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CROI 2021 Report Back

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March 2021 AIDS Clinical Conference:Virtual CROI 2021 Report Back Jehan Budak, MD Ruanne V. Barnabas, MBChB, MSc, DPhil Adrienne Shapiro, MD, PhD, MSc University of Washington March 16, 2021 AIDS Clinical Conference:Virtual CROI 2021 Report Back (ART) Jehan Budak, MD Acting Assistant Professor Division of Allergy & Infectious Diseases University of Washington March 16, 2021 No conflicts of interest or relationships to disclose. Outline Update from IMPAACT 2010 Update from ATLAS-2M Lenacapavir: Capella Study Update from IMPAACT 2010 Background: IMPAACT 2010 Chinula L et al, Virtual CROI 2021, Abstract #177 ART options in pregnancy remain limited IMPAACT 2010 is a global, multicenter, randomized trial of ART-nave pregnant women with HIV started on: TAF/FTC + DTG vs TDF/FTC + DTG vs TDF/FTC/EFV Interim results through delivery outcome (CROI 2020) DTG-containing arms had superior virologic efficacy TAF/FTC + DTG had lowest rate of adverse pregnancy outcome Study Design: IMPAACT 2010 Chinula L et al, Virtual CROI 2021, Abstract #177 Study Design: Maternal Baseline Characteristics Chinula L et al, Virtual CROI 2021, Abstract #177 DTG+FTC/TAF (n=217) DTG+FTC/TDF (n=215) EFV/FTC/TDF (n=211) Total (n=643) Age (median years) 26.8 26.0 26.6 26.6 Enrolled in Africa 187 (86%) 189 (88%) 188 (89%) 564 (88%) Gestational age (median weeks) 22.1 21.3 22.1 21.9 CD4 count (median cells/mm3) 407 481 439 466 HIV-1 RNA (median copies/mL) 781 715 1357 903 HIV-1 RNA <50 36 (16%) 37 (17%) 27 (13%) 100 (16%) ART in pregnancy prior to entry 176 (81%) 180 (84%) 176 (83%) 532 (83%) Median days on ART 6 6 6 6 BMI* (kg/m2), median (Q1,Q3) 25.1 (22.5, 29.4) 24.5 (22.0, 28.1) 24.2 (21.5, 28.0) 24.7 (22.0, 28.4) Median duration of antepartum follow-up: 17.4 weeks, *Pre-pregnancy BMI was not available Study Design: Outcomes to 50 Weeks Post-Partum Chinula L et al, Virtual CROI 2021, Abstract #177 Virologic Efficacy Safety Outcomes Maternal grade 3 or higher adverse events Infant grade 3 or higher adverse events Infant mortality Infant HIV infection Results: IMPAACT 2010 Virologic Efficacy Chinula L et al, Virtual CROI 2021, Abstract #177 Results: IMPAACT 2010 Adverse Events Chinula L et al, Virtual CROI 2021, Abstract #177 Maternal & Infant Grade 3 or Higher Adverse Events by Arm Through 50 Weeks Postpartum Results: IMPAACT 2010 Infant HIV Infection Chinula L et al, Virtual CROI 2021, Abstract #177 Summary: IMPAACT 2010 Chinula L et al, Virtual CROI 2021, Abstract #177 TAF and DTG were safe through 50-week post-partum data All regimens were safe and efficacious Infant mortality higher in EFV arm More women had virologic failure in the EFV arm Take-Away Point: This provides additional reassuring data about DTG and TAF use in pregnancy and post-partum Update from ATLAS-2M Background: ATLAS-2M Overton E et al, CROI 2020, Abstract #34. ATLAS (CROI 2019): CAB/RPV IM q4w in treatment-experienced PWH was non-inferior to standard PO ART 3 virologic failures occurred ATLAS-2M (CROI 2020): CAB/RPV IM q8w in treatment-experienced PWH was non-inferior to q4w at 48 weeks Participants preferred q8w dosing 10 virologic failures occurred (8 in q8w arm, 2 in q4w arm) and failed with both NNRTI and INSTI RAMs Study Design: ATLAS-2M Jaeger H et al, Virtual CROI 2021, Abstract #401 Primary Endpoint: Proportion of participants with HIV RNA 50 at week 48 Other Endpoints: Incidence of confirmed virologic failure (VF), incidence of