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The objective of the study was to assess the safety and efficacy of peginterferon alfa-2b (PEG-IFN alfa-2b) and ribavirin (RBV) administered to participants coinfected with Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV). Participants were treated by general practitioners in clinical practice as part of the post-marketing surveillance study. The study assessed the rates of eradication of the HCV and the rates of serious adverse events reported with PEG-IFN alfa-2b (1.5 ug/kg/week) and RBV (800-1200 mg/day) in common medical practice in Germany.
In this observational, non-interventional study, the time of enrollment and start of treatment was the sole decision of the physician. No investigational medicinal product was provided by the sponsor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEG-IFN alfa-2b + RBV | Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEG-IFN alfa-2b | Biological | Peginterferon alfa-2b administered subcutaneously at a dose 1.5 ug/kg/week, according to the European Medicines Agency (EMEA)-approved labeling |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Sustained Virologic Response (SVR) | SVR was defined as undetectable serum Hepatitis C Virus ribonucleic acid (HCV-RNA) at End of Treatment (EOT) and at the End of Follow-up (EOF). | From End of Treatment to 24 weeks post-treatment (up to 72 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Rapid Virologic Response (RVR) | RVR was defined as undetectable serum HCV-RNA at week 4. | At Treatment Week 4 |
| Number of Participants With Early Virologic Response (EVR) |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects coinfected with HIV and HCV seen in common medical practice by general practitioners and clinical doctors at 30 sites all over Germany.
Of 232 participants enrolled, only 229 patients were included in the Safety Analysis Set and had documented baseline data. Three participants were excluded due to violation of inclusion criteria, violation of exclusion criteria and no application of peginterferon alfa-2b (PEG-IFN alfa-2b).
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| ID | Title | Description |
|---|---|---|
| FG000 | PEG-IFN Alfa-2b + RBV | Participants received a combination of PEG-IFN alfa-2b plus ribavirin (RBV) according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PEG-IFN Alfa-2b + RBV | Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Sustained Virologic Response (SVR) | SVR was defined as undetectable serum Hepatitis C Virus ribonucleic acid (HCV-RNA) at End of Treatment (EOT) and at the End of Follow-up (EOF). | Analysis was performed on all participants in the Efficacy Analysis Set (all participants with HCV-RNA detectable for ≥6 months before the first application of PEG-IFN alfa-2b, Human Immunodeficiency Virus [HIV] co-infection, and who had received any amount of PEG-IFN alfa-2b) with documented visits at EOT or at follow-up 24 weeks after EOT. | Posted | Number | participants | From End of Treatment to 24 weeks post-treatment (up to 72 weeks) |
|
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Of 232 participants enrolled, only 229 patients were included in the Safety Analysis Set and had documented baseline data. Three participants were excluded due to 1) violation of inclusion criteria, 2) violation of exclusion criteria and 3) no application of PEG-IFN alfa-2b.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PEG-IFN Alfa-2b + RBV | Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA 14.1 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D006526 | Hepatitis C |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| C417083 | peginterferon alfa-2b |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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|
| RBV | Drug | Ribavirin administered at a dose of 800-1200 mg/day (on a weight-basis) according to the EMEA-approved labeling |
|
|
EVR was defined as undetectable serum HCV-RNA at week 12 and/or a
≥2 log decline in HCV-RNA levels at week 12 from baseline.
