in adults and children who weigh at least 77 pounds (35 kg) together with other HIV-1 medicines. Note to pharmacist: Evidence of risk behavior at entry into the trial included at least one of the following: two or more unique condomless anal sex partners in the past 12 weeks or a diagnosis of rectal gonorrhea/chlamydia or syphilis in the past 24 weeks. Tell your healthcare provider about all the medicines you take. HIV-1 containing the K103N substitution or other substitutions associated with resistance to NNRTIs was susceptible to FTC. The following adverse reactions are discussed in other sections of the labeling: 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. Descovy may be used alone or with other medications. Common Descovy side effects may include: headache, dizziness, feeling depressed or tired; trouble sleeping, strange dreams; nausea, stomach pain; weight loss; or. 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. Tell your healthcare provider if you become pregnant during treatment with Descovy. Descovy | C29H39FN9O8PS | CID 90469070 - structure, chemical names, physical and chemical properties, classification, patents, literature, biological activities . For specific dosing recommendations for coadministered antiretroviral drugs, refer to their respective prescribing information [see Drug Interactions (7)]. Coadministration of Descovy with other drugs that inhibit P-gp and BCRP may increase the absorption and plasma concentration of TAF. Approved as a pharmacy medicine, Sanofi will launch Cialis Together in the second half of the year. In clinical trials of an FTC+TAF-containing regimen for treatment of HIV-1, 80 of the 97 subjects enrolled aged 65 years and over received FTC+TAF and EVG+COBI. Medically reviewed by Drugs.com. The long-term clinical significance of these BMD changes is not known. Refill your prescription or talk to your healthcare provider before your Descovy is all gone. Price without insurance of brand-name drug. Tenofovir Alafenamide: Studies in rats and monkeys have demonstrated that tenofovir is secreted in milk. The median age of participants was 34 years (range, 18-76); 84% were White, 9% Black/Mixed Black, 4% Asian, and 24% Hispanic/Latino. Store Descovy between 68F to 77F (20C to 25C). If you have HBV infection and take Descovy, your HBV may get worse (flare-up) if you stop taking Descovy. Methodological limitations of the APR include the use of MACDP as the external comparator group. Emtricitabine: HIV-1 isolates with reduced susceptibility to FTC were selected in cell culture and in subjects treated with FTC. Examples of mild side effects that have been reported with Descovy include: nausea *. 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 (5.4)]. Read the latest news and reviews about the drug as well as potential side effects and popular alternatives. Descovy comes as an oral tablet that you . While you are taking Descovy for HIV-1 PrEP: Descovy does not prevent other sexually transmitted infections (STIs). When your Descovy supply starts to run low, get more from your healthcare provider or pharmacy. The pharmacokinetic (PK) properties of the components of Descovy are provided in Table 7. The MACDP population is not disease-specific, evaluates women and infants from a limited geographic area, and does not include outcomes for births that occurred at less than 20 weeks gestation. To maintain an undetectable viral load, your partners must keep taking HIV-1 medicines every day. Median urine protein-to-creatinine ratio (UPCR) was 44 mg per gram at baseline and at Week 48. The safety and effectiveness of Descovy coadministered with an HIV-1 protease inhibitor that is administered with either ritonavir or cobicistat have not been established in pediatric subjects weighing less than 35 kg. In animal studies, no adverse developmental effects were observed when the components of Descovy were administered separately during the period of organogenesis at exposures 60 and 108 times (mice and rabbits, respectively) the FTC exposure and at exposure equal to or 53 times (rats and rabbits, respectively) the TAF exposure at the recommended daily dose of Descovy (see Data). Gilead is based in Foster City, California and makes medications for HIV/AIDS, hepatitis, liver diseases, and other conditions. Emtricitabine: FTC, a synthetic nucleoside analog of cytidine, is phosphorylated by cellular enzymes to form emtricitabine 5'-triphosphate. Do not miss a dose of Descovy. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with use of drugs similar to Descovy. 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. Your risk of getting HIV-1 is lower if your partners with HIV-1 are taking effective treatment. The virus may develop resistance to Descovy and become harder to treat. Three subjects had virus with emergent R, H, or E at the polymorphic Q207 residue in reverse transcriptase. If you stop taking Descovy, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your liver, and may give you a medicine to treat hepatitis B. Tenofovir Alafenamide: The antiviral activity of TAF against laboratory and clinical isolates of HIV-1 subtype B was assessed in lymphoblastoid cell lines, PBMCs, primary monocyte/macrophage cells and CD4+-T lymphocytes. That Descovy does not prevent other sexually acquired infections and should be used as part of a complete prevention strategy including other prevention measures. Advise the patient to read the FDA-approved patient labeling (Medication Guide). Keep Descovy and all medicines out of reach of children. The 120 mg/15 mg tablets are film-coated with a coating material containing polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. Tenofovir is efficiently removed by hemodialysis with an extraction coefficient of approximately 54%. 