Table 1.
Clinical studies investigating the impact of Peginterferon in HBV/HDV infection.
| Authors,years | Type of study | Enrollment period | Sample size | Age at enrollment (mean and range) |
Follow up | Interventional group treatment | Control group treatment | HBsAg loss at the EOFU* | AST/ALT Normalization at the EOFU* | HDV-RNA Undetectability at the EOFU* | Adverse drug reaction leading discontinuation of IFN** treatment |
|---|---|---|---|---|---|---|---|---|---|---|---|
| ( Heller et al., 2014 ) | Clinical trial (Phase 2) | 2002-2006 | 13 | 42 (18–58) | 260 weeks | PEG-IFN£ alfa 180 mcg | – | 3(25%) | 3(25%) | 3(25%) | 3 patients required treatment discontinuation, two (15%) of whom were possibly related to peginterferon |
| ( Abbas et al., 2016 ) | Clinical trial | 2012-2014 | 40 | 26.4 ± 6.4 VS 27 ± 7.4 |
96 weeks | 21 pts PEG-IFNα-2a +entecavir | 19 pts PEG-IFNα-2a | – | 4 (19%) in interventional group 7(37%) in control group |
8 (38%) in interventional group 10(52.6%) in control group |
2 (5%) patients (one in each arm) |
| ( Wedemeyer et al., 2019b ) | Clinical trial (HIDIT-2) (Phase 2) | 2009-2011 | 120 | 38 vs 42 (20-64) vs 20-60) |
120 weeks | 59 pts PEG-IFN alfa-2a + tenofovir | 61 pts PEG-IFN alfa-2a + placebo | – | Interventional group: 27(46%) Control group: 16(26%) |
Interventional group: 18(31%) Control group: 14(23%) |
22 (19%) patients (13 in internventional group, 9 in control group) |
| ( Anastasiou et al., 2024 ) | Clinical trial (FU$ at 5 years of HIDIT-2) (Phase 2) | 2009-2011 | 61 | 38 vs 42 (20-64) vs 20-60) |
5 years | 28 pts PEG-IFNα and tenofovir | 33 pts PEG-IFNα + placebo | Interventional group 5 (18%) Control group 5 (15%) |
– | Interventional group 21 (75%) Control group 16(48%) |
|
| ( Etzion et al., 2023 ) | Phase 2, open label, clinical trial | 2016-2017 | 33 | 40 (20, 64) | 72 weeks | 19 pts PEG-IFN Lambda 120 mcg | 14 pts PEG-IFN lambda 180 mcg | – | 180 mcg group: ALT normalization 5 (36%) 120 mcg group: ALT normalization 5 (26%) |
180 mcg group: BLQ& (36%) 120 mcg group: BLQ& 3 (16%) |
13 (39%) cases of dose reduction 6 in Lambda 120 mcg and 7 in Lambda 180 mcg. 2 cases of dose interruption, one in each arm. 8 (24%) of drug discontinuation (4 in each arm) |
| ( Borzacov et al., 2016 ) | Prospective non-randomized study | 2011-2012 | 22 | 45 (18-70) | 72 weeks | PEG-IFN + entecavir | – | – | Reduction of ALT (p=0.0296) | 18 (81.8%) at the end of FU£ | No reported adverse events were considered serious |
*End of follow up; ** Interferon; £Peginterferon; $follow up; & below limit of quantification.