April 13, 2016, Barcelona, Spain: Two separate studies presented today at The International Liver Congress™ 2016 in Barcelona, Spain have offered alternative conclusions regarding the efficacy of direct-acting antivirals (DAAs) among patients co-infected with HIV and Hepatitis C virus (HCV).
GEHEP-SEIMC and HEPAVIR study group data: In this prospective, multi-cohort study from Spain, researchers have shown that HIV negatively impacts rates of response to DAA medications in people co-infected with HCV. Patients with HIV and HCV co-infection had an 11% lower rate of achieving SVR12 (or the eradication of HCV from the body at 12 weeks) with interferon-based DAAs compared to patients with only HCV. Those co-infected patients taking interferon-free DAAs had a 6% lower rate of achieving SVR12 compared to patients with only HCV.
"Our study demonstrates the impact of HIV co-infection on the effectiveness of DAA-based treatment," said Dr Karin Neukam from the Unit of Infectious Diseases and Microbiology, University Hospital of Valme, Seville, Spain and lead author of the study. "We must keep a close eye on co-infected patients to ensure that they receive the treatment they need."
The study was conducted in 1,276 patients from 33 hospitals throughout Spain. The primary efficacy outcome was the achievement of SVR at 12 weeks and the primary safety outcome was the discontinuation of therapy due to adverse events.
US Veterans Health Administration study data: By contrast, data from a US real-world retrospective study of 408 patients predominantly of genotype 1 (GT1=79%) HCV infection found SVR rates in excess of 88% at 12 weeks post treatment with combinations of simeprevir and sofosbuvir, ledipasvir and sofosbuvir, or ombitsavir, paritaprevir, ritonavir and dasabuvir. In this study, a logistic regression analysis controlling for patient demographics, disease severity and other co-morbidities led the study authors to conclude that a statistically significant impact of HIV co-infection on achieving SVR12 could not be found.
"Our analysis showed that across the three treatments in our study, there was no statistically significant impact of HIV co-infection on the effectiveness of the DAAs," said Justin McGinnis from the University of Southern California, California, USA. "We know that these patients are at increased risk of liver disease progression from their HCV status, and these data suggest the co-infected patient group could benefit from treatment."
"These differing data confirm that the study of HCV treatment in HIV co-infected patients remains an interesting and valuable subject for study," said Professor Laurent Castera, EASL Secretary General. "More research is needed to come to a viable resolution so we can provide the best care for these co-infected patients."
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About HCV and HIV coinfection
Between 130 and 150 million people globally have chronic Hepatitis C infection,2 with 15 million people in the World Health Organization's EU Region.3 A recent study demonstrated that worldwide, there are approximately 2.3 million people with HIV and HCV co-infection and 60% of these people with co-infection also are injecting drug users.1 Treatment with DAAs has become the gold standard of care for patients with HCV, with cure rates of nearly 100% demonstrated in clinical trials.4,5,6,7 Treatment of HIV and HCV co-infected patients requires healthcare professionals to be acutely aware of the complex drug interactions that can occur between DAAs and antiretroviral medications.
About The International Liver Congress™
This annual congress is the biggest event in the EASL calendar, attracting scientific and medical experts from around the world to learn about the latest in liver research. Attending specialists present, share, debate and conclude on the latest science and research in hepatology, working to enhance the treatment and management of liver disease in clinical practice. This year, the congress is expected to attract approximately 10,000 delegates from all corners of the globe. The International Liver Congress™ takes place from April 13 - 17, 2016, at the Fira Barcelona Gran Via, Barcelona, Spain.
About EASL
Since EASL's foundation in 1966, this not-for-profit organisation has grown to over 4,000 members from all over the world, including many of the leading hepatologists in Europe and beyond. EASL is the leading liver association in Europe, having evolved into a major European Association with international influence, with an impressive track record in promoting research in liver disease, supporting wider education and promoting changes in European liver policy.
Contact
For more information, please contact the ILC Press Office at:
- Email: ILCpressoffice@ruderfinn.co.uk
- Telephone: +44 (0)7841 009 252
Onsite location reference
Late breaker poster session, Hall 8.1
Thursday 14 April, 08:00 - Saturday 16 April, 18:00
Presenter: Karin Neukam, Spain
Abstract: LBP513, HIV coinfection impairs response to DAA-based HCV therapy
Late breaker poster session, Hall 8.1
Thursday 14 April, 08:00 - Saturday 16 April, 18:00
Presenter: Justin McGinnis, United States
Abstract: LBP514, Analysis of the impact of HIV co-infection on Hepatitis C treatment effectiveness for patients using new direct-acting antivirals
Author disclosures of interest
Karin Neukam: Lecture fees from Janssen-Cilag, Roche, Bristol-Meyers Squibb and Merck Sharp & Dohme; research support from Janssen-Cilag, Bristol-Meyers Squibb, Merck Sharp & Dohme, Gilead Sciences and Abbott Pharmaceuticals
Justin McGinnis: Funding for this research was provided to the University of Southern California by Abbvie Inc, (North Chicago, Illinois).
References
1 Platt L, et al. Prevalence and burden of HCV co-infection in people living with HIV: a global systematic review and meta-analysis. Lancet Infect Dis. 2016 Feb 24.
2 World Health Organization. Hepatitis C. Available from: http://www.who.int/mediacentre/factsheets/fs164/en/. Last accessed: March 2016.
3 World Health Organization. Hepatitis data and statistics. Available from: http://www.euro.who.int/en/health-topics/communicable-diseases/hepatitis/data-and-statistics. Last accessed: March 2016.
4 Afdhal N, et al. ION-1 Investigators. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med. 2014 May 15;370(20):1889-98.
5 Afdhal N, et al. ION-2 Investigators. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. N Engl J Med. 2014 Apr 17;370(16):1483-93.
6 Kowdley KV, et al. ION-3 Investigators. Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. N Engl J Med. 2014 May 15;370(20):1879-88.
7 Sulkowski MS, et al. AI444040 Study Group. Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection. N Engl J Med. 2014 Jan 16;370(3):211-21.