Total Body Bone Loss Reported In A Single Arm Adolescent Study on Truvada

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A recent study in Clinical Infectious diseases suggested that patients between the ages of 15 and 19 years of age taking PrEP for HIV prevention, may not recover from bone mineral density loss.  Of particular concern, is that the damage was incurred in the lumbar spine region and whole body BMD Z-scores.  Despite the reported total body bone loss of a participant, the FDA proceeded to approve Truvada, PrEP by drug manufacturer Gilead Sciences.   

This is very troubling news, given that bone growth occurs in the same window of time that patients incur damage from taking PrEP.  Healthy growth and development in adolescence is critical for a patient’s quality of life.  A drug that has been proven to decrease bone mass is very detrimental to the future health and quality of life for these adolescent patients.  Despite this clearly spelled out issue, the  the FDA went ahead and approved the use of PrEP against HIV for teens aged 15 to 17 with a body weight of 77 pounds.  The approval follows the findings of a single-arm, open label clinical trial with another issue – documented issues regarding adherence among the adolescent participants.

In 2012, the FDA approved Truvada for adults use only.  Six years later, the approval for teens followed the results of  ATN113, a study done on 67 high risk adolescents.  Three patients in the study experienced decreased bone mineral density z-scores at week 24 and 48.  One patient experienced a significant amount of bodily damage – suffering a total body bone density loss greater than 4% by week 24 of the study.  Despite these less than promising results, the drug was given a green light for use by adolescents weighing more than 77 pounds and at least 15 years of age.

Another major concern among the young participants in the study was the lack of adherence, with low rates among adolescents falling at the 12th week, followed by a very significant drop by the 48th week of the study.  Interestingly, upon the approval the NIH reported that “Researchers turned up no evidence of harmful effects on kidneys or bones in this group.”  This statement was made in a NICHD press release, even though the documentation on total body bone mineral loss in one participant.

The FDA’s decision to move forward with approval was based on the results of this NICHD-supported study.  The study author of NICHD’s Maternal and Pediatric Infectious Diseases Branch Dr. Bill Kapogiannis made a statement discounting the potential risks of PrEP use among adolescents.  Dr Kapogiannis stated that ”Our study showed that the benefit of protecting at-risk young males from HIV infection far outweigh the potential risk of the therapy.”

The NIH announced their participation and support of this study in a press release from their newsroom.  While the press release stated that no evidence of damage to the kidneys or bones occurred, the study had clear documentation of total body bone loss in one participant.  And yet, in the same press release, the lead doctor of the study stated that the protection far outweighs the potential risks.  This report on Truvada’s PrEP by the NICHD is troubling, given that the total body bone loss of one participant did not seem to be treated as a serious medical outcome.

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