886 | wileyonlinelibrary.com/journal/jvh J Viral Hepat. 2020;27:886–895. © 2020 John Wiley & Sons Ltd
Received: 12 March 2020
|
Accepted: 30 March 2020
DOI: 10.1111/jvh.13311
ORIGINAL PAPER
High sustained viral response rate in patients with hepatitis
C using generic sofosbuvir and daclatasvir in Phnom Penh,
Cambodia
Meiwen Zhang
1,2
| Daniel O’Keefe
1,3
| Momoko Iwamoto
1,2
| Kimchamroeun Sann
1
|
Antharo Kien
1
| Vithurneat Hang
1
| Cecile Brucker
1
| Pascal Jolivet
1
| Sovann Ly
4
|
Dimanche Chhit
5
| Suna Balkan
1
| Tonia Marquardt
1
| Mickael Le Paih
1
|
Jean-Philippe Dousset
1
1
Médecins Sans Frontières-France, Phnom
Penh, Cambodia
2
Epicentre, Paris, France
3
Burnet Institute, Melbourne, Australia
4
Department of Communicable Disease
Control, Ministry of Health, Phnom Penh,
Cambodia
5
Hepato-Gastro Department of Cambodia-
China Friendship Preah Kossamak Hospital,
Phnom Penh, Cambodia
Correspondence
Meiwen Zhang, Médecins Sans Frontières-
France, #205, Street 132, Sangkat
Teuklaak1, Khan Toulkork, PO Box 845,
Phnom Penh, Cambodia.
Email: meiwen.zhang@hotmail.com
Funding information
Funding for the study was provided
by Unitaid (https://unitaid.org/) and
Médecins Sans Frontières (MSF, https://
www.msf.org/). A grant from Unitaid
(SPHQ14-LOA-217) financed parts of this
implementation. Meiwen Zhang, Daniel
O’Keefe, Momoko Iwamoto, Jean-Philippe
Dousset, Kimchamroeun San, KienAntharo,
Vithurneat Hang, Cecile Brucker, Pascal
Jolivet, Mickael Le Paih, Tonia Marquardt,
Suna Balkan were employed by MSF, and
participated in planning the study, carrying
out the research, and writing the report.
Abstract
Safe and efficacious pan-genotypic direct-acting antiviral (DAA) regimens, such as
sofosbuvir and daclatasvir (SOF + DCV), facilitate simplified models of care for hep-
atitis C virus (HCV). However, in Cambodia access to HCV testing and treatment
has typically been low. In response, Médecins Sans Frontières (MSF) implemented
a HCV testing and treatment pilot project in Phnom Penh, Cambodia in 2016. This
project provides the first real-world evidence of SOF + DCV effectiveness across
a large patient cohort using a simplified care model in Cambodia. Patients treated
with SOF + DCV from September 2016 to June 2019 were included in the analy-
sis. Medical standard operational procedures (SOPs) were simplified significantly
across the study period. Treatment effectiveness was assessed by sustained viral
response at 12 weeks post-treatment (SVR12) according to a modified intention-to-
treat methodology. Treatment safety was assessed by clinical outcome and occur-
rence of serious and nonserious adverse events (S/AE). Of 9158 patients, median
age was 57 years and 39.6% were male. At baseline assessment, 27.2% of patients
had compensated cirrhosis and 2.9% had decompensated cirrhosis. Genotype 6 was
predominant (53.0%). Among patients analysed according to modified intention to
treat (n = 8525), treatment effectiveness was high, with 97.2% of patients achiev-
ing SVR12. Occurrence of SAE was low (0.7%). Treatment effectiveness and safety
was not affected by the iterative simplification to treatment modality. In conclusion,
in this large treatment cohort in Phnom Penh, Cambodia, the SOF + DCV regimen
showed high rates of treatment effectiveness and safety across patient sub-groups
and during progressive simplification.
KEYWORDS
Cambodia, Daclatasvir, Hepatitis C, Sofosbuvir, SVR12