Increased Diagnoses of Acute HIV Infection through Routine ED Screening and Rapid Linkage to Care and Initiation of HAART During the COVID-19 Pandemic
(Stanford K, et al: Abstract LB-6):

Stanford et al presented the results of acute HIV testing in the ER during the COVID-19 surge in a teaching hospital in Chicago (UC). They found that overall HIV testing in the UC labs declined 48% due to COVID-19, from 22,502 in January and February to 11,766 tests in April and May. UC performed 19,111 HIV screens (11,133 in the ED) between 1/1/20 and 8/17/20, as well as 100,635 COVID-19 RT-PCRs, of which 14,754 were in the ED. Nine patients were diagnosed with acute HIV infection (AHI) in the ED, which was a significant increase over the past 4 years, with a rate of 14.4/year, compared with 6.8/year. Of 9 new diagnoses, 7 were men, 6 were MSM, and 2 were cis-gender women, and the median age was 25 years, and the median VL was >6 million c/mL. Eight of the 9 patients presented with an influenza-like illness that was indistinguishable from COVID-19 clinically, and one patient had HIV and COVID-19 co-infection. All patients were started on ART with VL suppression. The investigators reported that since submission of the abstract on 9/9/20, three additional patients with AHI have been identified. These findings remind us of the importance of AHI in the differential diagnosis of COVID-19 and any flu-like illness and should encourage ERs to include AHI testing in the screening tests for patients presenting with a flu-like illness.

Persistence on F/TDF for HIV Pre-exposure Prophylaxis Insights from Real-world Evidence. (Tao L, et al; Abstract 103):

Tao et al presented real-world evidence of persistence among TDF/FTC PrEP users from 1/1/12 to 12/31/19 using retail pharmacy prescription fill data. A missed refill was identified after > 30 days following the last refill. Reporting over 313,000 prescriptions, the mean time on PrEP was 357 days, and the median persistence was 100 days. Older age > 26 years predicted persistence; persistence at day 60 was observed in 71% of patients over age 26, compared with 63% age 18-25 and 24% in age 12-17 years. Improvements were observed in the frequency of persistence in 2018-2019 (73%) and 2015-2017 (71%) compared with 2012-2014 (42%). Not surprisingly, a history of bone fracture or renal dysfunction was associated with non-persistence. These data show the potential value of the use of pharmacy refills to assess PrEP persistence.

META-INSTI: Metabolic Adverse Events Following Integrase Strand Transfer Inhibitor Administration in Spontaneous Adverse Event Reports. (Murray M, et al; Abstract 106):

Murray et al analyzed reports of weight gain (WG), hyperglycemia (H) or new diabetes (DM) among INSTI users to the FDA adverse event reporting system (FAERS) from 2007-2019. Of 10.1 million reports during this period, 7.2% were H/DM, and 1.1% were WG. FAERS reports were generated by patients (49%) or physicians (23%) in the US, UK, and Japan. Of 18,400 reports related to INSTIs, most were related to DTG (7,840), followed by RAL (5,551), ELV (4,034), and BIC (1,414). Significant associations were seen between weight gain and all INSTIs (OR 2.1) and each INSTI, and significant associations were seen between H/DM and all INSTIs, as well as BIC and DTG, but not RAL and ELV. The investigators pointed out the limitations in these data and suggested that their principle finding is further support for the linkage between weight gain, uncontrolled or new DM, and INSTI use. 

The Impact of Switching to an Antiretroviral Regimen Containing Tenofovir Alafenamide on Weight Gain and Development of Metabolic Side Effects. (Darnell J, et al; Abstract 107):

Darnell et al presented a real-world analysis from the Owen Clinic in San Diego of weight gain in 446 patients who switched from a non-TAF regimen to a TAF-containing regimen from 1/1/16 to 9/20/18, compared with 162 patients with no regimen change. The study group was 42% white, 36% Latinx, and 11% AA, with a median CD4 cell count of 600 cells/mL, and with VL suppression in 92% of patients. After 6 and 12 months, mean weight increases of 1.5 kg and 2.0 kg were observed. BMI increase occurred in twice as many switch patients (18%) as in non-switch patients (9.9%), and no instances of incident DM, HTN, or dyslipidemia were observed. These findings support other studies such as OPERA that found a modest weight gain of 2 kg after one year of a switch from TDF or other NRTIs to TAF-containing regimens.