| From Treatment Week 1 to Treatment Week 12 |
| Participant Study Status at End of Follow-up (EOF) | Participant study status was assessed at the End of Follow-up (defined as 24 weeks after the end of treatment) based on serum levels of HCV-RNA. SVR was defined as defined as undetectable serum HCV-RNA at EOT and EOF, Relapse was defined as undetectable HCV-RNA at EOT with detectable HCV-RNA at EOF, and Non-response was defined as a detectable serum HCV-RNA at EOT. | From EOT to EOF (up to 72 weeks) |
| Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment | HCV-RNA negativity/positivity was documented at baseline in the medical history (anamnesis), and assessed within the laboratory (lab) at baseline and during treatment by Polymerase Chain Reaction (PCR). HCV-RNA (+) = HCV-RNA positive, HCV-RNA (-) = HCV-RNA negative, HCV-RNA Missing = HCV-RNA data not documented, not applicable, not known, not examined, or missing. | From the Baseline Visit up to EOF (up to 72 weeks) |
| Number of Participants With Human Immunodeficiency Virus (HIV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment | HIV-RNA negativity/positivity was documented at baseline in the medical history (anamnesis), and assessed within the laboratory (lab) at baseline and during treatment. HIV-RNA (+) = HIV-RNA positive, HIV-RNA (-) = HIV-RNA negative, HIV-RNA Missing = HIV-RNA data not documented, not applicable, not known, not examined, or missing | From the Baseline Visit up to EOF (up to 72 weeks) |
| Median Cluster of Differentiation 4 (CD4) Cell Count During PEG-IFN Alfa-2b/RBV Treatment | The CD4 helper T cell count was used to assess participant HIV status and was determined in the laboratory at baseline and during the study course. | From the Baseline Visit up to EOF (up to 72 weeks) |
| Number of Participants With A Serious Adverse Event (SAE) During PEG-IFN Alfa-2b/RBV Treatment | An SAE was any adverse drug/biologic/device experience occurring at any dose that resulted in death, was life-threatening (i.e. placed the participant, in the view of the initial reporter, at immediate risk of death from the AE as it occurred), was a persistent or significant disability/incapacity, required in-patient hospitalization, or prolonged hospitalization, or led to a congenital anomaly or birth defect. | From First Participant Visit (12/30/2005) up to 30 days after Last Participant Visit (12/31/2011). |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Number of Participants With Rapid Virologic Response (RVR) | RVR was defined as undetectable serum HCV-RNA at week 4. | Analysis was performed on all participants in the Efficacy Analysis Set (all participants with HCV-RNA detectable for at least 6 months before the first application of PEG-IFN alfa-2b, HIV co-infection, and who had received any amount of PEG-IFN alfa-2b) with a documented visit at Treatment Week 4 | Posted | Number | participants | At Treatment Week 4 |
|
|
|
| Secondary | Number of Participants With Early Virologic Response (EVR) | EVR was defined as undetectable serum HCV-RNA at week 12 and/or a ≥2 log decline in HCV-RNA levels at week 12 from baseline. | Analysis was performed on all participants in the Efficacy Analysis Set (all participants with HCV-RNA detectable for at least 6 months before the first application of PEG-IFN alfa-2b, HIV co-infection, and who had received any amount of PEG-IFN alfa-2b) with a documented visit at Treatment Week 12. | Posted | Number | participants | From Treatment Week 1 to Treatment Week 12 |
|
|
|
