Among HIV-Positive Patients Hospitalized With COVID-19

Clinical Research Update 8.25.20 – Rapid antiretroviral therapy among individuals with acute and early HIV

Clinical Reserach Update 8.18.20 – HIV infection is associated with lower risk of hepatocellular carcinoma after sustained virological response to direct-acting antivirals in HCV infected-patients with advanced fibrosis

Clinical Research Update 8.11.20 – Deaths attributable to cancer in the United States HIV population during 2001-2015

Clinical Research Update 8.4.20 – AIDS 2020 Highlights – Part Four

Clinical Research Update 7.28.20 – AIDS 2020 Highlights – Part Three

Clinical Research Update 7.21.20 – AIDS 2020 Highlights – Part Two

Clinical Research Update 7.14.20 – AIDS 2020 Highlights – Part One

Clinical Research Update 7.7.20 – Distal Sensory Peripheral Neuropathy in HIV Type 1– Positive Individuals Before and After Antiretroviral Therapy Initiation in Diverse Resource-Limited Settings

Clinical Research Update 6.30.20 – Initiation of ART in the Hospital is Associated with Linkage to HIV Care for Persons with HIV and Substance Use

Clinical Research update 6.23.20 – Integrase Strand Transfer Inhibitors are associated with lower risk of incident Cardiovascular Disease in People Living with HIV

Clinical Research Update 6.16.20 – The Natural History of Anal High-grade Squamous Intraepithelial Lesions in Gay and Bisexual Men

Clinical Research Update 6.9.20 – The HIV Outpatient Study—25 Years of HIV Patient Care and Epidemiologic Research

Clinical Research Update 6.2.20 – Recurrence and Occurrence of Kaposi’s Sarcoma in Patients Living with HIV and on Antiretroviral Therapy, despite Suppressed HIV Viremia

Clinical Research Update 5.26.20 (CROI 2020) – Changes in Body Mass Index and the Risk of Cardiovascular Disease: The D:A:D Study

Clinical Research Update 5.19.20 (CROI 2020) – Trends in HIV Drug Resistance in the United States

Clinical Research Update 5.12.20 (CROI 2020) – 144-Week Efficacy and Safety of B/F/TAF in Treatment-Naive Adults ≥50 Years

Clinical Research Update 5.5.20 (CROI 2020) – Increased Overall Life Expectancy but Not Comorbidity-free Years for People with HIV

Clinical Research Update 4.28.20 (CROI 2020) – HIV Viral Blips in Adults Treated with INSTI-based Regimens through 144 weeks

Clinical Research Update 4.21.20 (CROI 2020) – Long-Acting Cabotegravir + Rilpivirine for HIV Treatment: FLAIR Week 96 Results

Clinical Research Update 4.14.20 (CROI 2020) – Safety and Efficacy of Dolutegravir vs Efavirenz and Tenofovir Disoproxil Fumarate vs Tenofovir Alafenamide in Pregnancy: IMPAACT 2010 Trial

Clinical Research Update 4.7.20 (CROI 2020) – Cabotegravir + Rilpivirine every 2 Months is Non-Inferior to Monthly: ATLAS-2M Study

Clinical Reseach Update 3.31.20 – Elvitegravir-Cobicistat-Emtricitabine-Tenofovir Alafenamide Single-tablet Regimen for HIV Postexposure Prophylaxis

Clinical Research Update 3.24.20 – Long-Acting Cabotegravir and Rilpivirine for Maintenance of HIV-1 Suppression

Clinical Research Update 3.17.20 – The Modern Epidemic of Syphilis

Clinical Research Update 3.10.20 – Outcomes in Human Immunodeficiency Virus-Infected Recipients of Heart Transplants

Clinical Research Update 3.3.20 – Dolutegravir- based Antiretroviral Therapy for Patients Coinfected with Tuberculosis and HIV

Clinical Research Update 2.25.20 – Adherence and Viral Suppression among Participants of the Patient-centered HIV Care Model Project: A Collaboration Between Community-based Pharmacists and HIV Clinical Providers

Clinical Research Update 2.18.20 – Atherosclerotic Cardiovascular Disease Risk Profile of Tenofovir Alafenamide versus Tenofovir Disoproxil Fumarate

Clinical Research Update 2.11.20 – HIV and Hepatitis C Virus Infection Testing Among Commercially Insured Persons Who Inject Drugs

Clinical Research Update 2.4.20 – Week 96 results of a phase 3 trial of D/C/F/TAF in treatment-naïve HIV-1 patients.

