HIV-associated Wasting Condition Information for HCPs

Young black male portraying doctor and older white male discussing, not actual Serostim® patients

HIV‑associated Wasting

What is HIV‑associated wasting?

HIV‑associated wasting is an HIV‑related condition characterized by abnormalities in protein synthesis, proteolysis, and lipid metabolism.² Over time, patients living with HIV may experience unintentional weight loss, which may manifest as a preferential loss of LBM and a relative preservation of fat.^3,4 The loss of LBM may be associated with a decline in strength and in the ability to complete tasks.^5,6

Who may be at risk?

HIV‑associated wasting is a serious, underdiagnosed condition that may impact a range of patients living with HIV, including those who are well controlled on ART.^7,8

HIV‑associated wasting may affect a range of patients ^2,7-9

Many of your patients may be at risk for HIV‑associated wasting, including:

Newly diagnosed patients
HIV Long-Term Survivors
HIV‑positive patients with normal CD4 counts and controlled viral loads
Patients on ART who fail to gain weight
Patients on ART with acute infection
Patients with advanced HIV disease
Poor virologic responders
Patients who have been nonadherent to ART

More men experience HIV‑associated wasting, but it can occur in women, too.

Many factors contribute to HIV‑associated wasting^2,5

The exact causes of HIV‑associated wasting remain unknown and are unique to every patient. HIV‑associated wasting is a diagnosis of exclusion. There are several factors associated with altered metabolism and/or reduced caloric intake that may result in unintentional weight loss in your patients living with HIV.

Opportunistic infections (OIs)^7,11-13

OIs related to HIV have been shown to increase the risk of unintentional weight loss and may lead to metabolic changes

Inflammatory response^14-16

Persistent HIV infection leads to long-term immune activation and chronic inflammation, even in HIV‑positive patients on ART with undetectable viral loads
In patients living with HIV, this chronic, systemic inflammatory response leads to the ongoing loss of LBM, which may lead to unintentional weight loss

Metabolic pathways⁴

Dysregulation of metabolic pathways can result in inappropriate depletion of LBM, body weight, and a relative preservation of body fat

View metabolic changes

Endocrine dysfunction^17,18

In HIV‑positive patients, endocrine dysfunction is a common clinical manifestation
- There is a high correlation between loss of LBM and hypogonadism in HIV‑positive men who are on ART
- Among HIV‑positive women, decreased levels of free testosterone are also significantly associated with HIV‑associated wasting

Growth hormone (GH) resistance ^2,9,17,19

GH secretion and action are affected by nutritional status and changes in body composition
In HIV‑associated wasting patients, a pattern of acquired GH resistance is seen, with increased GH and simultaneously decreased concentrations of insulin growth factor-1 (IGF-1)
- The GH/IGF-1 axis is one of the regulators of muscle protein metabolism that is altered in patients with HIV‑associated wasting

View growth hormone resistance

Evidence suggests that altered metabolism can have an important role in the development of HIV‑associated wasting

Serostim^® is the only product with anabolic and anticatabolic properties indicated to treat HIV‑associated wasting.¹

See

Are your patients experiencing symptoms of HIV‑associated wasting?

See

References:

Serostim^® (somatropin) for injection [prescribing information]. Rockland, MA: EMD Serono, Inc.
Gelato M, McNurlan M, Freedland E. Role of recombinant human growth hormone in HIV‑associated wasting and cachexia: pathophysiology and rationale for treatment. Clin Ther. 2007;29(11):2269-2288.
Dudgeon WD, Phillips KD, Carson JA, Brewer RB, Durstine JL, Hand GA. Counteracting muscle wasting in HIV‑infected individuals. HIV Med. 2006;7(5):299-310.
Perry CM, Wagstaff AJ. Recombinant mammalian cell-derived somatropin: a review of its pharmacological properties and therapeutic potential in the management of wasting associated with HIV infection. BioDrugs. 1997;8(5):394-414.
Grinspoon S, Mulligan K; for the Department of Health and Human Services Working Group on the Prevention and Treatment of Wasting and Weight Loss. Weight loss and wasting in patients infected with human immunodeficiency virus. Clin Infec Dis. 2003;36(Suppl 2):S69-S78.
Grinspoon S, Corcoran C, Rosenthal D, et al. Quantitative assessment of cross-sectional muscle area, functional status, and muscle strength in men with the acquired immunodeficiency syndrome wasting syndrome. J Clin Endocrinol Metab. 1999;84(1):201-206.
Wasserman P, Segal-Maurer S, Wehbeh W, Rubin DS. Wasting disease, chronic immune activation, and inflammation in the HIV‑infected patient. Top Clin Nutr. 2011;26(1):14-28.
Erlandson KM, Li X, Abraham AG, et al. Long-term impact of HIV wasting on physical function. AIDS. 2016;30(3):445-454.
Falutz J. Growth hormone and HIV infection: contribution to disease manifestations and clinical implications. Best Pract Res Clin Endocrinol Metab. 2011;25(3):517-529.
Macallan DC. Wasting in HIV infection and AIDS. J Nutr. 1999;129(1S Suppl):238S-242S.
Jacobson DL, Bica I, Knox TA, et al. Difficulty swallowing and lack of receipt of highly active antiretroviral therapy predict acute weight loss in human immunodeficiency virus disease. Clin Infect Dis. 2003;37(10):1349-1356.
Chu C, Selwyn PA. Complications of HIV infection: a systems-based approach. Am Fam Physician. 2011;83(4):395-406.
Melchior JC, Raguin G, Boulier A, et al. Resting energy expenditure in human immunodeficiency virus-infected patients: comparison between patients with and without secondary infections. Am J Clin Nutr. 1993;57(5):614-619.
Deeks SG, Tracy R, Douek DC. Systemic effects of inflammation on health during chronic HIV infection. Immunity. 2013;39(4):633-645.
Chang HR, Dulloo AG, Bistrian BR. Role of cytokines in AIDS wasting. Nutrition. 1998;14(11-12):853-863.
Castaneda C. Muscle wasting and protein metabolism. J Anim Sci. 2002;80(suppl 2):E98-E105.
Grinspoon S, Corcoran C, Lee K, et al. Loss of lean body and muscle mass correlates with androgen levels in hypogonadal men with acquired immunodeficiency syndrome and wasting. J Clin Endocrinol Metab. 1996;81(11):4051-4058.
Grinspoon S, Corcoran C, Miller K, et al. Body composition and endocrine function in women with acquired immunodeficiency syndrome wasting. J Clin Endocrinol Metab. 1997;82(5):1332-1337.
Melmed S. Disorders of the anterior pituitary and hypothalamus. In: Kasper DL, Fauci AS, Hauser SL, Longo DL, Jameson JL, Loscalzo J, eds. Harrison’s Principles of Internal Medicine. 19th ed. McGraw-Hill; 2015.

Important Safety Information and Indication

Expand

CONTRAINDICATIONS

Acute Critical Illness: Serostim^® (somatropin) 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 for full Prescribing Information.