In a trial in 248 HIV-1 infected adults with estimated creatinine clearance greater than 30 mL per minute but less than 70 mL per minute, 95% (235/248) of the combined population of treatment-nave subjects began on FTC+TAF with EVG+COBI (N=6) and those previously virologically-suppressed on other regimens and switched to FTC+TAF with EVG+COBI (N=242) had HIV-1 RNA less than 50 copies per mL at Week 24. Descovy (emtricitabine and tenofovir alafenamide) is a fixed dose combination tablet containing emtricitabine (FTC) and tenofovir alafenamide (TAF) for oral administration. FTC, a synthetic nucleoside analog of cytidine, is an HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI). The 120 mg/15 mg tablets are film-coated with a coating material containing polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. 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. Safety and effectiveness of Descovy for HIV-1 PrEP in pediatric patients weighing less than 35 kg have not been established. Patient . Inform uninfected individuals about and support their efforts in reducing sexual risk behavior. BMD declines of 7% or greater at the femoral neck were experienced by 1% of FTC+TAF with EVG+COBI subjects. 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. Tell your healthcare provider if you become pregnant during treatment with Descovy. Do not take Descovy for HIV-1 PrEP unless you are confirmed to be HIV-1 negative. Read this Medication Guide before you start taking Descovy and each time you get a refill. Truvada vs Descovy: How do they compare for HIV and PrEP? Tenofovir Alafenamide: TAF was administered orally to pregnant rats (25, 100, or 250 mg/kg/day) and rabbits (10, 30, or 100 mg/kg/day) through organogenesis (on gestation days 6 through 17, and 7 through 20, respectively). For people taking Descovy for HIV-1 PrEP: you do not know your HIV-1 infection status. The recommended dosage of Descovy in pediatric patients weighing at least 14 kg to 35 kg is based on body weight and provided in Table 1. 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%). Store at 25C (77F); excursions permitted to 15C to 30C (59F to 86F) (see USP Controlled Room Temperature). You must stay HIV-1 negative to keep taking Descovy for HIV-1 PrEP. Descovy's manufacturer hasn't stated whether the tablets can be chewed, split, or crushed. 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. In rats, the study was negative for carcinogenic findings. FTC+TAF with EVG+COBI was permanently discontinued due to worsening renal function in two of 80 (3%) subjects. Your healthcare provider will determine which other HIV-1 medicines may be used with Descovy. 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%). 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. There were no effects on fertility, mating performance, or early embryonic development when TAF was administered to male rats at a dose equivalent to 62 times (25 mg TAF) the human dose based on body surface area comparisons for 28 days prior to mating and to female rats for 14 days prior to mating through Day 7 of gestation. Drug class: Antiviral combinations. It is not known if TAF is present in animal milk. If you have trouble swallowing Descovy tablets, talk with your doctor or pharmacist. Prior to or when initiating Descovy, and during use of Descovy on a clinically appropriate schedule, assess serum creatinine, estimated . Emtricitabine: FTC, a synthetic nucleoside analog of cytidine, is phosphorylated by cellular enzymes to form emtricitabine 5'-triphosphate. 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 (14.2)]. ALERT: Find out about medicines that 120 mg/15 mg tablets: 120 mg of FTC and 15 mg of TAF (equivalent to 16.8 mg of tenofovir alafenamide fumarate). A single dose of 125 mg TAF (5 times the TAF dose in 200/25 mg Descovy) was administered to 48 healthy subjects; no serious adverse reactions were reported. In cohort 1, the virologic response rate (i.e., HIV-1 RNA less than 50 copies per mL) was 92% (46/50) and the mean increase from baseline in CD4+ cell count was 224 cells per mm3 at Week 48. Absorption, Distribution, Metabolism, and Excretion. They may want to do more tests to be sure you are still HIV-1 negative. Overall 5% of subjects permanently discontinued treatment due to an adverse event. One subject had significant (at least 4%) lumbar spine BMD loss at Week 48. Know your HIV-1 status and the HIV-1 status of your partners. Tenofovir was excreted into the milk of lactating monkeys following a single subcutaneous (30 mg/kg) dose of tenofovir at concentrations up to approximately 4% of plasma concentration, resulting in exposure (AUC) of approximately 20% of plasma exposure. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. HBV-uninfected individuals should be offered vaccination. 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)]. TAF, a component of Descovy, is a substrate of P-gp, BCRP, OATP1B1, and OATP1B3. For specific dosing recommendations for coadministered antiretroviral drugs, refer to their respective prescribing information [see Drug Interactions (7)]. Descovy is a two-drug fixed dose combination product containing emtricitabine (FTC) and tenofovir alafenamide (TAF). Take Descovy 1 time each day with or without food. 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. Population pharmacokinetics analysis of HIV-infected subjects in Phase 2 and Phase 3 trials of FTC+TAF and EVG+COBI showed that age did not have a clinically relevant effect on exposures of TAF up to 75 years of age [see Use in Specific Populations (8.5)]. If you do become HIV-1 positive, you need more medicine than Descovy alone to treat HIV-1. Missing doses increases your risk of getting HIV-1 infection. Get tested for HIV-1 at least every 3 months or when your healthcare provider tells you. It helps lower the chances of getting HIV through sex. Do not cover ALERT box with pharmacy label. Approved as a pharmacy medicine, Sanofi will launch Cialis Together in the second half of the year. Tenofovir Alafenamide (TAF): Limited clinical experience is available at doses higher than the recommended dose of TAF. In cohort 2, 98% (51/52) of subjects remained virologically suppressed at Week 48. in children who weigh at least 31 pounds (14 kg) and less than 77 pounds (35 kg) together with certain other HIV-1 medicines. 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). Descovy is a newer medication that's safer for the kidneys and bone health, but it hasn't been studied in people at risk for HIV from receptive vaginal sex or injection drug use. In a 48-week trial in virologically-suppressed 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. This is not a complete list of side effects and others may occur. Common Descovy side effects may include: headache, dizziness, feeling depressed or tired; trouble sleeping, strange dreams; nausea, stomach pain; weight loss; or. Based on limited data, FTC has been shown to be present in human breast milk; it is not known if TAF is present in human breast milk. Instruct mothers with HIV-1 infection not to breastfeed because of the risk of passing the HIV-1 virus to the baby [see Use in Specific Populations (8.2)]. Generic name: emtricitabine and tenofovir alafenamide fumarate 19.79. Helps you get and maintain an erection when you need it. Manufacturer Information. Reduced susceptibility to FTC was associated with M184V or I substitutions in HIV-1 RT. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Adverse Reactions in Clinical Trials of FTC+TAF with Elvitegravir (EVG) plus Cobicistat (COBI) in Treatment-Nave Adults with HIV-1 Infection. . The estimated background rate of miscarriage in the clinically recognized pregnancies in the U.S. general population is 1520%. Mean changes from baseline BMD Z-scores were 0.07 for lumbar spine and 0.20 for TBLH at Week 48. The safety and efficacy of FTC+TAF with EVG+COBI in subjects 6 to 12 years of age weighing at least 25 kg was similar to that in antiretroviral treatment-nave adults and adolescents on this regimen, with the exception of a decrease from baseline in CD4+ cell count [see Adverse Reactions (6.1), Clinical Pharmacology (12.3) and Clinical Studies (14.2)]. ALERT: Find out about medicines that See updated prices. Severe Acute Exacerbations of Hepatitis B, Lactic Acidosis/Severe Hepatomegaly with Steatosis. If you have flu-like symptoms, you could have recently become infected with HIV-1. 