Clinical Research Update 1.28.20 – Clinical and Economic Impact of Ibalizumab for People with Multidrug-Resistant HIV in the United States

Clinical Research Update 1.21.20 – Accuracy in self-report of viral suppression among HIV-positive men with HIV-negative male partners

Clinical Research Update 1.14.20 – Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in a Rapid Initiation Model of Care for HIV-1 Infection: Primary Analysis of the DIAMOND Study

Clinical Research Update 1.7.20 – Effect of Cannabis Use on HIV DNA during Suppressive Antiretroviral Therapy

Clinical Research Update 12.17.10 – Nonadherence to Any Prescribed Medication Due to Costs among Adults with HIV Infection

Clinical Research Update 12.10.19 – Female genital tract shedding of HIV-1 is rare in women with suppressed HIV-1 in plasma

Clinical Research Update 12.3.19 – Use of Contemporary Protease Inhibitors and Risk of Incident Chronic Kidney Disease in Persons with HIV: The D:A:D Study

Clinical Research Update 11.26.19 – Switching to Fixed-Dose Bictegravir, Emtricitabine, and Tenofovir Alafenamide (B/F/TAF) in Virologically Suppressed HIV-1 Infected Women

Clinical Research Update 11.19.19 – Effect of daily consumption of extra virgin olive oil on the lipid profile and microbiota of HIV-infected patients over 50 years of age

Clinical Research Update 11.12.19 – Changes in Body Mass Index and Atherosclerotic Disease Risk Score After Switching From Tenofovir Disoproxil Fumarate to Tenofovir Alafenamide

Clinical Research Update 11.5.19 – Noninferiority of simplified dolutegravir monotherapy compared to continued combination antiretroviral therapy that was initiated during primary HIV infection: A randomized, controlled, multisite, open-label noninferiority trial. 

Clinical Research Update 10.29.19 – Lipid management for the Prevention of Atherosclerotic Heart Disease

Clinical Research Update 10.22.19 – Use of Recommended Preventive Health Care Services and Variations in HIV Care among Women with HIV in the United States

Clinical Research Update 10.15.19 – Frailty Is an Independent Risk Factor for Mortality, Cardiovascular Disease, Bone Disease, and Diabetes Among Aging Adults with Human Immunodeficiency Virus

Clinical Research Update 10.8.19 – Association of Human Immunodeficiency Virus Infection and Risk of Peripheral Artery Disease

Clinical Research Update 10.1.19 – Non-AIDS comorbidity burden differs by sex, race, and insurance type in aging adults in HIV care.

Clinical Research Update 9.24.19 – Weight gain associated with Integrase Stand Transfer Inhibitor use in women

Clinical Research Update 9.17.19 – Serious clinical events in HIV-positive persons with chronic kidney disease

Clinical Research Update 9.10.19 – Update to the Varicella-Zoster Virus (VZV) Disease Section of the DHHS Adult and Adolescent Opportunistic Infections Guidelines

Clinical Research Update 9.3.19 – Renal safety of tenofovir alafenamide vs. tenofovir disoproxil fumarate: a pooled analysis of 26 clinical trials

Clinical Research Update 8.27.19 – Increased risk of anemia, neutropenia and thrombocytopenia in people with HIV and well-controlled viral replication

Clinical Research Update 8.20.19 – Alopecia After Switch to Tenofovir Alafenamide in 6 African American Women

Clinical Research Update 8.13.19 – Low level viremia and virologic failure in persons with HIV infection treated with antiretroviral therapy