| Secondary | Participant Study Status at End of Follow-up (EOF) | Participant study status was assessed at the End of Follow-up (defined as 24 weeks after the end of treatment) based on serum levels of HCV-RNA. SVR was defined as defined as undetectable serum HCV-RNA at EOT and EOF, Relapse was defined as undetectable HCV-RNA at EOT with detectable HCV-RNA at EOF, and Non-response was defined as a detectable serum HCV-RNA at EOT. | Analysis was performed on all participants in the Efficacy Analysis Set (all participants with HCV-RNA detectable for at least 6 months before the first application of PEG-IFN alfa-2b, with HIV co-infection, and who had received any amount of PEG-IFN alfa-2b) with documented visits at EOT or at follow-up 24 weeks after EOT. | Posted | Number | participants | From EOT to EOF (up to 72 weeks) |
|
|
|
| Secondary | Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment | HCV-RNA negativity/positivity was documented at baseline in the medical history (anamnesis), and assessed within the laboratory (lab) at baseline and during treatment by Polymerase Chain Reaction (PCR). HCV-RNA (+) = HCV-RNA positive, HCV-RNA (-) = HCV-RNA negative, HCV-RNA Missing = HCV-RNA data not documented, not applicable, not known, not examined, or missing. | Efficacy Analysis Set: all participants with HCV-RNA detectable for at least 6 months before the first application of PEG-IFN alfa-2b, HIV co-infection, and who had received any amount of PEG-IFN alfa-2b. | Posted | Number | participants | From the Baseline Visit up to EOF (up to 72 weeks) |
|
|
|
| Secondary | Number of Participants With Human Immunodeficiency Virus (HIV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment | HIV-RNA negativity/positivity was documented at baseline in the medical history (anamnesis), and assessed within the laboratory (lab) at baseline and during treatment. HIV-RNA (+) = HIV-RNA positive, HIV-RNA (-) = HIV-RNA negative, HIV-RNA Missing = HIV-RNA data not documented, not applicable, not known, not examined, or missing | Efficacy Analysis Set: all participants with HCV-RNA detectable for at least 6 months before the first application of PEG-IFN alfa-2b, HIV co-infection, and who had received any amount of PEG-IFN alfa-2b. | Posted | Number | participants | From the Baseline Visit up to EOF (up to 72 weeks) |
|
|
|
| Secondary | Median Cluster of Differentiation 4 (CD4) Cell Count During PEG-IFN Alfa-2b/RBV Treatment | The CD4 helper T cell count was used to assess participant HIV status and was determined in the laboratory at baseline and during the study course. | Analysis was performed on all participants in the Efficacy Analysis Set (all participants with HCV-RNA detectable for at least 6 months before the first application of PEG-IFN alfa-2b, HIV co-infection, and who had received any amount of PEG-IFN alfa-2b) with data available. | Posted | Median | Full Range | cells/μL | From the Baseline Visit up to EOF (up to 72 weeks) |
|
|
|
| Secondary | Number of Participants With A Serious Adverse Event (SAE) During PEG-IFN Alfa-2b/RBV Treatment | An SAE was any adverse drug/biologic/device experience occurring at any dose that resulted in death, was life-threatening (i.e. placed the participant, in the view of the initial reporter, at immediate risk of death from the AE as it occurred), was a persistent or significant disability/incapacity, required in-patient hospitalization, or prolonged hospitalization, or led to a congenital anomaly or birth defect. | Safety Analysis Set: All participants who received any amount of PEG-IFN alfa-2b. If the application of any PEG-IFN alfa-2b was not certain, the participant was considered part of this set. Participants who were not treated with PEG-IFN alfa-2b were also included in this set providing they did not violate any inclusion or exclusion criterion. | Posted | Number | participants | From First Participant Visit (12/30/2005) up to 30 days after Last Participant Visit (12/31/2011). |