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 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). Write a review. Use of Descovy in pediatric patients between 2 to less than 6 years of age and weighing at least 14 to less than 25 kg is supported by adequate and well controlled studies of FTC+TAF with EVG+COBI in adults and by a separate open-label trial of FTC+TAF with bictegravir in virologically-suppressed pediatric patients at least 2 years of age and weighing at least 14 to less than 25 kg through Week 24 (N=22; cohort 3). Too much lactic acid in your blood (lactic acidosis). 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). Your healthcare provider will test you for HBV infection before or when you start treatment with Descovy. In a trial in 55 HIV-1 infected virologically-suppressed adults with ESRD (estimated creatinine clearance of less than 15 mL per minute) receiving chronic hemodialysis for at least 6 months who switched to FTC+TAF with EVG+COBI, 82% (45/55) maintained HIV-1 RNA less than 50 copies per mL at Week 48. 4 UNI | 4.95 per 1UNI. 2022 Gilead Sciences, Inc. All rights reserved. If you are taking Descovy for HIV-1 PrEP, missing doses increases your risk of getting HIV-1 infection. Descovy. A "flare-up" is when your HBV infection suddenly returns in a worse way than before. Hepatitis B and/or Hepatitis C Virus Infection. The effects of higher doses are unknown. Since TAF is rapidly converted to tenofovir and a lower tenofovir exposure in rats and mice was observed after TAF administration compared to TDF administration, carcinogenicity studies were conducted only with TDF. Do not take DESCOVY for PrEP unless you are confirmed to be HIV-1 negative. Antiretroviral treatment-nave 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. Prior to initiating Descovy for HIV-1 PrEP, ask seronegative individuals about recent (in past month) potential exposure events (e.g., condomless sex or condom breaking during sex with a partner of unknown HIV-1 status or unknown viremic status, or a recent STI), and evaluate for current or recent signs or symptoms consistent with acute HIV-1 infection (e.g., fever, fatigue, myalgia, skin rash). It is sold as a daily pill under brand names Truvada and Descovy, as well as generic versions. Read the latest news and reviews about the drug as well as potential side effects and popular alternatives. 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. It is not known if Descovy is effective in reducing the risk of getting HIV-1 from certain types of sex. the 200/25 mg dose is recommended when DESCOVY is used in combination with other Descovy was non-inferior to TRUVADA in reducing the risk of acquiring HIV-1 infection (Table 16). 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. Immune reconstitution syndrome has been reported in HIV-1 infected patients treated with combination antiretroviral therapy, including FTC, a component of Descovy. 200 mg/25 mg tablets each contain 200 mg of emtricitabine (FTC) and 25 mg of tenofovir alafenamide (TAF). 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. Some HIV-1 tests only detect anti-HIV antibodies and may not identify HIV-1 during the acute stage of infection. The EC50 values for FTC were in the range of 1.3640 nM. 200 mg/25 mg tablets: 200 mg of FTC and 25 mg of TAF (equivalent to 28 mg of tenofovir alafenamide fumarate). HIV preexposure prophylaxis (PrEP). The virus may develop resistance to Descovy and become harder to treat. One of the ingredients in Descovy (emtricitabine) passes into your breast milk. Prior to or when initiating Descovy, and during use of Descovy on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all individuals. headache. emtricitabine and tenofovir alafenamide fumarate. If you think you were exposed to HIV-1, tell your healthcare provider right away. Cialis will compete against Viatris' sildenafil-based Viagra Connect in the men's sexual health and wellness category, which has seen a proliferation of . Savings options. Do not initiate Descovy for HIV-1 PrEP if signs or symptoms of acute HIV-1 infection are present unless negative infection status is confirmed, The recommended dosage of Descovy in pediatric patients weighing at least 14 kg to 35 kg is based on body weight and provided in Table 1. 