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Patients Who May BenefitThose who are living with HIVPitavastatin has been studied in several patient types, including those living with HIV. |
ZYPITAMAG may be an appropriate option for this patient population given the following:
- Drug Interactions/Metabolism: Pitavastatin undergoes minimal metabolism by CYP enzymes and can be co-administered with certain HIV protease inhibitors with no dose limitation1
- Safety and Efficacy: Pitavastatin has been studied in persons living with HIV and dyslipidemia.1,2 LDL-C reduction was 31% with pitavastatin 4 mg vs 21% with pravastatin 40 mg (p<0.0001) at 12 weeks.1,2
- Access: Zypitamag is available on the ADAP formulary, or through Marley Drug pharmacy for $34.50/month
Please note the limitation of use statement in the ZYPITAMAG (pitavastatin) Package Insert. The effect of ZYPITAMAG on cardiovascular morbidity and mortality has not been determined.1
Persons Living with HIV are at a Higher Risk for Heart Disease
People living with HIV infection are living longer thanks to advancements in medications to manage HIV infection. As a result, this patient population is now living long enough to experience non-AIDS-defining illnesses.
According to ACC/AHA Guidelines, HIV infection is considered to be an ASCVD risk-enhancing factor.
The presence of risk-enhancing factors may affect the threshold for statin initiation or intensification.3
REPRIEVE Trial Investigates Statins and HIV
A recent clinical trial called REPRIEVE aimed to determine whether statin use prevents atherosclerotic cardiovascular disease events in persons with HIV infection who are at low-to-moderate risk for cardiovascular events.4
The investigators used pitavastatin as the statin in this study because it does not interact with the drugs that are used in antiretroviral therapy.
The REPRIEVE trial demonstrated that daily pitavastatin reduced the risk of cardiovascular disease in people living with HIV by 35%. The effect of ZYPITAMAG on cardiovascular morbidity and mortality has not been determined.1
Statins Are Underutilized in people living with HIV
Treating dyslipidemia has historically been challenging for people living with HIV population given the increased potential for drug interactions due to competing cytochrome P450 (CYP450) metabolism with statins and antiretroviral therapies. These interactions can lead to issues with efficacy and statin tolerability.
Data analyzed from the National Ambulatory Medical Care Survey/National Hospital Ambulatory Medical Care Survey from 2006 to 2013 identified that physicians generally underused guideline-recommend cardiovascular care in people living with HIV.5
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Adapted from Figure 1 of Ladapo JA et al. J Am Heart Assoc. 2017;6:e007107.
ZYPITAMAG has reduced potential to interact with other medications
Most statins are processed by our body through an enzyme family called cytochrome 450, or CYP450 for short. 70-80% of drugs are also metabolized by this pathway.
ZYPITAMAG has no contraindications, dose restrictions, or limitations with certain medications, including Atazanavir, Darunavir/Ritonavir, and Lopinavir/Ritonavir.
ZYPITAMAG is only minimally metabolized via CYP and primarily metabolized by glucuronidation†. In combination with select drugs, ZYPITAMAG has a reduced potential for certain drug interactions.
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†The principal route of pitavastatin metabolism is glucuronidation via liver uridine 5'-diphosphate glucuronosyltransferase (UGT) with subsequent formation of pitavastatin lactone. There is only minimal metabolism by the cytochrome P450 system. Pitavastatin is marginally metabolized by CYP2C9 and to a lesser extent by CYP2C8.
*CYP2C9 isoenzyme is primarily involved in the metabolism of fluvastatin (approximately 75%), while CYP2C8 and CYP3A4 isoenzymes are involved to a much less extent, i.e., approximately 5% and approximately 20%, respectively.
Pitavastatin Significantly Reduces LDL-C Compared to Pravastatin in those with HIV2
The INTREPID trial was a randomized, double-blind, active-controlled, phase 4 trial which recruited adults aged 18-70 years with controlled HIV who were on antiretroviral therapy for at least six months and with dyslipidemia.
Patients were randomized to receive pitavastatin 4mg (n=126) or pravastatin 40mg (n=126) once daily for 12 weeks, followed by a 40-week safety extension.