viral resistance in participants with confirmed VF, safety and tolerability Results: ATLAS-2M 96 Week Data Jaeger H et al, Virtual CROI 2021, Abstract #401 Results: ATLAS-2M Adverse Effects Jaeger H et al, Virtual CROI 2021, Abstract #401 Q8W n = 522 n (%) Q4W n = 523 n (%) Any adverse event (AE) 488 (93) 499 (95) AE leading to withdrawal 18 (3) 19 (4) # of injections 12,832 23,855 Injection site reaction (ISR) events 3400 4157 ISR pain 2662 (21) 3295 (14) ISR nodule 188 (1) 297 (1) ISR discomfort 134 (1) 148 (<1) Median duration, days (IQR) 3 (2,5) 3 (2,5) Participants withdrawing for injection-related reasons 7 (1) 11 (2) Table adapted from Jaeger H et al: Results: ATLAS-2M Resistance Jaeger H et al, Virtual CROI 2021, Abstract #401 Key Points About Resistance: Total VFs from ATLAS-2M = 11 (9 in q8w arm, 2 in q4w arm) One additional VF occurred between weeks 48 and 96 in the q8w arm K103N and Y181C detected at VF & retrospectively at baseline in PBMC No INSTI RAMs present at VF or baseline, though substitution L74I was present at baseline 10/11 with confirmed VF resuppressed on an alternative regimen All with confirmed VF retained DTG susceptibility Summary: ATLAS-2M 96-Week Data Jaeger H et al, Virtual CROI 2021, Abstract #401 Virologic efficacy, adverse events, and injection site reactions were similar in IM CAB/RPV q8w and q4w arms Confirmed VF occurred in 11 total PWH 9 in the q8w arm, 2 in the q4w arm Most PWH with VF acquired both NNRTI and INSTI RAMs Take-Away Point: Q8W dosing of CAB/RPV is effective and there are few VFs, but with failure, RAMs occurred Lenacapavir: Capella Study Background: Lenacapavir Segal-Maurer S et al, Virtual CROI 2021, Abstract #127 Novel HIV-1 capsid inhibitor formerly known as GS-6207 that can be given as a long-acting subcutaneous injection Currently in development as a component of long-acting therapy for HIV-1 Has activity in NRTI, NNRTI, INSTI, and PI-resistant HIV-1 Study Design: Lenacapavir in MDR HIV-1 Segal-Maurer S et al, Virtual CROI 2021, Abstract #127 Results: Lenacapavir in MDR HIV-1 Segal-Maurer S et al, Virtual CROI 2021, Abstract #127 Participant Characteristics: Median age: 52 Median CD4 cell count: 150 cells/mm3 Median number of prior ARV regimens: 11 Median years since HIV diagnosis: 24 Summary: Lenacapavir in MDR HIV-1 Segal-Maurer S et al, Virtual CROI 2021, Abstract #127 In the Capella study, early data shows that use of lenacapavir demonstrated antiviral activity against MDR HIV after 14 days and led to virologic suppression when paired with an OBR Take-Away Point: Although much more data is needed, lenacapavir has the potential to become an important tool against MDR HIV in heavily treatment experienced PWH ART Conclusions from Virtual CROI 2021 Chinula L et al, Virtual CROI 2021, Abstract #177; Jaeger H et al, Virtual CROI 2021, Abstract #401; Segal-Maurer S et al, Virtual CROI 2021, Abstract #127 IMPAACT 2010: Data at 50 weeks post-partum show that TDF/FTC + DTG, TAF/FTC + DTG, and TDF/FTC/EFV are safe ART options during pregnancy and in the post-partum period ATLAS-2M: Data at 96 weeks demonstrated virologic efficacy and safety of CAB/RPV IM q8w dosing, as compared to q4w dosing, with 11 total VFs Capella Study: Early data of lenacapavir, a novel capsid inhibitor that can be administered in a long-acting fashion, demonstrated antiviral activity against MDR HIV Ruanne V. Barnabas, MBChB, MSc, DPhil University of Washington, Seattle, WA, USA ACC: vCROI UpdateHIV Epidemiology and Transmission Regeneron Pharmaceuticals ACC UPDATE HIV Epidemiology