This article is more than 5 years old. Information may no longer be current.

Chronic kidney disease stage G3 correlates with lower SVR rate

Sovaldi with ribavirin was safe and effective among a cohort of Japanese patients with hepatitis C genotype 2, according to a recently published study. However, renal dysfunction correlated significantly with a lower rate of sustained virologic response.

“HCV infection causes renal dysfunction via membrane-proliferative glomerulonephritis due to mixed cryoglobulinemia, and HCV eradication sometimes results in the improvement of renal dysfunction,” Takuya Sho, MD, from the Hokkaido University, Japan, and colleagues wrote. “As patients with HCV infection are getting older, age-related renal dysfunction becomes an additional problem. Thus, effective and safe treatment is highly required for HCV-infected patients with renal dysfunction.”

Sho and colleagues enrolled 231 patients with HCV genotype 2 into a prospective, multicenter study including treatment with Sovaldi (sofosbuvir, Gilead Sciences) with ribavirin. Median patient age was 62 years (range, 22-88 years) and 45.8% were men.

Patients had either HCV genotype 2a (68%) or 2b (32%). Additionally, 53 patients had chronic kidney disease stage G1 (estimated glomerular filtration rate > 90 mL/min/1.73 m²), 138 had CKD stage G2 (eGFR = 60-89 mL/min/1.73 m²), 33 had CKD stage G3a (eGFR = 45-59 mL/min/1.73 m²) and 7 had CKD stage G3b (eGFR = 30-44 mL/min/1.73 m²).

The overall SVR rate was 97%. Seven patients did not achieve SVR, six of whom experienced a virological relapse and one patient experienced a virological breakthrough. SVR rates among patients with CKD were 98.1% for stage G1, 98.6% for stage G2, 87.9% for stage G3a, and 100% for stage G3b.

Factors initially associated with patients who did not achieve SVR included age (P = .062), sex (P = .091), Fibrosis-4 index higher than 3.25 (P = .09), previous interferon treatment (P = .081) and CKD stage G3 (P = .018). After multivariate analysis, CKD stage G3 remained associated with a lack of SVR (OR = 6.963; 95% CI, 1.494-32.41).

Patients with stage G3 were significantly older (74 vs. 60 years; P < .001), had lower baseline hemoglobin (12.8 vs. 13.8 g/dL; P = .002) and platelet levels (14.9 x 10³ vs. 17 x 10³; P = .026), a lower baseline alanine aminotransferase level (33 vs. 41 IU/L; P = .039), a higher FIB-4 index (3.45 vs. 2.25; P < .001) and a higher rate of ribavirin dose reduction (67.5% vs. 22%; P < .001) compared with those with CKD stage G1 or G2.

All patients completed the therapy except the patients who experienced a virological breakthrough. The researchers observed no severe adverse events or deaths during therapy.

“Although the SVR rate in patients with mild renal dysfunction (CKD stage G3) was high (90%), these patients were older, had advanced liver fibrosis, a lower baseline hemoglobin level, and a higher rate of ribavirin dose reduction during this therapy, which was significantly associated with non-SVR,” the researchers concluded. “These results indicate that attention should be paid to baseline renal function when a sofosbuvir- and ribavirin-containing regimen is used for patients with renal dysfunction.” – by Talitha Bennett

Disclosure: Sho reports no relevant financial disclosures. Please see the full study for the other authors’ relevant financial disclosures.