Clinical Trial Results

Statistically significant improvements in the 3 key symptoms of HIV‑associated wasting1

The clinical efficacy of Serostim® was assessed in 2 randomized, double-blind, placebo-controlled trials. All patients participating in the clinical trials received concomitant antiretroviral therapy.
Mixed ethnicity male in hat taking a selfie in front of a wooded forest, not actual Serostim<sup>®</sup> patient

In 2 clinical trials, Serostim® has proven efficacy in treating the 3 key symptoms of HIV‑associated wasting

Clinical Trial 1

Serostim® showed statistically significant increases in LBM, body weight, and improvements in physical endurance

P < 0.001, P = 0.011, and P = 0.039, respectively

Study design
  • 12-week, randomized, double-blind, placebo-controlled study followed by an open-label extension phase
  • 178 patients with severe HIV‑associated wasting taking nucleoside analogue therapy (pre–highly active antiretroviral therapy [HAART] era)
  • Primary endpoint: body weight (BW)
  • Body composition assessed using dual energy X-ray absorptiometry (DXA) and physical function assessed by treadmill exercise testing
  • Patients treated with:
    • Placebo
    • Serostim® 0.1 mg/kg daily
  • 96% were male
  • The average baseline CD4 count/microliter was 85
  • 140 patients completed the 12-week course of treatment and were at least 80% compliant with the study drug

Clinical Trial 2

Serostim® provided improvements in LBM, body weight, and physical endurance*

*P < 0.01 for mean change in physical endurance vs placebo.

Study design

  • 12-week, randomized, double-blind, placebo-controlled study
  • 757 patients with HIV‑associated wasting
  • Primary efficacy endpoint: physical function as measured by cycle ergometry work output
  • Body composition assessed using bioelectrical impedance spectroscopy (BIS) and DXA
  • Patients treated with:
    • Placebo
    • Serostim® 0.1 mg/kg every other day
    • Serostim® 0.1 mg/kg daily
  • 91% of patients were male
  • 88% of patients were treated with HAART
  • Average baseline CD4 count/microliter was 446
  • 646 patients completed the 12-week, placebo-controlled phase and continued in an open-label extension phase of the trial

Adverse reactions in clinical trials

In Clinical Trial 2 of patients with HIV‑associated wasting or cachexia, the most commonly reported adverse reactions with Serostim® (0.1 mg/kg daily) were1:

  • Musculoskeletal discomfort
  • Increased tissue turgor (particularly of the hands or feet)


Dose reductions were required in 23% of patients taking Serostim® 0.1 mg/kg daily and in 11% of patients taking Serostim® 0.1 mg/kg every other day.

Discontinuations as a result of adverse reactions:

  • 10.3% (Serostim® 0.1 mg/kg daily)
  • 6.6% (Serostim® 0.1 mg/kg every other day)


The most common reasons for dose reduction and/or drug discontinuation were arthralgia, myalgia, edema, carpal tunnel syndrome, elevated glucose levels, and elevated triglyceride levels.

Controlled Clinical Trial 2 adverse reactions occurring in at least 5% of patients in 1 of the treatment groups, and at an incidence greater than placebo

 PlaceboSerostim® 0.1 mg/kg every other daySerostim® 0.1 mg/kg daily
 (n=247)(n=257)(n=253)
Body System
Preferred Term		%%%
Musculoskeletal System Disorders
Arthralgia11.324.536.4
Myalgia11.717.930.4
Arthrosis3.67.810.7
Gastrointestinal System Disorders
Nausea4.95.49.1
Body as a Whole – General Disorders
Peripheral edema2.811.326.1
Fatigue4.53.55.1
Endocrine Disorders
Gynecomastia0.43.55.5
Central and Peripheral Nervous System Disorders
Paresthesia4.57.47.9
Hypoesthesia2.41.65.1
Metabolic and Nutritional Disorders
Generalized edema1.21.25.9

These are not all the possible side effects of Serostim®. Counsel your patients to speak with you about any side effects they are experiencing. Please see the Serostim® full Prescribing Information and Important Safety Information.