Clinical Research Update 8.6.19 – Generalized anxiety disorder symptoms among persons with diagnosed HIV in the United States

Clinical Research Update 7.30.19 – Long-term evolution of CD4+cell count in patients under combined antiretroviral therapy

Clinical Research Update 7.23.19 – Durability of dolutegravir plus boosted darunavir as salvage or simplification of salvage regimens in HIV-1 infected, highly treatment-experienced individuals

Clinical Research Update 7.16.19 – Nonadherence and unsuppressed viral load across adolescence among US youth with perinatally acquired HIV

Clinical Research Update 7.9.19 – Herpes Zoster rates continue to decline in people living with HIV but remain higher than rates reported in the general US Population.

Clinical Research Update 7.2.19 – Pregnancy and Neonatal Outcomes Following Prenatal Exposure to Dolutegravir

Clinical Research Update 6.25.19 – Colorectal Cancer Screening in People With and Without HIV in an Integrated Health Care Setting

Clinical Research Update 6.18.19 – The benefit of immediate compared with deferred antiretroviral therapy on CD4+ cell count recovery in early HIV infection

Clinical Research Update 6.11.19 – Bictegravir combined with emtricitabine and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection: Week 96 results from a randomized, double-blind, multicenter, phase 3, non-inferiority trial

Clinical Research Update 5.30.19 – Clinical impact and cost-effectiveness of genotype testing at HIV diagnosis in the United States

Clinical Research Update 5.23.19 – Risk of HIV transmission through condomless sex in serodifferent gay couples with the HIV-positive partner taking suppressive antiretroviral therapy

Clinical Research Update 5.16.19 – Sexually Acquired Hepatitis C Infection in HIV-Uninfected Men Who Have Sex with Men Using Preexposure Prophylaxis Against HIV

Clinical Research Update 5.9.19 – Differences by Sex in Cardiovascular Comorbid Conditions Among Older Adults Receiving HIV

Clinical Research Update 5.2.19 – Characterizing the HIV Care Continuum among Transgender Women and Cisgender Women and Men in Clinical Care

Clinical Research Update 4.18.19 – Association of PrEP with Incidence of STIs Among High Risk Individuals

Clinical Research Update 4.11.19 – Short Physical Performance Battery (SPPB)

Clinical Research Update 4.4.19 – What’s New in the DHHS Guidelines?

Featured Literature 3/28/19
De Voux A. et al. Syphilis testing among sexually active men who have sex with men and who are receiving care in the United States: Medical Monitoring Project, 2013-2014. Clin Infect Dis, March 2019; 68:934-939.

Current guidelines from the CDC recommend yearly screening for syphilis in sexually active MSM including those with HIV. More frequent testing is recommended for MSM at high-risk or if clinically indicated. This study analyzed the most recent data from the Medical Monitoring Project – a surveillance system that includes cross-sectional estimates of clinical and behavioral characteristics of HIV-positive adults receiving medical care in the U.S. Data was abstracted from patient medical records looking specifically at the prevalence of syphilis testing in MSM by an HIV provider in the past 3, 6, or 12 months. The majority of subjects were >30 years and 86% identified as homosexual. Almost 50% reported condomless sex in the past 12 months and 58% reported multiple sex partners. Only 71% of all sexually active MSM had at least one syphilis test in the past 12 months. The numbers were slightly higher (75%) for men reporting condomless sex (75%) and for those reporting >two sex partners (77%). The prevalence of syphilis testing was only 43% in the past six months and 22% in the past three months in men reporting condomless sex. Being that almost one-third of sexually active MSM were not tested for syphilis in the past year, the authors conclude that this lack of screening represents missed opportunities to diagnose and treat this common STI and decrease the risk of HIV transmission as well.

Commentary: The low rate of screening is disconcerting as rates of syphilis (30,644 cases reported in 2017) and other STDs in the U.S. continue to increase. Greater efforts to improve syphilis screening, especially for high-risk patients are unquestionably needed.

