Search

Introduction Heavily treatment-experienced (HTE) people living with HIV-1 (PLWH) have limited viable antiretroviral regimens available because of multidrug resistance and safety concerns. The first-in-class HIV-1 attachment inhibitor fostemsavir demonstrated efficacy and safety in HTE participants in the ongoing phase III BRIGHTE trial. Objectives We describe patient-reported outcomes (PROs) through week 48. Methods Eligible participants for whom their current regimen was failing were assigned to the randomized cohort (RC; one to two fully active agents remaining) or the nonrandomized cohort (NRC; no fully active agents remaining). PRO assessments included the EQ-5D-3L, EQ-VAS, and Functional Assessment of HIV Infection (FAHI) instruments. Results Both cohorts achieved increases in EQ-5D-3L US- and UK-referenced utility score from baseline at week 24. Mean visual analog scale (VAS) scores in the RC and NRC increased from baseline by 8.7 (95% CI 6.2–11.2) and 5.6 points (95% CI 1.5–9.7) at week 24 and increased from baseline by 9.8 (95% CI 7.0–12.6) and 4.9 points (95% CI 0.6–9.2) at week 48, respectively. Mean increases in FAHI total score from baseline to weeks 24 and 48 in the RC were 6.9 (95% CI 4.2–9.7) and 5.8 (95% CI 2.7–9.0), respectively, whereas mean increases in physical and emotional well-being subscale scores were 2.7 (95% CI 1.9–3.6) and 2.4 (95% CI 1.3–3.4) and 3.2 (95% CI 2.2–4.2) and 2.6 (95% CI 1.6–3.7), respectively, with little to no change in other subscales. Conclusions Improvements in major domains of the EQ-VAS and FAHI through week 48, combined with efficacy and safety results, support the use of fostemsavir for HTE PLWH. Trial Registration Number and Date NCT02362503; February 13, 2015.

189 Background: Data at our institution shows lung cancer is more prevalent and aggressive in HIV patients. A study of lung cancer patients revealed a mean age of 55.8 years in those with HIV vs. 68.0 in those without. Additionally, 67% of HIV patients had metastasis at time of diagnosis, compared to 49% in the overall population. One study found an 18.9% reduction in lung cancer mortality among HIV patients who receive NLST-recommended screening. Despite this, data from 2018 estimated only 13% of eligible HIV patients had completed screening at our institution. We pursued a quality improvement initiative to increase lung cancer screening in our HIV clinics. Methods: Our multi-disciplinary team studied charts of the 628 HIV clinic patients seen in a four-month span to identify those who had not received lung cancer screening and potential reasons why referrals were not made. We also spoke with clinic providers to identify improvement areas. Our intervention encompassed HIV patients that met CMS screening criteria (i.e. age 55-77, 30 pack-year smoking). Our process measure was new referrals to our dedicated screening coordinator, who contacts patients to arrange for CT scans. We plotted trends in appointment referrals on a run chart. Results: Areas for improvement included EMR documentation to assess screening eligibility and an occasional lack of awareness regarding criteria. Providers also cited time constraints may limit referrals. Our team identified patients that met screening criteria and generated EMR reminders for providers to refer patients to radiology. We also held sessions with providers and nursing staff to increase awareness of our screening program. Of 628 patients, 128 (20.4%) had sufficient documented smoking history to assess for screening eligibility. 81 patients (63.3%) met our criteria. Of these patients, 58 (71.6%) had not been screened or referred for screening. Through our most recent interventions, 16 (31.3%) patients have been referred to our screening coordinator, and 7 (12.1%) have received screening CT scans. Our interventions ultimately led to an increase from 23 of 81 (28.4%) patients with completed screening to a projected 46 of 81 (56.8%). Conclusions: Providing education and EMR alerts to raise awareness regarding eligibility, we substantially increased the screening rate in our clinics. Our interventions will be broadened as we return from COVID stoppages. Future interventions include increasing smoking history documentation in the EMR to allow for automated identification of screening eligibility. PDSA and interventions are ongoing with continued follow-up of efficacy.

69 Background: Lung cancer screening for high risk populations has a major impact in reducing mortality.In our population, HIV patients are younger (mean age 68.0 vs 56.8, p= 0.014) and have a higher percentage of advanced disease at diagnosis (49% vs 68%, p< 0.001),when compared to non-HIV lung cancer patients.Due to this increased risk and aggressiveness, we embarked on a quality improvement initiative to increase screening in our HIV smoking population. Methods: Data was collected retrospectively from 10/18 to 1/19 in the HIV clinic. A multidisciplinary team was created involving thoracic oncologists, radiologists and HIV physicians to discuss methods to improve screening. We identified areas to be improved and utilized performance improvement tools such as a Pareto chart and PICK chart. Data was then collected prospectively. Results: In the initial 4 month period,among HIV positive patients 55–77 years old with significant smoking history, 13% (total n=54) of patients had a chest CT done for lung cancer screening and only 3.7% were referred for lung cancer screening during that specific period. Main barriers were lack of proper identification of screening candidates, discrepancies in smoking history within the EMR and lack of a consistent system for referral. An algorithm was created in the referral workflow, in which providers would need only to identify patients in the age group of 55-77 years old with any history of smoking and refer to a lung cancer screening program. The screening program would contact the patient and screen as per CMS guidelines. 17 Patients were referred from the HIV clinic from 4/8/19 to 5/2/19. Of these patients, 29% had a lung cancer screening CT scan done or scheduled, 18% of patients did not qualify for screening,and the remaining 53% of referrals are pending to be screened by telephone call. Further data on subsequent PDSAs and results of screening scans will be presented at the meeting. Conclusions: Modifying the screening algorithm for lung cancer in our HIV clinic by adding support from a dedicated screening program increased screening rates by 25% in the first month of intervention. Subsequent interventions include: patient education to reduce the stigma of lung cancer and EMR alerts when a patient meets criteria for screening.

Background VIKING-3 aimed to examine efficacy and safety of dolutegravir (DTG) 50 mg twice daily in patients with resistance to multiple ARV classes, including integrase inhibitors (INI). Methods RAL and/or EVG-resistant (current or historical) adult subjects with screening plasma HIV-1 RNA ≥500 c/mL and resistance to ≥2 other ART classes received open-label DTG 50 mg BID while continuing their failing regimen (without RAL/EVG). At Day 8 the background regimen was optimised and DTG continued. Activity of the optimized background regimen (OBR) was determined by Monogram Net Assessment. Primary endpoints were antiviral efficacy at Day 8 and Week 24. Results 183 subjects enrolled, 124 with INI-resistance at screening and 59 with historical (but no screening) resistance. Population was advanced: at BL, median CD4 140, prior ART 13 yrs, 56% CDC Class C; 79% had >2 NRTI, 75% >1 NNRTI, and 70% >2 PI resistance-associated mutations, and 61% had non-R5 HIV detected. Of the 114 subjects who had the opportunity to complete 24 weeks on study before data cutoff, 72 (63%) had 1 log HIV RNA decline of 2, respectively. Discontinuations due to adverse events were uncommon (6/183, 3%); the most common drug-related AEs were diarrhoea, nausea and headache, each reported in only 5% of subjects. Conclusion A majority of the highly treatment-experienced subjects in VIKING-3 achieved suppression with DTG-based therapy. Responses were associated with Baseline IN genotype but not OSS, highlighting the importance and independence of DTG antiviral activity. DTG had a low rate of discontinuation due to adverse events at 50 mg BID in this advanced patient population.