Meeting News Coverage

Study shows generics pose safe, economic option for patients with HCV

BARCELONA — Generic direct-acting antivirals for hepatitis C virus infection presented a similar biochemical makeup and sustained virological response rate in an Australian study, according to a presenter at the International Liver Congress.

“In this interim analysis, legally imported generic DAAs led to high SVR rates,” James Freeman, MD, executive director, GP2U Telehealth, Australia, said during a press conference. “A generic cure for hepatitis C is available now for $1,000 and works as expected. … Not in the future, but right now.”

James Freeman, MD

James Freeman

Freeman explained that this endeavor began with one patient asking for assistance in obtaining a generic DAA as, at the time, only Olysio (simeprevir, Janssen) was available in Australia. He chose to assist the patient and test the generics to ensure safety. That patient went on to achieve SVR with the generic medication.

“The news leaked and one became a dozen,” Freeman said.

With these patients, Freeman decided to study the safety and efficacy of the generic versions of Harvoni (sofosbuvir/ledipasvir, Gilead Sciences) and sofosbuvir/Daklinza (daclatasvir, Bristol-Myers Squibb). He has enrolled 448 patients, 63.9% of whom have genotype 1 HCV and 25% of whom were rejected from company-based clinical trials.

Freeman showed that the chemical makeup of the generic medications were comparable to the brand names and that 99.6% (220/221) of patients achieved sustained virologic response with no new or unknown side effects.

“More patients died last year than received the new treatments and the deployment problem is price. … The staggering prices of these new medications prevent patient access,” he said. “Generics work. Let’s deploy them and wipe hepatitis C off the face of the planet.”

Freeman said he plans to monitor the brand name medications now that Australia approved them. – by Katrina Altersitz

Reference:

Freeman, JAD. LB03. Presented at International Liver Congress. April 13-17, 2016; Barcelona.

Disclosure: Freeman reports no relevant financial disclosures.

BARCELONA — Generic direct-acting antivirals for hepatitis C virus infection presented a similar biochemical makeup and sustained virological response rate in an Australian study, according to a presenter at the International Liver Congress.

“In this interim analysis, legally imported generic DAAs led to high SVR rates,” James Freeman, MD, executive director, GP2U Telehealth, Australia, said during a press conference. “A generic cure for hepatitis C is available now for $1,000 and works as expected. … Not in the future, but right now.”

James Freeman, MD

James Freeman

Freeman explained that this endeavor began with one patient asking for assistance in obtaining a generic DAA as, at the time, only Olysio (simeprevir, Janssen) was available in Australia. He chose to assist the patient and test the generics to ensure safety. That patient went on to achieve SVR with the generic medication.

“The news leaked and one became a dozen,” Freeman said.

With these patients, Freeman decided to study the safety and efficacy of the generic versions of Harvoni (sofosbuvir/ledipasvir, Gilead Sciences) and sofosbuvir/Daklinza (daclatasvir, Bristol-Myers Squibb). He has enrolled 448 patients, 63.9% of whom have genotype 1 HCV and 25% of whom were rejected from company-based clinical trials.

Freeman showed that the chemical makeup of the generic medications were comparable to the brand names and that 99.6% (220/221) of patients achieved sustained virologic response with no new or unknown side effects.

“More patients died last year than received the new treatments and the deployment problem is price. … The staggering prices of these new medications prevent patient access,” he said. “Generics work. Let’s deploy them and wipe hepatitis C off the face of the planet.”

Freeman said he plans to monitor the brand name medications now that Australia approved them. – by Katrina Altersitz

Reference:

Freeman, JAD. LB03. Presented at International Liver Congress. April 13-17, 2016; Barcelona.

Disclosure: Freeman reports no relevant financial disclosures.

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