Featured Literature 3/21/19
High virologic suppression rates with immediate antiretroviral therapy initiation in a vulnerable urban clinic population.
Coffey, S et al. AIDS: April 1, 2019 – Volume 33(5):825–32

There has been a progressive move to encourage providers to start ART as soon as possible following a new HIV diagnosis. This study from theRAPIDprogram (Rapid ART for Individuals with HIV Diagnosis) in San Francisco included patients directly referred from testing sites for same or next-day intake visits. All received multidisciplinary evaluations and insurance enrollment/optimization. Patients were provided ART starter packs with close follow-up. Of the 225 patients referred to RAPID from 2013 to 2017, 96% were started on immediate-ART. More than 50% had a substance use disorder, 48% had a mental health diagnoses and 31% had unstable housing. Baseline median CD4+ cell count 441 and viral load was 37,000 copies. At one year after intake, 96% achieved viral suppression. Over a median follow-up time of 1.09 years (range of 0-3.92), 15% had viral rebound, but most (78%) re-suppressed. Viral suppression rates were 92% at last recorded viral load. The study concludes that in an urban clinic caring for patients with high rates of mental illness, substance use and housing instability, immediate ART is feasible, acceptable, and can be successfully implemented with adequate staffing and support.

Commentary: Same-day treatment has proven successful in various settings. Although immediate ART is discussed in the DHHS guidelines, it is not part of their current recommendations. This strategy is recommended by the WHO guidelines. Immediate treatment may not be clinically necessary for patients with less intensive needs but certainly should be started as early as possible.

Featured Literature:
Sakabumi, DZ. Chronic Distal Sensory Polyneuropathy Is a Major Contributor to Balance Disturbances in Persons Living With HIV Journal of Acquired Immune Deficiency Syndromes: 2019;80(5):568–573.

Medical comorbidities are common in older persons living with HIV (PLWH). Chronic distal sensory polyneuropathy(cDSPN), historically associated with peripheral nerve damage from advanced HIV disease or antiretroviral therapy-particularly dideoxynucleosides may contribute to balance difficulties and falls. The contribution of neuropathy has not been well-studied in the post-ART era. This study included 3,379 PLWH and HIV-negative adults. All participants underwent a thorough neurologic examination to document objective findings of cDSPN including pain, numbness, or pain. They also were asked specific questions regarding balance disturbance over the past 10 years that were classified as “mild to moderate”, “minimal” or “none”. Other variable assessed were age, HIV status, treatment characteristics and current medications including sedatives and opioids.  Fifty-two percent of the subject met criteria for cDSPN. Balance problems were more common in those with cDSPN. Eleven percent reported balance disturbances with the rate in PLWH exceeding that of HIV-negative persons [odds ratio 2.6] with older participants more likely to report balance disturbances than younger ones. Adjusting for relevant covariates, disturbances attributable to cDSPN were much more frequent among HIV+  adults. Among individuals with cDSPN, the authors conclude that this condition contributes to balance problems in PLWH. Office based assessment for sensory neuropathy in older PLWH should be a clinical priority. It can identify those at risk for falls and subsequent consequences – including fractures, intracranial injuries, hospitalization, and death.

Commentary: In the post-ART era, peripheral neuropathies are rarely discussed or assessed for clinically. The prevalence is this study was > 50%. This remains yet another co-morbidity in our aging HIV population that should be considered and evaluated diagnostically by EMG and nerve conduction studies if indicated.

Featured Literature: 
Althoff KN. Contributions of traditional and HIV-related risk factors on non-AIDS-defining cancer, myocardial infarction, and end-stage liver and renal diseases in adults with HIV in the USA and Canada: a collaboration of cohort studies. Lancet HIV 2019;6(2) PE93-E104.This study included patients from NA-ACCORD (US and Canada) who were in care from 2000 to 2014. The goal was to estimate population attributable factors (PAFs) of modifiable or preventable HIV-related and traditional risk factors for AIDS-defining cancers, Myocardial infarction (MI), end-stage liver disease, and end-stage renal disease. Traditional risk factors were addressed including smoking, hypertension, diabetes, hyperlipidemia, and stage 4 kidney disease. HIV risk factors included history of AIDS, CD4 count < 200, and detectable viremia (HIV-RNA > 400). The authors determined that smoking cessation would have avoided 24% of non-AIDS cancers and 37% of heart attacks. Treating hypertension and elevated cholesterol would have prevented between 44% and 42% of MIs. Similar benefits were seen for treating hypertension (39 % reduction in renal disease). Treatment of chronic HCV had the greatest PAF in preventing liver disease.

