Descovy Side Effects Center

Last updated on RxList: 1/24/2022
Descovy Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Descovy?

Descovy (emtricitabine and tenofovir alafenamide) is a two-drug combination of two HIV nucleoside analog reverse transcriptase inhibitors (NRTIs), and is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older.

What Are Side Effects of Descovy?

Common side effects of Descovy include:

  • nausea
  • changes in body fat distribution
  • changes in your immune system
  • new or worse kidney problems, including kidney failure,
  • bone problems such as bone pain, softening, or thinning and fractures, or
  • increased cholesterol.

Dosage for Descovy

The recommended dosage of Descovy is one tablet taken once daily with or without food in patients 12 years old and older with body weight at least 35 kg and a creatinine clearance greater than or equal to 30 mL per minute.

What Drugs, Substances, or Supplements Interact with Descovy?

Descovy may interact with protease inhibitors, anticonvulsants, antimycobacterials, and St. John's wort. Tell your doctor all medications and supplements you use.

Descovy During Pregnancy and Breastfeeding

During pregnancy, Descovy should be used only if prescribed. Tell your doctor if you are pregnant or become pregnant while taking Descovy. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Descovy during pregnancy. Because breast milk can transmit HIV, do not breastfeed.

Additional Information

Our Descovy (emtricitabine and tenofovir alafenamide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

What is HIV? See Answer
Descovy Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Mild symptoms of lactic acidosis may worsen over time, and this condition can be fatal. Get emergency medical help if you have: unusual muscle pain, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, feeling cold, or feeling very weak or tired.

Call your doctor at once if you have:

  • symptoms of new HIV infection--fever, night sweats, tiredness, muscle or joint pain, sore throat, vomiting, diarrhea, rash, swollen glands in your neck or groin;
  • sudden or unusual bone pain;
  • kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath; or
  • liver problems--nausea, swelling around your midsection, upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Emtricitabine and tenofovir affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:

  • signs of a new infection--fever, sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;
  • trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or
  • swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common side effects may include:

  • headache, dizziness, feeling depressed or tired;
  • trouble sleeping, strange dreams;
  • nausea, stomach pain;
  • weight loss; or
  • rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Descovy (Emtricitabine and Tenofovir Alafenamide Tablets)

SLIDESHOW

A Timeline of the HIV/AIDS Pandemic See Slideshow
Descovy Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in other sections of the labeling:

  • Severe Acute Exacerbations of Hepatitis B [see WARNINGS AND PRECAUTIONS].
  • Immune Reconstitution Syndrome [see WARNINGS AND PRECAUTIONS].
  • New Onset or Worsening Renal Impairment [see WARNINGS AND PRECAUTIONS].
  • Lactic Acidosis/Severe Hepatomegaly with Steatosis [see WARNINGS AND PRECAUTIONS].

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug (or a drug given in various combinations with other concomitant therapy) cannot be directly compared to rates in the clinical trials of another drug (or drug given in the same or different combination therapy) and may not reflect the rates observed in practice.

Adverse Reactions In Clinical Trials Of FTC+TAF With Elvitegravir (EVG) Plus Cobicistat (COBI) In Treatment-Naive Adults With HIV-1 Infection

In pooled 48-week trials of antiretroviral treatment-naive HIV-1 infected adult subjects, the most common adverse reaction in subjects treated with FTC+TAF with EVG+COBI (N=866) (incidence greater than or equal to 10%, all grades) was nausea (10%). In this treatment group, 0.9% of subjects discontinued FTC+TAF with EVG+COBI due to adverse events during the 48-week treatment period [see Clinical Studies]. The safety profile was similar in virologicallysuppressed adults with HIV-1 infection who were switched to FTC+TAF with EVG+COBI (N=799). Antiretroviral treatment-naive adult subjects treated with FTC+TAF with EVG+COBI experienced mean increases of 30 mg/dL of total cholesterol, 15 mg/dL of LDL cholesterol, 7 mg/dL of HDL cholesterol, and 29 mg/dL of triglycerides after 48 weeks of use.

Renal Laboratory Tests

In two 48-week trials in antiretroviral treatment-naive HIV-1 infected adults treated with FTC+TAF with EVG+COBI (N=866) with a median baseline eGFR of 115 mL per minute, mean serum creatinine increased by 0.1 mg per dL from baseline to Week 48. Median urine protein-to-creatinine ratio (UPCR) was 44 mg per gram at baseline and at Week 48. In a 48-week trial in virologicallysuppressed TDF-treated adults who switched to FTC+TAF with EVG+COBI (N=959) with a mean baseline eGFR of 112 mL per minute, mean serum creatinine was similar to baseline at Week 48; median UPCR was 61 mg per gram at baseline and 46 mg per gram at Week 48. Across these trials, renal serious adverse events or discontinuations due to renal adverse reactions were encountered in less than 1% of participants treated with FTC+TAF with EVG+COBI.

