For HCV patients with decompensated cirrhosis, or those who have undergone liver transplant, there are usually not many treatment choices left. Could the emerging DAAs meet the needs of these patients?

 

　　Edward Gane, MD, University of Auckland, New Zealand, reported the outcomes of a multinational (mainly Western European and North American countries), multi-centered clinical trial “LDV/SOF + RBV in HCV patients with decompensated cirrhosis or liver transplantation: SOLAR-1 and SOLAR-2” at APASL2016.

 

　　The researchers extracted data from the SOLAR-1 and SOLAR-2 studies, in which patients with HCV genotype 1 or 4 were randomized to receive 12 or 24 weeks of ledipasvir (LDV)/sofosbuvir (SOF) + ribavirin (RBV): patients without a transplant with (1) Child-Pugh-Turcotte (CPT) B or (2) CPT-C cirrhosis; or transplanted patients with (3) no cirrhosis (F0 to F3), (4) CPT-A, (5) CPT-B or, (6) CPT-C cirrhosis, or (7) fibrosing cholestasis hepatitis. Then the researchers evaluated SVR12, relapse and change from baseline in CPT and MELD scores 12 weeks after the end-of-treatment among those patients with SVR12.

 

　　The outcomes of the trial were striking. In the total of 667 patients, 27 were excluded because they have not reached the post-treatment week 12 visit. Subjects with GT1 responded better to the treatment. Overall, 92% (575 of 627 subjects) achieved SVR12. That included 92% (545 of 590 subjects) and 81% (30 of 37 subjects) in genotype 1 and genotype 4 infection, respectively.

 

　　The results also demonstrated that the relapse rates were low, only 4% overall (23 of 598 subjects), being 4% (20 of 565 subjects) and 9% (3 of 33 subjects) in GT1 and GT4 infection, respectively. The results suggested that relapse occurred more commonly in decompensated patients, but was not related to treatment duration, according to Dr. Gane.

 

　　The authors used MELD score to assess liver function and CPT score to predict prognosis. Of the 250 decompensated patients who achieved SVR12, 60% (150) had an improvement in MELD scores from baseline to post-treatment week 12, 61% (41/67) with baseline MELD >=15 had a post-treatment week 12 MELD<15, and 66% (164/248) had improvement in CPT scores.

 

　　In short, LDV/SOF + RBV for 12 or 24 weeks in patients with decompensated cirrhosis or recurrent HCV was efficacious with low relapse rates. And most patients with SVR12 also had improvements in CPT and MELD scores, concluded Dr. Gane.

 

　　This research was funded by Gilead Sciences.