Meeting News

Generic therapies ‘overtook’ branded DAAs in 2016

AMSTERDAM — A presenter at today’s viral hepatitis session at the International Liver Congress called on the clinical community to push the envelope in using generic direct-acting antiviral therapies.

Despite the presence of curative therapies, James Freeman, MD, of GP2U Telehealth FixHepC in Hobart, Australia, noted that every 45 seconds, another patient dies of hepatitis C. “It remains one of the greatest tragedies of modern time that these drugs are not being deployed on a mass scale,” he said, comparing the cost of Daklinza (daclatasvir, Bristol-Myers Squibb) to that of diamonds.

“We have seen great improvements in pricing,” Freeman said. “The price of generics is approaching the cost of production.”

He described 2016 as a “big year” for generics. “There was a lot of protesting about prices,” he said. “But generic DAA’s overtook branded medications. Bioequivalence has been demonstrated.”

Freeman stressed that high prices prevent patient access. However, some patients have taken it upon themselves to acquire generic drugs at a cheaper cost. “Some countries allow some medication importation,” he said. “We can observe patients importing these drugs. How do we respond? Oppose it, support it, ignore it? I made a decision to support my patients.”

Freeman reviewed some data to determine the efficacy and safety of generic therapies, assessing a group of 448 patients. He discussed some factors associated with failure. Results showed that 44% of his group’s patients that had relapsed were detectable at week 4 (P = .02).

“Patients who are still detectable at 4 weeks are in trouble,” he said. “They have twice the chance of failing therapy.”

Cirrhosis (P = .01) and genotype 3 disease also predicted failure.

Clinicians, then, need to step in and identify those patients in the interim. “If we can identify a group of patients at much higher risk of failure, we can intensify treatment,” he said. “It is more cost efficient to piggyback on top of a planned treatment rather than retreat. Add an NS3/4, or sofosbuvir. Or follow Jordan Feld’s advice of longer, stronger and add ribavirin.”

Freeman presented data for other patient cohorts treated with generic therapies. In one group, end of treatment results showed a 99.3% response rate, with a 94% SVR4 rate. That said, patients with genotype 3 saw an 84% SVR4 rate. “Genotype 3 remains the problem child,” he said, and then referenced his own clinical practice. “We now treat our genotype 3 patients for 16 weeks, and the results are much better.”

Freeman concluded that treatment with generic drugs is effective. “Unless we doctors start being more proactive, you can foresee a time where, on current trends, medications will be priced out of reach for all but the super-rich,” he said. “WHO has set a goal of elimination by 2030. At best, we are just keeping pace with transmission. We have to do better.” – by Rob Volansky

Reference:

Freeman J, et al. Abstract PS-097. Presented at: International Liver Congress; April 19-24, 2017; Amsterdam. 

Disclosure: Freeman reports no relevant financial disclosures.

AMSTERDAM — A presenter at today’s viral hepatitis session at the International Liver Congress called on the clinical community to push the envelope in using generic direct-acting antiviral therapies.

Despite the presence of curative therapies, James Freeman, MD, of GP2U Telehealth FixHepC in Hobart, Australia, noted that every 45 seconds, another patient dies of hepatitis C. “It remains one of the greatest tragedies of modern time that these drugs are not being deployed on a mass scale,” he said, comparing the cost of Daklinza (daclatasvir, Bristol-Myers Squibb) to that of diamonds.

“We have seen great improvements in pricing,” Freeman said. “The price of generics is approaching the cost of production.”

He described 2016 as a “big year” for generics. “There was a lot of protesting about prices,” he said. “But generic DAA’s overtook branded medications. Bioequivalence has been demonstrated.”

Freeman stressed that high prices prevent patient access. However, some patients have taken it upon themselves to acquire generic drugs at a cheaper cost. “Some countries allow some medication importation,” he said. “We can observe patients importing these drugs. How do we respond? Oppose it, support it, ignore it? I made a decision to support my patients.”

Freeman reviewed some data to determine the efficacy and safety of generic therapies, assessing a group of 448 patients. He discussed some factors associated with failure. Results showed that 44% of his group’s patients that had relapsed were detectable at week 4 (P = .02).

“Patients who are still detectable at 4 weeks are in trouble,” he said. “They have twice the chance of failing therapy.”

Cirrhosis (P = .01) and genotype 3 disease also predicted failure.

Clinicians, then, need to step in and identify those patients in the interim. “If we can identify a group of patients at much higher risk of failure, we can intensify treatment,” he said. “It is more cost efficient to piggyback on top of a planned treatment rather than retreat. Add an NS3/4, or sofosbuvir. Or follow Jordan Feld’s advice of longer, stronger and add ribavirin.”

Freeman presented data for other patient cohorts treated with generic therapies. In one group, end of treatment results showed a 99.3% response rate, with a 94% SVR4 rate. That said, patients with genotype 3 saw an 84% SVR4 rate. “Genotype 3 remains the problem child,” he said, and then referenced his own clinical practice. “We now treat our genotype 3 patients for 16 weeks, and the results are much better.”

Freeman concluded that treatment with generic drugs is effective. “Unless we doctors start being more proactive, you can foresee a time where, on current trends, medications will be priced out of reach for all but the super-rich,” he said. “WHO has set a goal of elimination by 2030. At best, we are just keeping pace with transmission. We have to do better.” – by Rob Volansky

Reference:

Freeman J, et al. Abstract PS-097. Presented at: International Liver Congress; April 19-24, 2017; Amsterdam. 

Disclosure: Freeman reports no relevant financial disclosures.

    See more from International Liver Congress