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Hepatitis CPhase 2TACNCT02405013

Feasibility, Tolerance and Efficacy of Interferon-free, Antiviral Treatment With Sofosbuvir + Ribavirin for the Treatment of Genotype 2 and Sofosbuvir/Ledipasvir for the Treatment of Genotype 1 and 4 Hepatitis C Virus-infected Patients in West and Central Africa

A Phase 2 study testing Sofosbuvir, Ribavirin and Ledipasvir in people with Hepatitis C and HIV Infection, run by ANRS, Emerging Infectious Diseases at 4 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Primary Objective: To evaluate the efficacy (sustained virological response 12 weeks after end-of-treatment [SVR12]) of 12-week course of an interferon-free regimen combining sofosbuvir and weight-dosed ribavirin (genotype 2), or sofosbuvir and ledipasvir (genotype 1 or 4) in treatment-naïve patients infected with HCV… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C, HIV Infection
What is being tested?
Sofosbuvir, Ribavirin and Ledipasvir
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
4 sitesin 3 countries
Study dates
Oct 2015to Nov 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age≥18 years
  • Confirmed G1, G2 or G4 HCV infection
  • Plasma HCV-RNA ≥1000 IU/mL
  • No history of HCV treatment of any kind
  • Willingness to use a birth control method (hormonal or intrauterine device for women, condoms for men), starting before HCV treatment initiation and continued until 4months (women) and 7 months (men) after end of treatment.
  • Weight ≥40 kg and ≤125 kg
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  • For patients infected with HIV :
  • Confirmed HIV-1 infection
  • Stable HIV treatment for at least 8 weeks with two NRTIs (tenofovir or abacavir, and lamivudine or emtricitabine) and a third agent (raltegravir, lopinavir/ritonavir, atazanavir/ritonavir, darunavir/ritonavir, efavirenz, nevirapine)
  • Current CD4+ lymphocytes count ≥100/mm3
  • Current plasma HIV-1 RNA <200 copies/mL

Who cannot join

  • For each patient:
  • Cirrhosis classified Child-Pugh B or C
  • Co-infection by the Hepatitis B virus
  • Pregnant or breastfeeding ongoing
  • History of transplantation of organs or tissues
  • Progressive Cancer, including hepatocellular carcinoma
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  • Epilepsy
  • Sickle Cell Disease
  • A history of myocardial infarction or other severe heart disease
  • Excessive consumption of alcohol or drug users, in the absence of substitution by methadone, a stable weaning for more than three months should be required
  • Ongoing Participation in another clinical trial
  • Contraindications to the Sofosbuvir as defined in the Summary of Product Characteristics
  • At least one of the following laboratory abnormalities:
  • Haemoglobin <10 g / 100 ml (woman) <11 g / 100 ml (man) Platelet count <50,000 / mm3 polymorphonuclear neutrophils rate <750 / mm3 Creatinine clearance <50ml / min
  • For patients infected with HIV:
  • Severe opportunistic infections in the last 6 months
  • Poor adherence to antiretroviral treatment history
  • Use of antiretroviral drugs other than those permitted in the test

Trial locations and contacts

4 sites in 3 countries.

4 sites in 3 countries

Côte d’Ivoire2 sites

  • Centre de suivi des donneurs de sang

    Abidjan

  • CHU de Youpougon - Service de Gastro-entéro-hépatologie

    Abidjan

Other trials in Côte d’Ivoire

Cameroon1 site

  • Clinique de la Cathédrale

    Yaoundé

Other trials in Cameroon

Senegal1 site

  • CHU Fann, Service des Maladies Infectieuses

    Dakar

Other trials in Senegal

About this study

Official title: TAC (Treatment Africa Hepatitis C) : Feasibility, Tolerance and Efficacy of Interferon-free, Antiviral Treatment With Sofosbuvir + Ribavirin for the Treatment of Genotype 2 and Sofosbuvir/Ledipasvir for the Treatment of Genotype 1 and 4 Hepatitis C Virus-infected Patients in West and Central Africa

Primary Objective:

To evaluate the efficacy (sustained virological response 12 weeks after end-of-treatment [SVR12]) of 12-week course of an interferon-free regimen combining sofosbuvir and weight-dosed ribavirin (genotype 2), or sofosbuvir and ledipasvir (genotype 1 or 4) in treatment-naïve patients infected with HCV genotype 1, 2 or 4 in West and Central Africa

Read more

Secondary Objectives:

  1. To estimate the study treatment SVR24 rate
  2. To evaluate the clinical and biological tolerance of study treatment
  3. To describe HCV kinetics under HCV treatment, and identify associated factors
  4. To describe the evolution of HIV disease under HCV treatment in HVC-HIV co-infected patients
  5. To describe the changes of liver fibrosis based on non-invasive tests between treatment initiation, week 24, and week 36 after treatment, and estimate its association with SVR12 or SVR24
  6. To identify factors associated with SVR12 and SVR24 (including HIV status)
  7. To evaluate the performance of a nanodevice for rapid diagnosis of HCV viral load and genotypying and for assessing response to treatment (SVR12 and SVR24)
  8. Facilitate the detection and treatment of those infected with HCV by supporting national initiatives for access to strategies without interferon
  9. To set up a HCV clinical research network across French and English-speaking African countries, able to run large-scale comparative randomized clinical trials in a near future.
Read the detailed description

Study design Multicenter, phase IIb, non randomized, open-label trial involving 3 groups of HCV-mono infected or HCV-HIV co-infected patients: group G1 (patients infected with HCV genotype 1), group G2 (patients infected with HCV genotype 2), and group G4 (patients infected with HCV genotype 4).

Number of Subjects A sample size of 40 patients per group will allow to demonstrate that the SVR12 is >70% ("expected efficacy" in difficult-to-treat patients, according to SPARE interim results), with the lower bound of the confidence interval being >50% ("unacceptable" efficacy). The overall sample size is 3x40=120 patients.

Participating Countries 3 countries from West Africa (Senegal, Côte d'Ivoire) and Central Africa (Cameroon) Number of Sites 5 clinical sites:

  • Côte d'Ivoire: Hepatology Departementat the Yopougon University Teaching Hospital, , Abidjan; and Blood Donors clinic (CMSDS) at the National Blood Bank (CNTS), Abidjan
  • Senegal: CRCF (Centre Régional de Recherche et de Formation), and Fann University Teaching Hospital
  • Cameroon: Clinique de la Cathédrale

Duration of Recruitment : 6 months

Duration of Treatment : 12 weeks

Duration of follow-up : 36 weeks

Anticipated Start Date / Anticipated End Date: November 2015 - October 2016

Target Population /Demographics : Patients >18 years, living with chronic hepatitis C genotype 1, 2 or 4, in West and Central Africa. In each genotype group approx. 50% of patients will be HCV-HIV co-infected, and 50% of patients will be mono-infected with HCV

This study will enable us to assess the feasibility, tolerance and efficacy of such a strategy in resource-constrained settings with considerable treatment needs.

Being tested
Sofosbuvir, Ribavirin, Ledipasvir
Keywords
Africa, Hepatitis C, HIV, Antiviral treatment, Adults, HCV genotype 1, HCV genotype 2, HCV genotype 4
Medical subject headings
Hepatitis C, HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SofosbuvirDrug

    Also called Sovaldi®

    Sofosbuvir 400mg QD (Sovaldi®) in treatment-naïve patients infected with HCV genotype 2 (12-week course)

  • RibavirinDrug

    Ribavirin weight-adjusted dosing (1000mg BID in patients < 75kg and 1200mg BID in patients ≥ 75kg) in treatment-naïve patients infected with HCV genotype 2 (12-week course)

  • SofosbuvirDrug

    Also called Harvoni®

    Sofosbuvir/Ledipasvir 400mg/90mg (Harvoni®) in treatment-naïve patients infected with HCV genotype 1 or genotype 4 (12-week course)

  • LedipasvirDrug

    Also called Harvoni®

    Sofosbuvir/Ledipasvir 400mg/90mg (Harvoni®) in treatment-naïve patients infected with HCV genotype 1 or genotype 4 (12-week course)