In a 24-week trial in adults with renal impairment (baseline eGFR 30 to 69 mL per minute) who received FTC+TAF with EVG+COBI (N=248), mean serum creatinine was 1.5 mg per dL at both baseline and Week 24. Median UPCR was 161 mg per gram at baseline and 93 mg per gram at Week 24. FTC+TAF with EVG+COBI was permanently discontinued due to worsening renal function in two of 80 (3%) subjects.

Bone Mineral Density Effects

In the pooled analysis of two 48-week trials of antiretroviral treatment-naive HIV- 1 infected adult subjects, bone mineral density (BMD) from baseline to Week 48 was assessed by dual-energy X-ray absorptiometry (DXA). Mean BMD decreased from baseline to Week 48 -1.30% with FTC+TAF with EVG+COBI at the lumbar spine and -0.66% at the total hip. BMD declines of 5% or greater at the lumbar spine were experienced by 10% of FTC+TAF with EVG+COBI subjects. BMD declines of 7% or greater at the femoral neck were experienced by 7% of FTC+TAF with EVG+COBI subjects. The long-term clinical significance of these BMD changes is not known.

In 799 virologically-suppressed TDF-treated adult subjects that switched to FTC+TAF with EVG+COBI, at Week 48 mean BMD increased (1.86% lumbar spine, 1.95% total hip). BMD declines of 5% or greater at the lumbar spine were experienced by 1% of FTC+TAF with EVG+COBI subjects. BMD declines of 7% or greater at the femoral neck were experienced by 1% of FTC+TAF with EVG+COBI subjects.

Adverse Reactions In A Clinical Trial Of FTC+TAF With EVG+COBI In Virologically-Suppressed Adults With End Stage Renal Disease (ESRD) Receiving Chronic Hemodialysis

In a 48-week trial of virologically-suppressed HIV-1 infected adult subjects with end stage renal disease (ESRD) (estimated creatinine clearance of less than 15 mL/min) on chronic hemodialysis treated with FTC+TAF with EVG+COBI (N=55), the most commonly reported adverse reaction (adverse event assessed as causally related by investigator and all grades) was nausea (7%). Serious adverse events were reported in 53% of subjects and the most common serious adverse events were pneumonia (13%), fluid overload (7%), hyperkalemia (7%) and osteomyelitis (7%). Overall 5% of subjects permanently discontinued treatment due to an adverse event.

Adverse Reactions In Clinical Trials In Pediatric Subjects With HIV-1 Infection

Pediatric Subjects Weighing At Least 25 kg

The safety profile of FTC+TAF in pediatric subjects weighing at least 25 kg is informed by an open-label trial of antiretroviral treatment-naive HIV-1 infected pediatric subjects between the ages of 12 to less than 18 years weighing at least 35 kg through 48 weeks (N=50; Cohort 1) and virologically-suppressed subjects between the ages of 6 to less than 12 years weighing at least 25 kg (N=52; Cohort 2). Subjects received FTC+TAF with EVG+COBI through 48 weeks. With the exception of a decrease in the mean CD4+ cell count observed in cohort 2, the safety of this combination was similar to that in adults.

Bone Mineral Density Effects

Cohort 1: Treatment-Naive Adolescents (12 to less than 18 years; at least 35 kg)

Among the subjects in cohort 1 receiving FTC+TAF with EVG+COBI, mean BMD increased from baseline to Week 48, +4.2% at the lumbar spine and +1.3% for the total body less head (TBLH). Mean changes from baseline BMD Z-scores were -0.07 for lumbar spine and -0.20 for TBLH at Week 48. One subject had significant (at least 4%) lumbar spine BMD loss at Week 48.

Cohort 2: Virologically-Suppressed Children (6 to less than 12 years; at least 25 kg)

Among the subjects in cohort 2 receiving FTC+TAF with EVG+COBI, mean BMD increased from baseline to Week 48, +3.9% at the lumbar spine and +4.2% for TBLH. Mean changes from baseline BMD Z-scores were -0.24 for lumbar spine and -0.19 for TBLH at Week 48. Six subjects had significant (at least 4%) lumbar spine BMD loss at Week 48 and 2 subjects also had at least 4% TBLH BMD loss at Week 48.

Change From Baseline In CD4+ Cell Counts

Cohort 2: Virologically-Suppressed Children (6 to less than 12 years; at least 25 kg)

Cohort 2 evaluated pediatric subjects (N=52) who were virologicallysuppressed and who switched from their antiretroviral regimen to FTC+TAF with EVG+COBI. Although all subjects had HIV-1 RNA < 50 copies/mL, there was a decrease from baseline in CD4+ cell count at Weeks 24 and 48. The mean baseline and mean change from baseline in CD4+ cell count and in CD4% from Week 2 to Week 48 are presented in Table 2. All subjects maintained their CD4+ cell counts above 400 cells/mm³ [see Use In Specific Populations].