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%). The time from initiation of Descovy for HIV-1 PrEP to maximal protection against HIV-1 infection is unknown. If you take Descovy to treat HIV-1 infection, you need to take Descovy with other HIV-1 medicines. Tenofovir Alafenamide: Tenofovir resistance substitutions K65R and K70E result in reduced susceptibility to abacavir, didanosine, emtricitabine, lamivudine, and tenofovir. The effects of higher doses are unknown. Some HIV-1 tests only detect anti-HIV antibodies and may not identify HIV-1 during the acute stage of infection. This medicine is also used for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 . You must stay HIV-1 negative to keep taking Descovy for HIV-1 PrEP. Use Descovy for HIV-1 PrEP to reduce the risk of HIV-1 infection as part of a comprehensive prevention strategy, including adherence to daily administration and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs). 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 (14.3)]. US Brand Name. Descovy is a prescription medicine used to treat the symptoms of HIV Infection and as Pre-exposure Prophylaxis for HIV-1. Other Names. It is not known if TAF is present in animal milk. No dosage adjustment of Descovy is recommended in individuals with estimated creatinine clearance greater than or equal to 30 mL per minute, or in adults with ESRD (estimated creatinine clearance below 15 mL per minute) who are receiving chronic hemodialysis. Because of the potential for: 1) HIV transmission (in HIV-negative infants); 2) developing viral resistance (in HIV-positive infants); and 3) adverse reactions in a breastfed infant similar to those seen in adults, instruct mothers not to breastfeed if they are taking Descovy for the treatment of HIV-1 (see Data). ALERT: Find out about medicines that From a mean (SD) baseline CD4+ cell count of 961 (275.5) cells per mm3, the mean change from baseline in CD4+ cell count was -66 cells per mm3 and the mean (SD) change in CD4% was -0.6% (4.4%) at Week 48. Based on prospective reports to the APR of over 660 exposures to TAF-containing regimens during pregnancy resulting in live births (including over 520 exposed in the first trimester and over 130 exposed in the second/third trimester), the prevalence of birth defects in live births was 4.2 % (95% CI: 2.6 % to 6.3 %) and 3.0% (95% CI: 0.8% to 7.5 %) following first and second/third trimester exposure, respectively, to TAF-containing regimens. Fertility was normal in the offspring of mice exposed daily from before birth (in utero) through sexual maturity at daily exposures (AUC) of approximately 60 times higher than human exposures at the recommended 200 mg daily dosage in Descovy. The safety and efficacy of FTC+TAF with EVG+COBI in adolescent subjects was similar to that in adults on this regimen. Learn how to get Descovy, a pre-exposure prophylaxis (PrEP) medication that is up to 99% effective at preventing HIV. Inform uninfected individuals about and support their efforts in reducing sexual risk behavior. Must be taken in combination with another antiretroviral (s) that does . One subject had significant (at least 4%) lumbar spine BMD loss at Week 48. No significant toxicological effects were observed in embryo-fetal toxicity studies performed with FTC in mice at exposures (area under the curve [AUC]) approximately 60 times higher and in rabbits at approximately 108 times higher than human exposures at the recommended daily dose. You must get tested to make sure that you do not already have HIV-1 infection. In a case-control substudy of intracellular drug levels and estimated number of daily doses as measured by dried blood spot testing, median intracellular tenofovir diphosphate concentrations were substantially lower in participants infected with HIV-1 at the time of diagnosis compared with uninfected matched control participants. Tenofovir diphosphate inhibits HIV-1 replication through incorporation into viral DNA by the HIV reverse transcriptase, which results in DNA chain-termination. The resistance-associated substitutions that emerged were M184V/I (N=7) and K65R (N=1). Genotypic resistance developed in 7 of 14 evaluable subjects. 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). are pregnant or plan to become pregnant. TAF is a weak inhibitor of CYP3A in vitro. These tablets are white, round-shaped, film coated, debossed with "GSI" on one side and "15" on the other side. 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. Treatment of overdose with Descovy consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the individual. Median duration of exposure was 86 and 87 weeks, respectively. Safety and effectiveness of Descovy coadministered with an HIV-1 protease inhibitor that is administered with either ritonavir or cobicistat have not been established in pediatric patients weighing less than 35 kg [see Dosage and Administration (2.4)]. Screen all individuals for HIV-1 infection immediately prior to initiating Descovy for HIV-1 PrEP and at least once every 3 months while taking Descovy, and upon diagnosis of any other sexually transmitted infections (STIs) [see Indications and Usage (1.2), Contraindications (4), and Warnings and Precautions (5.2)]. Take Descovy exactly as your healthcare provider tells you to take it. In a separate open-label single arm trial of FTC+TAF with bictegravir that enrolled 24 virologically-suppressed children at least 2 years of age and weighing at least 14 to less than 25 kg (cohort 3), 91% (20/22) of subjects remained virologically suppressed at Week 24. Pricing based on most commonly-filled versions: 30 tablets of Descovy 200mg/25mg. Inform individuals that severe acute exacerbations of hepatitis B have been reported in patients who are infected with HBV and have discontinued products containing FTC and/or TDF and may likewise occur with discontinuation of Descovy [see Warnings and Precautions (5.1)]. DESCOVY breastfeed, due to the potential for HIV transmission. An open-label, single arm trial of FTC+TAF with EVG+COBI enrolled 50 treatment-nave HIV-1 infected adolescents aged 12 to less than 18 years weighing at least 35 kg (cohort 1) and 52 virologically suppressed children aged 6 to less than 12 years weighing at least 25 kg (cohort 2). 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