Clinical Evaluation of Terap C Vaccine in Combined Treatment with Interferon and Ribavirin in Patients with Hepatitis C
- PMID: 29158855
- PMCID: PMC5681293
- DOI: 10.1016/j.curtheres.2017.04.006
Clinical Evaluation of Terap C Vaccine in Combined Treatment with Interferon and Ribavirin in Patients with Hepatitis C
Abstract
Background: An estimated 170 million individuals worldwide are infected with the hepatitis C virus (HCV). Although treatment options using a combination of pegylated interferon and ribavirin (P-IFN/RBV) are available, sustained clearance of the virus is only achieved in approximately 40% of individuals infected with HCV genotype 1. Recent advances in the treatment of HCV using directly acting antiviral agents have been achieved; however, treatment can be very expensive and is associated with substantial side effects. The development of a new treatment modality is needed. One possible modality could be specific immunotherapy. Terap C is a therapeutic vaccine candidate composed of pIDKE2, a plasmid expressing HCV structural antigens, with a recombinant HCV core protein, Co.120.
Objective: To assess the safety and efficacy of concomitant therapy with the candidate vaccine, Terap C, IFN α-2b and ribavirin in untreated individuals with HCV genotype 1 infection.
Methods: This was a Phase II randomized, placebo-controlled, double-blind clinical trial evaluating the safety and efficacy of Terap C concomitant with IFN α-2b/RBV in 92 treatment-naïve patients with HCV genotype 1 infection. The study was conducted at the Gastroenterology Institute in Havana, Cuba. Patients were randomly assigned to 1 of 5 groups. The control group (Group 1) received IFN α-2b/RBV and placebo for 48 weeks. Groups 2 and 3 were administered Terap C 6 and 9 times, respectively, in addition to standard IFN α-2b/RBV treatment. In groups 4 and 5, Terap C was introduced 12 weeks after the initiation of IFN α-2b/RBV and administered 6 and 9 times, respectively, concomitant with IFN α-2b/RBV.
Results: All patients showed some adverse events. Out of 3615 adverse events, only 18.8% were considered to be probably associated with administration of Terap C. Most events (47.4%) were considered to be improbably associated with of administration Terap C. Only 33.8% were considered possibly temporarily associated with Terap C, and can be explained by the use of conventional IFN α-2b + RBV or by HCV itself. The most common adverse events (≥65%) observed were pain at the injection site, headache, asthenia, psychiatric disturbances, fever, and gastrointestinal symptoms. Regarding sustained virological response, a 20% superiority was observed in the patients who received concomitant Terap C treatments from the beginning of the study compared with those who started after Week 12.
Conclusions: Vaccination with Terap C in patients with chronic HCV infection was safe and well tolerated. Clinical trial protocol code: IG/VHI/HC/0701; Public Register Code: RPCEC00000074.
Keywords: Hepatitis C; Therapeutic vaccine.
Similar articles
-
Interferon beta 1a versus interferon beta 1a plus ribavirin for the treatment of chronic hepatitis C in Chinese patients: a randomized, placebo-controlled trial.Dig Dis Sci. 2008 Aug;53(8):2238-45. doi: 10.1007/s10620-007-0129-2. Epub 2007 Dec 13. Dig Dis Sci. 2008. PMID: 18080763 Clinical Trial.
-
Low Efficacy of Pegylated Interferon plus Ribavirin plus Nitazoxanide for HCV Genotype 4 and HIV Coinfection.PLoS One. 2015 Dec 7;10(12):e0143492. doi: 10.1371/journal.pone.0143492. eCollection 2015. PLoS One. 2015. PMID: 26640956 Free PMC article. Clinical Trial.
-
Retreatment of hepatitis C patients with pegylated interferon combined with ribavirin in non-responders to interferon plus ribavirin. Is it different in real life?BMC Infect Dis. 2010 Jul 20;10:212. doi: 10.1186/1471-2334-10-212. BMC Infect Dis. 2010. PMID: 20646277 Free PMC article.
-
Pegylated interferon alpha-2a and -2b in combination with ribavirin in the treatment of chronic hepatitis C: a systematic review and economic evaluation.Health Technol Assess. 2004 Oct;8(39):iii-iv, 1-125. doi: 10.3310/hta8390. Health Technol Assess. 2004. PMID: 15461877 Review.
-
Phase III results of Boceprevir in treatment naïve patients with chronic hepatitis C genotype 1.Liver Int. 2012 Feb;32 Suppl 1:27-31. doi: 10.1111/j.1478-3231.2011.02725.x. Liver Int. 2012. PMID: 22212568 Review.
References
-
- Lavanchy D. Evolving epidemiology of hepatitis C virus. Clinical Microbiology and Infection. 2011;17(2):107–115. - PubMed
-
- Lavanchy D. The global burden of hepatitis C. Liver International. 2009;29(s1):74–81. - PubMed
-
- Davis G.L., Alter M.J., El-Serag H., Poynard T., Jennings L.W. Aging of hepatitis C virus (HCV)-infected persons in the United States: a multiple cohort model of HCV prevalence and disease progression. Gastroenterology. 2010;138(2):513–521. .e6. - PubMed
LinkOut - more resources
Full Text Sources
Other Literature Sources