Commentary: Although not surprising, these data can be useful in screening, counseling, and treating patients regarding co-morbid conditions and risk factors for cancer, heart disease as well as kidney and liver disease. As with other studies, smoking cessation has a significant impact on reducing disease incidence in PLWH.

Featured Literature:
Cessation of cigarette smoking and the impact on cancer incidence in HIV-infected persons: The data collection on adverse events of Anti-HIV Drugs Study. Clin Infect Dis 15 February 2019;68(4)650-656.

Cancers continue to be a major source of morbidity and mortality in persons living with HIV. The reasons are likely multifactorial and include chronic immune suppression and inflammation, longer life-expectancy but also lifestyle-related factors. This study from the D:A:D cohort included 35,442 patients who contributed 310,000-person years of follow-up. At baseline, 49% were active smokers and 21% were ex-smokers. The incidence of all cancers in this group was 2,183 and was highest in the first year after patients stopped smoking. There were 271 cases of lung cancer and the risk for this malignancy, although greatest in year one of smoking cessation, remained 8-fold higher even at five years after smoking cessation. For other cancers related to smoking (head and neck, esophageal, gastric, GU, colon, rectal, ovarian and cervical), incidence declined after one year of not smoking to a level similar to that in non-smokers.

Commentary: The D:A:D cohort continues to provide valuable observational data regarding co-morbidities in PLWH. Despite this discouraging data related to lung cancer, smoking cessation should remain a priority in caring for these individuals.

Featured Literature:
Eron J et al. Safety of elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in HIV-1 infected adults with end-stage renal disease on chronic hemodialysis: an open-label, single-arm, multicenter phase 3 trial. Lancet HIV 2019,6(1): PE15-E24.

This was open-label, single-arm, that included 55 patients with ESRD (creatinine clearance <15 mL/min), on chronic hemodialysis (HD). All had viral suppression (HIV-1 RNA <50 copies per mL) and a CD4 count of at least 200 while on a stable ART for at least 6 months. Patients were switched to co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide (Genvoya) daily after HD. The primary endpoint was the incidence of treatment-emergent adverse events > grade 3 up to week 48. Thirty-three percent experienced an AE but none were felt to be treatment-related and only 3 stopped ART. At 48 weeks, switching to the single-tablet regimen of elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide was well tolerated. 82% maintained HIV-RNA levels of < 50 copies. This study will continue for at least 96 weeks.

Commentary: Although not recommended by the current DHHS guidelines, this STR may be a reasonable option for patients with HIV on HD who are often on multiple medications and thus lessen pill burden. Per the original study design, these patients will be followed for 96 weeks so more data regarding efficacy and safety should be forthcoming.

Prophylaxis for disseminated Mycobacterium avium Complex Disease (MAC) no longer recommended by DHHS Guidelines. Included in the most recent update from the DHHS is a new recommendation the primary prophylaxis against disseminated MAC disease is NOT recommended for adults and adolescents with HIV who immediately initiate ART. Primary MAC prophylaxis, if previously initiated, should be discontinued in adults and adolescents who are on a fully suppressive ART regimen. Patients who are not receiving ART or who remain viremic on ART and have no current options for a fully suppressive ART regimen should receive chemoprophylaxis against disseminated MAC if they have CD4 counts <50 cells/mm3. These new recommendations are based on two randomized, placebo-controlled trials and observational data which found that persons with HIV taking ART could discontinue primary prophylaxis with minimal risk of developing MAC disease. These recommendations are now consistent with the IAS-USA guidelines published in July 2018.

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