For treatment-naïve and virologically suppressed adults with HIV-1. See Full Indication.

TREATMENT-NAÏVE
CLINICAL TRIAL

TREATMENT-NAÏVE
CLINICAL TRIAL

RAPID INITIATION CLINICAL TRIAL

The STAT clinical trial for DOVATO was a Phase 3b, single‐arm, 48‐week study conducted in the US in 131 newly diagnosed patients with HIV‐1. The primary objective of the study was to evaluate the feasibility of rapid initiation of DOVATO as ART treatment at or within 14 days after diagnosis of HIV‐1 in treatment‐naïve adults. Healthcare professionals are encouraged to explore the results in detail below.

TRIAL DESIGN

STAT: Rapid Initiation in Treatment-Naive Adults With HIV-1

A Phase 3b, open-label, multicenter, single-arm, 48-week study1

Trials Phase 3b
baseline

Study Limitations: Open-label, single-arm, non-comparative study conducted at US sites only. 

Exclusion Criteria1:

  • Pregnant in first trimester, breastfeeding, or planning to become pregnant
  • Active CDC stage 3 disease
  • Known HIV‐1 drug resistance genotype test results prior to screening
  • Known or suspected HBV co‐infection
  • Known severe renal impairment (CrCl <30 mL/min/1.73 m2)
  • Known or suspected severe hepatic impairment or unstable liver disease

Patients receiving DOVATO had CrCl ≥50 mL/min.
Except for esophageal candidiasis and cutaneous Kaposi’s sarcoma not requiring systemic therapy.

 

3TC=lamivudine; AE=adverse event; BL=baseline; CDC=Centers for Disease Control and Prevention; CrCl=creatinine clearance; DTG=dolutegravir; HBV=hepatitis B virus; ITT–E=intent‐to‐treat–exposed.

Baseline Characteristics1

baseline
Baseline Characteristics

 

One (<1%) participant had missing plasma HIV‐1 RNA results at BL.

BL resistance was identified at Week 4, and HIV‐1 viral load, CD4+ cell count, and HBV coinfection were identified at Week 1 from samples taken at BL.

Lower limit of quantification is <40.

Lower limit of quantification is <20.

Two participants with HBV co‐infection remained on DTG/3TC.

EFFICACY

Virologic suppression and treatment modifications at 24 weeks1

PRIMARY ENDPOINT: ITT–E MISSING=FAILURE

OBSERVED ANALYSIS

RESISTANCE

Reference:

  1. Data on file, ViiV Healthcare

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