At 52 weeks, LDL-cholesterol was reduced by 30% with pitavastatin and 20% with pravastatin.
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INTREPID (HIV-infected patients and treatment with Pitavastatin vs pravastatin for Dyslipidemia) randomized, double-blind, active-controlled, phase , 52-week trial. 252 HIV-infected patients with dyslipidemia were treated with either pitavastatin 4 mg once daily (n=126) or another statin (n=126). All patients were taking antiretroviral therapy (excluding darunavir) and had HIV-1 RNA less than 200 copies/mL and CD4 count greater than 200 cell/μL for at least 3 months prior to randomization.
Help your patient find the Right Statin, Right Away
Zypitamag is accessible like a generic statin.
ZYPITAMAG is covered on many state ADAP formularies. It is also available through Marley Drug pharmacy for $1.15/day. That's $34.50/month. Plus, the first 30-days is free to patients new to ZYPITAMAG.
ADAP - AIDS Drug Assistance Program
States Available |
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Click another example of a patient group who may benefit from Zypitamag:
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Are living with HIV |
IMPORTANT SAFETY INFORMATION FOR ZYPITAMAG™ (pitavastatin) tablets
INDICATIONS & USAGE
ZYPITAMAG is indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in adult patients with primary hyperlipidemia.
Pediatric use information is approved for Kowa Co Ltd LIVALO (pitavastatin) tablets. However, due to Kowa Co Ltd marketing exclusivity rights, this drug product is not labeled with that information.
CONTRAINDICATIONS
ZYPITAMAG is contraindicated in the following conditions:
- Concomitant use of cyclosporine.
- Acute liver failure or decompensated cirrhosis.
- Hypersensitivity to pitavastatin or any excipients in ZYPITAMAG. Hypersensitivity reactions including angioedema, rash, pruritus, and urticaria have been reported with pitavastatin.
WARNINGS & PRECAUTIONS
- Myopathy and Rhabdomyolysis: Risk factors include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs (including other lipid-lowering therapies), and higher ZYPITAMAG dosage. ZYPITAMAG is contraindicated in patients taking cyclosporine and not recommended in patients taking gemfibrozil. The following drugs when used concomitantly with ZYPITAMAG may also increase the risk of myopathy and rhabdomyolysis: lipid-modifying dosages of niacin (>1 g/day), fibrates, and colchicine. Discontinue ZYPITAMAG if markedly elevated CK levels occur or if myopathy is either diagnosed or suspected. Temporarily discontinue ZYPITAMAG in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis; e.g., sepsis; shock; severe hypovolemia; major surgery; trauma; severe metabolic, endocrine, or electrolyte disorders; or uncontrolled epilepsy. Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing the ZYPITAMAG dosage. Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever.
- Immune-Mediated Necrotizing Myopathy (IMNM): There have been rare reports of IMNM, an autoimmune myopathy, associated with statin use, including reports of recurrence when the same or a different statin was administered. IMNM is characterized by proximal muscle weakness and elevated serum creatine kinase that persist despite discontinuation of statin treatment; positive anti-HMG CoA reductase antibody; muscle biopsy showing necrotizing myopathy; and improvement with immunosuppressive agents. Additional neuromuscular and serologic testing may be necessary. Treatment with immunosuppressive agents may be required. Discontinue ZYPITAMAG if IMNM is suspected.
- Hepatic Dysfunction: Increases in serum transaminases can occur. Rare postmarketing reports of fatal and non-fatal hepatic failure have occurred. Consider liver enzyme testing before initiating therapy and as clinically indicated thereafter. If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue ZYPITAMAG.
- Increases in HbA1c and Fasting Serum Glucose Levels: Increases of each have been reported with statins, including ZYPITAMAG. Optimize lifestyle measures, including regular exercise, maintaining a healthy body weight, and making healthy food choices.
ADVERSE REACTIONS: The most frequent adverse reactions (rate ≥ 2%) are myalgia, constipation, diarrhea, back pain, and pain in extremity. This is not a complete list of all reported adverse events.
For additional information, refer to full Prescribing Information.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.