Race and COVID-19 infection rates among people living with HIV in the US HIV Transmission HIV Prevention Oral PrEP on Demand Long-acting injectable PrEP Delivery of HIV Care during COVID-19 Lots of exciting work! Outline Addressing gaps to eliminate disparities in access to HIV Treatment and Prevention Racial Differences in COVID-19 Infection Rates Among PWH in the United States Islam. CROI 2021. Abstr 141. Race and COVID-19 Infection Rates Among People living with HIV: Background Racial minorities disproportionately affected by COVID-19 and HIV[1,2] HIV: Black MSM had the highest number of new HIV diagnoses in 2018, followed by Hispanic MSM, then White MSM COVID-19: Highest mortality rate among Blacks followed by American Indians/Alaska Natives, Hispanics/Latinos, Native Hawaiian/Pacific Islanders, Whites, and Asians Using EMR data, this study examined racial and ethnic disparities in COVID-19 infection rates among people with and without HIV in the US National COVID Cohort Collaborative[3] Slide credit: clinicaloptions.com 1. CDC. HIV Surveillance Report. 2020;31. 2. The COVID Tracking Project. 3. Islam. CROI 2021. Abstr 141. MSM, men who have sex with men; People living with HIV, people with HIV. 31 Slide credit: clinicaloptions.com Race and COVID-19 Infection Rates Among People living with HIV: COVID-19 Positivity by Race and HIV Status Islam. CROI 2021. Abstr 141. Reproduced with permission. % of COVID Positive Patients Non-HispanicBlack Hispanic Non-HispanicAsian Non-HispanicWhite 2.4 2.4 7.5 8.6 15.4 44.1 50.1 27.9 Racial/Ethnic Categories P < 0.001 P < 0.001 P = 0.057 P = 0.844 60 40 20 0 Persons with HIVPersons without HIV NH, non-Hispanic; People living with HIV, people with HIV. 32 Slide credit: clinicaloptions.com Race and COVID-19 Infection Rates Among People living with HIV: Odds of COVID-19 Positivity By Race/Ethnicity in People living with HIV *Reference category: non-Hispanic White; estimates adjusted for age, sex, Charlson-Deyo comorbidity score (modified to exclude HIV status). Islam. CROI 2021. Abstr 141. Reproduced with permission. Adjusted OR (95% CI)* Non-HispanicBlack Hispanic Non-HispanicAsian 1 10 Racial/Ethnic Categories Null value aOR: 2.18,95% CI: 1.30-3.63 aOR: 2.17,95% CI: 1.68-2.83 aOR: 1.59,95% CI: 1.37-1.86 aOR, adjusted odds ratio; OR, odds ratio; NH, non-Hispanic; People living with HIV, people with HIV. 33 Race and COVID-19 Infection Rates Among People living with HIV: Conclusions Racial and ethnic disparities evident among people living with HIV testing positive for COVID-19 in the US Non-Hispanic Black, Hispanic, and non-Hispanic Asian patients with HIV more likely to contract COVID-19 vs non-Hispanic White patients Limitations Data limited to US National COVID Cohort Collaborative dataset Racial and ethnicity data were missing from > 10% of dataset Sexual orientation or gender not available; birth sex was used Social determinants of health (eg, income, employment type, health insurance) not available Represent structural inequities in access to health: parallels in HIV and COVID-19 Slide credit: clinicaloptions.com Islam. CROI 2021. Abstr 141. People living with HIV, people with HIV. 34 Opportunities for outreach and innovation What do we need to do to achieve equity? DISPARITIES IN TIMELY RECEIPT OF ART PRESCRIPTION IN HIV CARE IN THE US, 2012-2018, CDC HIV Epidemiology Race and COVID-19 infection rates among people living with HIV in the US HIV Transmission HIV Prevention Oral PrEP on Demand Long-acting injectable PrEP Delivery of HIV Care during COVID-19 