Patient Case: Vera

Tolerability

Model portrayal

Vera’s Chief Complaint & History of Present Illness

Vera, a 33-year-old, HIV-1-positive African American female,* reports depression, anxiety, insomnia, and weight gain of 10 pounds over the past year.

HIV-1 diagnosis at age 30
Multi-tablet regimen prescribed at that time
Virologic failure ~1 year ago; switched to Triumeq^® (DTG/ABC/3TC) at that time
Anxiety, depression, and trouble falling/staying asleep developed 10 months ago
9 months ago: Started on sertraline 50 mg daily for depression. Symptoms improved with treatment

*This is a hypothetical patient.

3TC = lamivudine; ABC = abacavir; DTG = dolutegravir

Triumeq is a registered trademark of ViiV Healthcare.

Model portrayal

Vera’s Personal & Social History

Sexual history: Stable, heterosexual relationship

Occupation: Full-time hairdresser; busy working mom

Appreciates convenience of current STR

Lifestyle:

Divorced, lives with her two young children
Long hours at salon
Juggling work and childcare often makes her feel stressed and overwhelmed

STR = single-tablet regimen

Vera’s Physical Exam & Lab Tests

Physical exam: Normal

Fasting glucose: 90 mg/dL
Fasting lipids:
TC: 165 mg/dL
LDL-C: 75 mg/dL
HDL-C: 70 mg/dL
Trig: 100 mg/dL
Serum creatinine: 0.89 mg/dL
AST and ALT: WNL
Pregnancy test: negative

HIV panel
HIV Genotypic Resistance: Results from ~1 year ago, after initial virologic failure on an MTR. M184V mutation reported
Viral load: undetectable (<50 copies/mL) for 9 months
CD4+ cell count: 520 cells/mm³

ALT = alanine aminotransferase; AST = aspartate aminotransferase; CD4+ = cluster of differentiation 4; MTR = multi-tablet regimen

Model portrayal

Vera’s Assessment

33-year-old female with HIV-1 who is virologically suppressed on current therapy but experiencing tolerability issues:

Previous treatment failure with MTR; known resistance
Currently experiencing tolerability issues
Hectic lifestyle; stressed and overwhelmed balancing work/home demands
Appreciates convenience of STR

MTR = multi-tablet regimen; STR = single-tablet regimen

Model portrayal

If you are considering switching Vera’s ARV regimen, what potential factor(s) may be relevant in your regimen recommendation?

9 months of virologic suppression (<50 copies/mL)
Adherence to current regimen
Co-morbid conditions (eg, depression)
All of the above

ARV = antiretroviral

In addition to patient counseling and a follow-up visit in 2-4 weeks, which of the following single-tablet regimens would you consider prescribing for Vera?

Atripla^® (EFV/FTC/TDF)
Biktarvy^® (BIC/FTC/TAF)
Juluca^® (DTG/RPV)
SYMTUZA^® (DRV/c/FTC/TAF)

BIC = bictegravir; c = cobicistat; DRV = darunavir; DTG = dolutegravir; EFV = efavirenz; FTC = emtricitabine; RPV = rilpivirine; TAF = tenofovir alafenamide; TDF = tenofovir disoproxil fumarate

Atripla and Biktarvy are registered trademarks of Gilead Sciences. Juluca is a registered trademark of ViiV Healthcare.

BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

Severe acute exacerbations of hepatitis B (HBV) have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine and/or tenofovir disoproxil fumarate (TDF) and may occur with discontinuation of SYMTUZA^®.
Action: Monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue SYMTUZA^®. If appropriate, anti-hepatitis B therapy may be warranted.

CONTRAINDICATIONS

Darunavir and cobicistat are both inhibitors and substrates of the cytochrome P450 3A (CYP3A) isoform. SYMTUZA^® should not be co-administered with medicinal products that are highly dependent on CYP3A for clearance and for which increased plasma concentrations are associated with serious and/or life-threatening events. In addition, co-administration of SYMTUZA^® with CYP3A inducers is expected to lower plasma concentrations of darunavir and cobicistat which may lead to loss of efficacy of darunavir and development of resistance.

Action: Examples of drugs that are contraindicated for co-administration with SYMTUZA^® due to the potential for serious and/or life-threatening events or loss of therapeutic effect are listed below: alfuzosin, carbamazepine, colchicine (in patients with renal and/or hepatic impairment), dronedarone, elbasvir/grazoprevir, ergot derivatives (such as: dihydroergotamine, ergotamine, methylergonovine), ivabradine, lomitapide, lovastatin, lurasidone, oral midazolam, naloxegol, phenobarbital, phenytoin, pimozide, ranolazine, rifampin, St. John’s wort (Hypericum perforatum), sildenafil for pulmonary arterial hypertension, simvastatin, and triazolam.

WARNINGS AND PRECAUTIONS

Hepatotoxicity: Drug-induced hepatitis (e.g., acute hepatitis, cytolytic hepatitis) and cases of liver injury, including some fatalities, have been reported in patients receiving darunavir, a component of SYMTUZA^®. Patients with pre-existing liver dysfunction, including chronic active hepatitis B or C, have an increased risk for liver function abnormalities, including severe hepatic adverse reactions.

