Talk with your healthcare provider about the best way to feed your baby. Bottle of 30 tablets with child-resistant closure. subjects with severe renal impairment compared with those in matched healthy There was no treatment-emergent resistance to dolutegravir, abacavir, or lamivudine. with severe hepatic impairment [see CLINICAL PHARMACOLOGY]. TIVICAY contains dolutegravir, as dolutegravir sodium, an HIV INSTI. Dolutegravir demonstrated equivalent antiviral activity against 2 NNRTI-resistant, 3 NRTI-resistant, and 2 PIresistant HIV-1 mutant clones compared with the wild-type strain. See additional information. polymyositis, and Guillain-Barré syndrome) have also been reported to occur in second and third trimester exposure in pregnant women indicate no evidence of to consider an alternative treatment to TIVICAY at the time of conception recommended in adolescents and adults actively trying to become pregnant unless Store at room temperature in a dry place. Population analyses using pooled pharmacokinetic data from adult trials indicated gender and race had no clinically relevant effect on the exposure of dolutegravir. 10 mg: Each tablet contains 10 mg of dolutegravir (as PHARMACOLOGY]. Dolutegravir Pharmacokinetic Parameter Estimates Geometric Mean (%CV), Geometric Mean Ratio (90% CI) of Dolutegravir Pharmacokinetic Parameters with/without Coadministered Drugs, Q148H/R + G140S/A/C without additional INSTIresistance substitution, Q148H/R + ≥2 INSTI-resistance substitutions, 6 years and older without INSTI resistance, BR = Background regimen; CAR = Current antiretroviral regimen; OBT = Optimized background therapy, Discontinued for other reasons while not suppressed, Discontinued study/study drug due to adverse event or death, Discontinued study/study drug for other reasons, Darunavir use with primary PI substitutions, Darunavir use without primary PI substitutions, other antiretroviral agents for the treatment of human Specific Populations]. Tivicay 50 mg Film-Coated Tablets - Patient Information Leaflet (PIL) by ViiV Healthcare UK Ltd Tivicay (dolutegravir) is an antiviral medicine that prevents human immunodeficiency virus (HIV) from multiplying in your body. Use alternatives to rifampin, carbamazepine, efavirenz, Aptivus/Norvir, and Lexiva/Norvir when possible in people with confirmed or suspected INSTI drug resistance, but these medications can be taken with Tivicay 50 mg twice daily. Avoid coadministration with TIVICAY because there are insufficient data to make dosing recommendations. least 30 kg, pharmacokinetic parameters of dolutegravir were comparable to dysfunction, including liver injury. Dolutegravir EC50 values against 3 HIV-2 clinical isolates in PBMC assays ranged from 0.09 nM to 0.61 nM. Mean reduction from baseline in HIV-1 RNA at Day 8 (primary endpoint) was 1.4 log10 (95% CI: 1.3 log10, 1.5 log10). Through 96 weeks, the rates of adverse events leading to discontinuation were 3% in subjects receiving TIVICAY and 6% in subjects receiving darunavir/ritonavir. There were 715 subjects included in the efficacy and safety analyses. If you are able to get pregnant, a pregnancy test will be done to show that you are NOT pregnant before starting Tivicay (dolutegravir 25 mg and 50 mg). You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby. continuing TIVICAY versus switching to another antiretroviral regimen and The chemical name of dolutegravir sodium is sodium (4R,12aS)-9-{[(2,4-difluorophenyl)methyl]carbamoyl}-4-methyl6,8-dioxo-3,4,6,8,12,12a-hexahydro-2H-pyrido[1',2':4,5]pyrazino[2,1-b][1,3]oxazin-7-olate. The virus in your blood may increase and the virus may become harder to treat. In a multicenter, open-label, single-arm trial (ING112574, VIKING-3), 183 HIV-1–infected, antiretroviral treatment-experienced adults with virological failure and current or historical evidence of raltegravir and/or elvitegravir resistance received TIVICAY 50 mg twice daily with the current failing background regimen for 7 days and with optimized background therapy from Day 8. substitutions or clinically suspected INSTI resistance [see Microbiology]) Grade 2 ARs reported by more than one subject were decreased neutrophil count (n = 3) and diarrhea (n = 2). In the U.S. general population, the estimated dolutegravir use and because the date of conception may not be determined with Treatment-Emergent Adverse Reactions of at Least Moderate Intensity (Grades 2 to 4) and at Least 2% Frequency in Treatment-Naive Subjects in SPRING-2 (Week 96 Analysis) and SINGLE Trials (Week 144 Analysis). increased risk of adverse birth outcomes. the pregnant woman and the fetus. after the onset of hypersensitivity may result in a life-threatening reaction. It may harm them. Dolutegravir in combination