Outline Addressing gaps to eliminate disparities in access to Treatment and Prevention ANRS Prvenir: High Efficacy of Daily or On-Demand FTC/TDF PrEP Among Parisian MSM in Interim Analysis of Open-Label Prospective Cohort Study Molina. CROI 2021. Abstr 148. ANRS Prvenir: Background ANRS IPERGAY: double-blind, randomized, placebo-controlled study showed on-demand FTC/TDF PrEP (taken before and after sex) highly effective in preventing HIV infection among MSM[1] Relative reduction in HIV incidence with on-demand FTC/TDF vs placebo: 86% (95% CI: 40-98; P = .002) Relative reduction in HIV incidence during open-label extension phase: 97% (95% CI: 81-100)[2] Efficacy of on-demand PrEP in real-world settings not fully established Current study among participants at high risk for HIV in Paris region designed to evaluate impact of on-demand and daily FTC/TDF PrEP on overall HIV incidence and HIV incidence with each dosing strategy among MSM[3] 1. Molina. NEJM. 2015;373:2237. 2. Molina. Lancet HIV. 2017;4:e402. 3. Molina. CROI 2021. Abstr 148. Slide credit: clinicaloptions.com FTC, emtricitabine; MSM, men who have sex with men; PrEP, pre-exposure prophylaxis; TDF, tenofovir disoproxil fumarate. 38 ANRS Prvenir: Study Design Molina. CROI 2021. Abstr 148. Slide credit: clinicaloptions.com Multicenter, open-label, prospective cohort study mainly in MSM (98.5%) from Paris HIV-negative adults at high risk of HIV infection with inconsistent condom use; eGFR 50 mL/min; HBsAg negative in on-demand arm (N = 3059)* Daily FTC/TDF PrEP (n = 1544) On-Demand FTC/TDF PrEP (2-1-1: 2 doses before sex, 1 dose QD for 2 days after sex) (n = 1515) *Participants enrolled on arm of their choice with ability to switch. Plus condoms, gels, risk reduction and adherence counseling, questionnaire on sexual behavior. Follow-up every 3 mos with STI and/or HIV testing, plasma creatinine measurement. Current AnalysisSept 20, 2020 Beginning of StudyMay 3, 2017 Primary endpoint: 15% reduction in new HIV diagnoses among MSM in Paris vs rate reported by National Surveillance network in 2016 Secondary endpoints: HIV incidence, PrEP adherence, sexual behavior, safety eGFR, estimated glomerular filtration rate; FTC, emtricitabine; HBsAg, hepatitis B surface antigen; MSM, men who have sex with men; PrEP, pre-exposure prophylaxis; STI, sexually transmitted infection; TDF, tenofovir disoproxil fumarate. 39 ANRS Prvenir: HIV Incidence Global HIV incidence: 0.11/100 PY (95% CI: 0.04-0.23) PrEP stopped in all 6 cases of HIV infection Mean follow-up: 22.1 mos (5633 PYFU) Overall HIV infections averted: n = 361 Assuming incidence of 6.6/100 PY as reported for placebo arm in ANRS IPERGAY study Rate of study discontinuation: 14.4/100 PY Slide credit: clinicaloptions.com mITT Analysis Daily PrEP (2583.25 PYFU) On-Demand PrEP (2553.68 PYFU) IRR (95% CI) HIV incidence/100 PY (95% CI) 0.12 (0.02-0.34) 0.12 (0.02-0.34) 0.99 (0.13-7.38) Molina. CROI 2021. Abstr 148. IRR, incidence rate ratio; mITT, modified intention-to-treat; PrEP, pre-exposure prophylaxis; PY, patient-years; PYFU, patient-years of follow-up. 40 ANRS Prvenir: STI Incidence Molina. CROI 2021. Abstr 148. Reproduced with permission. Slide credit: clinicaloptions.com Chlamydia (P < .0001) Any STI (P < .0001) Gonorrhea (P < .0001) Mycoplasma (P = .3819) Syphilis (P = .1315) 0 10 20 30 40 50 60 70 80 75.5 66.5 32.4 31.1 25.3 10.8 37.8 33.7 13.4 15.7 11.7 13.0 8.5 10.6 7.9 Until 2 mos before lockdown (May 2, 2017 - Jan 21, 2020) 2 mos before lockdown (Jan 22, 2020 - Mar 16, 2020) During lockdown (Mar 17, 2020 - May 11, 2020 Incidence per 100 PY PY, patient-year; STI, sexually transmitted infection. 