Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Other
Safety study (incl. comparative)

If ‘other’, further details on the scope of the study

Observational cohort analysis

Data collection methods

Combined primary data collection and secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Study drug International non-proprietary name (INN) or common name

LAMIVUDINE

Medical condition to be studied

Human immunodeficiency virus transmission
Population studied

Short description of the study population

The study sample will be identified from the OPERA Observational Database for analysis per the inclusion/exclusion criteria defined below.
Inclusions:
1) A diagnosis of HIV, a positive HIV Western Blot, or a positive HIV enzymelinked immunosorbent assay (ELISA); and a detectable HIV viral load test
2) At least 13 years of age at the time of 3TC initiation
3) eGFR ≤ 49 ml/min/1.73m2 and ≥ 30 ml/min/1.73m2 at baseline
4) Initiating 3TC for the first time while in the target eGFR range
Exclusions:
1) HIV negative
2) eGFR <30 ml/min/1.73m2 at time of 3TC initiation
3) eGFR >49 ml/min/1.73m2 at time of 3TC initiation

Age groups

  • Adolescents (12 to < 18 years)
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)

Special population of interest

Immunocompromised
Renal impaired

Estimated number of subjects

15000
Study design details

Main study objective

To estimate the association between 3TC doseprescribed (300 mg vs 150 mg) and the rate of a composite outcome consisting of specific diagnoses of interest and severe laboratory abnormalities among patients with a baseline eGFR between ≥ 30 ml/min/1.73m2 and ≤ 49 ml/min/1.73m2

Data analysis plan

Descriptive analyses will be conducted for patients prescribed 3TC 150 mg and 300 mg per day. Medians and interquartile ranges for continuous variables will be compared between daily dose groups using Wilcoxon Rank Sum test. Frequencies (counts and percentages) for categorical variables will be compared using Pearson Chi-Square test. The incidence rate of the composite outcome (specific diagnoses of interest and/or laboratory abnormalities of grade 3-4) will be estimated within each dose group and also compared across each of the total daily dosing groups (i.e. 300 mg vs. 150 mg) using univariate Poisson regression (including treatment term only). Multivariable Poisson regression adjusting for retained covariates will be employed to estimate the incidence rate ratio for the composite outcome comparing total 3TC daily doses of 300 mg vs.150 mg, using time since 3TC initiation as the offset. Statistical hypothesis test will be based on the adjusted rate ratio from the final Poisson model