CROI 2020 Abstract eBook

Abstract eBook

Poster Abstracts

574 EFFECTIVENESS OF LDV/SOF FOR HIV-POSITIVE PATIENTS WITH HCV GENOTYPE 2 INFECTION Hsin-Yun Sun 1 , Chia-Jui Yang 2 , Bo-Huang Liou 3 , Wen-Chien Ko 4 , Shu-Hsing Cheng 5 , Yu-Lin Lee 6 , Hung-Jen Tang 7 , Guan-Jhou Chen 1 , Chi-Ying Lin 8 , Chien- Ching Hung 1 , for the Taiwan HIV Study Group 1 National Taiwan University Hospital, Taipei, Taiwan, 2 Far EasternMemorial Hospital, New Taipei City, Taiwan, 3 Mackay Memorial Hospital, Hsinchu, Taiwan, 4 National Cheng Kung University Hospital, Tainan, Taiwan, 5 Taoyuan General Hospital, Taoyuan, Taiwan, 6 Changhua Christian Hospital, Changhua, Taiwan, 7 Chi Mei Medical Center, Tainan, Taiwan, 8 National Taiwan University Hospital, Yunlin County, Taiwan Background: While the fixed-dose combination of ledipasvir (90 mg)/ sofosbuvir (400 mg) (LDV/SOF) is not approved in the US for the treatment of hepatitis C virus infection genotype 2 (HCV-2), it is approved in Taiwan, Japan, and New Zealand. Data regarding its use for HIV-positive patients with HCV-2 are sparse, however. Methods: From Jan-Jun 2019, HIV-positive patients with HCV-2 seeking care at 14 designated hospitals who received LDV/SOF were included for analysis. Laboratory investigations at baseline, end of treatment (EOT) and 12 weeks off therapy (SVR12), as required by the HCV treatment program of the Taiwan National Health Insurance. Results: Of the 101 patients (mean age, 38.4 years) initiating LDV/SOF during the study period, 99.0%were men, 76.0%men who have sex with men, 19% injecting drug users, and 3.0% heterosexuals. At the time of LDV/SOF initiation, all had estimated glomerular filtration rate (eGFR) ≥30 ml/min/1.73m 2 and were receiving combination antiretroviral therapy (cART) with TAF-containing regimen in 38.6%, TDF 13.9%, non-TDF/TAF 47.5%, NNRTI 12.9%, PI 14.9%, and InSTI 72.3% (dolutegravir 46.6% and elvitegravir 53.4%%), with 98.0% having CD4 counts ≥200 cells/mm 3 and 94.1% HIV RNA load <50 cp/mL. 8.9% of them tested positive for HBsAg, 1.0% had cirrhosis of the liver and 5.0%were HCV treatment-experienced. HCV seroconversion within one year was documented in 20.8% of the patients. Sexually transmitted HCV infection was reported in 67.7% and injection-related in 21.8%. The mean plasma HCV RNA load was 6.3 log 10 IU/mL before LDV/SOF initiation, and 97.7% had undetectable HCV viral load at week 4 of LDV/SOF, 98.9% at the end of the treatment, and 97.4% had SVR12 with eGFR >30 ml/min/1.73m 2 in all patients. eGFR increased in 34.1% with a mean increase of 7.2 ml/min/1.73m 2 , while eGFR decreased in 65.9%with a mean decrease of 12.6 ml/min/1.73m 2 . Conclusion: Similar to the reported treatment response among HIV-negative patients, LDV/SOF is effective for HIV-positive patients infected with HCV-2. 575 EFFECTIVENESS OF DAA IN HIV-POSITIVE PATIENTS WITH HCV GENOTYPE 6 INFECTION Hsin-Yun Sun 1 , Chien-Yu Cheng 2 , Chi-Ying Lin 3 , Chia-Jui Yang 4 , Ming-Jui Tsai 1 , Bo-Huang Liou 5 , Nan-Yao Lee 6 , Hung-Jen Tang 7 , Yi-Chia Huang 1 , Chien-Ching Hung 1 , for the the Taiwan HIV Study Group 1 National Taiwan University Hospital, Taipei, Taiwan, 2 Taoyuan General Hospital, Taoyuan, Taiwan, 3 National Taiwan University Hospital, Yunlin County, Taiwan, 4 Far Eastern Memorial Hospital, New Taipei City, Taiwan, 5 Mackay Memorial Hospital, Hsinchu, Taiwan, 6 National Cheng Kung University Hospital, Tainan, Taiwan, 7 Chi Mei Medical Center, Tainan, Taiwan Background: Hepatitis C virus genotype 6 (HCV-6) is prevalent predominantly in Southeast Asia, and the data on the virologic response of HCV-6 to direct- acting antivirals (DAA) are sparse in HIV-positive patients. Methods: FromMay 2017 to July 2019, HIV-positive patients coinfected with HCV-6 who initiated DAAs were included for analysis. Laboratory investigations were performed at baseline, the end of therapy (EOT), and 12 weeks off therapy (SVR12), as required by the HCV treatment program of the Taiwan National Health Insurance. Results: Of 264 patients (mean age, 50.7 years) initiating DAAs during the study period, 84.8%were men, 83.3% injecting drug users, 15.5%men who have sex with men, and 1.1% heterosexuals. Sofosbuvir-ledipasvir (SOF/LED) was used in 52.3% of the patients, glecaprevir-pibrentasvir (GP) in 45.8%, and sofosbuvir- velpatasvir (SOF/VEL) in 1.9%. At the time of DAA initiation, all had estimated glomerular filtration rate ≥30 ml/min/1.73m 2 , and combination antiretroviral therapy included regimens containing TAF in 27.3% of the patients, TDF 32.2%, non-TDF/TAF 40.5%, NNRTI 29.9%, PI 3.4%, and InSTI 68.6% (dolutegravir 55.8%, elvitegravir 39.8%, and raltegravir 4.4%), with 95.5% of the patients having CD4 counts ≥200 cells/mm 3 and 96.6% plasma HIV RNA load <50 copies/mL. 11.4% of the patients tested positive for HBsAg and 12.2% had liver