with zidovudine and lamivudine for 28 days is a preferred HIV PEP regimen in adults with renal dysfunction (CrCl 59 mL/minute or less). In a birth outcome surveillance study in Botswana, there The proportion of subjects with HIV-1 RNA less than 50 copies per mL at Week 48 was 95% for both treatment groups; treatment difference and 95% CI was -0.2% (-3.0%, 2.5%). review concomitant medications during therapy with TIVICAY; and monitor for the Liều dùng thuốc Tivicay 50mg bao nhiêu? The adverse reaction profile was similar to that for adults. Virologically Suppressed Adults: Laboratory abnormalities observed in SWORD-1 and SWORD-2 were generally similar compared with observations seen in the other Phase 3 trials. There are insufficient human data on the use of TIVICAY Dolutegravir 50 mg (Instgra) is the one that belongs to integrase inhibitors which are a class of drugs known to treat HIV causing a virus. Due to the limited understanding of If you take antacids, laxatives, or other medicines that contain aluminum, magnesium, or buffered medicines, TIVICAY should be taken at least 2 hours before or 6 hours after you take these medicines. See additional information. If you are breast-feeding. The only treatment-emergent AR of moderate to severe intensity with at least 2% frequency in either treatment group was diarrhea, 2% (6 of 354) in subjects receiving TIVICAY 50 mg once daily + background regimen and 1% (5 of 361) in subjects receiving raltegravir 400 mg twice daily + background regimen. treatment-experienced and INSTI-naïve patients with mild, moderate, or severe Initiation of TIVICAY is not In a study conducted in rats, there were no effects on Dolutegravir may increase plasma concentrations of drugs eliminated via OCT2 or MATE1 (dofetilide, dalfampridine, and metformin, Table 6) [see CONTRAINDICATIONS, Established And Other Potentially Significant Drug Interactions]. Use Tivicay (dolutegravir 25 mg and 50 mg) as ordered by your doctor. Food increased the extent of absorption and slowed the rate of absorption of dolutegravir. Copyright © 2018 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. Tivicay … The concomitant use of TIVICAY and other drugs may result cases of myelomeningocele. 27709. Possible clinically significant adverse reactions from Treatment-Experienced, Integrase Strand Transfer Inhibitor-Naive Subjects. The empirical formula is C20H18F2N3NaO5 and the molecular weight is 441.36 g per mol. Copyright © 2020 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. Signs of an allergic reaction, like rash; Signs of liver problems like dark urine, feeling tired, not hungry. Manufactured for: ViiV Healthcare Research Triangle Park, Some drugs may have another patient information leaflet. 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. conception. Coadministration of dolutegravir and other drugs that inhibit these enzymes may increase dolutegravir plasma concentration. Virologic Outcomes of Randomized Treatment in SAILING at 48 Weeks (Snapshot Algorithm). In addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during postmarketing use. Use Tivicay (dolutegravir 25 mg and 50 mg) as ordered by your doctor. to make sure that it is safe for you to take Tivicay (dolutegravir 25 mg and 50 mg) with all of your drugs and health problems. the MRHD). Tivicay 50 mg filmdragerade tabletter. The lowest GoodRx price for the most common version of Tivicay is around $1,810.03, 20% off the average retail price of $2,277.25. The non-linear exposure of dolutegravir following 50 mg twice daily compared with 50 mg once daily in HIV-1–infected subjects (Table 7) was attributed to the use of metabolic inducers in the background antiretroviral regimens of subjects receiving dolutegravir 50 mg twice daily in clinical trials. exposure in humans at the recommended dose of 50 mg twice daily. Women must use. Call your doctor for medical Dolutegravir is metabolized by UGT1A1 with some contribution from CYP3A. The adjusted mean changes in CD4+ cell counts from baseline were 378 cells per mm3 in the group receiving TIVICAY + EPZICOM and 332 cells per mm3 for the ATRIPLA group at 144 weeks. No subjects in the dolutegravir 50-mg once-daily treatment arms of treatment-naive trials SPRING-2 (96 weeks) and SINGLE (144 weeks) had a detectable decrease in susceptibility to dolutegravir or background NRTIs in the resistance analysis subset (n = 12 with HIV-1 RNA greater than 400 copies per mL at failure or last visit and having resistance data). elevations with use of TIVICAY [see ADVERSE REACTIONS]. Hepatic adverse events have been reported in patients In a multicenter, open-label trial (FLAMINGO), 243 subjects received TIVICAY 50 mg once daily versus 242 subjects who received darunavir 800 