Patient Case: Ray

Patient Profile: Ray

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Model portrayal

Ray’s Chief Complaint & History of Present Illness

A 29-year-old Caucasian man* with HIV-1 infection reports urethral burning and discharge.

Symptoms began 3 days ago
HIV-1 diagnosed 2 years ago
- - HIV genotypic resistance test showed no mutations
- - Started on Tivicay^® (DTG) 50 mg and Descovy^® (FTC/TAF) at that time
Reports having trouble maintaining routines due to irregular travel and work schedule
Asks about single-tablet regimen options

*This is a hypothetical patient

DTG = dolutegravir; FTC = emtricitabine; TAF = tenofovir alafenamide

Descovy is a registered trademark of Gilead Sciences. Tivicay is a registered trademark of Viiv Healthcare.

Model portrayal

Ray’s Personal & Social History

Sexual history: MSM

Occupation: Long-haul trucker

Lifestyle:

Couch-surfs with friends and family when not on the road
Social drinker
No reported history of illicit drug use

MSM = men who have sex with men

Ray’s Physical Exam & Lab Tests

Pertinent physical findings:
- Purulent urethral discharge
- No genital lesions or inguinal adenopathy

Fasting glucose: 85 mg/dL
Fasting lipids:
TC: 138 mg/dL
LDL-C: 60 mg/dL
HDL-C: 60 mg/dL
Trig: 90 mg/dL
Serum creatinine: 0.75 mg/dL
AST and ALT: WNL
HBV vaccinated

HIV laboratory results
Viral load (over past 12 months):
- 200 copies/mL ~11 months ago
- 400 copies/mL ~9 months ago
- Undetectable (<50 copies/mL) since then
CD4+ cell count: 410/mm³
STD screening:
Positive for gonorrhea

ALT = alanine aminotransferase; AST = aspartate aminotransferase; CD4+ = cluster of differentiation 4; STD = sexually transmitted disease

Model portrayal

Ray’s Assessment

29-year-old man with HIV-1 infection and gonorrhea, at risk for suboptimal adherence with his antiretroviral regimen:

Diagnosed and treated for STD during this visit
Currently on an MTR; interested in STR options

MTR = multi-tablet regimen; STD = sexually transmitted disease; STR = single-tablet regimen

Model portrayal

What potential factor(s) may support switching Ray to a different ARV regimen?

Decrease pill burden
Prior virologic failure
Virologic suppression
Suboptimal adherence

ARV = antiretroviral

In addition to recommending patient counseling and scheduling a follow-up visit in 2-4 weeks, which of the following ARV regimens would you consider recommending for Ray?

Biktarvy^® (BIC/FTC/TAF)
Odefsey^® (RPV/FTC/TAF)
SYMTUZA^® (DRV/c/FTC/TAF)
Triumeq^® (DTG/ABC/3TC)

3TC = lamivudine; ABC = abacavir; ARV = antiretroviral; BIC = bictegravir; c = cobicistat; DRV = darunavir; DTG = dolutegravir; FTC = emtricitabine; RPV = rilpivirine; TAF = tenofovir alafenamide

Biktarvy and Odefsey are registered trademarks of Gilead Sciences. Triumeq 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: Ray

Patient Profile: Ray

Ray’s Chief Complaint & History of Present Illness

Ray’s Personal & Social History

Ray’s Physical Exam & Lab Tests

Ray’s Assessment

What potential factor(s) may support switching Ray to a different ARV regimen?

In addition to recommending patient counseling and scheduling a follow-up visit in 2-4 weeks, which of the following ARV regimens would you consider recommending for Ray?

EXTERNAL LINK

Healthcare Professionals