In the Journals

Sovaldi-based regimens lead to high SVR rates in Egypt

Patients with hepatitis C virus infection in Egypt achieved rates of sustained virologic response at week 12 with Sovaldi-based regimens that were comparable to those demonstrated in phase 3 clinical trials, according to real-world study data.

HCV is one of the most significant health problems in Egypt, and accordingly, the country’s Ministry of Health National Treatment Programme “ensured that [Sovaldi; sofosbuvir, Gilead Sciences] became available in 2014 at prices appropriate for the scale of the epidemic of HCV and for the economic situation in Egypt,” investigators wrote. “Our aim was to assess the clinical effectiveness of the [sofosbuvir]-based treatment regimens,” — both dual and triple therapies — “and to demonstrate the predictors of response in our chronic HCV genotype 3 Egyptian patients.”

Investigators evaluated post-treatment data on 8,742 patients who were eligible for interferon and treated with triple therapy (sofosbuvir/peg-interferon-alfa-2a/ribavirin) for 3 months, and 5,667 patients who were ineligible for interferon who were treated with dual therapy (sofosbuvir/ribavirin) for 6 months. Patients were followed up to 12 weeks after treatment.

Overall, 94% of the triple therapy group and 78.7% of the dual therapy group achieved SVR12.

Multivariate logistic regression analysis using treatment failure as the dependent variable showed male sex, difficult-to-treat status and prior exposure to interferon significantly predicted nonresponse in both groups.

The researchers acknowledged the study is limited by the low rate of follow-up, with only 72.2% of 28,142 total patients being followed to treatment completion and only 51.2% being followed to 12 weeks after the end of treatment.

“It is not possible to estimate the treatment success rate in patients who were not followed up but it is reasonable to assume that it may not be as high as the rates seen in patients who were fully adherent to the monitoring regimen,” they wrote.

The investigators concluded that sofosbuvir-based therapies resulted in higher SVR rates compared with the previous standard of care, but noted “there is still a need for further novel [direct-acting antiviral]-based therapy to have better response rates especially in patients with advanced fibrosis.” – by Adam Leitenberger

Disclosures: The researchers report no relevant financial disclosures.

Patients with hepatitis C virus infection in Egypt achieved rates of sustained virologic response at week 12 with Sovaldi-based regimens that were comparable to those demonstrated in phase 3 clinical trials, according to real-world study data.

HCV is one of the most significant health problems in Egypt, and accordingly, the country’s Ministry of Health National Treatment Programme “ensured that [Sovaldi; sofosbuvir, Gilead Sciences] became available in 2014 at prices appropriate for the scale of the epidemic of HCV and for the economic situation in Egypt,” investigators wrote. “Our aim was to assess the clinical effectiveness of the [sofosbuvir]-based treatment regimens,” — both dual and triple therapies — “and to demonstrate the predictors of response in our chronic HCV genotype 3 Egyptian patients.”

Investigators evaluated post-treatment data on 8,742 patients who were eligible for interferon and treated with triple therapy (sofosbuvir/peg-interferon-alfa-2a/ribavirin) for 3 months, and 5,667 patients who were ineligible for interferon who were treated with dual therapy (sofosbuvir/ribavirin) for 6 months. Patients were followed up to 12 weeks after treatment.

Overall, 94% of the triple therapy group and 78.7% of the dual therapy group achieved SVR12.

Multivariate logistic regression analysis using treatment failure as the dependent variable showed male sex, difficult-to-treat status and prior exposure to interferon significantly predicted nonresponse in both groups.

The researchers acknowledged the study is limited by the low rate of follow-up, with only 72.2% of 28,142 total patients being followed to treatment completion and only 51.2% being followed to 12 weeks after the end of treatment.

“It is not possible to estimate the treatment success rate in patients who were not followed up but it is reasonable to assume that it may not be as high as the rates seen in patients who were fully adherent to the monitoring regimen,” they wrote.

The investigators concluded that sofosbuvir-based therapies resulted in higher SVR rates compared with the previous standard of care, but noted “there is still a need for further novel [direct-acting antiviral]-based therapy to have better response rates especially in patients with advanced fibrosis.” – by Adam Leitenberger

Disclosures: The researchers report no relevant financial disclosures.