41 ANRS Prvenir: Conclusions Among MSM electing to use daily or on-demand oral FTC/TDF PrEP for prevention of HIV infection: Both regimens highly effective for HIV prevention Overall HIV incidence (6 infections): 0.11/100 PY (95% CI: 0.04-0.23) Participants using daily FTC/TDF had more frequent sex Both regimens generally well tolerated with few discontinuations Most participants remained on study High incidence of STIs Slide credit: clinicaloptions.com Molina. CROI 2021. Abstr 148. FTC, emtricitabine; MSM, men who have sex with men; PrEP, pre-exposure prophylaxis; PY, patient-years; STIs, sexually transmitted diseases; TDF, tenofovir disoproxil fumarate. 42 HPTN 083: Incident Infections and Emergent Resistance in MSM and TGW Receiving Cabotegravir Long-Acting PrEP Marzinke. CROI 2021. Abstr 153. HPTN 083: Background Efficacy of oral FTC/TDF as PrEP among MSM, TGW, and heterosexual men demonstrated across multiple placebo-controlled trials Reduction in HIV incidence vs placebo: daily dosing, 44% to 84%; on-demand dosing, 86%[1-4] PrEP with long-acting injectable CAB was significantly superior to daily oral FTC/TDF in reducing incident HIV infection among MSM and TGW at high risk of HIV infection in randomized phase IIb/III HPTN 083 study[5] Current report is a longitudinal analysis of HIV infections, viral load, CAB concentrations, and emergent resistance in HPTN 083[6] Slide credit: clinicaloptions.com 1. Grant. NEJM. 2010;363:2587. 2. Thigpen. NEJM. 2012;367:423. 3. Baeten. NEJM. 2012;367:399. 4. Molina. NEJM. 2015;373:2237. 5. Landovitz. AIDS 2020. Abstr OAXLB0101. 6. Marzinke. CROI 2021. Abstr 153. CAB, cabotegravir; FTC, emtricitabine; MSM, men who have sex with men; PrEP, pre-exposure prophylaxis; TDF, tenofovir disoproxil fumarate; TGW, transgender women. 44 Primary endpoints: incident HIV infections, grade 2 clinical and laboratory events Analysis of HIV infections in CAB arm: group A) HIV positive test at study enrollment; group B) no recent CAB exposure; group C) Infected during CAB oral lead-in period; group D) Infected in setting of on-time CAB injections International, randomized, double-blind phase IIb/III study At interim analysis on May 14, 2020, with 25% of endpoints accrued, DSMB recommended termination of blinded study due to crossing of prespecified O'Brien-Fleming stopping bound HIV-uninfected MSM and TGW aged 18 yrs at high risk of HIV infection*; no HBV/HCV infection, contraindication to gluteal injection, seizures, or gluteal tattoos/skin conditions (N = 4566) HPTN 083: Study Design *Any noncondom receptive anal intercourse, > 5 partners, stimulant drug use, incident rectal or urethral STI or incident syphilis in past 6 mos; or SexPro Score 16 (US only). First 2 doses given in Wks 5 and 9, then every 2 mos thereafter. PBO for CAB injection was a 20% intralipid solution. Slide credit: clinicaloptions.com CAB 30 mg PO QD + PBO PO QD (n = 2282) FTC/TDF PO QD + PBO PO QD (n = 2284) CAB LA 600 mg IM Q2M + PBO PO QD for ~ 3 yrs FTC/TDF PO QD + PBO IM Q2M for ~ 3 yrs Wk 5 Step 1 Step 2 FTC/TDF PO QD for 1 yr Step 3 Marzinke. CROI 2021. Landovitz. AIDS 2020. Abstr OAXLB0101. Abstr 153. NCT02720094. CAB, cabotegravir; DSMB, data and safety monitoring board; FTC, emtricitabine; HBV, hepatitis B virus; HCV, hepatitis C virus; LA, long acting; MSM, men who have sex with men; PBO, placebo; STI, sexually transmitted infection; TDF, tenofovir disoproxil fumarate; TGW, transgender women. 