NCT02071082已完成3 期
A Phase 3b Open-label Study of the Efficacy and Safety of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single-Tablet Regimen in HIV-1/Hepatitis B Co-infected Adults
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 24
- 主要终点
- Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL
研究概览
简要总结
This study will assess the efficacy, safety, and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) in human immunodeficiency virus (HIV)/hepatitis B virus (HBV) coinfected adults.
Participants will be enrolled into two cohorts:
- Cohort 1: HIV/HBV coinfected adults who are HIV treatment-naive and HBV treatment-naive
- Cohort 2: HIV/HBV coinfected adults who are HIV-suppressed
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both Cohorts 1 and 2:
- •The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
- •HIV/HBV co-infected adult males and non-pregnant and non-lactating females
- •No evidence of hepatocellular carcinoma (HCC) or clinical or imaging evidence of cirrhosis (ascites, variceal bleeding, encephalopathy).
- •-- Subjects should have documentation of an abdominal ultrasound in the 12 months prior to screening, or an abdominal ultrasound at screening, demonstrating the absence of cirrhosis and HCC.
- •Acute Hepatitis A virus (HAV) immunoglobulin M (IgM) negative
- •Hepatitis C virus (HCV) Ab negative, or HCV Ab positive with negative HCV RNA
- •Hepatitis D virus (HDV) Ab negative, or HDV Ab positive with negative HDV RNA
- •Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min according to the Cockcroft-Gault formula
- •CD4+ count of > 200 cells/μL
- •Chronic HBV infection as defined by
- •HBsAg positive for ≥ 6 months Or
- •HBsAg positive at screening and either hepatitis B e antigen (HBeAg) or HBV DNA positive ≥ 6 months Or
- •At screening: positive total hepatitis B core antibody (HBcAb) and negative immunoglobulin M antibody to hepatitis B core antigen (HBcIgM) antibody, and
- •HBsAg positive, or
- •HBeAg positive, or
- •HBV DNA positive
- •Cohort 1 (HIV and HBV treatment naive) only:
- •No current or prior anti-HIV treatment, including antiretroviral medications received for prevention (PrEP), or post exposure prophylaxis (PEP)
- •No current or prior anti-HBV treatment
- •Plasma HIV-1 RNA level ≥ 500 copies/mL at screening
- •Screening HBV DNA ≥ 3 log10 IU/mL and < 9 log10 IU/mL
- •Cohort 2 (HIV suppressed) only:
- •Receiving current antiretroviral regimen for at least 4 consecutive months
- •No current or prior regimen containing 3 active anti-HBV agents (i.e. cannot be on tenofovir alafenamide (TDF)/emtricitabine (FTC)/Entecavir or TDF/lamivudine(3TC)/Entecavir)
- •Maintained plasma HIV-1 RNA < 50 copies/mL for 6 consecutive months prior to and at the time of the screening visit. Unconfirmed virologic evaluation of ≥ 50 copies/mL after previously reaching viral suppression (transient detectable viremia, or "blip") and prior to screening is acceptable
- •Documented positive HIV antibody test
- •Screening HBV DNA < 9 log10 IU/mL
排除标准
- •Females who are breastfeeding
- •Positive serum pregnancy test (female of childbearing potential)
- •Have an implanted defibrillator or pacemaker
- •Current alcohol or substance use
- •A history of malignancy within the past 5 years (prior to screening) or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive carcinoma.
- •Received solid organ or bone marrow transplant
- •Any history of, or current evidence of, clinical hepatic decompensation (e.g., ascites, encephalopathy or variceal hemorrhage).
- •Significant bone disease (e.g., osteomalacia, chronic osteomyelitis, osteogenesis imperfecta, osteochondroses), or multiple bone fractures
- •Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1
- •Subjects on hemodialysis, other forms of renal replacement therapy, or on treatment for underlying kidney diseases (including prednisolone, and dexamethasone)
- •Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements
- •Investigational agents (unless approved by Gilead Sciences). Participation in any other clinical trial without prior approval from the sponsor is prohibited while participating in this trial
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
HIV treatment-naive and HBV treatment-naive
Experimental
HIV/HBV coinfected participants who are HIV treatment-naive and HBV treatment-naive will receive E/C/F/TAF for 48 weeks.
干预措施: E/C/F/TAF (Drug)
HIV-suppressed
Experimental
HIV/HBV coinfected participants who are HIV-suppressed will receive E/C/F/TAF for 48 weeks.
干预措施: E/C/F/TAF (Drug)
结局指标
主要结局
Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL
时间窗: Week 24
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Percentage of Participants With Plasma HBV DNA Levels < 29 IU/mL
时间窗: Week 24
The percentage of participants with HBV DNA \< 29 IU/mL at Week 24 was calculated using the missing = failure method.
次要结局
- Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL(Week 48)
- Percentage of Participants With Normalized ALT at Week 48(Baseline; Week 48)
- Percentage of Participants With Seroconversion to Hepatitis B e Antibody (Anti-HBe) at Week 24(Baseline; Week 24)
- Percentage of Participants With Seroconversion to Anti-HBe at Week 48(Baseline; Week 48)
- Change From Baseline in FibroTest® Score at Week 24(Baseline; Week 24)
- Change From Baseline in FibroTest® Score at Week 48(Baseline; Week 48)
- Percentage of Participants With Seroconversion to Anti-HBs at Week 48(Baseline; Week 48)
- Percentage of Participants With Plasma HBV DNA Levels < 29 IU/mL(Week 48)
- Percentage of Participants With Normalized Alanine Aminotransferase (ALT) at Week 24(Baseline; Week 24)
- Percentage of Participants With Seroconversion to Hepatitis B Surface Antibody (Anti-HBs) at Week 24(Baseline; Week 24)
研究者
研究点 (24)
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