Action: Monitor liver function prior to initiating and during therapy, especially in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pretreatment elevations of transaminases. Patients with evidence of new or worsening liver function should consider discontinuing SYMTUZA^®. SYMTUZA^® is not recommended in patients with severe hepatic impairment (Child-Pugh Class C).
Severe Skin Reactions: In patients receiving darunavir, a component of SYMTUZA^®, severe skin reactions may occur, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis. These include conditions accompanied by fever and/or elevations of transaminases.

Action: Discontinue SYMTUZA^® immediately if signs or symptoms of severe skin reactions develop. These can include but are not limited to severe rash or rash accompanied with fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, hepatitis, and/or eosinophilia.
Risk of Serious Adverse Reactions or Loss of Virologic Response Due to Drug Interactions: Consult the full Prescribing Information prior to and during treatment for potential drug interactions.
Immune Reconstitution Syndrome: Patients receiving SYMTUZA^® may develop new onset or exacerbations of immune reconstitution syndrome.
New Onset or Worsening Renal Impairment: Postmarketing cases of renal impairment, including acute renal failure, proximal renal tubulopathy (PRT), and Fanconi syndrome have been reported with tenofovir alafenamide (TAF)-containing products; while most of these cases were characterized by potential confounders that may have contributed to the reported renal events, it is also possible these factors may have predisposed patients to tenofovir-related adverse events. SYMTUZA^® is not recommended in patients with estimated creatinine clearance below 30 mL per minute. Patients taking tenofovir prodrugs who have impaired renal function and those taking nephrotoxic agents including nonsteroidal anti-inflammatory drugs are at increased risk of developing renal-related adverse reactions.

Action: Prior to initiating or during treatment, on a clinically appropriate schedule, monitor serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus. Discontinue SYMTUZA^® in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Patients who experience a confirmed increase in serum creatinine of greater than 0.4 mg/dL should be closely monitored for renal safety.
Sulfa Allergy: Darunavir contains a sulfonamide moiety. The incidence and severity of rash were similar in subjects with or without a history of sulfonamide allergy.

Action: Monitor patients with a known sulfonamide allergy.
Lactic Acidosis/Severe Hepatomegaly With Steatosis: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including emtricitabine, a component of SYMTUZA^®, and tenofovir disoproxil fumarate (TDF), another prodrug of tenofovir, alone or in combination with other antiretrovirals.

Action: Discontinue SYMTUZA^® in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity.
Diabetes Mellitus/Hyperglycemia: New-onset or exacerbations of pre-existing diabetes mellitus and hyperglycemia have been reported in patients receiving protease inhibitors.

Action: Initiation or dose adjustments of insulin or oral hypoglycemic agents may be required.
Fat Redistribution: Redistribution and/or accumulation of body fat have been observed in patients receiving antiretroviral therapy.
Hemophilia: Patients with hemophilia may develop an increase in bleeding events.

ADVERSE REACTIONS

The most common clinical adverse reactions (all grades) occurring in at least 2% of treatment-naïve patients were diarrhea, rash,* nausea, fatigue, headache, abdominal discomfort, and flatulence.

*Includes pooled reported terms: dermatitis, dermatitis allergic, erythema, photosensitivity reaction, rash, rash generalized, rash macular, rash maculopapular, rash morbilliform, rash pruritic, toxic skin eruption, and urticaria.

Grade 2-4 laboratory abnormalities have been reported in patients receiving SYMTUZA^®, including elevations in serum creatinine, liver function tests, triglycerides, total cholesterol, low-density lipoproteins, and glucose levels. This is not a complete list of all adverse reactions reported with the use of SYMTUZA^®. Please refer to the full Prescribing Information for a complete list of adverse drug reactions.

USE IN SPECIFIC POPULATIONS

Pregnancy: SYMTUZA^® is not recommended for use during pregnancy and should not be initiated in pregnant individuals because of substantially lower exposures of darunavir and cobicistat during pregnancy.

Lactation: The Centers for Disease Control and Prevention recommends that HIV-infected mothers in the United States must not breastfeed their infants to avoid risking postnatal transmission of HIV-1 infection.
Pediatric Use: The safety and effectiveness of SYMTUZA^® have not been established and is not recommended in pediatric patients weighing less than 40 kg.
Consult the full Prescribing Information for SYMTUZA^® for additional information on the Uses in Specific Populations.

Please see full Prescribing Information, including Boxed WARNING for SYMTUZA^®.

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Patient Case: Vera

Tolerability

Vera’s Chief Complaint & History of Present Illness

Vera’s Personal & Social History

Vera’s Physical Exam & Lab Tests

Vera’s Assessment

If you are considering switching Vera’s ARV regimen, what potential factor(s) may be relevant in your regimen recommendation?

In addition to patient counseling and a follow-up visit in 2-4 weeks, which of the following single-tablet regimens would you consider prescribing for Vera?

EXTERNAL LINK

Healthcare Professionals