Serostim® (somatropin) for injection is indicated for the treatment of HIV-positive patients with wasting to increase lean body mass (LBM) and weight as well as to improve physical endurance.2 Concomitant antiretroviral therapy is necessary.
Serostim® has anabolic and anticatabolic properties:
- Promotes growth of new LBM
- Preserves existing LBM
- In a 12-week, double-blind, placebo-controlled study in patients with HIV-associated wasting (n=757), Serostim® significantly improved physical endurance for patients, as assessed by a stationary bike exercise2
- In an extension phase, improvements were maintained or improved through 24 weeks
Serostim® increased lean body mass and weight2
- In a 12-week, double-blind, placebo-controlled study in patients with HIV-associated wasting (n=757), patients experienced a statistically significant median increase in lean body mass with Serostim®
- In a 12-week open label extension phase:
- Increases in LBM were maintained or improved through 24 weeks
- Increases in weight gain were maintained through 24 weeks
- Results based on a subset who completed the 12 week study and took at least 80% of their medicine (PI contains entire study population results)
The Bristol-Myers Anorexia/Cachexia Recovery Instrument (BACRI) is a visual analogue instrument to quantify patient perception of benefit in areas such as decreased concern over weight and appearance, increased pleasure in eating, and increase in global perception of well-being.
Patients with HIV-associated wasting treated with Serostim® every day and every other day completed the BACRI questionnaire. Their perception of the impact of Serostim® therapy on their wasting symptoms was reported. Both groups treated with Serostim® reported improvements in their symptoms. After taking Serostim®, patients’ perceptions included included1:
- Having a better appetite
- More enjoyment in eating
- Positive changes in appearance
- Improvements in how they felt
- That increases in weight significantly improved their health
Setting treatment goals for your patients and monitoring progress should be part of their follow-up visits. Methods for monitoring and assessing whether patients reach treatment goals:
- Evaluating physical endurance
- Measuring weight
- Calculating BMI
- Visually examining physical appearance
- Assessing patient-reported outcomes
- Serostim® is contraindicated in patients with active malignancy, diabetic retinopathy, and in those with hypersensitivity to growth hormone.
- Serostim® should not be used in patients with acute critical illness due to complications following open-heart surgery or abdominal surgery, multiple accidental trauma, or acute respiratory failure.
- The most common adverse reactions (incidence >10%) were increased tissue turgor, arthralgia, myalgia, and arthrosis.
- Symptoms were dose-related and generally mild to moderate in severity, and often subsided with continued treatment or dose reduction. Alternate-day treatment is associated with fewer side effects and resulted in a similar improvement in work output, and should be considered in patients at increased risk for adverse events.
- Post-marketing cases of new-onset impaired glucose intolerance, new-onset type 2 diabetes mellitus, and exacerbation of pre-existing diabetes mellitus have been reported, some of which were serious and persisted following treatment discontinuation.
- Hyperglycemia has been reported in Serostim® clinical trials. Patients with a history of hyperglycemia or other risk factors for glucose intolerance should be monitored closely during Serostim® use.
A 12-week, randomized, double-blind, placebo-controlled study enrolled 757 patients with HIV-associated wasting, or cachexia. The primary endpoint was physical function as measured by cycle ergometry work output. Body composition was assessed using bioelectrical impedance spectroscopy (BIS) and also by dual energy X-ray absorptiometry (DXA) at a subset of centers. Patients meeting the inclusion/exclusion criteria were treated with either placebo, approximately 0.1 mg/kg every other day (qod) of Serostim® (somatropin) for injection, or approximately 0.1 mg/kg daily of Serostim®. All results were analyzed in intent-to-treat populations (for cycle ergometry work output, n=670). Ninety-one percent (91%) were male and 88% were on HAART antiretroviral therapy. The average CD4 count/μL was 446. Six hundred and forty-six (646) patients completed the 12-week study and continued in the Serostim® treatment extension phase of the trial.
Extension Phase: All patients (n=646) completing the 12-week placebo-controlled phase of Clinical Trial 2 continued Serostim® treatment into an extension phase. Five hundred and forty-eight (548) of these patients completed an additional 12 weeks of active treatment. In these patients, changes in cycle ergometry work output, LBM, BW, and fat mass either improved further or were maintained with continued Serostim® treatment.