CROI 2016 Abstract eBook

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Oral Abstracts

Methods: Following joint protocol development and IRB approval, enrollment of survivors > 12 year began in June 2015 followed by contacts and pediatric survivors <12yrs in August 2015. Participants are seen at baseline and every 6 months for 5 years at 3 sites in Liberia. Data collection includes demographics, detailed medical exam, labs including serology to determine the presence of antibodies specific to EVD, and for survivors, information about ETU course, treatment, and discharge. Examinations may also include detailed an ophthalmologic exam, a comprehensive neurologic assessment, collection of semen, lumbar punctures, and the enrollment of newborns and breast milk anal Results: Through December, 1022 survivors and 754 close contacts have been enrolled. The average age of survivors and close contacts is 30 and 27 years, respectively. For survivors, the median (IQR) time from EVD symptoms to enrollment is 352 days (307,395). A total of 76 individuals have had 1-4 semen samples obtained for PCR analysis. Overall 25% have been positive with 37% of subjects having at least 1 positive sample. The maximum amount of time between the onset of symptoms and a positive result was 488 days. 65% of survivors reported sexual activity without a condom since ETU discharge including 48% of those with a positive semen PCR for Ebola. EVD serology is in progress and has been completed for 527 survivors and 97 close contacts. 88% of survivors and 49% of close contacts had a positive EVD serology. Conclusions: Preliminary findings indicate the prevalence of eye complications, musculoskeletal problems, and neurological findings are greater among EVD survivors than close contact controls. Most survivors report sexual contact and many do not use condoms. A surprising number of contacts have positive EVD serology, a finding now being confirmed with analysis of blood samples. Study findings have implications for EVD sexual transmission risk and indicate the importance of enrolling close contacts with EVD serology to use as controls.

75LB Dynamics of Ebola Virus Clearance in Semen in Guinea Daouda Sissoko 1 ; Sophie Duraffour 2 ; Jacques Kolie 3 ; Abdoul H. Beavogui 4 ;Thi HuyenTram Nguyen 5 ; Jeremie Guedj 6 ; Denis Malvy 7 ; MilesW. Carroll 8 ; Xavier Anglaret 9 ; Stephan Gunther 10 1 INSERM U897, Bordeaux, France; 2 Bernhard-Nocht Inst for Tropical Medicine, Hamburg, Germany; 3 Ministry of Hlth Guinea, Conakry, Guinea; 4 Cntr de Recherche en Santé Rurale de Mafèrinyah, Conakry, Guinea; 5 UMR 1137, INSERM, Université Paris Diderot, Paris, France; 6 French National Inst of Hlth and Med Rsr, Paris, France; 7 CHU de Bordeaux, Bordeaux, France; 8 Public Hlth England, Salisbury, UK; 9 INSERM, Abidjan, Côte d’Ivoire (Ivory Coast); 10 European Mobile Laboratory Project, Hamburg, Germany Background: While it is well known that testes may be a reservoir for long term persistence of Ebola virus (EBOV), the dynamics of the persistence of EBOV in semen remained unexplored. We aimed to estimate the probability of EBOV RNA clearance in semen over time.

Oral Abstracts

Methods: We enrolled a cohort of 25 men discharged from three Ebola Treatment Units (ETU) in Coastal region of Guinea between February 6, 2015 and July 6, 2015. Semen specimens were obtained every 3-6 weeks until reaching non-detectable levels of EBOV RNA (eg, CT values ≥ 45) on two consecutive samples. Specimens were tested on-site using Altona RT-PCR. Furthermore, a nonlinear mixed effect model was used to estimate the slope of evolution of Ct values over time Results: A total of 116 semen samples were collected. The median time between EVD onset and first semen collection was 49 days (IQR: 40-85). The median time between first and last semen collection was 193 days (IQR: 150-204). Of the 25 participants, 18 (72%) had a positive EBOV RT-PCR in the first semen sample. The median Ct value in the 18 positive semen was 28.1 (IQR= 22.4-36.3). The semen of the patient having the longest follow-up was still positive to EBOV at day 300 post-disease onset. Using a linear mixed model, the mean increase of Ct in semen was estimated to +0.086 per day (SD 0.65), corresponding to a mean decrease of RNA of -0.87 log 10 copies/ml per month. Based on these numbers, the time to achieve negative RT-PCR in semen in 50% and 90% of the patients was predicted at 127 (95% Prediction interval -95% PI-=

71-221) and 375 (95% PI=222- 638) days, respectively (Figure 1). Conclusions: About 10% of patients may have detectable viremia in semen up a year after onset of disease. Therefore long term programs of care for EVD survivors should include implementation of semen testing, dedicated counselling and condom use in order to avoid potential sexual transmission. The evaluation of drug intervention among individuals harbouring EBOV insemen is highly desirable.

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CROI 2016