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Ledipasvir plus sofosbuvir achieve excellent response in HCV/HIV coinfection
Treatment with ledipasvir and sofosbuvir achieves sustained virologic response at 12 weeks in patients with hepatitis C who also are infected with HIV, according to the results of the open-label ION-4 study presented at the International AIDS Society Conference on HIV Pathogenesis and Treatment.
The multicenter study in 335 patients – published simultaneously online July 21 by the New England Journal of Medicine – showed, overall, that 96% of patients had a sustained virologic response 12 weeks after the end of therapy, while the response rates were higher (100%) among individuals with HCV genotype 4 but lower in black patients.
“This association between black race and a decreased rate of virologic response was not observed in the 308 black patients who were monoinfected with HCV receiving ledipasvir-sofosbuvir across the phase III program,” wrote Dr. Susanna Naggie of the Duke Clinical Research Institute, Durham, N.C., and her coauthors.
Response rates were not influenced by previous treatments or the presence of cirrhosis, and while there were some adverse events such as headache, fatigue, and diarrhea, no patient had confirmed HIV-1 virologic rebound (N. Engl. J. Med. 2015 July 21 [doi:10.1056/NEJMoa1501315]).
The study was supported by Gilead Sciences. Some authors declared grants, support, advisory board positions, and consultancies from pharmaceutical companies, including Gilead Sciences, and several authors are employees of Gilead Sciences.
Treatment with ledipasvir and sofosbuvir achieves sustained virologic response at 12 weeks in patients with hepatitis C who also are infected with HIV, according to the results of the open-label ION-4 study presented at the International AIDS Society Conference on HIV Pathogenesis and Treatment.
The multicenter study in 335 patients – published simultaneously online July 21 by the New England Journal of Medicine – showed, overall, that 96% of patients had a sustained virologic response 12 weeks after the end of therapy, while the response rates were higher (100%) among individuals with HCV genotype 4 but lower in black patients.
“This association between black race and a decreased rate of virologic response was not observed in the 308 black patients who were monoinfected with HCV receiving ledipasvir-sofosbuvir across the phase III program,” wrote Dr. Susanna Naggie of the Duke Clinical Research Institute, Durham, N.C., and her coauthors.
Response rates were not influenced by previous treatments or the presence of cirrhosis, and while there were some adverse events such as headache, fatigue, and diarrhea, no patient had confirmed HIV-1 virologic rebound (N. Engl. J. Med. 2015 July 21 [doi:10.1056/NEJMoa1501315]).
The study was supported by Gilead Sciences. Some authors declared grants, support, advisory board positions, and consultancies from pharmaceutical companies, including Gilead Sciences, and several authors are employees of Gilead Sciences.
Treatment with ledipasvir and sofosbuvir achieves sustained virologic response at 12 weeks in patients with hepatitis C who also are infected with HIV, according to the results of the open-label ION-4 study presented at the International AIDS Society Conference on HIV Pathogenesis and Treatment.
The multicenter study in 335 patients – published simultaneously online July 21 by the New England Journal of Medicine – showed, overall, that 96% of patients had a sustained virologic response 12 weeks after the end of therapy, while the response rates were higher (100%) among individuals with HCV genotype 4 but lower in black patients.
“This association between black race and a decreased rate of virologic response was not observed in the 308 black patients who were monoinfected with HCV receiving ledipasvir-sofosbuvir across the phase III program,” wrote Dr. Susanna Naggie of the Duke Clinical Research Institute, Durham, N.C., and her coauthors.
Response rates were not influenced by previous treatments or the presence of cirrhosis, and while there were some adverse events such as headache, fatigue, and diarrhea, no patient had confirmed HIV-1 virologic rebound (N. Engl. J. Med. 2015 July 21 [doi:10.1056/NEJMoa1501315]).
The study was supported by Gilead Sciences. Some authors declared grants, support, advisory board positions, and consultancies from pharmaceutical companies, including Gilead Sciences, and several authors are employees of Gilead Sciences.
FROM IAS 2015
Key clinical point: Treatment with ledipasvir and sofosbuvir achieves sustained virologic response in patients coinfected with hepatitis C and HIV.
Major finding: Ledipasvir and sofosbuvir are associated with a 96% sustained virologic response at 12 weeks after treatment in patients coinfected with HCV and HIV.
Data source: A prospective open-label study in 335 patients with HCV and HIV.
Disclosures: The study was supported by Gilead Sciences. Some authors declared grants, support, advisory board positions, and consultancies from pharmaceutical companies, including Gilead Sciences, and several authors are employees of Gilead Sciences.