HTB

Statins reduce heart disease by 35% in the international HIV REPRIEVE study

Simon Collins, HIV i-Base

The largest randomised controlled study of statin therapy in people living with HIV has proved benefits earlier than expected, with all participants now being offered statins. [1, 2]

This international US-funded REPRIEVE study (NCT02344290) randomised just over 7,750 participants to either oral pitavastatin calcium (4 mg daily) or matched placebo.  Entry criteria included HIV positive adults aged 40 to 75, on ART with CD4 counts >100 cells/mm3.

Participants also could only have with low-to-moderate cardiovascular risk, when statins would not be routinely used. This definition included having a 10-year risk of serious cardiovascular events that was less than 10%. The study notes that pitavastatin was used because it has fewer drug interactions, other statins have similar lipid and anti-inflammatory properties.

The study started in 2015 and included more than 100 sites in the US, Canada, Thailand, South Africa, Brazil, Peru, Haiti, Zimbabwe, Botswana, Uganda and India.

A planned early interim analysis showed that people in the statin group had 35% fewer cardiovascular events including heart attacks and strokes, and the placebo arm has now closed early. All participants will be offered open-label pitavastatin and will continue to be followed until the planned end of the study. 

Important sub-studies in REPRIEVE include an analysis presented at CROI 2023 reporting that integrase inhibitors were associated with modestly higher BMI increases over two years, and that these were significantly higher in women and Black African/American participants. [3]

Although pitavastatin is approved and available in the UK, similar results would be expected with other statins that are available as genrics. [4]

comment

Notably important in the context of HIV, a recent meta-analysis of three large RCTs in the general population and a related editorial comment, reported on the role of immune inflammation (measured as CRP) as a risk factor for cardiovascular disease in people taking statins. [5, 6]

References

  1. NIH press release. Daily statin reduces the risk of cardiovascular disease in people living with HIV large NIH study finds. (11 April 2023).
    https://www.nih.gov/news-events/news-releases/daily-statin-reduces-risk-cardiovascular-disease-people-living-hiv-large-nih-study-finds
  2. Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) study website.
    https://www.reprievetrial.org/
  3. Kileel E et al. Changes in body mass index with integrase inhibitor use in REPRIEVE. CROI 2023. Poster abstract 706.
    https://www.croiconference.org/abstract/changes-in-body-mass-index-with-integrase-inhibitor-use-in-reprieve/
  4. MHRA. Pitavastatin (Livazo).Summary of product characteristics (SPC)
    https://products.mhra.gov.uk/substance/?substance=PITAVASTATIN CALCIUM (download page)
    https://mhraproducts4853.blob.core.windows.net/docs/ffa93e31acfb534017d60ac65977dda995cde568 (direct PDF)
  5. Tardif J-C and Samuel M.  Inflammation contributes to cardiovascular risk in patients receiving statin therapy. Lancet, comment. 401(10384); p1245-1247. (15 April 2023).
    https://doi.org/10.1016/S0140-6736(23)00454-3
  6. Ridker PM et al. Inflammation and cholesterol as predictors of cardiovascular events among patients receiving statin therapy: a collaborative analysis of three randomised trials. Lancet. 2023.
    https://doi.org/10.1016/S0140-6736(23)00215-5

Links to other websites are current at date of posting but not maintained.