P1384EFFECT OF ANEMIA ON EFFICACY AND SAFETY OF CHRONIC HEPATITIS C TREATMENT AMONG RENAL PATIENTS USING DIRECT ACTING ANTI-VIRUS
Authors: Elmowafy Ahmed , Abbas Mohamed , Elmaghrabi Han , Soliman Reham , Elwasif Salwa , Sheashaa Hussein , Shiha Gamal , Rostaing Lionel , Bakr Mohammed 
Published: June 2020

Background and Aims

With the advance of new direct acting antiviral, treatment of HCV became safer and easier. Renal impairment makes treatment of HCV more difficult due to poor drug tolerability. Anemia is a common side effect occurring in renal patients. Effect of anemia on the efficacy and safety of these drugs in those particular populations is a point of interest.

Method

This is a single center cohort study was held in Urology and Nephrology Center, Mansoura, Egypt, including 235 renal patients who were divided into 2 groups according to presence/absence of anemia; hemoglobin below 10.5 g/dL is considered cut-off value: 70 chronic kidney disease patients (CKD) (42 anemic and 28 non-anemic), 40 hemodialysis patients (HD) (24 anemic and 16 non-anemic) and 125 kidney-transplant recipients (KTRs) (40 anemic and 85 non-anemic). Hemodialysis patients received ritonavir-boosted paritaprevir and ombitasvir±ribavirin (OMV/PTV/RTV), KTRs received sofosbuvir and daclatasvir. CKD with eGFR &gt;30 ml/min/1.73m2 received sofosbuvir and daclatasvir. CKD with eGFR &lt;30 ml/min/1.73m2 received OMV/PTV/RTV. All patients were followed-up for 6 months after completing HCV treatment.

Results: Demographics: Mean age was 49.17y for CKD, 43.2y for HD and 45.2y for KTRs. Most of them were males with body mass index around 23.8. Out of 235, 22 patients had been previously treated with interferon-IFN- (14 patients showed relapse after primary response on IFN and 8 patients could not tolerate IFN due to severe anemia, leucopenia and recurrent infection) and 7 patients had been co-infected with hepatitis B virus (all patients were cleared from the virus prior to HCV treatment).

Efficacy: Rapid virologic response was achieved in all groups. 12-week sustained viral response (SVR-12) among CKD patients was 92.86% in anemic group and 96.42% in no-anemic group (p=91%). SVR-24 was lower in both groups. There were 16 relapse cases among CKD patients (11 in anemic group and 5 in non-anemic group; p value=0.69). Relative Risk for relapse incidence among anemic CKD patients was 1.4 with 95% CI 3.58 to 8.58 (p value: 0.42). Among HD patients, there was only 1 relapse case and it was in anemic group. All KTRs achieved SVR-12 and SVR-24.

Safety: Deterioration of kidney function within 1 month from starting DAAs was the major side effect in both groups among CKD patients but it was more profound in anemic group (59.5%) (p value: 0.024). Deterioration of creatinine clearance was more obvious in anemic group (26.7±11.8mL/min, 21.28±12.97mL/min; p value: 0.014). More cases needed hemodialysis either temporary (3 cases) or permanently (13 cases) in anemic group (p value: 0.03 for temporary hemodialysis and 0.005 for permanent hemodialysis). Relative Risk for A/CKD incidence with anemia among CKD patients was 1.85 with 95% CI from 22.94 to 1.98 (p value: 0.04). Anemia was associated with rise of serum creatinine among kidney transplant recipient also. Graft impairment among anemia group was 30% (12 out of 40 patients) in comparison to 3.5% in no-anemia group (3 out of 85 patients); p value: 0.0002. Relative Risk for graft impairment with anemia among KTRs was 8.5 with 95% CI 6.95 to 2.64. Subsequently, drug interruption was more frequent among anemia group in both CKD and KTRS as treatment was suspended during AKI period.

Regarding hemodialysis patients, the only difference was that worsening of anemia was more frequent among no-anemia group (p value: 0.0002). Ribavirin resulted in this this difference as no-anemia group received ribavirin while the other group did not receive it.

Conclusion

Direct-acting anti viral drugs are considered advance in treatment of hepatitis C infection and it is well tolerated by kidney disease patients. However, this particular population needs special care. Correction of anemia before starting DAAs may improve the outcome. Hemoglobin levels below 10.5 g/dL prior to DAAs are associated with rise of serum creatinine among KTRs and CKD patients.