Sustained virologic response rates in patients with chronic hepatitis C genotype 6 treated with ledipasvir+sofosbuvir or sofosbuvir+velpatasvir

Abstract

Summary Background Hepatitis C virus (HCV) genotype 6 (GT 6) is the predominant genotype among certain Asian populations. The availability of newer DAA options is limited in many parts of Asia. Aim To compare sustained virologic response (SVR‐12) rates between ledipasvir and sofosbuvir (LDV+SOF) and velpatasvir+SOF (SOF+VEL) for patients with HCVGT6 infection. Method Retrospective study of consecutive adult HCVGT6 patients identified via ICD 9 code: 070.5 from United States treatment centers. Treatment was LDV+SOF or SOF+VEL for 8‐24 weeks. A 1:1 propensity score matching (PSM) on HCV RNA, cirrhosis, alanine aminotransferase, aspartate aminotransferase, platelets, and fibrosis score was conducted among the treatment‐naïve HCVGT6 patients to balance groups and isolate treatment effects. Results After exclusion criteria, 149 patients remained (n = 135 treatment‐naïve; n = 14 treatment‐experienced). The mean age was 63.8 ± 10.2 years, 66.9% male, and 93.9% Vietnamese. In treatment‐naïve arm, 52.2% LDV+SOF cohort were cirrhotic compared to 11.6% SOF+VEL cohort (P < 0.0001). SVR‐12 for LDV+SOF was 96.4% and 100% for the SOF+VEL cohort (P = 0.22). SVR‐12 for cirrhotic patients was 95.4% (n = 41/43) for LDV+SOF and 100.0% (n = 5/5) for SOF+VEL (P = 0.62). After PSM (n = 33 per group), LDV+SOF SVR‐12 rate was 97.0% compared to SOF+VEL SVR‐12 of 100% (P = 0.31). The treatment‐experienced group (n = 14), were all treated with LDV+SOF with an SVR‐12 of 92.3%. Conclusion Whether treatment‐naïve, treatment‐experienced, or cirrhotic patients with HCV GT 6 residing in the US had excellent outcomes when treated with SOF+VEL or LDV+SOF. Since LDV+SOF is more readily available globally, our results may provide clinicians with a treatment option when cost and availability limit the treatment choice.

Hepatitis C Guidance 2019 Update: American Association for the Study of Liver Diseases–Infectious Diseases Society of America Recommendations for Testing, Managing, and Treating Hepatitis C Virus Infection

“…Several well‐designed, robust clinical trials have demonstrated the safety and high curative efficacy of glecaprevir/pibrentasvir and sofosbuvir/velpatasvir among treatment‐naive persons without cirrhosis regardless of HCV genotype. These findings have been confirmed in real‐world cohort studies for both glecaprevir/pibrentasvir and sofosbuvir/velpatasvir . Based on these data, 8 weeks of glecaprevir/pibrentasvir or 12 weeks of sofosbuvir/velpatasvir is recommended for adults eligible for the simplified treatment algorithm.…”

“…These findings have been confirmed in real-world cohort studies for both glecaprevir/pibrentasvir (165)(166)(167) and sofosbuvir/velpatasvir. (167)(168)(169)(170)(171) Based on these data, 8 weeks of glecaprevir/pibrentasvir or 12 weeks of sofosbuvir/velpatasvir is recommended for adults eligible for the simplified treatment algorithm.…”

“…These findings have been confirmed in real-world cohort studies for both glecaprevir/ pibrentasvir (153,(165)(166)(167)(181)(182)(183) and sofosbuvir/ velpatasvir. (169,170,(184)(185)(186)(187)(188)(189) Based on these data, recommended regimens for adults eligible for the simplified treatment algorithm are 8 weeks of glecaprevir/pibrentasvir for patients with genotype 1-6 or 12 weeks of sofosbuvir/velpatasvir for those with genotype 1, 2, 4, 5, or 6. Pretreatment RAS testing is recommended for persons with genotype 3 because only those without a baseline NS5A Y93H RAS are eligible for a 12-week course of sofosbuvir/ velpatasvir.…”

Real‐world effectiveness and safety of ledipasvir/sofosbuvir for genotype 6 chronic hepatitis C patients in Taiwan

“…Because determination of subtypes of GT6 was not performed in this study, our preliminary phylogenetic analysis of 10 patients showed that 6g is the predominant subtype (eight patients) followed by 6a (unpublished data). When comparing the efficacy with other DAA regimens, the treatment result of LDV/SOF in this study was comparable with those from SOF/velpatasvir and glecaprevir/pibrentasvir . A small fraction of patients experienced adverse events in the treatment period, indicating that LDV/SOF treatment is well tolerated and safe.…”

“…Most involved fewer than 50 patients. They also presented a wide variation of treatment results, and the SVR rates ranged from 64.1% to 100% . In contrast, this study enrolled patients with a single HCV GT and the most GT6 CHC patients of any study in the literature; it was also conducted in a real‐world setting.…”