At least 120 adult male survivors, already in the PREVAIL Ebola Natural History Study, with evidence of the Ebola viral genetic material (RNA) present in one or two semen samples, will participate in PREVAIL IV investigation of a drug, identified as GS-5734. The aim is to determine if the drug can safely reduce the amount of Ebola viral RNA that may persist in their semen.
The study was announced by Liberia-U.S. Clinical Research Partnership (PREVAIL) and the study’s results are expected to be available in May 2017, a release said yesterday.
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 fight off the virus that is hiding in these protected places, the release added.
“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.” The study is voluntary and participants may withdraw at any time if they do not wish to continue in the study, he said.
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.
“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.
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.