cirrhosis and 0.8% hepatocellular carcinoma. 9.5% of the patients were HCV treatment-experienced. HCV seroconversion within one year was documented in 3.8%, while injection-related HCV infection was reported in 82.2% (217/264) and sexually transmitted infection in 13.6% (36/264). The mean plasma HCV RNA load was 6.2 log 10 IU/mL before DAA initiation. Overall, 98.3% achieved undetectable plasma HCV RNA load (<15 IU/mL) at EOT and 96.6% achieved SVR12 (97.2% in patients receiving SOF/LED, 96.0% in GP, and 100% in SOF/VEL). Conclusion: Similar to the observation in HIV-negative patients, SVR12 with DAAs is high in HIV-positive patients with HCV-6. 576LB ADHERENCE AND 007-TP DBS LEVELS IN ACTIVE DRUG USERS WITH HCV: THE INCLUD TRIAL Kristina M. Brooks 1 , Jose R. Castillo-Mancilla 1 , Mary Morrow 2 , Samantha MaWhinney 2 , Sarah E. Rowan 3 , David L. Wyles 3 , Joshua Blum 3 , Ryan T. Huntley 1 , Lana M. Salah 1 , Arya Tehrani 1 , Laura Roon 1 , Lane R. Bushman 1 , Peter L. Anderson 1 , Jennifer J. Kiser 1 1 University of Colorado Anschutz Medical Campus, Aurora, CO, USA, 2 Colorado School of Public Health, Aurora, CO, USA, 3 Denver Health and Hospital Authority, Denver, CO, USA Background: Active drug users may be overlooked for HCV treatment due to adherence concerns. Here, we report treatment outcomes, objective adherence data, and predictors of adherence and 007-TP in dried blood spots (DBS) (a pharmacologic measure of sofosbuvir [SOF] adherence) in active drug and/or alcohol users receiving ledipasvir (LDV)/SOF. Methods: INCLUD was a prospective, open-label study of LDV/SOF x 12 wks in active drug users ages 18-70 yrs. Participants were randomized to wireless (WOT) by Wisepill® or video-based directly observed therapy (DOT) with miDOT (Emocha®). DBS and drug use by urine tox screen and self-report were collected every 2 wks. Two-wk adherence (adh2wk) was calculated as # doses taken/# days between visits by WOT or DOT. Generalized linear models examined risk factors for ≥1 missed dose between visits (i.e., adh2wk ≥100% vs. <100%) and mixed models identified predictors of ln-transformed 007-TP. Select covariates (n=17) were screened (p≤0.2), followed by backward selection (p≤0.1). Results: 60 participants received ≥1 LDV/SOF dose (47 HIV/HCV, 13 HCV only; 78%male; 22% black; 25% cirrhotic). Drug use during treatment (286 person- visits) included: 20% IV drug use, 60% THC, 37%methamphetamine, 22% opioids (street or Rx), 16% cocaine, and 57% alcohol (21% binge, 20% heavy). The SVR rate by ITT was 83% (50/60). Two did not comply with study requirements and were withdrawn, 5 were LTFU, and 3 failed treatment (1 relapse, 1 reinfection, 1 unknown). As treated (≥1 LDV/SOF dose and SVR12 available), the SVR rate was 93% (50/53). Median (IQR [range]) total adherence was 96% (83-99% [1-101%]) and adh2wk was 90% (86-100% [0-107%]). As treated total adherence was 98% (87-100% [30-101%]) in cures vs. 90% [90-91% [89-92%]) in failures. HIV coinfection, black race, meth and cocaine use were associated with lower odds of adh2wk ≥100%, whereas THC use and DOT were associated with higher odds (Table). Geometric mean 007-TP (%lnCV) in DBS were 218 (20.1%), 495 (9.7%), and 665 (6.3%) fmol/punch for 0-50%, 50-80%, and ≥80% adh2wk. Higher eGFR, black race, younger age, and higher BMI were associated with lower 007-TP levels after controlling for adh2wk (Table). Conclusion: Active drug users with HCV had good but variable LDV/SOF adherence using technology-based methods, with improved adherence using video DOT. 007-TP in DBS increased with adherence, and SVR12 rates were high demonstrating substantial PK forgiveness. These findings support efforts to expand HCV treatment to active drug users.

Poster Abstracts

577 OVERALL SURVIVAL IN HIV-POSITIVE LIVER TRANSPLANT RECIPIENTS AND THE ROLE OF DAAs Roberto Rossotti 1 , Marco Merli 1 , Chiara Mazzarelli 1 , Stefano Di Sandro 1 , Giovanna Travi 1 , Raffaella Viganò 1 , Andrea Lauterio 1 , Marco Cantone 1 , Maria Cristina Moioli 1 , Luca S. Belli 1 , Luciano G. De Carlis 1 , Massimo Puoti 1

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