Results of Sofosbuvir Plus Ribavirin in Patients With Hepatitis C Related Decompensated Cirrhosis

Abstract

Background: Sofosbuvir (SOF), a direct acting antiviral, has revolutionized the treatment of chronic Hepatitis C Virus (HCV) infection. However, data is scarce about efficacy of SOF plus Ribavarin (RBV) in Indian patients with decompensated cirrhosis. We evaluated the efficacy of SOF plus RBV in decompensated cirrhosis, and compared the outcome with compensated cirrhosis and non-cirrhotics. Patients and methods: Consecutive decompensated cirrhotic patients of chronic HCV with detectable HCV RNA were treated with 24-week course of SOF (400 mg) plus weight based RBV. Sustained Virological Response (SVR), Child Turcotte Pugh (CTP) and Model for Endstage Liver Disease (MELD) scores were assessed at 36 weeks (i.e. 12 weeks after completion of therapy). Non-cirrhotic chronic hepatitis C patients and patients with compensated cirrhosis treated with SOF plus RBV during the same period were used as controls. During the period of this study ledipasvir and daclatasvir were not available in India. Results: A total of 47 patients [median age 50 (29-82) years, 64% males] with decompensated cirrhosis were included as 'cases' in the study; while, 27 patients with compensated cirrhosis and 29 patients with chronic hepatitis were included as 'controls'. Age, gender, HCV RNA levels, and genotype distribution were similar in cases and controls. The median CTP and MELD scores of cases were 8 (7-12) and 13 (6-25), respectively. Among cases 39 (83%) could complete the therapy, while 1 (2%) was intolerant and 7 (15%) died before completion of therapy. End of Treatment Response (ETR) was achieved in 37/39 (95%) cases. Of these, another 3 died before SVR, and 7 failed to achieve SVR, thus 27/34 (79%) could achieve SVR. Thus according to intention-to-treat analysis, only 27/47 (57%) cases could achieve SVR. In comparison, 24/28 (86%) compensated cirrhotics and 27/28 (96%) of chronic hepatitis achieved SVR. There was a significant improvement in mean CTP score in cases who achieved SVR (P < 0.01) compared to those who did not achieve SVR/ETR. On multivariate analysis the only independent factor influencing successful outcome patients was a serum albumin >3.5 g/dL. Conclusions: A 24-week course of SOF plus ribavirin in decompensated HCV cirrhosis could lead to SVR in only 57% of patients. The failure of therapy in 43% patients was either due to non-response, intolerance, or death. A serum albumin of more than 3.5 is associated with success of antiviral therapy. Thus an early initiation of antiviral therapy is recommended before decompensation sets in as it precludes successful outcome.

Results of interferon-free treatment for HCV-infected patients with decompensated cirrhosis from a Brazilian real-life cohort

“…Genotype 1 (84%) was the most common (G1a 42%; G1b 27%; G1 without subgenotype 15%). The median MELD score was 12 (7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24), and 79% were Child-Pugh B. Two patients had a history of hepatocellular carcinoma before treatment.…”

“…[6][7][8] Some further real-life also confirmed these encouraging results. [9][10][11][12][13][14][15][16][17][18][19] Nevertheless, most studies on this topic were randomized controlled trials, with scarce data on real-life cohorts. [10,12,13,19] Also, this population is prone to the development of complications of cirrhosis, which was explicitly a significant issue in patients treated with interferon-based [20] and simeprevir-containing regimens.…”

Seroprevalence of hepatitis C virus antigen in patients with chronic liver disease and hepatocellular carcinoma at 12th week of treatment: a cross-sectional study

“…Indeed, it is known that the treatment of hepatitis C using DAAs very rarely eliminates HCV in all people treated. This is probably due to certain risk factors such as on the one hand the advanced age and health status of the patient and on the other hand, the cost, the duration, and the missed doses can negatively affect the results of the treatment [ 23 , 26 - 28 ]. Added to this, the lack of inexpensive viral diagnostic tests and universally accessible treatment adapted to resource-limited settings represent an obstacle to the implementation of HCV surveillance in difficult contexts [ 22 ].…”

Factors affecting the recovery of hepatic reserve after sustained virologic response by direct‐acting antiviral agents in chronic hepatitis C virus‐infected patients

“…A limitation of our study is that it did not include patients with decompensated liver cirrhosis because DAA therapy had not been approved for decompensated liver cirrhosis in Japan until SOF 400 mg/velpatasvir 100 mg tablets were marketed in January 2019. It is necessary to examine long‐term changes in hepatic reserve and therapeutic benefits in patients with decompensated liver cirrhosis because improving of hepatic reserve, introduction of liver transplantation, and even death owing to liver failure have been observed in these patients even after achievement of SVR 26–28 . In addition, CT was not performed in all patients during the first year after the start of DAA therapy, and binomial logistic regression analysis was performed only in 318 of 403 patients.…”