Outcomes Related to COVID-19 Among People Living with HIV: Cohort from a Large Academic Center. (Virata M, et al; Abstract 111):

Virata et al reported a single site experience with COVID-19 diagnoses (48, 3.3%) and hospitalizations (19, 1.3%) in a cohort of 1,469 PHIV. Most patients were well-controlled with high CD4 cell counts, and no HIV characteristics predicted the need for hospitalization. To date, there were no mortalities. Predictors of hospitalization included older age > 50 years (OR 1.6), DM (OR 2.0), CV disease (OR 2.5), and multiple co-morbidities (1.9). These data further support observations from the VA Cohort and other centers suggesting that the strongest predictors of hospitalization among PWHIV are age and medical co-morbidities and not HIV-specific parameters.

Antiviral Activity and Safety of Long-acting Cabotegravir (CAB LA) Plus Long-acting Rilpivirine (RPV LA) Administered Every 2 Months (Q2M), in HIV-positive Subjects: Results from the POLAR Study (Mills A, et al; Abstract 116):

Mills et al presented the 48-week data from the POLAR Study, which was a follow-on study of the LATTE comparison of oral once-daily rilpivirine (25 mg) plus cabotegravir (30 mg) for maintenance viral suppression. POLAR compared every two-month CAB (600 mg)/RPV (900 mg) injections in 90 subjects to oral administration of DTG/RPV in 7 subjects, according to the LATTE study subjects' choice of the route of administration. The study group was 25% AA, 69% white, and 6% other, 97% male, and 21% age ≥50 with a median CD4 cell count of 842 cells/mL. Viral suppression was achieved in 97.8% of the IM CAB/RPV arm and 100% in the oral DTG/RPV arm. Side effects were more common in the injectable CAB/RPV arm, primarily due to injection site reactions that were painful in 27% of injections and lasted an average of 3 days. There were no study drug discontinuations due to injection site reactions, and only one patient (1%) discontinued treatment due to an AE. The IM regimen was favored over the previous oral regimen by 88% of participants. Together with ATLAS-2M, these data reinforce the comparable antiviral efficacy and the excellent tolerability of this long-acting regimen to an oral two-drug combination.

Characteristics of HIV SARS-COV-2 Coinfection in a Highly HIV Seropositive Population
in New York City (Willner D, et al; Abstract 525):

Willner et al described a single hospital experience with HIV and SARS-CoV-2 co-infection in 39 patients from March to June, 2020, noting a mean age of 57, 67% AA, and common comorbidities of HTN (69%), DM (51%), and a mean BMI of 28. Sixty percent had an undetectable VL, 13% had CD4 cells < 200 c/mL, and 77% were reliably adherent to ART. Overall, 7 (18%) died and 8 (21%) were intubated, and these rates were lower and not significantly different that the general population with COVID-19, in whom 56 (31.6%) died and 58 (33%) were intubated. The authors concluded that their experience was consistent with the VA Cohort and others that have seen no signal of greater mortality or morbidity from COVID-19 in people living with HIV infection. 

HIV Patients with COVID-19 in the Bronx: A Retrospective Cohort Study
(Sirichand S, et al; Abstract 536):

Sirichand et al also described a single hospital experience in the Bronx, NY with HIV and SARS-CoV-2 co-infection in 72 PWHIV from January to May, 2020, of whom 17 (24%) were mild and required no supplemental oxygen, 31 (43%) were moderate needing only low flow oxygen supplementation, and 24 (33%) were severe and either required intubation or had serious end-organ damage. Mechanical ventilation was required in 15 (20%) patients, and was predicted by male gender, leukocytosis, and obesity. The in-hospital mortality was 20 (28%), and mortality was predicted by acute or chronic renal disease, leukocytosis, and elevated IL-6 levels. The investigators found no association between VL suppression and severity of COVID-19.