Study groups in NCT02405013
Study groupRoleWhat they receive
Sofosbuvir+RibavirinExperimentalSofosbuvir 400mg QD (Sovaldi®) + Ribavirin weight-adjusted dosing (1000mg BID in patients < 75kg and 1200mg BID in patients ≥ 75kg) in treatment-naïve patients infected with HCV genotype 2 (12-week course)
Receives: Drug: Sofosbuvir; Drug: Ribavirin
Sofosbuvir+LedipasvirExperimentalSofosbuvir/Ledipasvir 400mg/90mg (Harvoni®) in treatment-naïve patients infected with HCV genotype 1 or genotype 4 (12-week course)
Receives: Drug: Sofosbuvir; Drug: Ledipasvir

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sustained Viral Load Response (SVR)

    Measured: Week 12

Secondary outcomes (10)

  1. Tolerance

    Grade 1, 2, 3 and 4 clinical or biological events (ACTG grading table), Adverse events-related HCV treatment discontinuation Adverse events-related ARV treatment modification

    Measured: 36 weeks

  2. Viral kinetics as measured by SVR 24 and HCV-RNA

    SVR 24 and HCV-RNA

    Measured: W0, W2, W4, W12, W24, W36

  3. HIV treatment clinical parameters

    Number, nature and incidence of severe morbid events related to HIV, and clinical and biological events of grade 3 or 4 (ANRS scale) related to the ARV treatment

    Measured: 36 weeks

  4. Liver fibrosis

    Elastometry score and only for cirrhotic patients : Child-Pugh score

    Measured: W0, W24 and W36

  5. Adherence measured by number of remaining tablets at each visit based on the number of tablets should have been taken as a percentage of the total dose

    Number of remaining tablets at each visit based on the number of tablets should have been taken as a percentage of the total dose

    Measured: W4, W8, W12

  6. Quality of life

    proportion of people reporting symptoms in the scale of symptoms experienced (scale of side effects perception SF12)

    Measured: 36 weeks

  7. Performance of an unit of nanotechnology

    calculation of sensitivity / specificity / positive predictive value and negative of each of the steps that will be performed (genotype, viral load) compared to the reference measurement (PCR for viral load and sequencing to genotype).

    Measured: 36 weeks

  8. Setting up the network:

    number of network meetings that have taken place before the end of the trial, the number of training sessions (on site or online) and the numbers enrolled in the network active partners. The ultimate goal is the establishment of an e-learning platform that will be an ancillary project.

    Measured: 36 weeks

  9. Integration Access initiatives evaluated by the number of patients off protocol that will have access to new anti-HCV treatment due to "ACCESS" programs of pharmaceutical companies conducting such programs in Sub-Saharan Africa

    It will be evaluated by the number of patients off protocol that will have access to new anti-HCV treatment due to "ACCESS" programs of pharmaceutical companies conducting such programs in Sub-Saharan Africa

    Measured: 36 weeks

  10. Biological events

    Plasma HIV-RNA and CD4 count

    Measured: W0, W24 and W36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionJul 2017
  4. Study completionNov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02405013
Sponsor's protocol ID
ANRS 12311 TAC
Acronym
TAC
Status last verified
Dec 2017
First submitted
20 Feb 2015
Last updated
13 Dec 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Marcellin F, Mourad A, Lemoine M, Kouanfack C, Seydi M, Carrieri P, Attia A, Protopopescu C, Lacombe K, Boyer S. Patient-reported outcomes with direct-acting antiviral treatment for hepatitis C in West and Central Africa (TAC ANRS 12311 trial). JHEP Rep. 2022 Dec 28;5(3):100665. doi: 10.1016/j.jhepr.2022.100665. eCollection 2023 Mar.

    PubMed 36686592

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sofosbuvir, Ribavirin and Ledipasvir in people with Hepatitis C and HIV Infection, run by ANRS, Emerging Infectious Diseases at 4 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Côte d’Ivoire, Cameroon, Senegal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sustained Viral Load Response (SVR) (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02405013, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2017.

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