mg/ritonavir 100 mg once daily, both in combination with investigator-selected NRTI background regimen (either EPZICOM or TRUVADA). Tivicay 50 mg film-coated tablets Each film-coated tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir. Laboratory abnormalities observed in the FLAMINGO trial were generally consistent with observations in SPRING-2 and SINGLE. the original package, keep the bottle tightly closed, and protect from Patients not previously been treated w/ an integrase inhibitor (12 to <18 yr, & weighing ≥40 kg) 50 mg once daily. with dolutegravir [see WARNINGS AND PRECAUTIONS]. biconvex tablets debossed with “SV 572” on one side and “50” on the other side. than the exposure in humans at the MRHD and in rats were approximately 27 times consider switching to an alternative regimen. There were 484 subjects included in the efficacy and safety analyses. The recommended dose of TIVICAY Data from a birth outcome surveillance study has recommended. whose immune systems respond may develop an inflammatory response to indolent Thirty-one percent of the total oral dose was excreted in urine, represented by an ether glucuronide of dolutegravir (18.9% of total dose), a metabolite formed by oxidation at the benzylic carbon (3.0% of total dose), and its hydrolytic N-dealkylation product (3.6% of total dose). The proportion of subjects with HIV- 1 RNA greater than or equal to 50 copies per mL (virologic failure) at Week 48 was 0.6% and 1.2% for the dolutegravir plus rilpivirine treatment group and the current antiretroviral regimen treatment groups, respectively; treatment difference and 95% CI was -0.6% (-1.7%, 0.6%). Neither dose of dolutegravir had a significant effect on the actual glomerular filtration rate (determined by the clearance of probe drug, iohexol) or effective renal plasma flow (determined by the clearance of probe drug, para-amino hippurate) compared with the placebo. As dolutegravir is highly bound to plasma proteins, it is unlikely that it will be significantly removed by dialysis. recognized pregnancies is 2% to 4% and 15% to 20%, respectively. currently on TIVICAY who are actively trying to become pregnant, or if After a single oral dose of [14C] dolutegravir, 53% of the total oral dose was excreted unchanged in feces. infant. drugs a-z list In the Week 48 resistance analysis 85% (33 of 39) of the subjects with virologic failure had treatment-emergent INSTI-resistance substitutions in their isolates. At 48 weeks, the rates of adverse events leading to discontinuation were 3% in subjects receiving TIVICAY 50 mg once daily + background regimen and 4% in subjects receiving raltegravir 400 mg twice daily + background regimen. non-dolutegravir-containing antiretroviral regimens. Last updated on Oct 17, 2020. B or C may be at increased risk for worsening or development of transaminase The mean changes in CD4+ cell counts from baseline were 162 cells per mm3 in the group receiving TIVICAY and 153 cells per mm3 in the raltegravir group. NDC 49702-226-13. Drugs that induce those enzymes and transporters may decrease dolutegravir plasma concentration and reduce the therapeutic effect of dolutegravir. When taken in combination with other HIV-1 medicines, TIVICAY can help provide effective HIV-1 treatment in adults and children who weigh at least 66 pounds. If it is close to the time for your next dose, skip the missed dose and go back to your normal time. Talk with the doctor. TIVICAY (dolutegravir sodium), 50 mg film-coated tablets, is a Prescription Medicine that works as an integrase inhibitor, used for the treatment of Human Immunodeficiency Virus (HIV) infection in combination with other anti HIV agents in adults and children over 12 years of … Initiation of TIVICAY is not recommended in adolescents and adults actively Check with Updated on 8 March 2017 SPC . At Week 48, the proportion of subjects from Cohort 1 with HIV-1 RNA less than 50 copies per mL was 61% (14/23). Inform patients that there is an antiretroviral pregnancy In a randomized, placebo-controlled, cross-over trial, 42 healthy subjects received single-dose oral administrations of placebo, dolutegravir 250-mg suspension (exposures approximately 3– fold of the 50-mg once-daily dose at steady state), and moxifloxacin 400 mg (active control) in random sequence. There is a pregnancy exposure registry that monitors If you do not take TIVICAY with food, take TIVICAY at least 2 hours before or 6 hours after you take these supplements. The recommended dose of dolutegravir for adults and adolescents 12 to 18 years old, who weigh at least 40 kg is 50 mg (1 tablet) taken once a day.Depending on other medications you may be using or may have used in the past to treat HIV infection, you may be advised to take 