Rapid Migration to Telemedicine in a Boston Community Health Center Is Associated with Maintenance of Effective Engagement in HIV Care (Mayer K, et al; Abstract 541):

Mayer et al described the impact of COVID-19 on HIV care services at the Fenway Clinic in Boston serving 2,016 PWHIV and 25,606 total individuals with 563-689 monthly visits prior to the pandemic. They noted that visits fell to a mean of 146/mo in March and April, 2020, with the lowest recorded total of 45/mo in May, and then rebounded to 192 face-to-face visits in September, 2020. Telemedicine visits rose from 264/mo in March to 758/mo in April and then fell to 485/mo in September. As a result, from March- September there were more combined visits, i.e. both virtual and direct encounters, (mean=702, sd=87.0), than in March-September in 2019 (mean=628, sd=35.6). Compared with March, 2019, when 282 viral load tests were performed, in March 2020, only 134 viral load tests were performed. However, the investigators found no evidence of a reduction in the percentage with VL suppression in any time point: 93% of viral load values were < 200 c/mL (monthly average from March through September, 2020), and 80% of patients achieved undetectable VL (< 20 c/mL) in 2019 and in 2020. The investigators concluded that telemedicine had successfully enabled adequate engagement for a large portion of their clinic patients with no apparent decline in VL suppression.

Increasing incidence of obstructive sleep apnea in patients with HIV: A nationwide database analysis (Mansoor AER, et al; Abstract 922):

Mansoor et al used the National Inpatient Sample (NIS) database of ICD 9 and ICD 10 codes to examine trends in obstructive sleep apnea (OSA) among 1.36 million PHWIV from 2007 to 2016, and found an increase in cases over time to 21,413 (2.7%) of cases in 2016, compared with 0.5% in 2007. The predictors of OSA include female gender (OR 1.4), Midwest U.S. residence (OR 1.5), and Western U.S. residence (OR 1.1). Several co-morbid conditions were strongly associated with OSA, including obesity (RR 13), lipodystrophy (RR=7), and restless leg syndrome (RR=8), and 1.5-2 fold increases in the risk of OSA were seen with HTN, DM, CHF, COPD, PUDx, and depression. These data reinforce the importance of pulmonary complications of HIV infection and the need for careful screening of OSA symptoms such as fatigue, daytime somnolence, sleep disturbances, irritability, restless leg syndrome, and snoring.

Adverse Events Due to Inappropriate Prescribing in Older Adults Living with HIV
(Cinquegrani M, et al; Abstract 925):

Cinquegrani et al presented a single hospital experience with adverse drug events due to inappropriate prescribing in 104 elderly PLWHIV ≥65 years of age with polypharmacy, i.e., more than 5 non-HIV medications, in New Mexico. The cohort was 86% white, 5% AA, and 29% Latinx, with a mean BMI of 24 and an average of 22 years living with HIV disease. The median number of non-HIV medications per patient was 8, and 88% of patients were virologically suppressed using a regimen anchored with an INSTI (69%), a PI (7%), an NNRTI (13%) and non-traditional regimens (10%). Inappropriate prescribing was identified in 51 (49%) patients using the Beers criteria, and in 60 (57.7%) patients using the STOPP criteria, and most commonly involved NSAIDs, benzodiazepines, and first-generation antihistamines. The investigators reported 30 (28.8%) of patients with an adverse event, of which 20 (69%) were severe, 14 (13%) required an ER visit, and 2 (1.9%) resulted in hospitalization. The most common AER was a fall (28 or 93% of patients). Receiving seven or more non-HIV medications increased the risk of a serious AER five-fold compared with receiving fewer than seven drugs. These findings remind us of the importance of polypharmacy among older PWHIV and reinforce the need for careful management of multiple medications, as well as the need for dose reduction and/or treatment simplification and fall precautions among older PLWHIV.

