Rationale and design of the Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE)

Area of Science:

• Cardiology
• Infectious Diseases
• Clinical Trials

Background:

• Cardiovascular disease (CVD) is more prevalent in people with HIV (PWH), potentially due to inflammation and immune activation.
• A significant need exists for effective CVD prevention strategies tailored to PWH.
• Traditional and nontraditional risk factors contribute to CVD risk in PWH.

Purpose of the Study:

• To evaluate the efficacy of a statin strategy for primary CVD prevention in PWH.
• To assess the impact of pitavastatin on major adverse cardiovascular events (MACE) in a low-to-moderate risk PWH population.
• To investigate the safety and efficacy of statin therapy in HIV-infected individuals on antiretroviral therapy.

Main Methods:

• The Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) is a prospective, randomized, placebo-controlled trial.
• Over 7,500 PWH aged 40-75 on stable antiretroviral therapy were randomized to pitavastatin or placebo for up to 8 years.
• Eligibility was based on the 2013 ACC/AHA ASCVD risk score and LDL-C levels, targeting individuals with low to moderate traditional risk.

Main Results:

• REPRIEVE has successfully enrolled over 7,500 diverse participants across 11 countries.
• The trial has generated a representative population of PWH for investigating CVD primary prevention.

Conclusions:

• REPRIEVE is the first trial to investigate a primary CVD prevention strategy specifically in PWH.
• Findings will inform the efficacy and safety of statin use in PWH on antiretroviral therapy.
• The study will provide crucial insights into CVD mechanisms and non-CVD events within the PWH population.