Table 2 : Mean Change in CD4+ Count and CD4 Percentage from Baseline to Week 48 in Virologically-Suppressed Pediatric Patients from 6 to <12 Years Who Switched to FTC+TAF with EVG+COBI

Baseline Mean Change from Baseline
Week 2 Week 4 Week 12 Week 24 Week 32 Week 48
CD4+ Cell Count (cells/mm³) 961 (275.5)a -117 -114 -112 -118 -62 -66
CD4% 38 (6.4)a +0.3% -0.1% -0.8% -0.8% -1.0% -0.6%
a Mean (SD)

Pediatric Subjects Weighing At Least 14 To Less Than 25 kg

In a separate open-label trial of virologically-suppressed subjects at least 2 years of age and weighing at least 14 to less than 25 kg (N=22; Cohort 3) who received FTC+TAF with bictegravir through 24 weeks, no new adverse reactions or laboratory abnormalities were identified compared to those observed in adults. In this trial, the mean (SD) change from baseline to Week 24 in CD4+ cell count was -126 (264) cells per mm³ and the mean (SD) change in CD4% from baseline to Week 24 was 0.2% (4.4%).

Adverse Reactions From Clinical Trial Experience In HIV-1 Uninfected Individuals Taking DESCOVY For HIV-1 PrEP

The safety profile of DESCOVY for HIV-1 PrEP was comparable to that observed in clinical trials of HIV-infected subjects based on a double-blind, randomized, active-controlled trial (DISCOVER) in which a total of 5,387 HIV-1 uninfected adult men and transgender women who have sex with men received DESCOVY (N=2,694) or TRUVADA (N=2,693) once daily for HIV-1 PrEP [see Clinical Studies]. Median duration of exposure was 86 and 87 weeks, respectively. The most common adverse reaction in participants who received DESCOVY (incidence greater than or equal to 5%, all grades) was diarrhea (5%). Table 3 provides a list of the most common adverse reactions that occurred in 2% or more of participants in either treatment group. The proportion of participants who discontinued treatment with DESCOVY or TRUVADA due to adverse events, regardless of severity, was 1.3% and 1.8%, respectively.

Table 3 : Adverse Reactions (All Grades) Reported in ≥2% in Either Arm in the DISCOVER Trial of HIV-1 Uninfected Participants

DESCOVY
(N=2,694)
TRUVADA
(N=2,693)
Diarrhea 5% 6%
Nausea 4% 5%
Headache 2% 2%
Fatigue 2% 3%
Abdominal paina 2% 3%
a Includes the following terms: abdominal pain, abdominal pain upper, abdominal pain lower, gastrointestinal pain, and abdominal discomfort

Renal Laboratory Tests

Changes from baseline to Week 48 in renal laboratory data are presented in Table 4. The long-term clinical significance of these renal laboratory changes on adverse reaction frequencies between DESCOVY and TRUVADA is not known.

Table 4 : Laboratory Assessments of Renal Function Reported in HIV-1 Uninfected Participants Receiving DESCOVY or TRUVADA in the DISCOVER Trial

DESCOVY
(N=2,694)
TRUVADA
(N=2,693)
Serum Creatinine (mg/dL)a Change at Week 48 -0.01 (0.107) 0.01 (0.111)
eGFRoG (mL/min)b Change at Week 48 1.8 (-7.2, 11.1) -2.3 (-10.8, 7.2)
Percentage of Participants who Developed UPCR ≥200 mg/gc At Week 48 0.7% 1.5%
eGFRCG=estimated Glomerular Filtration Rate by Cockcroft-Gault; UPCR=urine protein/creatinine ratio
a Mean (SD).
b Median (Q1, Q3).
c Based on N who had normal UPCR (≤ 200 mg/g) at baseline.

Bone Mineral Density Effects

In the DISCOVER trial, mean increases from baseline to Week 48 of 0.5% at the lumbar spine (N=159) and 0.2% at the total hip (N=158) were observed in participants receiving DESCOVY, compared to mean decreases of 1.1% at the lumbar spine (N=160) and 1.0% at the total hip (N=158) in participants receiving TRUVADA. BMD declines of 5% or greater at the lumbar spine and 7% or greater at the total hip were experienced by 4% and 1% of participants, respectively, in both treatment groups at Week 48. The long-term clinical significance of these BMD changes is not known.

Serum Lipids

Changes from baseline to Week 48 in total cholesterol, HDL-cholesterol, LDLcholesterol, triglycerides, and total cholesterol to HDL ratio are presented in Table 5.

