Sofosbuvir, daclatasvir combo best treatment for HCV cryoglobulinemia vasculitis

 

WASHINGTON – A combined regimen of sofosbuvir and daclatasvir is the best option to treat patients with hepatitis C virus infections experiencing cryoglobulinemia vasculitis, according to the findings of a new study presented at the annual meeting of the American College of Rheumatology.

“The HCV cryoglobulinemia vasculitis is a very important vasculitis because it represents 5% of chronically infected HCV patients in the world,” explained David Saadoun, MD, of Sorbonne Universities, Paris. “It’s sometimes a life-threatening vasculitis because patients may develop inflammation [so] there’s a need for very active and well-tolerated treatment.”

Dr. Saadoun and his coinvestigators recruited 35 HCV patients experiencing cryoglobulinemia vasculitis. The median age for the entire cohort was 57 years; 45% of subjects were female. Twenty-one patients had HCV genotype 1, two patients had genotype 2, seven had genotype 3, three had genotype 4, and two had genotype 5. All individuals were placed on a regimen of sofosbuvir (400 mg) and daclatasvir (60 mg), administered daily for 12-24 weeks.

The primary endpoint – complete response to treatment at the end of the regimen – was achieved in 91% of subjects by the end of 24 weeks. Furthermore, 50% of patients experienced complete immunological response, defined as the complete clearance of cryoglobulin, within 24 weeks. At 12 weeks, average cryoglobulin levels decreased from 0.36 ± 0.12 to 0.10 ± 0.08 g/L, (P = .019), while average aminotransferase levels decreased from 57.6 ± 7.1 to 20.4 ± 2.0 IU/mL, (P less than .01).

But perhaps most significant, according to Dr. Saadoun, is that less than 5% of subjects required any additional treatment via immunosuppressants, such as steroids or rituximab. Average HCV viral loads dropped from 5.6 to 1.18 IU/mL at week 4 (P less than .01), with similarly sustained results through to week 12, indicating good virological responses. No serious adverse events were reported by any subjects throughout the trial period.

“The limitation is that there are quite a few patients, because it is only 35 patients this time, [and] that it’s a prospective, open-label study with no comparators,” Dr. Saadoun explained, adding that, in terms of further research, “[any] new study would focus on the way to avoid rituximab and steroid use in these patients, and to also have more patients treated with this regimen.”

No funding source was disclosed for this study. Dr. Saadoun did not report any relevant financial disclosures.

[email protected]

 

WASHINGTON – A combined regimen of sofosbuvir and daclatasvir is the best option to treat patients with hepatitis C virus infections experiencing cryoglobulinemia vasculitis, according to the findings of a new study presented at the annual meeting of the American College of Rheumatology.

“The HCV cryoglobulinemia vasculitis is a very important vasculitis because it represents 5% of chronically infected HCV patients in the world,” explained David Saadoun, MD, of Sorbonne Universities, Paris. “It’s sometimes a life-threatening vasculitis because patients may develop inflammation [so] there’s a need for very active and well-tolerated treatment.”

Dr. Saadoun and his coinvestigators recruited 35 HCV patients experiencing cryoglobulinemia vasculitis. The median age for the entire cohort was 57 years; 45% of subjects were female. Twenty-one patients had HCV genotype 1, two patients had genotype 2, seven had genotype 3, three had genotype 4, and two had genotype 5. All individuals were placed on a regimen of sofosbuvir (400 mg) and daclatasvir (60 mg), administered daily for 12-24 weeks.

The primary endpoint – complete response to treatment at the end of the regimen – was achieved in 91% of subjects by the end of 24 weeks. Furthermore, 50% of patients experienced complete immunological response, defined as the complete clearance of cryoglobulin, within 24 weeks. At 12 weeks, average cryoglobulin levels decreased from 0.36 ± 0.12 to 0.10 ± 0.08 g/L, (P = .019), while average aminotransferase levels decreased from 57.6 ± 7.1 to 20.4 ± 2.0 IU/mL, (P less than .01).

But perhaps most significant, according to Dr. Saadoun, is that less than 5% of subjects required any additional treatment via immunosuppressants, such as steroids or rituximab. Average HCV viral loads dropped from 5.6 to 1.18 IU/mL at week 4 (P less than .01), with similarly sustained results through to week 12, indicating good virological responses. No serious adverse events were reported by any subjects throughout the trial period.

“The limitation is that there are quite a few patients, because it is only 35 patients this time, [and] that it’s a prospective, open-label study with no comparators,” Dr. Saadoun explained, adding that, in terms of further research, “[any] new study would focus on the way to avoid rituximab and steroid use in these patients, and to also have more patients treated with this regimen.”

No funding source was disclosed for this study. Dr. Saadoun did not report any relevant financial disclosures.

[email protected]

 

WASHINGTON – A combined regimen of sofosbuvir and daclatasvir is the best option to treat patients with hepatitis C virus infections experiencing cryoglobulinemia vasculitis, according to the findings of a new study presented at the annual meeting of the American College of Rheumatology.

“The HCV cryoglobulinemia vasculitis is a very important vasculitis because it represents 5% of chronically infected HCV patients in the world,” explained David Saadoun, MD, of Sorbonne Universities, Paris. “It’s sometimes a life-threatening vasculitis because patients may develop inflammation [so] there’s a need for very active and well-tolerated treatment.”

Dr. Saadoun and his coinvestigators recruited 35 HCV patients experiencing cryoglobulinemia vasculitis. The median age for the entire cohort was 57 years; 45% of subjects were female. Twenty-one patients had HCV genotype 1, two patients had genotype 2, seven had genotype 3, three had genotype 4, and two had genotype 5. All individuals were placed on a regimen of sofosbuvir (400 mg) and daclatasvir (60 mg), administered daily for 12-24 weeks.

The primary endpoint – complete response to treatment at the end of the regimen – was achieved in 91% of subjects by the end of 24 weeks. Furthermore, 50% of patients experienced complete immunological response, defined as the complete clearance of cryoglobulin, within 24 weeks. At 12 weeks, average cryoglobulin levels decreased from 0.36 ± 0.12 to 0.10 ± 0.08 g/L, (P = .019), while average aminotransferase levels decreased from 57.6 ± 7.1 to 20.4 ± 2.0 IU/mL, (P less than .01).

But perhaps most significant, according to Dr. Saadoun, is that less than 5% of subjects required any additional treatment via immunosuppressants, such as steroids or rituximab. Average HCV viral loads dropped from 5.6 to 1.18 IU/mL at week 4 (P less than .01), with similarly sustained results through to week 12, indicating good virological responses. No serious adverse events were reported by any subjects throughout the trial period.

“The limitation is that there are quite a few patients, because it is only 35 patients this time, [and] that it’s a prospective, open-label study with no comparators,” Dr. Saadoun explained, adding that, in terms of further research, “[any] new study would focus on the way to avoid rituximab and steroid use in these patients, and to also have more patients treated with this regimen.”

No funding source was disclosed for this study. Dr. Saadoun did not report any relevant financial disclosures.

[email protected]