45 HPTN 083: HIV Incidence Slide credit: clinicaloptions.com Marzinke. CROI 2021. Abstr 153. Reproduced with permission. 3187 PY 3204 PY 0.37 1.22 CABn = 2241 FTC/TDFn = 2247 12 Infections 39 Infections 0 0.2 0.4 0.6 0.8 1 1.2 1.4 1.6 1.8 HIV Incidence Rate/100 PY HIV Incidence Favors FTC/TDF Favors CAB Superiority Non-Inferiority 0 0.75 1.23 2 1 Hazard Ratio (95% CI) 0.16 0.32 0.58 CAB, cabotegravir; FTC, emtricitabine; NI, noninferiority; PY, patient-year; TDF, tenofovir disoproxil fumarate. 46 HPTN 083: HIV Infections in Cabotegravir Arm Slide credit: clinicaloptions.com Marzinke. CROI 2021. Abstr 153. Reproduced with permission. 4 baseline and 12 incident HIV infections observed in CAB arm 5 4 8 6.3 1.3 7.1 8.9 8 3.9 5.1 8 8 4 5 8 8 8 8 8 5.3 10.7 7.3 8 8 4 4.7 2.7 2.1 6.6 1.3 3.9 4 5 44.9 5.1 3.6 8.3 6.3 11.7 13.1 9 5.1 6.3 6.9 6.9 31 5 98.4 5.4 9.9 37.9 20.2 10 53.1 5.4 3.6 4 5 5.7 2.9 4 D4 90% D3 97% D2 97% D1 100% C3 96% C2 98% C1 96% B5 3% B4 95% B3 100% B2 ? B1 78% A4 97% A2 93% A1 93% A3 90% Step 1: Oral CAB lead-in Step 2: CAB LA 600 mg IM Step 2: CAB LA injection > 2 week overdue Step 3: Open-label FTC/TDF Step 3: Overdue FTC/TDF dispensation Annual follow-up Percent adherence to oral lead-in CAB LA 600 mg IM Open-label FTC/TDF dispensed HIV-infection First site positive HIV test 10 20 30 40 50 60 70 80 90 100 110 120 130 140 Wk CAB, cabotegravir; FTC, emtricitabine; TDF, tenofovir disoproxil fumarate. 47 HPTN 083: Conclusions Most infections occurred in the TDF/FTC arm due to low adherence. Suboptimal adherence observed in 37/39 incident infections in FTC/TDF arm Of 12 incident HIV infections in CAB arm, 8 occurred due to low adherence/low conc. 4 observed in participants with on-time injections and sufficient CAB concentrations Detection of HIV infection using standard testing algorithms delayed in patients receiving CAB LA screen with viral load before starting CAB INSTI resistance Observed upon viremic "escape" at higher CAB concentrations Not observed in 3 tail-phase infections or 1 tail "escape" case Continue to monitor for INSTI resistance Therefore, prompt diagnosis and initiation of ART are important to avoid resistance with CAB LA Slide credit: clinicaloptions.com Marzinke. CROI 2021. Abstr 153. CAB, cabotegravir; FTC, emtricitabine; LA, long acting; TDF, tenofovir disoproxil fumarate. 48 HIV Epidemiology Race and COVID-19 infection rates among people living with HIV in the US HIV Transmission HIV Prevention Oral PrEP on Demand Long-acting injectable PrEP Delivery of HIV Care during COVID-19 Lots of exciting work! Outline Addressing gaps to eliminate disparities in access to Treatment and Prevention RESILIENCE OF HIV ACTIVITIES DURING COVID-19 PANDEMIC AT HEALTH FACILITIES IN AFRICA (ICAP) ART delivery adapted to COVID-19 restrictions Large study COVID-19 pandemic acceleration from Q2 to Q3, # HIV tested decreased along with declines in number of HIV+ persons identified and new ART initiations Rebound was brisk as the pandemic progressed (Q4), demonstrating HIV program resilience. The # on ART, VL testing and VLS continued to increase throughout the period. This may have been, in part, due to recent expansions of non-HF-based differentiated service delivery models that include more diverse groups. One-time fee for home delivery was tiered based on participant income (ZAR 30, 60, and 90; ~$2, 4, 6). Outcomes: Payment of fee, acceptability, viral suppression (<20 copies/mL) Deliver Health Study: Design Home delivery Home Home Clinic group Clinic Clinic People living with HIV Not on ART or