Use of Simplified HCV Testing, Diagnosis and Generic Sofosbuvir/Velpatasvir Treatment Leading to 100% SVR12 In Myanmar (USAID/EQUIP Project)


Author: Thaung YM, Aung NM, Chasela C, Chew KW, Barnard T, Cavanaugh C, Kelly R, Lwin AA, Sein YY, Marange F, van der Horst C, Xulu T, Thwin HT, Sanne I, Kyi KP

Theme: Epidemiology & Public Health Research Year: 2018

Background:
Hepatitis C Virus (HCV) infection prevalence is 2.65% in Myanmar, highest amongst
key population groups, particularly people who inject drugs (PWIDs). Access to HCV
testing and treatment is costly and limited. This study explores a simplified HCV
testing, diagnosis and treatment program using generic sofosbuvir/velpatasvir
treatment for those with HCV infection with or without HIV co-infection.
Methods:
Targeting key populations, the study used rapid test kits for HCV/HIV/HBV screening
and viral load for HCV diagnosis. Generic oral sofosbuvir/velpatasvir with or without
ribavirin for 12 weeks was used for all HCV genotypes. The first 150 participant
samples were tested for HCV detection and quantification using three methods
(Roche, Gene Xpert and ABL). HCV viral load (VL) was obtained at baseline and
week 24 (12 weeks after completion of treatment). Laboratory monitoring was limited
to baseline and week 24 except for those on tenofovir and ribavirin, who had
creatinine and hemoglobin monitored.
Results:
From December 2017 – May 2018, 533 patients of 1028 screened were diagnosed
with HCV and 492 were initiated on treatment. Of those treated, the median age was
44.6 years, 190 (36%) PWID, 99 (20%) HIV co-infected, 23 (4.7%) HBV co-infected,
most were male and had HCV genotype 3 and 6. To date, 111 patients reached
week 24 with 100% SVR12 who received sofosbuvir/velpatasvir without adding
ribavirin. We anticipate 285 patients including 96 (34%) PWIDs will have reached
SVR12 in September. There was 96% correlation in quantitative HCV VL between
Roche and Gene Xpert testing, and 100% sensitivity and specificity by GeneXpert
compared to Roche for HCV detection.
Conclusion:
Generic sofosbuvir/velpatasvir was effective in treating HCV patients in Myanmar
regardless of HCV genotype or HIV or HBV co-infection status and with minimal
laboratory monitoring. Alternative low-cost, point of care HCV VL testing
demonstrated excellent correlation with standard quantitative PCR.
Disclosure of Interest Statement:
USAID EQUIP Grant No. AID-OAA-A-1500070), no pharmaceutical industry funds

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