Data presented last week demonstrates that generic direct-acting antivirals (DAAs) are as effective and safe as branded treatments to cure hepatitis C.
The summary results presented at The International Liver Congress™ 2016 in Barcelona, Spain, showed high sustained virologic response (SVR) after treatment with generic sofosbuvir, ledipasvir, daclatasvir and ribavirin, confirming clinical efficacy equivalent to outcomes seen in Phase 3 clinical trials of branded combination treatments.
The high costs of branded DAAs prevent access to treatment in many countries. Generic DAAs are being mass-produced and are available for less than 1% of the retail price of their branded counterparts. Medication costing $94,000 per person in the US can currently be obtained for less than $1,000 as a generic, and a 12 week course of treatment could be produced for as little as $200 in the future.
"Our interim data suggests a potential solution for hepatitis C patients in areas where treatment access has been restricted as a result of the high prices demanded for branded treatment," said Dr. James Freeman, of GP2U Telehealth, Hobart, Australia and lead author of the study. "At the price level of generic direct-acting antivirals, treating the entire global Hepatitis C epidemic could be financially feasible. Furthermore, if a patient is cured of hepatitis C, there is evidence for improved survival, and lower risks of liver cancer and liver cirrhosis and cured patients could return to work, delivering further economic benefits to society."
In this study, people with HCV legally imported low-cost generic treatment to cure their infection. The study included people treated in Australia, U.S., UK, Canada, Europe, SE Asia and Africa.
Generic DAAs were first evaluated for quality in Australia, using high precision liquid chromatography, nuclear magnetic resonance and mass spectroscopy. Patients were assessed pre-treatment, during treatment, and then at weeks 4 (SVR4) and 12 (SVR12) following the end of treatment. The objective of the analysis was to assess the efficacy and safety of generic DAAs legally imported for each patient's personal use.
The interim results show that for genotype 1 the overall SVR rate was 95 percent. Treatment with generic sofosbuvir and ledipsavir led to SVR4 rates of 93 percent and treatment with generic sofosbuvir and daclatasvir led to SVR4 rates of 97 percent.
"Across all genotypes, the SVR rate was 94 percent after treatment with generic DAAs. This indicates that generic DAAs can deliver the same success rates as branded equivalents, but at a price which is 1/100th of the current cost," explained Freeman.
"There is a clear role for generic treatments such as these for people with hepatitis C across the world. The implications of increased availability of these drugs could be enormous, presenting more people with the possibility of a 'cure' for what is often a debilitating condition," said professor Laurent Castera, EASL secretary general.
Source: European Association for the Study of the Liver
Dear Helpdesk: Working in a Toxic Health Care Environment
March 28th 2024Dear Helpdesk is your steadfast companion, offering life coaching and workplace advice from 2 seasoned IPs for some of your most challenging real-life situations. Let us help you navigate the intersection between work and life, guiding you to navigate the dynamic world of infection prevention with confidence and grace. This article is on handling a toxic health care environment.
Product Locator: Spring and Early Mother's Day Gift Guide for Infection Prevention Personnel
March 27th 2024Whether it's a spring holiday, birthdays, or no reason at all, infection prevention personnel love to give and receive gifts that help at the end of a stressful day. Infection Control Today® offers some gift ideas for infection prevention personnel and their families.
Catching Up With Vangie Dennis, AORN 2022-2023 President at AORN 2024
March 26th 2024Infection Control Today (ICT) had the privilege of catching up with Vangie Dennis, MSN, RN, CNOR, CMLSO, at the Association of periOperative Registered Nurses' (AORN’s) International Surgical Conference & Expo 2024. As the former president of AORN and an esteemed figure in perioperative services, Vangie Dennis shared insights into her recent endeavors and the exciting new chapter she's embarked upon.
How To Optimize Your Time Management Strategies for the Busy Infection Preventionist
March 25th 2024Is your calendar resembling a chaotic masterpiece of overlapping tasks? Join the club of infection preventionists striving to balance responsibilities. Dive into proven strategies from a fellow infection preventionist to reclaim control of your time, streamline tasks, and boost productivity effectively. This is an IP Lifeline article.
Dear Helpdesk: Working in a Toxic Health Care Environment
March 28th 2024Dear Helpdesk is your steadfast companion, offering life coaching and workplace advice from 2 seasoned IPs for some of your most challenging real-life situations. Let us help you navigate the intersection between work and life, guiding you to navigate the dynamic world of infection prevention with confidence and grace. This article is on handling a toxic health care environment.
Product Locator: Spring and Early Mother's Day Gift Guide for Infection Prevention Personnel
March 27th 2024Whether it's a spring holiday, birthdays, or no reason at all, infection prevention personnel love to give and receive gifts that help at the end of a stressful day. Infection Control Today® offers some gift ideas for infection prevention personnel and their families.
Catching Up With Vangie Dennis, AORN 2022-2023 President at AORN 2024
March 26th 2024Infection Control Today (ICT) had the privilege of catching up with Vangie Dennis, MSN, RN, CNOR, CMLSO, at the Association of periOperative Registered Nurses' (AORN’s) International Surgical Conference & Expo 2024. As the former president of AORN and an esteemed figure in perioperative services, Vangie Dennis shared insights into her recent endeavors and the exciting new chapter she's embarked upon.
How To Optimize Your Time Management Strategies for the Busy Infection Preventionist
March 25th 2024Is your calendar resembling a chaotic masterpiece of overlapping tasks? Join the club of infection preventionists striving to balance responsibilities. Dive into proven strategies from a fellow infection preventionist to reclaim control of your time, streamline tasks, and boost productivity effectively. This is an IP Lifeline article.
2 Commerce Drive
Cranbury, NJ 08512