Mixed ethnicity male in hat taking a selfie in front of a wooded forest, not actual Serostim® patient

Treatment Results

In clinical trials, Serostim® increased lean body mass and body weight, and improved physical endurance

2 clinical trials tested the effects of Serostim® on lean body mass (LBM), body weight, and physical endurance. All study participants also received antiretroviral therapy during the course of the trials.

 

Clinical Trial 1

Study design

In Clinical Trial 1, Serostim® was studied in 178 participants living with HIV and diagnosed with HIV‑associated wasting. Participants received placebo for 12 weeks or Serostim® daily. Some participants continued on treatment for another 12 weeks, for a total of 24 weeks.

Results

Participants diagnosed with HIV‑associated wasting and treated with Serostim® daily for 12 weeks experienced:

Results at 12 weeks were evaluated in 70 participants treated with Serostim® and 71 participants who received placebo.

During the additional 12 weeks of the study, participants on Serostim® had no significant changes and maintained the increases in LBM and total body weight.

At 12 weeks of treatment, participants taking Serostim® significantly improved their physical endurance as measured by treadmill exercise.

Clinical Trial 2

Study design

In Clinical Trial 2, Serostim® was studied in 757 participants diagnosed with HIV‑associated wasting. Participants received placebo for 12 weeks, Serostim® every other day or Serostim® daily. Some participants continued on treatment to 24 weeks.

Results

After 12 weeks of treatment:

The average increases in LBM and total body weight were significantly greater in both Serostim® treatment groups compared with the placebo group after 12 weeks of treatment.

A total of 646 participants completed the 12-week study and continued on Serostim® treatment for an additional 12 weeks. 548 of these participants completed the additional 12 weeks of treatment. These participants maintained their increases in LBM and total body weight.

Participants taking Serostim® significantly improved their physical endurance as measured by a stationary bike exercise after 12 weeks of treatment. On average:

A total of 646 participants completed the 12-week study and continued on Serostim® treatment for an additional 12 weeks. 548 of these participants completed an additional 12 weeks of active treatment. Participants continuing on Serostim® treatment maintained or improved their physical endurance throughout the study extension period.

Patients’ perceptions of the impact of 12 weeks of treatment on their wasting symptoms as assessed by the Bristol-Meyers Anorexia/Cachexia Recovery Instrument improved with both doses of Serostim® in Clinical Trial 2.

Common side effects of Serostim® reported in clinical trials:

  • Bone, muscle, and joint pain or stiffness
  • Tingling, numbness, and pain in the fingers, thumb, or wrist
  • Nausea
  • Swelling, especially in the hands or feet or around the eyes
  • Extreme tiredness
  • Gynecomastia
  • Unusual skin sensations

Other less common but serious side effects of Serostim® are:

  • High blood sugar (hyperglycemia/diabetes), which can include symptoms of increased thirst and urination, tiredness, or trouble concentrating
  • Headaches, changes in vision, nausea, or vomiting, which require immediate medical attention
  • Serious allergic reactions that require immediate medical attention
  • Pain and tenderness in the abdomen

These are not all the possible side effects. Let your healthcare provider know about any side effects you experience. 

Learn more about what to expect with treatment with Serostim®.