Currently on ART Clinically stable ART initiation/ continuation ART monitoring & resupply 51 *Relative risks adjusted for age >30 years and gender Secondary objective results: Viral suppression Home ART vs Clinic RR = 1.21 (1.02 - 1.42) Superior p = 0.0259 Overall 269/426 Home ART delivery Clinic Group 306/414 Fee for home ART delivery and monitoring increased viral suppression 52 A fee for home delivery and monitoring of ART significantly increased viral suppression exceeding UNAIDS goal Home ART was highly acceptable in the context of low income and high unemployment, and improved health outcomes as a result Client fees may offset cost and increase treatment intention ART dispensing and monitoring outside the clinic has the potential to simplify access for client-centered care Discussion Disparities in access to care are opportunities for advocacy, innovation, scholarship, and collaboration New tools will be available for HIV prevention Intermittent dosing for PrEP Long-acting injectable CAB OLE demonstration projects will help determine clinical guidelines COVID-19 ART delivery and monitoring Could be superior to clinic based services Could address disparities Ongoing demonstration, monitoring, and evaluation will determine role of services outside the clinic vCROI take home messages for Epi and Prevention CROI Update: HIV co-infections and comorbidities Adrienne Shapiro, MD, PhD, MSc Acting Assistant Professor, Departments of Global Health & Medicine (Division of Allergy & Infectious Diseases) 16 March 2021 Grant funding: Vir Biotechnology HIV & COVID-19 HIV & COVID-19 #142 Lee (UK): Multicenter retrospective matched cohort of PLWH hospitalized with PCR+ COVID-19 in the UK, Feb-May 2020. (N=68) Matched up to 3:1 to persons without HIV hospitalized with COVID-19 on hospital site, gender, 5-year age band, SARS-CoV-2 test date week, socioeconomic index. (N=181) Outcome: time to improvement or discharge PLWH more likely to have CKD, ESRD, liver disease; less likely to have rheumatologic disease vs PLwoH PLWH had longer time to improvement/discharge (HR 0.57, 95%CI 0.39-0.85, p=0.005) vs PLwoH in crude analysis, but attenuated difference & significance after adjusting for comorbidities, age, and race/ethnicity. (HR 0.7, 95% CI 0.43,1.17, p=0.18). No difference in mortality seen Conclusion: Among people hospitalized with COVID-19 in the UK, PLWH did not have significantly different outcomes vs. PLwoH after adjusting for other comorbidities HIV & COVID-19 #103 Sun (USA): National Covid Cohort Collaborative routinely collected clinical data from 39 centers across US. PCR+ COVID between Jan 2020-Feb 2021 Odds of hospitalization in people with immuno-suppression, defined as HIV or SOT Odds of invasive mechanical ventilation in hospitalized patients with immuno-suppression, defined as HIV or SOT HIV & COVID-19 Lightning round # 547 Moran (USA): N=180 adults with HIV. Risk of hospitalization among PLWH with PCR+ COVID-19 is associated with # of comorbidities in a dose-dependent fashion. Age-adjusted OR for hospitalization (95% CI) of each additional comorbidity: 1.25 (1.01-1.53) # 548 Yendewa (USA): Large commercial healthcare database cohort: 297,194 COVID-19 cases, including 1638 (0.6%) PLWH (83% on ART, 48% virally suppressed). In this cohort, propensity score-matched PLWH had higher odds of hospitalization (OR 1.26; 95% CI(1.04,1.53), ICU and/or invasive mech vent (OR 1.32, 95% CI 1.10, 1.58), vs PLwoH; comparable mortality at 30d (2.9% vs 2.3% p=0.12). #543 Shapiro (USA): CNICS Cohort of PLWH (N=15,969); N=582 (3.6%) COVID-19 cases identified Mar-Dec 2020. Disproportionate # of COVID-19 cases in Black, Hispanic PLWH. Female, diabetes, BMI>=30 (but not CD4 count) associated with having COVID-19 among PLWH. Increased adjusted relative risk (95% CI) of hospitalization for PLWH w/ COVID-19 and: Age >=60 1.78 (1.25, 2.54) p=0.001 ASCVD risk score Per 10% incr 1.41 (1.25, 1.60) p<0.001 CD4 <=350 2.29 (1.63, 3.22) p<0.001 DM2 1.45 (1.02, 2.06) p=0.038 HCV 1.53 (1.04,2.25) p=0.03 eGFR<60 2.28 (1.61, 3.24) p=<0.001 TB & HIV TB & HIV Primary endpoint: TB-free survival @12M after randomization Non-inf margin: 6.6% TB & HIV Criteria for PLWH-CD4+ count>100 cells/mm3-EFV-based ART*already on EFV-based with VL <200*starting EFV-based ART within 8 weeks of TB tx TB & HIV 4M RPT-MOXI non-inferior to 6M SOC in PLWH TB & HIV Lightning Round #131 Cresswell (Uganda): Phase II TB Meningitis tx w/ high-dose RIF-90% participants had HIV, median CD4+=50-SOC RIF reached detectable CSF levels in <50%, vs 94% in both intensified arms-No excess toxicity with high-dose RIF (not powered for clinical endpoints) #132 Sun (Taiwan): BIC/TAF/FTC with 1HP for LTBI in PLWH with VL <200 - N=50 started, 1 discontinued -16 had VL rebound during 1HP, all re-suppressed at 3 & 6 months post-1HP #178 Gupta (multi): Pregnancy outcomes in PLWH receiving 9M INH for prevention of TB N=128 women with known pregnancy outcomes while on study Increased risk of non-live birth (RR 1.92 (1.11, 3.33) and other adverse pregnancy outcome in INH-exposed 1st trimester Hepatitis C Hep C #135 Epclusa Exclusion: De-compensated cirrhosis Pregnancy Chronic HBsAg+ N=20 nonresponders (34% self-reported incompleted adherence) SAE occurrence: 3.5%, none related to treatment or resulting in d/c study med Multi-month dispensing, minimal-interaction HCV treatment safe and effective for treatment-nave persons without decompensated cirrhosisLimitations:-No control group-Not fully generalizable PLWH limited to persons with VL<400 may be more adherent-Sequence data needed to determine non-response/relapse vs reinfection Conclusions HCV Lightning Round #446 Reipold: Self-testing for HCV is acceptable and preliminarily feasible in multi-country study using an OraQuick HCV rapid antibody test.N=775 PWID and MSM in Georgia, Kenya, Vietnam, China (unassisted ST), and gen pop in Egypt (assisted)High acceptability (>90%) would use, variable ease of use & reliability of results. #440 Martin: Cost-effectiveness modeling to determine testing frequency to achieve HCV elimination in MSM in the US (90% reduction in incidence by 2030): q6M for MSM with HIV; annually for MSM using PrEP; at time of HIV testing for non-PrEP-using MSM Modestly Increased frequency vs CDC/IDSA/AASLD guidelines ICER: $35,000/QALY gained (WTP $100,000/QALY gained) HIV & Malignancies # 478 Sigel : VACS cohort analysis: No increased risk of toxicities/side effects in PLWH receiving chemo or XRT for lung cancer (stage I-III) vs PLwoH#471 Chiao: In a cohort of male US Veterans with well-controlled HIV (N=25,088), colorectal cancer risk (total cases 105) was decreased (HR, 0.60; 95% CI, 0.36-1.00) in persons with a statin use history (vs never stains) and increased in persons with diabetes (HR, 1.57; 95% CI, 1.00-2.48). Lower nadir CD4 also associated with increased risk.#473 Weiss: In a cohort of N=144 cis WLH screened for anal cancer and cervical HPV, 31% had bx-proven anal HSIL, anal HPV more common than cervical; high-risk HPV types not concordant between anal and cervical sites. HIV & Malignancies Lightning Round