Exclusive HCV therapy clinical trials with genotype 6 patients in high prevalence areas have been sparse. We analysed the safety and efficacy of two generic, pangenotypic NS5A/NS5B combination oral DAA regimens, primarily in genotypes 3 and 6, in a real‐world setting: (a) daclatasvir/sofosbuvir (DCV/SOF) ± ribavirin (RBV) and (b) Velpatasvir/sofosbuvir (VEL/SOF ± RBV). Between December 2015 and November 2017, data from 522 patients were analysed, 311 of whom were treated with DCV/SOF ± RBV for 12/24 weeks (genotype 3: n = 193, genotype 6: n = 89) and 211 were treated with VEL/SOF ± RBV for 12/24 weeks (genotype 3: n = 83, genotype 6: n = 77). Overall SVR rates were high for both DCV/SOF ± RBV (96.1%, n = 299/311) and VEL/SOF ± RBV (95.3%, n = 201/211), and there was a good adverse event profile. Treatment naïve status and inclusion of RBV (in advanced fibrosis/cirrhosis) were significant independent predictors of achieving SVR12, while type of DAA regimen was not predictive. In this large cohort of genotypes 3 (n = 276) and 6 (n = 166; n = 127 unique subtype of 6c‐l), high SVR rates of 94.9% (n = 262/276) and 95.2% (n = 158/166), respectively, were noted. In conclusion, generic and pangenotypic DCV/SOF and VEL/SOF ± RBV regimens were highly effective and safe, in genotypes 3 and 6 chronic HCV in Myanmar. These efficacious pangenotypic regimens suggest that baseline genotype testing can be eliminated moving forward. While RBV may still be needed for those with advanced fibrosis/cirrhosis, in a global elimination strategy it would not be practical even if it does compromise SVR in a minority with difficult to treat characteristics.
Due to the unfortunate epidemic of opioid overdose deaths among people who inject drugs (PWID) in North America, there has been an increase in the availability of hepatitis C (HCV)‐positive organs for transplantation and consequently the potential to decrease waiting times for solid organ transplantation if an HCV‐uninfected recipient is willing to accept an HCV‐positive donor. The confidence in this potential new strategy comes as a result of the advent of safe and highly effective pan‐genotypic direct‐acting antivirals (DAAs). This promising strategy has been the most widely studied in kidney transplantation. Liver transplantation has positive results preliminarily, but has even less available data because viable HCV‐infected donor livers are typically transplanted into HCV‐infected individuals. Further, while HCV‐infected heart and lung transplantation, which face additional post‐transplant issues, have shown encouraging results, these studies are small scale and are limited by short‐term follow‐up. Thus, it would be premature to implement this strategy as standard of care without large scale clinical and real‐world trials and longer‐term follow‐up studies. Further, the ethics of this practice need to be considered. While some transplant professionals argue that more harm will be done by not utilizing HCV‐infected organs, others contend that cautiously conducted multi‐centre studies involving extensive post‐transplant follow‐up are paramount prior to endorsing widespread implementation of this strategy. The ethical permissibility of this practice hinges on whether access to DAA therapy can be secured in advance, and prospective recipients understand and accept all the risks associated with acquiring HCV.
Chronic hepatitis C virus (HCV) infection afflicts nearly 71 million people worldwide, and left unchecked, and can cause cirrhosis, hepatocellular carcinoma (HCC) and liver-related death. 1 Since 2011, the standard of care treatment for HCV infection has shifted from pegylated interferon (PEG-IFN)-based therapy to direct-acting antiviral (DAA)-based treatments. This change has
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