|
|
|
| 16 |
| 229 |
| 39 |
| 229 |
| Myocardial Infarction | Cardiac disorders | MedDRA 14.1 |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 |
|
| Nausea | Gastrointestinal disorders | MedDRA 14.1 |
|
| Vomiting | Gastrointestinal disorders | MedDRA 14.1 |
|
| Fatigue | General disorders | MedDRA 14.1 |
|
| Pyrexia | General disorders | MedDRA 14.1 |
|
| Toxicity to Various Agents | Injury, poisoning and procedural complications | MedDRA 14.1 |
|
| Haemoglobin Decreased | Investigations | MedDRA 14.1 |
|
| Weight Decreased | Investigations | MedDRA 14.1 |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.1 |
|
| Disturbance in Attention | Nervous system disorders | MedDRA 14.1 |
|
| Dizziness | Nervous system disorders | MedDRA 14.1 |
|
| Paraesthesia | Nervous system disorders | MedDRA 14.1 |
|
| Depression | Psychiatric disorders | MedDRA 14.1 |
|
| Psychotic Disorder | Psychiatric disorders | MedDRA 14.1 |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 |
|
| Hospitalisation | Surgical and medical procedures | MedDRA 14.1 |
|
| Headache | Nervous system disorders | MedDRA 14.1 |
|
| Headache | Nervous system disorders | MedDRA 14.1 |
|
| Depression | Psychiatric disorders | MedDRA 14.1 |
|
| Sleep Disorder | Psychiatric disorders | MedDRA 14.1 |
|
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| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| Title | Measurements |
|---|---|
|
| Non-response |
|
| Lost to Follow-up/Premature Discontinuation |
|
| Title | Measurements |
|---|---|
|
| Baseline (lab) HCV-RNA (+) [n=197] |
|
| Baseline (lab) HCV-RNA (-) [n=197] |
|
| Baseline (lab) HCV-RNA Missing [n=197] |
|
| Week 2 HCV-RNA (+) [n=200] |
|
| Week 2 HCV-RNA (-) [n=200] |
|
| Week 2 HCV-RNA Missing [n=200] |
|
| Week 4 HCV-RNA (+) [n=194] |
|
| Week 4 HCV-RNA (-) [n=194] |
|
| Week 4 HCV-RNA Missing [n=194] |
|
| Week 6 HCV-RNA (+) [n=168] |
|
| Week 6 HCV-RNA (-) [n=168] |
|
| Week 6 HCV-RNA Missing [n=168] |
|
| Week 8 HCV-RNA (+) [n=185] |
|
| Week 8 HCV-RNA (-) [n=185] |
|
| Week 8 HCV-RNA Missing [n=185] |
|
| Week 12 HCV-RNA (+) [n=180] |
|
| Week 12 HCV-RNA (-) [n=180] |
|
| Week 12 HCV-RNA Missing [n=180] |
|
| Week 18 HCV-RNA (+) [n=153] |
|
| Week 18 HCV-RNA (-) [n=153] |
|
| Week 18 HCV-RNA Missing [n=153] |
|
| Week 24 HCV-RNA (+) [n=142] |
|
| Week 24 HCV-RNA (-) [n=142] |
|
| Week 24 HCV-RNA Missing [n=142] |
|
| Week 30 HCV-RNA (+) [n=93] |
|
| Week 30 HCV-RNA- [n=93] |
|
| Week 30 HCV-RNA Missing [n=93] |
|
| Week 36 HCV-RNA (+) [n=85] |
|
| Week 36 HCV-RNA (-) [n=85] |
|
| Week 36 HCV-RNA Missing [n=85] |
|
| Week 42 HCV-RNA (+) [n=78] |
|
| Week 42 HCV-RNA (-) [n=78] |
|
| Week 42 HCV-RNA Missing [n=78] |
|
| Week 48 HCV-RNA (+) [n=73] |
|
| Week 48 HCV-RNA (-) [n=73] |
|
| Week 48 HCV-RNA Missing [n=73] |
|
| EOF HCV-RNA (+) [n=158] |
|
| EOF HCV-RNA (-) [n=158] |
|
| EOF HCV-RNA Missing [n=158] |
|
| Title | Measurements |
|---|---|
|
| Baseline (lab) HIV-RNA (+) [n=197] |
|
| Baseline (lab) HIV-RNA (-) [n=197] |
|
| Baseline (lab) HIV-RNA Missing [n=197] |
|
| Week 4 HIV-RNA (+) [n=194] |
|
| Week 4 HIV-RNA (-) [n=194] |
|
| Week 4 HIV-RNA Missing [n=194] |
|
| Week 12 HIV-RNA (+) [n=180] |
|
| Week 12 HIV-RNA (-) [n=180] |
|
| Week 12 HIV-RNA Missing [n=180] |
|
| Week 24 HIV-RNA (+) [n=142] |
|
| Week 24 HIV-RNA (-) [n=142] |
|
| Week 24 HIV-RNA Missing [n=142] |
|
| Week 48 HCV-RNA+ [n=73] |
|
| Week 48 HIV-RNA (-) [n=73] |
|
| Week 48 HIV-RNA Missing [n=73] |
|
| EOF HIV-RNA (+) [n=158] |
|
| EOF HIV-RNA (-) [n=158] |
|
| EOF HIV-RNA Missing [n=158] |
|
| Title | Measurements |
|---|---|
|
| Week 24 [n=86] |
|
| Week 48 [n=58] |
|
| EOF [n=138] |
|