Table 5 : Fasting Lipid Values, Mean Change from Baseline, Reported in HIV-1 Uninfected Participants Receiving DESCOVY or TRUVADA in the DISCOVER Triala

DESCOVY
(N=2,694)
TRUVADA
(N=2,693)
Baseline mg/dL Week 48 Changeb Baseline mg/dL Week 48 Changeb
Total Cholesterol (fasted) 176c 0 c 176 d -12 d
HDL-Cholesterol (fasted) 51 c -2 c 51 d -5 d
LDL-Cholesterol (fasted) 103 e 0 e 103 f -7 f
Triglycerides (fasted) 109 c +9 c 111 d -1 d
Total Cholesterol to HDL ratio 3.7 c 0.2 c 3.7 d 0.1 d
a Excludes subjects who received lipid lowering agents during the treatment period.
b The baseline and change from baseline are for subjects with both baseline and Week 48 values.
c N=1,098
d N=1,124
e N=1,079
f N=1,107

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of products containing TAF. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Skin And Subcutaneous Tissue Disorders

Angioedema, urticaria, and rash

Renal And Urinary Disorders

Acute renal failure, acute tubular necrosis, proximal renal tubulopathy, and Fanconi syndrome

DRUG INTERACTIONS

Potential For Other Drugs To Affect One Or More Components Of DESCOVY

TAF, a component of DESCOVY, is a substrate of P-gp, BCRP, OATP1B1, and OATP1B3. Drugs that strongly affect P-gp and BCRP activity may lead to changes in TAF absorption (see Table 5). Drugs that induce P-gp activity are expected to decrease the absorption of TAF, resulting in decreased plasma concentration of TAF, which may lead to loss of therapeutic effect of DESCOVY and development of resistance. Coadministration of DESCOVY with other drugs that inhibit P-gp and BCRP may increase the absorption and plasma concentration of TAF. TAF is not an inhibitor of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, or UGT1A1. TAF is a weak inhibitor of CYP3A in vitro. TAF is not an inhibitor or inducer of CYP3A in vivo.

Drugs Affecting Renal Function

Because FTC and tenofovir are primarily excreted by the kidneys by a combination of glomerular filtration and active tubular secretion, coadministration of DESCOVY with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of FTC, tenofovir, and other renally eliminated drugs and this may increase the risk of adverse reactions. Some examples of drugs that are eliminated by active tubular secretion include, but are not limited to, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs [see WARNINGS AND PRECAUTIONS].

Established And Other Potentially Significant Interactions

Table 6 provides a listing of established or potentially clinically significant drug interactions with recommended steps to prevent or manage the drug interaction (the table is not all inclusive). The drug interactions described are based on studies conducted with either DESCOVY, the components of DESCOVY (emtricitabine and tenofovir alafenamide) as individual agents, or are predicted drug interactions that may occur with DESCOVY. For magnitude of interaction, see CLINICAL PHARMACOLOGY.

Table 6 : Established and Other Potentially Significanta Drug Interactions

Concomitant Drug Class: Drug Name Effect on Concentrationb Clinical Comment
Antiretroviral Agents: Protease Inhibitors (PI)
tipranavir/ritonavir ↓TAF Coadministration with DESCOVY is not recommended.
Other Agents
Anticonvulsants: carbamazepine
oxcarbazepine
phenobarbital
phenytoin
↓ TAF Consider alternative anticonvulsant.
Antimycobacterials: rifabutin rifampin rifapentine ↓ TAF Coadministration of DESCOVY with rifabutin, rifampin, or rifapentine is not recommended.
Herbal Products: St. John's wort (Hypericum perforatum) ↓TAF Coadministration of DESCOVY with St. John's wort is not recommended.
a This table is not all inclusive.
b ↓=Decrease

Drugs Without Clinically Significant Interactions With DESCOVY

Based on drug interaction studies conducted with the components of DESCOVY, no clinically significant drug interactions have been either observed or are expected when DESCOVY is combined with the following antiretroviral agents: atazanavir with ritonavir or cobicistat, darunavir with ritonavir or cobicistat, dolutegravir, efavirenz, ledipasvir, lopinavir/ritonavir, maraviroc, nevirapine, raltegravir, rilpivirine, and sofosbuvir. No clinically significant drug interactions have been either observed or are expected when DESCOVY is combined with the following drugs: buprenorphine, itraconazole, ketoconazole, lorazepam, methadone, midazolam, naloxone, norbuprenorphine, norgestimate/ethinyl estradiol, and sertraline.

Read the entire FDA prescribing information for Descovy (Emtricitabine and Tenofovir Alafenamide Tablets)

© Descovy Patient Information is supplied by Cerner Multum, Inc. and Descovy Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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