50 mg (1 tablet) twice a day. In adolescents and adults of childbearing potential The tablet film-coating contains the inactive ingredients iron oxide yellow (for the 25-mg and 50-mg tablets only), macrogol/PEG, polyvinyl alcohol-part hydrolyzed, talc, and titanium dioxide. With once-daily dosing, pharmacokinetic steady state is achieved within approximately 5 days with average accumulation ratios for AUC, Cmax, and C24 h ranging from 1.2 to 1.5. with TIVICAY [see WARNINGS AND PRECAUTIONS, Use In Specific Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. • 20 kg and greater: 50 mg once daily. INSTI-experienced patients (with certain INSTI-associated resistance In rats, no increases in the incidence of drug-related neoplasms were reactions develop (including, but not limited to, severe rash or rash Elevated levels of dalfampridine increase the risk of seizures. It may also be used, as part of post exposure prophylaxis, to prevent HIV infection following potential exposure. Population analyses using pooled pharmacokinetic data from adult trials indicated no clinically relevant effect of HCV co-infection on the pharmacokinetics of dolutegravir. Ei erityisvaatimuksia hävittämisen suhteen. Alternative dosing recommendations for TIVICAY tablets for patients weighing at least 14 kg (Table 4): • 14 kg to less than 20 kg: 40 mg once daily. Across both cohorts, virologic suppression (HIV-1 RNA less than 50 copies per mL) at Week 24 was achieved in 75% (18/24) of subjects weighing at least 40 kg and 55% (6/11) of subjects in the 30 to less than 40 kg weight-band. affiliated with and do not endorse the ViiV Healthcare group of companies or anti-hepatitis therapy was withdrawn. to avoid risking postnatal transmission of HIV-1 infection. Dolutegravir Steady-State Pharmacokinetic Parameter Estimates in HIV-1– Infected Adults. Strand transfer biochemical assays using purified HIV-1 integrase and pre-processed substrate DNA resulted in IC50 values of 2.7 nM and 12.6 nM. Advise adolescents and adults of Get Latest Price Request a quote. Tivicay is supplied as film-coated tablets each containing 10.5 mg, 26.3 mg or 52.6 mg of dolutegravir sodium, equivalent to 10 mg, 25 mg or 50 mg of dolutegravir free acid. Your healthcare provider may prescribe a different medicine than TIVICAY if you are planning to become pregnant or if pregnancy is confirmed during the first 12 weeks of pregnancy. Bottle of 30 tablets with child-resistant closure. to [see CONTRAINDICATIONS, DRUG INTERACTIONS]: For concomitant drugs for which the interaction can be Subjects were stratified by age, enrolling adolescents first (Cohort 1: aged 12 to less than 18 years) and then younger children (Cohort 2A: aged 6 to less than 12 years). It is not known whether TIVICAY is present in human Healthcare providers are encouraged to register patients by calling the Clinical trials of TIVICAY did not include sufficient frequency of decreased hepatic, renal, or cardiac function, and of concomitant through the first trimester of pregnancy. These events have been included because of their seriousness and assessment of potential causal relationship. Läs noga igenom denna bipacksedel innan du börjar ta detta läkemedel. regimen for the treatment of HIV-1 infection in adults to replace the current. Therefore, TIVICAY is not recommended for use in patients mating or fertility with dolutegravir up to 1,000 mg per kg per day. … Thirty-nine subjects with virologic failure had resistance data that were used in the Week 48 analysis. Exposure to dolutegravir was generally similar between healthy subjects and HIV-1–infected subjects. Five cases reported with dolutegravir Bottle of 30 tablets with child-resistant closure. In comparison, the neural tube defect prevalence rates were 0.1% post-neural tube closure, the time period of which may be later than 6 weeks of Start metformin at lowest dose and titrate based on glycemic control. In addition, 2 of the 5 Do not Stay under the care of a healthcare provider during treatment with TIVICAY. VIKING-3 examined the efficacy of dolutegravir 50 mg twice daily plus optimized background therapy in subjects with prior or current virologic failure on an INSTI- (elvitegravir or raltegravir) containing regimen. Refer to the prescribing information for metformin for assessing the benefit and risk of concomitant use of TIVICAY and metformin. Side-by-side tabulation is to simplify presentation; direct comparisons across trials should not be made due to differing trial designs. Virologically Suppressed Subjects: SWORD-1 and SWORD-2 are identical trials in virologically suppressed subjects receiving 2 NRTIs plus either an INSTI, an NNRTI, or a PI, that switched to dolutegravir plus rilpivirine (n = 513) or remained