CROI 2018 Abstract eBook
Abstract eBook
Poster Abstracts
516 ROUTINE VS TARGETED VIRAL LOAD STRATEGY AMONG PATIENTS STARTING ART IN HANOI, VIETNAM Todd Pollack 1 , Duong T. Hao 1 , Thuy T. Pham 2 , Thang D. Nguyen 2 , Howard Libman 1 , Long Ngo 1 , Julian Elliot 3 , Cuong D. Do Duy 2 , Donn Colby 4 1 Beth Israel Deaconess Medical Center, Boston, MA, USA, 2 Bach Mai Hospital, Hanoi, Vietnam, 3 Alfred Hospital, Melbourne, VIC, Australia, 4 SEARCH, Bangkok, Thailand Background: HIV viral load (VL) testing is recommended by the WHO as the most accurate method for monitoring patients on antiretroviral therapy (ART). VL monitoring has higher sensitivity and positive predictive value for diagnosing treatment failure compared to immunologic or clinical monitoring and allows earlier detection of virological failure and switch to 2nd-line ART before the accumulation of drug resistance mutations. However, evidence that routine VL (RVL) monitoring improves clinical outcomes is lacking. Methods: We conducted a prospective, randomized controlled trial of RVL monitoring every 6 months versus standard targeted VL (TVL, VL testing to confirm suspected treatment failure) in patients starting ART at Bach Mai Hospital in Hanoi. 648 HIV+ adults (median CD4 count=130 cells/mm 3 , IQR=33- 287) were randomized and followed for 3 years. Primary endpoints were death or WHO clinical stage IV events after 6 months of ART and rate of virological suppression at 3 years. Proportions were calculated and compared using Chi- squared test. Survival analysis was used to compare time to occurrence of death or stage IV event between two groups. Person-time at risk was calculated from date of ART initiation up to date of death, new or recurrent stage IV event, or last study visit. Results: Of 648 patients, 343 were assigned to TVL and 305 to RVL. Approximately 44% of study events (death, lost to follow up, withdrawal, or new or recurrent stage IV event) and 68% of deaths occurred within the first 6 months of ART. Among patients on ART at 6 months, death or stage IV event occurred in 3.6% of RVL and 4.0% of TVL (p=0.805). Survival analysis showed no difference between the two groups (p=0.826). Viral suppression at 36 months of ART was 97.2% in RVL and 98.9% in TVL (p=.157) at a VL threshold of 400 cps/ mL and was 98.0% in RVL and 98.9% in TVL (p=.404) at a threshold of 1000 cps/ mL. There was no difference in switching to 2nd-line ART (3.61% in RVL; 2.05% in TVL, p=.228). Conclusion: We found no difference in death, stage IV events, virological suppression, or switching to 2nd line ART in patients with RVL monitoring compared to those followed with a TVL strategy after 3 years of follow-up. Overall, patient outcomes were remarkably good in both groups. Most adverse events occurred within the first 6 months of ART, suggesting that earlier HIV diagnosis and ART treatment may be needed to improve treatment outcomes. VL monitoring every 6 months did not improve clinical outcomes in this population.
Poster Abstracts
517 CLINICAL AND VIROLOGICAL IMPACT OF LOW-LEVEL VIREMIA IN TREATED HIV INFECTED PATIENTS Enrique Bernal 1 , Inma Jarrin 2 , Alfredo Cano 3 , Antonia Alcaraz 3 , Angeles Muñoz 3 , Pascual Balsalobre 4 , Jorge Romero 5 , Jose-Ramón Blanco 6 , Federico García 7 , Miguel Górgolas 8 , Félix Gutiérrez 9 1 Catholic University of Murcia, Murcia, Spain, 2 Institute of Health Carlos III, Madrid, Spain, 3 Hospital Universitario Reina Sofia, Murcia, Spain, 4 University Hospital Gregorio Marañon, Madrid, Spain, 5 Centro Sandoval, Madrid, Spain, 6 Hospital San Pedro, La Rioja, Spain, 7 Hospital Universitario San Cecilio, Granada, Spain, 8 Fundacion Jimenez Diaz, Madrid, Spain, 9 Hospital General Universitario de Elche, Elche, Spain Background: There are patients where complete control of viral load is not achieved. The clinical impact of persistent low-level viremia (LLV) is unknown. The objetive was to assess the impact of different levels of LLV on AIDS/death, virological failure and any serious non-AIDS events (NAE) Methods: We analyzed adults, naïve to antiretroviral therapy (ART) from the cohort of the Spanish AIDS Research Network (CoRIS) who initiated ART from 2004 to 2015 and achieved viral load (VL) ≤50 copies/ml within 3–9 months after ART initiation. LLV50-199 was defined as two consecutive VL between 50 and 199 copies/ml, and LLV200-499 as two consecutive VL between 50 and 499 copies/ml with at least one between 200 and 499 copies/ml. Multivariable Cox models, modeling LLV as a time-varying covariate, were used to estimate the association of LLV with AIDS events/death, any serious NAE (non-AIDS-defining malignancies, cardiovascular-, renal, and liver-related) and virological failure (at least two consecutive viral loads ≥500 copies/ml) after virological suppression. Results: Of 5986 patients included, 237 (4.0%) experienced at least one episode of LLV50–199 with no LLV200-499 and 168 (2.8%) at least one episode of LLV200–499. Median follow-up time after viral suppression was 3.5 (IQR: 1.5 – 5.5) years in patients not experiencing neither LLV50-199 nor LLV200-499, 4.9 (IQR: 3.5 – 7.2) in patients experiencing at least one episode of LLV50-199 without LLV200-499 and 6.3 (IQR: 4.8 – 8.3) in those experiencing at least one episode of LLV200-499. One hundred seventy-one patients died or developed an AIDS event, 245 had any serious NAE and 280 had virological failure. In multivariable analyses, LLV200-499 was strongly associated with a higher risk of both AIDS event/death [adjusted hazard ratio (aHR): 2.89; 95% confidence interval (CI): 1.41 – 5.92] and virological failure (aHR: 3.25; 95% CI: 1.77 – 5.99), while no differences were observed between LLV50-199 and no LLV neither for AIDS event/death (aHR: 1.84; 95% CI: 0.89 – 3.82) nor virological failure (aHR:
CROI 2018 188
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