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."
More information: 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: www.who.int/mediacentre/factsheets/fs164/en/. Last accessed: March 2016.
3 World Health Organization. Hepatitis data and statistics. Available from: www.euro.who.int/en/health-top … /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.
Provided by European Association for the Study of the Liver