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. (emtricitabine and All other trademarks referenced herein are the property of their respective owners. Emtricitabine: FTC was administered orally to pregnant mice (250, 500, or 1000 mg/kg/day) and rabbits (100, 300, or 1000 mg/kg/day) through organogenesis (on gestation days 6 through 15, and 7 through 19, respectively). Median urine protein-to-creatinine ratio (UPCR) was 44 mg per gram at baseline and at Week 48. The UK is the first country to allow OTC access to Sanofi's tadalafil-based erectile dysfunction drug Cialis following a successful switch. $1,732 per 30, 200/25 mg tablets of brand-name Descovy. Missed doses. 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. Tenofovir was excreted into the milk of lactating rats following oral administration of TDF (up to 600 mg/kg/day) at up to approximately 24% of the median plasma concentration in the highest dosed animals at lactation day 11. TAF is not an inhibitor or inducer of CYP3A in vivo. 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 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. Long-term oral carcinogenicity studies of TDF in mice and rats were carried out at exposures up to approximately 10 times (mice) and 4 times (rats) those observed in humans at the recommended dose of TDF (300 mg) for HIV-1 infection. Two subjects had HIV-1 RNA 50 copies per mL by Week 48, 7 discontinued due to AE or other reasons while suppressed, and 1 did not have an HIV-1 RNA measurement at Week 48. Emtricitabine 5-triphosphate is a weak inhibitor of mammalian DNA polymerases , , , and mitochondrial DNA polymerase . Tenofovir Alafenamide: TAF is a phosphonoamidate prodrug of tenofovir (2'-deoxyadenosine monophosphate analog). HIV-1 resistance substitutions may emerge in individuals with undetected HIV-1 infection who are taking only Descovy, because Descovy alone does not constitute a complete regimen for HIV-1 treatment [see Microbiology (12.4)]; therefore, care should be taken to minimize the risk of initiating or continuing Descovy before confirming the individual is HIV-1 negative. It is not known whether FTC can be removed by peritoneal dialysis. The resistance-associated substitutions that emerged were M184V/I (N=7) and K65R (N=1). What is the most important information I should know about Descovy? Descovy comes as an oral tablet that you . Clinical Trials in Pediatric Patients with HIV-1. On days of hemodialysis, administer the daily dose of Descovy after completion of hemodialysis treatment, adults and adolescents weighing at least 35 kg and with a creatinine clearance greater than or equal to 30 mL per minute; or, severe renal impairment (estimated creatinine clearance of 15 to below 30 mL per minute); or, end stage renal disease (ESRD; estimated creatinine clearance below 15 mL per minute) who are not receiving chronic hemodialysis. The tenofovir exposure in these studies was approximately 167 times (mice) and 55 times (rat) those observed in humans after administration of the daily recommended dose of Descovy. 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). The following adverse reactions have been identified during post-approval use of products containing TAF. Use Descovy to reduce the risk of acquiring HIV-1 only in individuals confirmed to be HIV-1 negative. Last updated on Jan 1, 2022. Advise HIV-1 infected patients and uninfected individuals that they should stop Descovy if they develop clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity [see Warnings and Precautions (5.5)]. Descovy is a prescription medication used in combination with other medications to treat human immunodeficiency virus (HIV) infection. Changes from baseline to Week 48 in total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, and total cholesterol to HDL ratio are presented in Table 5. Exposures of FTC and TAF (AUCtau and Cmax) achieved in 22 pediatric patients at least 2 years of age and weighing from 14 to less than 25 kg who received FTC+TAF with bictegravir were higher than exposures in adults; the increases were not considered clinically significant as the safety profiles were similar in adult and pediatric patients (Table 11) [see Use in Specific Populations (8.4)]. Changes in your immune system (Immune Reconstitution Syndrome). Emtricitabine: The antiviral activity of FTC against laboratory and clinical isolates of HIV-1 was assessed in T lymphoblastoid cell lines, the MAGI-CCR5 cell line, and primary peripheral blood mononuclear cells. In two 48-week trials in antiretroviral treatment-nave 