Tesamorelin in hiv-associated lipodystrophy and excess visceral adiposity: effect on the anchor outcome
In the population defined for hiv-associated lipodystrophy and excess visceral adiposity, what is the effect of Tesamorelin compared with the comparator used in its contributing trials on the anchor outcome for this indication?
Templated review frame. This review question was generated by crossing an indication with a compound for which contributing trials exist. Its prose frame is templated and is shared with other questions of the same shape. Its included studies, its summary of findings and its certainty rating are computed from the underlying records and are not templated. The Institute publishes these questions because the alternative is to leave a question the document set can answer unanswered, and it labels them because the alternative is to present a templated frame as an authored one.
§1Abstract
§1.1Review question
In the population defined for hiv-associated lipodystrophy and excess visceral adiposity, what is the effect of Tesamorelin compared with the comparator used in its contributing trials on the anchor outcome for this indication?
§1.2PICO frame
Table 1. The registered PICO frame. Any change made after protocol registration is recorded in the amendment log at §5 and is identified there as post hoc.
| Element | As registered |
|---|---|
| Population | Abnormal regional fat distribution with excess visceral adipose tissue, in the setting of HIV infection and antiretroviral therapy. |
| Intervention | Tesamorelin administered as subcutaneous once daily. |
| Comparator | The comparator used in each contributing trial, reported per trial rather than pooled across comparator types. |
| Outcomes | Anchor outcome for this indication: Change in visceral adipose tissue area by computed tomography. Additional outcomes: Change in triglycerides; Change in IGF-1; Glucose tolerance. |
§1.3Method in brief
A review of the effects of an intervention on pre-specified outcomes, with a quantitative synthesis where the contributing studies are sufficiently similar. The protocol was registered with the Institute's secretariat before the search was executed. The search was run on 12 May 2025 across 8 sources and is reproduced in full at §2. Screening, extraction and certainty assessment were performed independently by two members of the secretariat with disagreement resolved by a third.[1,2]
§1.4Conclusion
Moderate certainty evidence from 2 contributing trials bears on the effect of Tesamorelin on the anchor outcome for hiv-associated lipodystrophy and excess visceral adiposity. The estimate the Institute carries in the monograph is: Visceral adipose tissue reduced by 15.2 % versus 5.0 % increase with placebo at 26 weeks. Two pivotal trials in HIV-associated lipodystrophy with computed-tomography endpoints. Downgraded for indirectness when applied to any population outside that indication.
The conclusion rests on 2 contributing studies, listed with their extracted data at §3 and summarised outcome by outcome at §4.
§1.5Limitations
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- Falutz J, Allas S, Blot K, Potvin D, Kotler D, Somero M, Berger D, Brown S, Richmond G, Fessel J, Turner R, Grinspoon S. Metabolic effects of a growth hormone-releasing factor in patients with HIV. New England Journal of Medicine 2007;357(23):2359–2370. doi:10.1056/NEJMoa072375 · PMID 18052660
- Prakash A, Goa KL. Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency. BioDrugs 1999;12(2):139–157. doi:10.2165/00063030-199912020-00007 · PMID 18031173
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.