To document that 8 weeks treatment with ledipasvir-sofosbuvir is effective in chronic HCV genotype 4 patients without cirrhosis.
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Sustained viral response 12 weeks after the end of therapy (SVR12) in
on-treatment study population with HCV RNA < 10.000.000 IU/ml at moment of
baseline visit (=start therapy).
Secondary outcome
SVR12 in ITT study population
SVR12 in the population with < 6 million IU/ml HCV RNA
SVR12 in the population with HCV RNA < limit of detection at week 4 of therapy
SVR12 in HIV positive population
Background summary
Recently, the phase III randomized clinical trial called ION-3, confirmed the
data from the phase II LONESTAR trial and showed that for patients without
cirrhosis and infected with HCV genotype 1, a treatment duration of 8 weeks
with the direct acting antivirals (DAAs) ledipasvir and sofosbuvir is
non-inferior to a 12-week regimen. The efficacy of a shortened treatment of 8
weeks for genotype 4 non-cirrhotic patients has never been studied. As the
response rates in patients treated for 12 weeks for a HCV genotype 1 and 4 are
very comparable, irrespective of the DAAs that were used (see table 1 in
protocol), we postulate that the treatment duration in genotype 4 infected
patients can be shortened to 8 weeks as well in non-cirrhotic patients.
Study objective
To document that 8 weeks treatment with ledipasvir-sofosbuvir is effective in
chronic HCV genotype 4 patients without cirrhosis.
Study design
Prospective open label interventional clinical trial in which 50 chronic HCV
genotype 4 patients co-infected with or without HIV will receive 8 weeks of
Ledipasvir-Sofosbuvir in the Netherlands and Belgium (with at least 41
HIV-positive patients).
Intervention
Ledipasvir/sofosbuvir during 8 weeks
Study burden and risks
In general, therapy with these drugs was very well tolerated. In the ION-1,2,3
and 4 trials headache and fatique were most reported. In the ION-1, 2 and 4
trials, none of the patients treated with ledipasvir-sofosbuvir without
ribavirine stopped due to AE*s[1-3]. The currently available treatment for
hepatitis C genotype 4 consists of ledipasvir-sofosbuvir for 12 weeks, thus
treatment for 8 weeks will be a lower burden for patients. There will be no
additional visits of additional blood samples for patients compared to the
current standard of care. The study will be beneficial for those patients that
reach a SVR12 as they will be cured of HCV.
's-Gravendijkwal 230
Rotterdam 3015CE
NL
's-Gravendijkwal 230
Rotterdam 3015CE
NL
Listed location countries
Age
Inclusion criteria
1. >=18 years
2. Chronic HCV genotype 4 infection
3. F0-3 with biopsy or fibroscan result (stiffness <12.5 kPa) <=24 months old for F0-2 and <=12 months old for F3*
4. HVC viral load < 10 million IU/ml, <=6 months old;**In case the HCV infection is <24 months old (=documented negative HCV IgG or negative HCV RNA < 24 months) and there is no HBV infection currently active or a history of alcohol abuse, then a fibroscan is not mandatory.
Exclusion criteria
1. HCV viral load > 10 million IU/ml
2. Fibroscan > 12.5 Kpa or F4 on liver biopsy or signs of portal hypertension or liver cirrhosis on imaging*
3. Disallowed co-medication that cannot be stopped or replaced
4. eGFR < 30 ml/min
5. Previous therapy with any DAA for current HCV genotype 4 infection;**In case the HCV infection is <24 months old (=documented negative HCV IgG or negative HCV RNA < 24 months) and there is no HBV infection currently active or a history of alcohol abuse, then a fibroscan is not mandatory.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2016-000318-31-NL |
| CCMO | NL56571.078.16 |
| OMON | NL-OMON21818 |