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Meet William

Meet William†

No matter what I do, I can’t lose this excess visceral abdominal fat.

† Stock photo. Posed by model. Data is reflective of clinical trial results.

Overview

  • William is 45 and has had HIV and has been on ART for 9 years
  • He noticed the changing shape and increasing size of his belly
  • He tried diets, exercise, and stress management but did not see results
  • It is difficult for him to bend and turn over in bed
  • William is worried and would like to do something about his medical condition

William’s progress (waist circumference)

After 12 weeks of treatment:

  • William has lost a total of 2.2 inches around his waist
  • His stomach feels softer
  • He feels positive about his progress

Clinical studies with tesamorelin for injection demonstrate:

Average reduction in excess visceral abdominal fat in responders

26 weeks

16% in patients treated with tesamorelin for injection‡
27% in responders§

52 weeks

18% in patients treated with tesamorelin for injection‡
31% in responders§

Average reduction in waist circumference in responders§

26 weeks 1.65”
52 weeks 1.85”

Reduction in triglyceride levels in responders§

26 weeks

20.8% (50 mg/dL from 240 mg/dL)

52 weeks

27.5% (68 mg/dL from 247 mg/dL)

The results of the post‑hoc responder analysis were not part of the New Drug Application (NDA), and therefore were not reviewed by the FDA to support approval of EGRIFTA®. Tesamorelin is not indicated to reduce triglyceride levels.

‡ In two multicenter, randomized, placebo‑controlled trials. The primary outcome for these trials was change from Week 26 to Week 52 in excess visceral abdominal fat by treatment group (tesamorelin for injection Week 0–52 or tesamorelin for injection Week 0–26 and placebo Week 26–52).
§ In a post‑hoc responder analysis of data, ≥8% decrease in excess visceral abdominal fat was determined to be clinically significant and used to define responders.

Medical history

  • Hypertension, well‑controlled with medication
  • Hyperlipidemia, treated with atorvastatin, fenofibrates, and fish oil
  • Low testosterone, treated with topical testosterone replacement
  • No history of opportunistic infections
  • No history of hepatitis co‑infection
  • Non-smoker

Initial assessment

Weight189 lbs
Height5’10”
Waist circumference40.2” (102 cm)
Hip circumference37” (94 cm)
Waist-to-hip ratio1.09

Could your patients with HIV and lipodystrophy be struggling with excess visceral abdominal fat?

Learn how to identify these patients with 3 simple steps

Not all patients respond to tesamorelin for injection.

Patients responses may vary.

EGRIFTA SV® is not indicated for weight loss management.

EGRIFTA SV® is not approved for use in clinical conditions other than the reduction of excess abdominal fat.

ART = antiretroviral therapy.

Learn more about the THERA patient support® Program.

IMPORTANT SAFETY INFORMATION (Please see below for full limitations of use and additional important safety information)

Indication

EGRIFTA SV® is indicated for the reduction of excess abdominal fat in HIV‑infected adult patients with lipodystrophy.

Limitations of Use:

  • The impact and safety of EGRIFTA SV® on cardiovascular health have not been studied.
  • EGRIFTA SV® is not indicated for weight loss management.
  • It is not known whether taking EGRIFTA SV® helps improve compliance with anti‑retroviral medications.

Contraindications:

Do not use EGRIFTA SV® if patient:

  • Has a pituitary gland tumor, has had pituitary gland surgery, has other problems related to their pituitary gland, or has had radiation treatment to their head or a head injury.
  • Has active cancer.
  • Is allergic to tesamorelin or any of the ingredients in EGRIFTA SV®.
  • Is pregnant or planning to become pregnant.

Warnings and Precautions

Drug Interactions

Use in Specific Populations

Adverse Reactions

The most commonly reported adverse reactions include injection site reactions, arthralgia, pain in extremity, myalgia, and peripheral edema.

To report suspected adverse reactions, contact THERA patient support® at 1‑833‑23THERA (1‑833‑238-4372) or FDA at 1‑800‑FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information for EGRIFTA SV®.