Trial Outcomes & Findings for Liver Fibrosis in Zambian HIV-HBV Co-infected Patients (NCT NCT02344680)

Last Updated: 2026-07-02

Results Overview

Based on transient elastography, we calculated the number and proportion of participants with at least significant fibrosis at their first measure who regressed to minimal-no fibrosis during follow-up. This outcome excluded participants with no-minimal fibrosis at enrollment.

Recruitment status

COMPLETED

Target enrollment

349 participants

Primary outcome timeframe

From baseline to 10 years of follow-up

Results posted on

2026-07-02

Participant Flow

Adults who were newly entering HIV care were screened for study eligibility and if they met all criteria and gave informed consent, they enrolled.

This was a single arm prospective cohort study. All participants received standard of care medication for treatment of HBV/HIV coinfection.

Participant milestones

Participant milestones
Measure	HBV/HIV Cohort All participants had HBV/HIV coinfection at enrollment and were prospectively followed up as they received standard of care treatments.
Overall Study STARTED	349
Overall Study COMPLETED	218
Overall Study NOT COMPLETED	131

Reasons for withdrawal

Reasons for withdrawal
Measure	HBV/HIV Cohort All participants had HBV/HIV coinfection at enrollment and were prospectively followed up as they received standard of care treatments.
Overall Study Lost to Follow-up	25
Overall Study Death	47
Overall Study Withdrawal by Subject	18
Overall Study Transfer out	41

Baseline Characteristics

Missing lab data

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HBV/HIV Cohort n=349 Participants All participants had HBV/HIV coinfection at enrollment and were prospectively followed up as they received standard of care treatments.
Age, Categorical <=18 years	0 Participants n=349 Participants
Age, Categorical Between 18 and 65 years	349 Participants n=349 Participants
Age, Categorical >=65 years	0 Participants n=349 Participants
Sex: Female, Male Female	139 Participants n=349 Participants
Sex: Female, Male Male	210 Participants n=349 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=349 Participants
Race (NIH/OMB) Asian	0 Participants n=349 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=349 Participants
Race (NIH/OMB) Black or African American	349 Participants n=349 Participants
Race (NIH/OMB) White	0 Participants n=349 Participants
Race (NIH/OMB) More than one race	0 Participants n=349 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=349 Participants
Region of Enrollment Zambia	349 Participants n=349 Participants
Baseline CD4 T cell count <200 cells/mm3	149 Participants n=295 Participants • Missing lab data
Baseline HBV DNA >2000 IU/ml	158 Participants n=277 Participants • Missing lab data

PRIMARY outcome

Timeframe: From baseline to 10 years of follow-up

Population: Due to losses to follow-up, transfers, deaths, and withdrawals from the study, the total number analyzed for this outcome was reduced.

Outcome measures

Outcome measures
Measure	HBV/HIV Cohort n=86 Participants All participants had HBV/HIV coinfection at enrollment and were prospectively followed up as they received standard of care treatments.
Reduction in Liver Fibrosis Stage	46 Participants

SECONDARY outcome

Timeframe: At enrollment

Population: All people with enrollment data available (i.e., at time of starting treatment) were analyzed for this outcome.

Proportion of participants with median liver stiffness based on transient elastography of \>=7 kPa

Outcome measures

Outcome measures
Measure	HBV/HIV Cohort n=269 Participants All participants had HBV/HIV coinfection at enrollment and were prospectively followed up as they received standard of care treatments.
Prevalence of Significant Liver Fibrosis (Metavir F2 or Greater)	78 Participants

SECONDARY outcome

Timeframe: Month 24

Proportion of participants with measure of HBV DNA above detection at month 24

Outcome measures

Outcome measures
Measure	HBV/HIV Cohort n=143 Participants All participants had HBV/HIV coinfection at enrollment and were prospectively followed up as they received standard of care treatments.
Prevalence of Persistent HBV Viremia: Measure HBV DNA at Month 24	34 Participants

SECONDARY outcome

Timeframe: From baseline to 10 years of follow-up

Population: We attempted to document new cases of HCC during follow-up. HCC in Zambia is based on international criteira including triple phase CT scan +/- histology. During the study, every 6-12 months we performed an abdominal ultrasound to screen for liver masses.

Number of new cases of hepatocellular carcinoma during follow-up

Outcome measures

Outcome measures
Measure	HBV/HIV Cohort n=349 Participants All participants had HBV/HIV coinfection at enrollment and were prospectively followed up as they received standard of care treatments.
Incidence of Hepatocellular Carcinoma	0 Participants

Adverse Events

HBV/HIV Cohort

Serious events: 47 serious events

Other events: 0 other events

Deaths: 47 deaths

Serious adverse events

Serious adverse events
Measure	HBV/HIV Cohort n=349 participants at risk All participants had HBV/HIV coinfection at enrollment and were prospectively followed up as they received standard of care treatments.
General disorders All-cause mortality	13.5% 47/349 • From enrollment to up to 10 years of follow-up Participants received standard of care treatments. During follow-up, we ascertained SAEs, including all-cause mortality, which was based on verbal reported by participant family/friend or documented by the clinic. In Zambia is it very challenging to obtain death records (due to limitations in vital statistics infrastructure) and to determine specific causes of death (because most people die at home and few families allow autopsies). Other (Not Including Serious) Adverse Events were not monitored

Other adverse events

Adverse event data not reported

Additional Information

Professor Michael Vinikoor

University of Alabama at Birmingham

Phone: +1 205 934 5191

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place