%0 Journal Article %1 Nguyen2013a %A Nguyen, Nguyet Minh %A Tran, Chau Nguyen Bich %A Phung, Lam Khanh %A Duong, Kien Thi Hue %A Huynh, Huy le Anh %A Farrar, Jeremy %A Nguyen, Quyen Than Ha %A Tran, Hien Tinh %A Nguyen, Chau Van Vinh %A Merson, Laura %A Hoang, Long Truong %A Hibberd, Martin L. %A Aw, Pauline P K. %A Wilm, Andreas %A Nagarajan, Niranjan %A Nguyen, Dung Thi %A Pham, Mai Phuong %A Nguyen, Truong Thanh %A Javanbakht, Hassan %A Klumpp, Klaus %A Hammond, Janet %A Petric, Rosemary %A Wolbers, Marcel %A Nguyen, Chinh Tran %A Simmons, Cameron P. %D 2013 %J J Infect Dis %K dengue virus drug %N 9 %P 1442--1450 %R 10.1093/infdis/jis470 %T A randomized, double-blind placebo controlled trial of balapiravir, a polymerase inhibitor, in adult dengue patients. %U http://dx.doi.org/10.1093/infdis/jis470 %V 207 %X Dengue is the most common arboviral infection of humans. There are currently no specific treatments for dengue. Balapiravir is a prodrug of a nucleoside analogue (called R1479) and an inhibitor of hepatitis C virus replication in vivo.We conducted in vitro experiments to determine the potency of balapiravir against dengue viruses and then an exploratory, dose-escalating, randomized placebo-controlled trial in adult male patients with dengue with <48 hours of fever.The clinical and laboratory adverse event profile in patients receiving balapiravir at doses of 1500 mg (n = 10) or 3000 mg (n = 22) orally for 5 days was similar to that of patients receiving placebo (n = 32), indicating balapiravir was well tolerated. However, twice daily assessment of viremia and daily assessment of NS1 antigenemia indicated balapiravir did not measurably alter the kinetics of these virological markers, nor did it reduce the fever clearance time. The kinetics of plasma cytokine concentrations and the whole blood transcriptional profile were also not attenuated by balapiravir treatment.Although this trial, the first of its kind in dengue, does not support balapiravir as a candidate drug, it does establish a framework for antiviral treatment trials in dengue and provides the field with a clinically evaluated benchmark molecule.NCT01096576.

@article{Nguyen2013a, abstract = {Dengue is the most common arboviral infection of humans. There are currently no specific treatments for dengue. Balapiravir is a prodrug of a nucleoside analogue (called R1479) and an inhibitor of hepatitis C virus replication in vivo.We conducted in vitro experiments to determine the potency of balapiravir against dengue viruses and then an exploratory, dose-escalating, randomized placebo-controlled trial in adult male patients with dengue with <48 hours of fever.The clinical and laboratory adverse event profile in patients receiving balapiravir at doses of 1500 mg (n = 10) or 3000 mg (n = 22) orally for 5 days was similar to that of patients receiving placebo (n = 32), indicating balapiravir was well tolerated. However, twice daily assessment of viremia and daily assessment of NS1 antigenemia indicated balapiravir did not measurably alter the kinetics of these virological markers, nor did it reduce the fever clearance time. The kinetics of plasma cytokine concentrations and the whole blood transcriptional profile were also not attenuated by balapiravir treatment.Although this trial, the first of its kind in dengue, does not support balapiravir as a candidate drug, it does establish a framework for antiviral treatment trials in dengue and provides the field with a clinically evaluated benchmark molecule.NCT01096576.}, added-at = {2013-06-08T02:07:48.000+0200}, author = {Nguyen, Nguyet Minh and Tran, Chau Nguyen Bich and Phung, Lam Khanh and Duong, Kien Thi Hue and Huynh, Huy le Anh and Farrar, Jeremy and Nguyen, Quyen Than Ha and Tran, Hien Tinh and Nguyen, Chau Van Vinh and Merson, Laura and Hoang, Long Truong and Hibberd, Martin L. and Aw, Pauline P K. and Wilm, Andreas and Nagarajan, Niranjan and Nguyen, Dung Thi and Pham, Mai Phuong and Nguyen, Truong Thanh and Javanbakht, Hassan and Klumpp, Klaus and Hammond, Janet and Petric, Rosemary and Wolbers, Marcel and Nguyen, Chinh Tran and Simmons, Cameron P.}, biburl = {https://www.bibsonomy.org/bibtex/21f46a340f92da050c5d131638e91a489/aorchid}, description = {have paper version from JID. Did not work. Used R for stats and ggplot2 graphics!}, doi = {10.1093/infdis/jis470}, groups = {public}, institution = {Oxford University Clinical Research Unit, Ho Chi Minh City, Vietnam.}, interhash = {0f18741263f89206e97edc534495c820}, intrahash = {1f46a340f92da050c5d131638e91a489}, journal = {J Infect Dis}, keywords = {dengue virus drug}, language = {eng}, medline-pst = {ppublish}, month = May, number = 9, pages = {1442--1450}, pii = {jis470}, pmid = {22807519}, timestamp = {2013-06-08T02:07:48.000+0200}, title = {A randomized, double-blind placebo controlled trial of balapiravir, a polymerase inhibitor, in adult dengue patients.}, url = {http://dx.doi.org/10.1093/infdis/jis470}, username = {aorchid}, volume = 207, year = 2013 }