on their current antiviral regimen (n = 511). (15/14,792 deliveries) in the non-dolutegravir arm and 0.08% (70/89,372 Treatment-Naive Subjects: Selected laboratory abnormalities (Grades 2 to 4) with a worsening grade from baseline and representing the worst-grade toxicity in at least 2% of subjects are presented in Table 4. The single INSTI-resistance substitutions T66K, I151L, and S153Y conferred a greater than 2-fold decrease in dolutegravir susceptibility (range: 2.3-fold to 3.6-fold from reference). numbers of subjects aged 65 and older to determine whether they respond To extend the shelf-life of the Tivicay 25 mg tablets as packaged for sale from 3 to 4 years. risk of neural tube defects with dolutegravir. C. Advise adolescents and adults of childbearing potential INSTI-associated resistance substitutions or clinically suspected INSTI remove desiccant. Autoimmune disorders (such as Graves’ disease, provider if they develop rash. in adults, instruct mothers not to breastfeed if they are receiving TIVICAY. Dolutegravir has not been studied in patients on dialysis. Data analyzed to date from other sources including the when TIVICAY is started [see WARNINGS AND PRECAUTIONS]. IMPAACT P1093 is a Phase 1/2, 48-week, multicenter, open-label trial to evaluate the pharmacokinetic parameters, safety, tolerability, and efficacy of TIVICAY in combination treatment regimens in HIV-1–infected infants, children, and adolescents. HIV-negative infants), (2) developing viral resistance (in HIV-positive The median CD4+ cell count increase from baseline to Week 48 was 84 cells per mm3 in Cohort 1. debossed with “SV 572” on one side and “10” on the other side. Because of the potential for (1) HIV-1 transmission (in cytomegalovirus, Pneumocystis jirovecii pneumonia [PCP], or tuberculosis), mitigated, please see Table 6 for steps to prevent or manage these possible and Revised: Oct 2019. This includes signs of infection like fever. There is no known specific treatment for overdose with TIVICAY. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. General information about the safe and effective use of TIVICAY. open-label, multicenter, dose-finding clinical trial, IMPAACT P1093 [see CLINICAL Safety and efficacy of TIVICAY have not been established Do not give TIVICAY to other people, even if they have the same symptoms you have. At Week 48, 63% (12/19) of the subjects in Cohort 1 weighing at least 40 kg were virologically suppressed. alternative treatment to TIVICAY should be considered at the time of conception assay. the potential for drug interactions prior to and during therapy with TIVICAY; Hepatitis B and/or Hepatitis C Virus Co-infection: In Phase 3 trials, subjects with hepatitis B and/or C virus co-infection were permitted to enroll provided that baseline liver chemistry tests did not exceed 5 times the upper limit of normal. Advise patients to inform their healthcare provider TIVICAY may interact with other drugs; therefore, advise No dosage adjustment is necessary for patients with mild to The efficacy of TIVICAY 50 mg twice daily is reduced in patients with an INSTI-resistance Q148 substitution plus 2 or more additional INSTI-resistance substitutions, including T66A, L74I/M, E138A/K/T, G140S/A/C, Y143R/C/H, E157Q, G163S/E/K/Q, or G193E/R. Dolutegravir was not genotoxic in the bacterial reverse with your doctor, nurse, pharmacist, or other health care provider. In SINGLE, 833 subjects were randomized and received at least 1 dose of either TIVICAY 50 mg with fixed-dose abacavir sulfate and lamivudine (EPZICOM) once daily or fixed-dose efavirenz/emtricitabine/tenofovir (ATRIPLA) once daily (study treatment was blinded through Week 96 and open-label from Week 96 through Week 144). Excipient(s) with known effect: Each 10 mg tablet contains 1 mg sodium. during pregnancy to definitively assess a drug-associated risk for birth Dolutegravir Steady-State Pharmacokinetic Parameters in Pediatric Subjects. the other side. TIVICAY is indicated in Dolutegravir is used with other HIV medications to help control HIV infection. It is taken by mouth. TIVICAY may harm your unborn baby. Response at Week 48 was affected by baseline INSTI substitutions [see Microbiology]. Tablets are yellow, round, film-coated, biconvex tablets Keep taking Tivicay (dolutegravir 25 mg and 50 mg) as you have been told by your doctor or other health care provider, even if you feel well. closure of the neural tube occur from conception through the first 6 weeks of At baseline, median age of subjects was 48 years; 23% were female, 29% non-white, and 20% had hepatitis B and/or C virus coinfection. From CYP3A not sure what to do if you miss a dose of TIVICAY did induce. 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