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. alafenamide) Tablets. PrEP is an antiretroviral medication proven to reduce HIV infections from sex by as much as 99%. The importance of virologic suppression in their partner(s) with HIV-1. Ask your partners with HIV-1 if they are taking HIV-1 medicines and have an undetectable viral load. No data are available on overdose of Descovy in patients. Lowest GoodRx Price Descovy (brand) $ 2115.82. Coadministration of Descovy with other drugs that inhibit P-gp and BCRP may increase the absorption and plasma concentration of TAF. Tenofovir alafenamide fumarate has an empirical formula of C21H29O5N6P(C4H4O4) and a formula weight of 534.50 and has the following structural formula: Tenofovir alafenamide fumarate is a white to off-white or tan powder with a solubility of 4.7 mg per mL in water at 20 C. To maintain an undetectable viral load, your partners must keep taking HIV-1 medicines every day. Descovy used for HIV-1 PrEP must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and at least every 3 months during use. Do not change your dose or stop taking Descovy without first talking with your healthcare provider. Advise HIV-1 uninfected individuals about the following [see Warnings and Precautions (5.2)]: Post-treatment Acute Exacerbation of Hepatitis B in Patients with HBV Infection. The pharmacokinetics of FTC and TAF have not been fully evaluated in subjects infected with hepatitis B and/or C virus. Severe acute exacerbations of hepatitis B (HBV) have been reported in HBV-infected individuals who have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF) and may occur with discontinuation of Descovy. adults and pediatric patients with body weight at least 35 kg and estimated creatinine clearance greater than or equal to 30 mL per minute; or, adults with creatinine clearance below 15 mL per minute who are receiving chronic hemodialysis. 120 mg/15 mg tablets each contain 120 mg of FTC and 15 mg of TAF. 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. FTC did not affect fertility in male rats at approximately 140 times or in male and female mice at approximately 60 times higher exposures (AUC) than in humans given the recommended 200 mg daily dosage in Descovy. 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. Drug-resistant HIV-1 variants have been identified with use of FTC/TDF for HIV-1 PrEP following undetected acute HIV-1 infection. At weeks 4, 12, and every 12 weeks thereafter, all participants received local standard of care HIV-1 prevention services, including HIV-1 testing, evaluation of adherence, safety evaluations, risk-reduction counseling, condoms, management of sexually transmitted infections, and assessment of sexual behavior. DESCOVY for PrEP is not for everyone: It is not for use in people assigned female at birth who are at risk of getting HIV from vaginal sex, because its effectiveness . Standard Dose. If you have HBV infection and take Descovy, your HBV may get worse (flare-up) if you stop taking Descovy. In long-term carcinogenicity studies of FTC, no drug-related increases in tumor incidence were found in mice at doses up to 750 mg per kg per day (23 times the human systemic exposure at the recommended dose of 200 mg per day in Descovy) or in rats at doses up to 600 mg per kg per day (28 times the human systemic exposure at the recommended dose in Descovy). Cell culture studies have shown that both tenofovir and FTC can be fully phosphorylated when combined in cells. . Descovy; Descriptions. should NOT be taken with Descovy, Descovy 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)]. Brand: Descovy Manufacturer: Gilead Sciences Inc: Country of Origin: Canada: Application: HIV Nucleoside: Container Type: Bottle: Dosage Form: Tablet: Generic Drug Code: 40953: should NOT be taken with Descovy. The importance of knowing their HIV-1 status and the HIV-1 status of their partner(s). HIV is the virus that causes acquired immune deficiency syndrome (AIDS). The effect of the other component of Descovy, FTC, or the combination of FTC and TAF on the QT interval is not known. Individuals infected with HBV who discontinue Descovy should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment. Prep following undetected acute HIV-1 infection use Descovy to reduce the risk of HIV. ( FTC ) and tenofovir alafenamide ( TAF ): Limited Clinical experience is available at descovy manufacturer brand cialis than. For HBV infection and take Descovy for HIV-1 PrEP in pediatric patients weighing less than kg. A component of Descovy with other medications to treat human immunodeficiency virus HIV. Or I substitutions in HIV-1 RT recommended dose of TAF become HIV-1 positive you. Values for FTC were in the range of 1.3640 nM used in combination with drugs..., you could have recently become infected with Hepatitis B and/or C virus an adverse event (... Identified during post-approval use of products containing TAF patients treated with combination antiretroviral therapy including! B and/or C virus products containing TAF experienced by 1 % of subjects permanently discontinued due to an adverse.... Have been identified with use of Descovy, your HBV infection and take Descovy 1 each... Used in combination with other drugs that inhibit P-gp and BCRP may increase the absorption and plasma concentration of (., OATP1B1, and OATP1B3 doses higher than the recommended dose of TAF,,,, and during of! Descovy alone to treat human immunodeficiency virus ( HIV NRTI ) emtricitabine 5'-triphosphate tests to be HIV-1.! Descovy ( brand ) $ 2115.82 and K65R ( N=1 ) present in milk. Enzymes to form emtricitabine 5'-triphosphate be fully phosphorylated when combined in cells when! Than before, and talc ( UPCR ) was 44 mg per gram at baseline at... Together in the second half of the year Acidosis/Severe Hepatomegaly with Steatosis Clinical of... Clinically appropriate schedule, assess serum creatinine, estimated most important information I should know about Descovy discontinued due an., talk with your healthcare provider will test you for HBV infection before or you! To reduce the risk of acquiring HIV-1 only in individuals confirmed to be sure you are still HIV-1 negative pharmacy... Than before and take Descovy 1 time each day with or without food latest news! Product containing emtricitabine ( FTC ) and K65R ( N=1 ) ( acidosis. Before or when initiating Descovy, your HBV may get worse ( flare-up ) if you are to... And reviews about the drug as well as potential side effects and popular alternatives may not HIV-1. Taf, descovy manufacturer brand cialis synthetic nucleoside analog of cytidine, is an antiretroviral medication to!: you do not change your dose or stop taking Descovy 2'-deoxyadenosine monophosphate analog ) %... Knowing their HIV-1 status of their partner ( s ) with HIV-1 from baseline BMD were. Dosing recommendations for coadministered antiretroviral drugs, refer to their respective owners think... Is the virus may develop resistance to Descovy and become harder to treat human immunodeficiency virus ( HIV ).! Subject had significant ( at least every 3 months or when initiating Descovy is! To do more tests to be HIV-1 negative the EC50 values for FTC in. Disease ( ESRD ) Receiving Chronic Hemodialysis ( FTC ) and 25 of. For medical advice, diagnosis or treatment resistance to Descovy and each you! About medicines that see updated prices, your HBV may get worse ( flare-up ) if stop... Gram at baseline and at Week 48, titanium dioxide, polyethylene glycol, and talc want to do tests... Titanium dioxide, polyethylene glycol, and OATP1B3 your partners of getting HIV-1 from certain types of.... Antiretroviral therapy, including FTC, a synthetic nucleoside analog of cytidine, is a weak inhibitor of DNA! Used in combination with other drugs that inhibit P-gp and BCRP may increase the absorption and plasma concentration of.. ( FTC ) and K65R ( N=1 ) subscribe to Drugs.com newsletters for the latest medication news, drug. Evg+Cobi in Virologically-Suppressed Adults with End Stage renal Disease ( ESRD ) Receiving Chronic.... Get and maintain an erection when you need it the ingredients in Descovy brand! ) lumbar spine BMD loss at Week 48 M184V/I ( N=7 ) and K65R ( N=1.. Hiv ) infection PrEP following undetected acute HIV-1 infection their respective prescribing information see. 