Acute hepatitis C infection
Conditions
Interventions
Trade Name: Incivo
Product Name: Incivo (telaprevir)
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Telaprevir
Concentrati
Sponsors
St Stephen's AIDS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Is male or female aged 18 years or above 2. Has signed the Informed Consent Form voluntarily 3. Documented current acute hepatitis C genotype 1 infection with detectable HCV-RNA (PCR-assay) with an estimated duration less than 24 weeks as defined below: a. HCV RNA positive AND b. Prior negative anti-HCV antibody or HCV RNA test within 6 months OR c. Rise of liver transaminases above 2.5 x ULN within the past 6 months with prior normal transaminases during the year before AND d. Exclusion of other causes of acute hepatitis 4. Confirmed HIV infection 5. Receiving a atazanavir- or efavirenz- or raltegravir-based ART regimen or able to switch regimen to these agents with an undetectable HIV viral load for at least 3 months, or not receiving ART with no immediate plans to start ART during the first 6 months of study 6. CD4 T cell count >200/µl at screening in patients under ART, CD4 T cell count >500/µl at screening in patients without ART 7. If female and of childbearing potential, is using effective birth control methods (as agreed by the investigator) and is willing to continue practising these birth control methods during the trial and for at least 4 months after the last dosage of ribavirin (ie 4 months after week 12, 24 or 48, depending on study arm and treatment response). Routine monthly pregnancy tests must also be performed during this time. Note: Women who are postmenopausal for least 2 years, women with total hysterectomy, and women who have a tubal ligation are considered of non-childbearing potential 8. Heterosexually active male participants or their female partners must use effective birth control methods (as agreed by the investigator) during the trial and for at least 7 months after the last dosage of ribavirin (ie 7 months after week 12, 24 or 48, depending on study arm and treatment response). Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1. HCV infection with non-1 genotype 2. Acute opportunistic infection requiring treatment 3. Malignancy requiring chemotherapy or radiotherapy 4. Active HBV infection (HBs Ag + with positive hepatitis B DNA) 5. Known autoimmune disease 6. Hepatic failure 7. History of ischaemic heart disease or other serious cardiac disease 8. Serious psychiatric disease which in the view of the investigator precludes the use of interferon 9. Haemoglobinopathy or severe anaemia of any cause 10. Serious abnormality on screening blood tests including, but not limited to: Hemoglobin <10g/dl, absolute neutrophil count <1000/mm3, platelets <90000/mm3, creatinine clearance <60ml/min 11. If female, she is pregnant or breastfeeding 12. Known hypersensitivity to one of the trial drugs or its excipients 13. Other contraindicated concomitant treatment 14. Any condition (including drug/alcohol abuse), or laboratory results which in the investigators opinion, interfere with assessments or completion of the trial 15. Any other reason why, in the opinion of the investigator, the patient should not be enrolled in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Comparison of rates of sustained virologic response(SVR24) between treatment arms; defined as HCV RNA not detectable at 24 weeks after planned completion of therapy.;Timepoint(s) of evaluation of this end point: 24 weeks after end of study treatment (which may be 12, 24 or 48 weeks in duration);Main Objective: To find out whether treating acute hepatitis C infection with PEGylated interferon, ribavirin and telaprevir gets rid of the virus as effectively as when acute hepatitis C infection is treated with PEGylated interferon and ribavirin alone;Secondary Objective: To find out whether a treatment of acute hepatitis C infection with PEGylated interferon, ribavirin plus telaprevir over 12 weeks is as good as treatment with PEGylated interferon and ribavirin alone over 24 weeks, when aiming for no levels of hepatitis C virus left in the blood 24 weeks after the end of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 12 weeks after end of study treatment (which may be 12, 24 or 48 weeks in duration); Secondary end point(s): - Comparison of proportion of treated patients achieving sustained virological response after 12 weeks of therapy (SVR12) between treatment arms; defined as HCV RNA not detected at 12 weeks after planned completion of therapy. - Comparison of proportion of treated patients with HCV RNA not detected at the planned end of treatment (EOT) between treatment arms - Comparison of reduction in HCV RNA from baseline to week 4 between treatment arms - Comparison of change in CD4 cell count between baseline and EOT between treatment arms - Comparison of change in HIV RNA from baseline to EOT between treatment arms - Summary comparison of adverse events of grade III / IV intensity between treatment arms | — |
Countries
United Kingdom
Contacts
Public ContactAlice Shields
St Stephen's AIDS Trust
Outcome results
None listed