Efficacy and Tolerance of Peg-interferon Alpha 2a Added to Tenofovir and Emtricitabine in AgHBe Positive HBV-HIV Co-infected Patients

HIV Infections Clinical Trial

— HB01EMVIPEG  

Official title:

Pilot Study on Efficacy and Tolerance of Peg-interferon Alpha-2a (Pegasys) Added to Tenofovir DF and Emtricitabine (Truvada) in AGHBe Positive HBV-HIV Co-infected Patients. ANRS HB 01 EMVIPEG.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00391638
• Other study ID #: 2006-004137-15
• Secondary ID: ANRS HB 01 EMVIP
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 23, 2006
• Last updated: January 14, 2015
• Start date: January 2007
• Est. completion date: October 2012

Study information

• Verified date: January 2015
• Source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

HBe seroconversion is an important goal for anti-HBV treatment, since it is associated with a non progressive liver infection and a better clinical outcome. However, the rate of HBe seroconversion is low in HIV-HBV co-infected patients, mostly treated by tenofovir and emtricitabine. This study will evaluate the efficacy and the safety of a one-year Peg-interferon alpha 2a additional treatment in patients already treated by tenofovir and emtricitabine without reaching HBe seroconversion.

Description:

Many HBV-HIV co-infected patients are currently treated with dual activity drugs such as tenofovir and emtricitabine, often in combination. However, despite the potent antiviral activity of these drugs, the rate of HBe seroconversion is quite low, and not always sustained over time. HBe seroconversion is an important goal for anti-HBV treatment, since it is associated with a non progressive liver infection and a better clinical outcome. On the other hand, treatments with antiviral and immuno-modulator activity such as Peg-interferon, are infrequently used in co-infected patients, despite promising data in the field of HBV mono-infection with increased rates and sustained HBe seroconversions. This pilot study will evaluate the efficacy and the safety of a one-year Peg-interferon alpha 2a additional treatment (180 micro-g once a week, by injection), in 55 patients already treated by tenofovir and emtricitabine for at least 6 months, and who did not reached HBe seroconversion

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: October 2012
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• HIV infection

• Karnofsky above 80 per cent

• Stable ARV since 4 months

• CD4 above 200 per mm3

• ARN VIH below 10000 copies per ml

• hepatitis B chronic with : positive antigenaemia HBe and negative antiHBe, positive DNA HBV before or under tenofovir treatment, DNA HBV negative or below 10000 copies per ml at W-8.

• Previous treatment by tenofovir and lamivudine or emtricitabine more than 6 months

Exclusion Criteria:

• HIV 2 infection

• Hepatitis C or D

• Opportunistic infection

• Alcool consummation more than 50g/d

• Cirrhosis

• Pregnancy or plan of pregnancy

• Breastfeeding

• Immunosuppressive or modulating of the immune response treatment

• Other Hepatitis B treatments than tenofovir, lamivudine or emtricitabine since 6 months

• Malabsorption

• Exclusive HIV therapy with Truvada

• Evolutive cancer under chemotherapy

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis B
• HIV Infections

Intervention

Drug:
• TRUVADA (EMTRICITABINE + TENOFOVIR DF)
Truvada ® (200 mg tablet of 300 mg of emtricitabine + tenofovir DF) Dosage 1 tablet taken orally once a day

Biological:
• PEGASYS 180µg (Interféron pégylé alpha -2a)
Pegasys ® injection 180µg Dosage: A subcutaneous injection per week

Locations

Country	Name	City	State
France	Service des Maladies Infectieuses CHU	Dijon cedex
France	Service d'Hépato-Gastroentérologie Hopital Hôtel-Dieu	Lyon Cedex 02

Sponsors (3)

Lead Sponsor	Collaborator
French National Agency for Research on AIDS and Viral Hepatitis	Gilead Sciences, Roche Pharma AG

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of patients with seroconversion HBe (loose of HBe antigen and acquisition of HBe antibody) and HBV DNA below 2.3 log10 copies per ml		at Week 72	No
Secondary	proportion of patients with negative HBe antigen.		at Week 72 and Week 144	No
Secondary	proportion of patients with HBV DNA under 2.3 log 10 copies per ml.		at Week 72 and Week 144	No
Secondary	proportion of seroconversion HBs.		at Week 72 and Week 144	No
Secondary	proportion of patients with no more HBs antigen.		at Week 72 and Week 144	No
Secondary	proportion of patients with HBV DNA below 2.3 log 10 copies per ml in relation with 3TC resistance or not before tenofovir treatment; increased of ALT before tenofovir treatment;duration of tenofovir treatment before study.		before tenofovir treatment, duration of tenofovir treatment before study	No
Secondary	Biological evolution and histological of hepatic activity and fibrosis.		at day 0 and Week 72	No
Secondary	Biochemical response (ALT at normal value).		at Week 72 and Week 144	No
Secondary	proportion of patients with :seroconversion HBe and HBV DNA below 2.3 log 10 copies per ml		at Week 48	No
Secondary	HBV and HIV resistance mutations to tenofovir DF and Emtricitabine.		at Week 72	No
Secondary	Immunological and virological evolution of HIV infection.		between Day 0 and Week 144	No
Secondary	Safety		between Day 0 and Week 144	Yes
Secondary	Quality of life		Day 0, Week 12, Week 24, Week 48, Week 72	No
Secondary	Treatment adherence		Day 0 to Week 144	No