Risk factors and Metabolic Implications of Integrase Inhibitor Associated Weight Gain
(Asundi A, et al; Abstract 946):

Asundi et al presented a single hospital experience with weight gain and incident DM following initial ART comparing INSTI with non-INSTI-based regimens in 612 antiretroviral drug naïve HIV+ patients in Boston from 2007-2017 after 24 months, of whom 489 (80%) received a non-INSTI regimen and 123 (20%) received an INSTI. In the overall population, about 1/3 were women, 55% were AA and 20% Latinx, and the mean CD4 cell count was 352. After 24 months, weight gain on INSTIs was 7%, and 3% on non-INSTI regimens, and these differences were more common in non-whites than whites and in women compared with men, and highest overall in non-white women with an 11% increase in weight. In addition, incident DM was significantly more common among INSTI recipients (HR 3.3). These data add to the growing evidence of weight gain and adverse metabolic consequences in patients who initiate INSTI therapy and the greater severity among women.

A Daily Single Tablet Regimen of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Virologically-Suppressed Adults Living with HIV and End-stage Renal Disease on Chronic Hemodialysis (Eron J, et al; Abstract 1002):

Eron et al presented a follow-on study of 55 PWHIV with ESRD on hemodialysis who were treated with elvitegravir/C/TAF/FTC for 96 weeks, of whom 36 completed the study, and who were then transitioned to receive bictegravir/TAF/FTC for 48 weeks, of whom 10 completed 48 weeks of treatment. The mean age in the cohort was 55 years, with 8 men and 2 women, all patients with virologic suppression and a median CD4 cell count of 563 c/mL. All ten patients maintained viral suppression throughout the 48 weeks. BIC trough levels were 4-7 fold higher than the BIC established paEC95 at 4, 24, and 48 week time points. No significant changes from baseline were seen in fasting lipids after the switch. Median adherence was 89%, and high patient satisfaction with the switch was observed. The authors concluded that a simplification to B/F/TAF was safe and effective in PLWH on hemodialysis. 

Efficacy and Safety of Doravirine in Treatment-Naïve Adults ≥50 Years Old With HIV-1
(Mills A, et al; Abstract 1011):

Mills et al presented the outcomes of doravirine in combination with TDF/FTC in 187 PLWH over age 50 years in the doravirine registrational Phase 2b and Phase III trials in comparison to EFV or DRV/+r based regimens. Compared with other subjects, older subjects were more likely to be women, less likely to be Latinx, and more likely to have lower CD4 cell counts and multiple co-morbidities. Compared with younger patients, older subjects discontinued treatment less frequently (14.7% vs 21.7%), and less frequently than patients in the EFV arm (15% vs 24.4%). Overall, 85.5% of subjects over 50 on DOR/TDF/3TC were suppressed, compared with 81.9% in younger patients. Serious adverse events (SAEs) and discontinuations due to SAEs were similar in older and younger patients, although grade 3 creatinine increases were more common in older adults on both DOR and EFV regimens, and no significant lipid changes were observed. Weight gain at weeks 48 and 96 were similar in older and younger adults receiving DOR, and was modest, with 1.0 kg increases at 48 weeks and 1.5 kg increases at 96 weeks. The investigators concluded that DOR/TDF/3TC is a useful treatment option for older patients with comparable antiviral efficacy, lipid neutrality, and minimal weight effect.

Weight Gain in Persons Living with HIV Treated with Bictegravir vs. Other Integrase Strand Transfer Inhibitor-based Antiretroviral Therapy (Fang M, et al; Abstract 1049)

Fang et al presented the experience at the San Diego VA with 18 months of follow-up in 425 drug naïve patients started on INSTIs from 11/15 to 10/19, of whom 265 were on bictegravir, 123 elvitegravir, and 36 were on DTG. At baseline, mean age was 48-56 years, AA were 23%-24%, white 53%-69%, and 97% were male. Median CD4s were 630-667, and 67%-77% were virologically suppressed. Weight increases at 12 and 18 months were significant with all INSTIs. Weight increases at 12 and 18 months were significant with all INSTIs, and equaled 4 lbs for BIC, 8.4 lbs with EVG/c, and 6.7 lbs with DTG. These data suggest a class effect of weight gain in patients starting INSTIs, and the magnitude of the weight gain is consistent with clinical trial evidence of modest weight gains in men starting INSTIs.