Clinical trials and real-life studies show high rates of success after all-oral therapy (Rx) with direct-acting antivirals (DAA) in HCV-monoinfected patients with decompensated cirrhosis (De-C). We assessed real-life outcomes of all-oral DAA Rx in HIV/HCV-coinfected patients with De-C.
MADRID-CoRe is a prospective registry of coinfected adults receiving all-oral DAA in hospitals of the Madrid Regional Health Service (SERMAS). De-C was defined as current/prior Child-Turcotte-Pugh (CTP) stage B or C or current/prior liver decompensation or hepatocellular carcinoma (HCC). The primary endpoint was sustained viral response at week 12 (SVR12). Between Nov. 2014 and Aug. 2016, 2662 coinfected individuals in MADRID-CoRe initiated DAA. Of the 1953 patients who were scheduled to finish treatment on May 31, 2016, severity of liver disease was as follows: no cirrhosis (No-C), 1066 (54.58%); compensated cirrhosis (Co-C), 736 (37.69%); De-C, 146 (7.48%); and unknown, 5 (0.26%).
The main characteristics of the 146 patients with De-C were male sex, (102, 69.86%), median age of 51.58 yr., cART (125, 85.62%), and Rx-naïve (88, 60.27%). One patient had had a liver-transplant (LT), 7 were on the LT waiting list, and 15 had HCC. CTP scores were as follows: A, 75 (51.37%); B, 62 (42.47%); and C, 9 (6.16%). The HCV genotypes were G1a (49, 33.56%), G1b (32, 21.92%), G4 (30, 20.55%), G3 (22, 15.07%), and other (13, 8.90%). The DAA regimens were SOF/LDV (73), SOF+DCV (36), SOF+SMV (26), SOF+RBV (7), PrOD (3), and SMV+DCV (1). RBV was used in 69 patients (47.26%). SVR12 was achieved by 118 patients with De-C (80.82%). This figure was significantly lower than SVR12 achieved by patients with Co-C (91.17%) (P<.001) and patients with No-C (93.53%) (P<.001). The differences between Co-C and No-C were not statistically significant. Of the De-C patients without SVR12, 17 (11.64%) relapsed, 5 (3.42%) died, 2 (1.37%), stopped Rx owing to AE, 1 (0.68%) had breakthrough infection, and 3 (2.05%) stopped for other reasons. The variables associated with SVR12 in the multivariate logistic regression analysis are shown in the table.
The SVR12 rate with all-oral DAAs in coinfected patients with De-C was 81%, ie, significantly lower than in patients with compensated liver disease. Male sex and CTP stage C were associated with treatment failure in De-C. The long-term impact of all-oral DAA Rx in HIV/HCV-coinfected patients with De-C remains to be determined.