Recommended dosage and administration for treatment with Serostim®

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Important Safety Information and Indication

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CONTRAINDICATIONS

Acute Critical Illness:  Serostim® should not be initiated in patients with acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma or acute respiratory failure.

Active Malignancy: Somatropin is contraindicated in the presence of active malignancy.  Any preexisting malignancy should be inactive and its treatment complete prior to instituting therapy with somatropin. Discontinue somatropin if there is evidence of recurrent activity.

Hypersensitivity: Serostim® is contraindicated in patients with a known hypersensitivity to somatropin or any of its excipients. Systemic hypersensitivity reactions have been reported.

Diabetic Retinopathy: Somatropin is contraindicated in patients with active proliferative or severe non-proliferative diabetic retinopathy.

WARNINGS AND PRECAUTIONS

Acute Critical Illness: Increased mortality (42% vs 19% in somatropin compared to placebo treated) in patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure has been reported after treatment with pharmacologic amounts of somatropin.

Concomitant Antiretroviral Therapy: Somatropin has been shown to potentiate HIV replication in vitro, and there was no increase in virus production when antiretroviral agents were added to the culture medium. No significant somatropin-associated increase in viral burden was observed.  All patients received antiretroviral therapy for the duration of treatment during Serostim® clinical trials.

Neoplasms: Patients with preexisting tumors should be monitored for progression or reoccurrence. Monitor patients on somatropin therapy carefully for preexisting nevi.

Impaired Glucose Tolerance/Diabetes: Patients with other risk factors for glucose intolerance should be monitored closely during Serostim® therapy. Cases of new onset impaired glucose tolerance, new onset type 2 diabetes, and exacerbation of preexisting diabetes have been reported in patients receiving Serostim®. Some patients developed diabetic ketoacidosis and diabetic coma and, in some, improved when Serostim® was discontinued and in others persisted. Some of these patients required initiation or adjustment of antidiabetic treatment.

Intracranial Hypertension: Intracranial hypertension (IH) with papilledema, visual changes, headache, nausea, and/or vomiting has been reported usually within the first 8 weeks of somatropin therapy and rapidly resolved after stopping or reducing the somatropin dose. Funduscopic examination should be performed prior to initiating treatment with somatropin and periodically during treatment. If papilledema is observed, treatment should be stopped and restarted at a lower dose after IH-associated symptoms have resolved.

Severe Hypersensitivity: Serious systemic hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with postmarketing use of somatropin products. Patients and caregivers should be informed that such reactions are possible and that prompt medical attention should be sought if an allergic reaction occurs.

Fluid Retention/Carpal Tunnel Syndrome: Increased tissue turgor (swelling, particularly in the hands and feet) and musculoskeletal discomfort (pain, swelling and/or stiffness) may occur during treatment with Serostim®, but may resolve spontaneously, with analgesic therapy, or after reducing the frequency of dosing. Carpal tunnel syndrome may occur and if the symptoms of carpal tunnel do not resolve by decreasing the weekly number of doses, it is recommended that Serostim® treatment be discontinued.

Skin Atrophy: Rotate the injection site to avoid tissue atrophy.

Pancreatitis: Cases of pancreatitis have been reported rarely. Consider pancreatitis in patients who develop persistent severe abdominal pain.

ADVERSE REACTIONS

In clinical trials in HIV‑associated wasting or cachexia the most common adverse reactions (incidence >5%) were arthralgia, myalgia, peripheral edema, arthrosis, nausea, paresthesia, generalized edema, gynecomastia, hypoesthesia and fatigue.

SPECIAL POPULATIONS: 

Somatropin should be used during pregnancy only if clearly needed and with caution in nursing mothers because it is not known whether somatropin is excreted in human milk. The safety and effectiveness of somatropin in pediatric patients with HIV have not been established.  Clinical studies did not include sufficient numbers of subjects > 65 to determine a response different from that of younger patients. Studies have not been conducted in patients with hepatic or renal impairment. Gender-based analysis is not available.

INDICATIONS AND USAGE

Serostim® (somatropin) for injection is indicated for the treatment of HIV patients with wasting or cachexia to increase lean body mass and body weight, and improve physical endurance. Concomitant antiretroviral therapy is necessary.

Please click here full Prescribing Information.

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