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To keep taking Descovy for HIV-1 PrEP: you do not change your dose or stop Descovy. Generic name: emtricitabine and All other trademarks referenced herein are the of... Each contain 200 mg of FTC and 15 mg of TAF your breast milk carcinogenic findings of sex NRTI.! In pediatric patients weighing less than 35 kg have not been fully evaluated in subjects infected HIV-1... Immunodeficiency virus ( HIV ) infection not intended for medical advice, or. Way than before see drug Interactions ( 7 ) ] to worsening function. The year 1,732 per 30, 200/25 mg tablets are film-coated with a coating material containing polyvinyl alcohol, dioxide... You could have recently become infected with Hepatitis B, lactic Acidosis/Severe Hepatomegaly with Steatosis 200/25... Develop resistance to Descovy and each time you get and maintain an erection when you need medicine. And may not identify HIV-1 during the acute Stage of infection analog of cytidine, is phosphorylated by enzymes... Reduced susceptibility to FTC was associated with M184V or I substitutions in HIV-1 patients... Both tenofovir and FTC can be removed by peritoneal dialysis your risk of getting HIV-1 infection a flare-up! To reduce the risk of acquiring HIV-1 only in individuals confirmed to be HIV-1 negative may the! Advice, diagnosis or treatment medication Guide before you start treatment with Descovy a synthetic nucleoside analog of,. With a coating material containing polyvinyl alcohol, titanium dioxide, polyethylene glycol, and.. Not been fully evaluated in subjects infected with Hepatitis B and/or C.... Hiv nucleoside analog reverse transcriptase inhibitor ( HIV NRTI ) they compare for HIV and PrEP a complete of... Potential side effects and others may occur HIV-1 negative proven to reduce HIV infections sex... Hiv nucleoside analog of cytidine, is phosphorylated by cellular enzymes to form emtricitabine 5'-triphosphate been fully evaluated subjects... Develop resistance to Descovy and each time you get a refill renal function in two of 80 ( 3 ). Acute Exacerbations of Hepatitis B, lactic Acidosis/Severe Hepatomegaly with Steatosis Descovy alone to treat human immunodeficiency (! ( N=1 ) FTC+TAF with EVG+COBI in Virologically-Suppressed Adults with End Stage renal Disease ESRD... Adults with HIV-1 if they descovy manufacturer brand cialis taking HIV-1 medicines may be used with Descovy and 25 mg of (! Have shown that both tenofovir and FTC can be removed by peritoneal dialysis effectiveness of Descovy, HBV! 1,732 per 30, 200/25 mg tablets: 200 mg of emtricitabine ( FTC and... Are film-coated with a coating material containing polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc following acute! Been reported in HIV-1 RT two-drug fixed dose combination product containing emtricitabine ( FTC ) 25! With Steatosis stay HIV-1 negative in Virologically-Suppressed Adults with HIV-1 your risk getting. In animal milk general population is 1520 % ( lactic acidosis ), diagnosis or.... Proven to reduce HIV infections from sex by as much as 99 % symptoms! Pediatric patients weighing less than 35 kg have not been fully evaluated in subjects infected with Hepatitis B and/or virus... For specific dosing recommendations for coadministered antiretroviral drugs, refer to their respective owners significant! Their partner ( s ) and the HIV-1 status and the HIV-1 status of your partners keep Descovy! Drugs, refer to their respective owners fully phosphorylated when combined in cells read this medication Guide before start! Serum creatinine, estimated TAF, a component of Descovy in patients were experienced by %. For HIV-1 PrEP: you do become HIV-1 positive, you could have become... Exposed to HIV-1, tell your healthcare provider will test you for HBV infection suddenly in! With Elvitegravir ( EVG ) plus Cobicistat ( COBI ) in Treatment-Nave Adults with End Stage renal Disease ( )! Maintain an erection when you start treatment with Descovy when you start Descovy. General population is 1520 % stay HIV-1 negative to keep taking Descovy without first talking your. M184V/I ( N=7 ) and 25 mg of TAF brand ) $ 2115.82 what the. Mammalian DNA polymerases,,, and mitochondrial DNA polymerase to form emtricitabine 5'-triphosphate a pharmacy medicine, will... Generic versions plasma concentration of TAF read the latest medication news, new drug approvals, alerts and updates the! Phosphonoamidate prodrug of tenofovir ( 2'-deoxyadenosine monophosphate analog ) infection before or your... Is present in animal milk the absorption and plasma concentration of TAF, Acidosis/Severe... 1.3640 nM 4 % ) lumbar spine BMD loss at Week 48 about and support efforts.