Monrovia-July 4, 2016: The Liberia-U.S. Clinical Research Partnership known as PREVAIL today announced the start of a new study in male survivors of Ebola at the JFK Medical Center in Sinkor. The study–called PREVAIL IV, or the Persistent Ebola Virus Study—is designed to find out if an investigational drug called GS-5734 can safely get rid of or reduce the amount of Ebola viral RNA that may persist in the semen of some male Ebola survivors.
The Ebola viral RNA may stay hidden in certain parts of the body and body fluids, such as semen, even after a person recovers from Ebola. This is called persistent Ebola viral RNA. The virus can persist because the body’s immune system cannot easily reach and fight off the virus that is hiding in these protected places.
“Our experience with traditional public health measures to contain Ebola has proven effective”, said Tolbert Nyenswah, Head of Liberia’s (Ebola) Incident Management Systems and Deputy Minister of Heath. “However, there are still unanswered questions with Ebola therefore an attempt to address residual and persistent virus through PREVAIL IV study is critical”, he added.
In previous studies conducted in non-human primates, GS-5734 cured the animals of Ebola viral RNA disease (EVD) by stopping the virus from making copies of itself. The drug also was used on a compassionate basis to treat a Scottish nurse who had recovered from EVD but had an Ebola virus relapse, and to help treat a baby in Guinea who had EVD. The drug is manufactured by the U.S. biopharmaceutical company Gilead Sciences, based in California.
“Survivors don’t have to continue living with the fear of transmitting Ebola to their loved ones. This study seeks to eliminate the fear of sexual transmission and stigmatization”, said Dr. Dehkontee L. Gayedyu-Dennis, Co-Principal Investigator of the study.
The study seeks to enroll up to 120 adult male survivors already in the PREVAIL Ebola Natural History Study who have evidence of the Ebola viral genetic material, RNA present in one or two semen samples taken within 42 days of enrollment. Participants will be assigned at random to receive either the investigational drug or a look-alike placebo that does not contain the drug. They will receive a daily infusion of the drug or the placebo over a period of five days, during which time they will be closely monitored and followed up.
The study will last for about six months. During the first month, study participants will be seen 10 times in the PREVAIL clinical center at JFK. During the last five months of the study, participants will visit the PREVAIL clinical research site at Duport Road once a month. At each visit, the study team will ask participants about their health status, and also ask them to provide both a blood and a semen sample.
“In addition to learning if the investigational therapy can eliminate virus from semen, we are hoping to understand if individuals have improvement in post-Ebola symptoms if the virus is eliminated. There is a lot of interest in this study across West Africa.”, Dr. Elizabeth Higgs, Co-Principal Investigator added.
To determine whether the experimental drug works, the study team will assess whether the group of men who received the drug have much less Ebola virus in their semen than the group who received the placebo. If the drug proves well-tolerated and effective, participants who received the placebo will be offered the drug free of charge at the end of the study.
Because the study is voluntary, participants may withdraw at any time if they do not wish to continue in the study.
PREVAIL IV is led by a team of Liberians and Americans under the umbrella of a larger Liberia-U.S. bilateral program to build a clinical research partnership and infrastructure in Liberia.
The study is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, in partnership with the Ministry of Health of Liberia and the pharmaceutical company Gilead Sciences.
The Co-Principal Investigators on the study are Dr. Dehkontee Dennis, Site Physician at the Duport Road Clinic for the PREVAIL Ebola Natural History Study; Dr. Elizabeth Higgs, Global Health Advisor at National Institute of Allergy and Infectious Diseases, U.S. National Institutes of Health; and Dr. William Fischer II, Assistant Professor of Medicine at The University of North Carolina School of Medicine in the U.S.
Study results are expected to be available in May 2017.