Similar levels of virologic suppression were maintained in both the Early and Late Switch groups at 48 weeks.For the comparators typical resistance was detected with TDF/FTC/EFV (SINGLE; six with NNRTI associated resistance and one with major NRTI resistance) and with 2 NRTIs + raltegravir (SPRING-2; four with major NRTI resistance and one with raltegravir resistance), while no In a Phase I/II 48 week multicentre, open-label study (P1093/ING112578), the pharmacokinetic parameters, safety, tolerability and efficacy of dolutegravir was evaluated in combination regimens in HIV-1 infected infants, children and adolescents.At 24 weeks, 16 of 23 (69%) adolescents (12 to 17 years of age) treated with dolutegravir once daily (35 mg n=4; 50 mg n=19) plus OBR achieved viral load less than 50 copies/mL.Twenty out of 23 children and adolescents (87%) had >1 logThe Triumeq tablet has been shown to be bioequivalent to dolutegravir single entity tablet and abacavir/lamivudine fixed-dose combination tablet (ABC/3TC FDC) administered separately. Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Liver chemistry elevations consistent with immune reconstitution syndrome were observed in some hepatitis B and/or C co-infected patients at the start of dolutegravir therapy. These findings included decreased foetal body weight, foetal oedema, and an increase in skeletal variations/malformations, early intra-uterine deaths and still births. I read that calcium can affect the way the drug works? The pharmacokinetics of abacavir have been studied in patients with mild hepatic impairment (Child-Pugh score 5-6) receiving a single 600 mg dose.
Typically, such reactions have been observed within the first few weeks or months of initiation of CART. The adverse reactions considered at least possibly related to treatment with the components of Triumeq from clinical study and post-marketing experience are listed in Table 2 by body system, organ class and absolute frequency. The terminal intracellular half-life of lamivudine-TP was prolonged to 16-19 hours, compared to the plasma lamivudine half-life of 5-7 hours, supporting once daily dosing of ABC and 3TC.Pharmacokinetic data has been obtained for dolutegravir, abacavir and lamivudine separately. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.Some medicines can make Triumeq much less effective when taken at the same time.
Triumeq contain a combination of abacavir, dolutegravir, and lamivudine.Abacavir, dolutegravir, and lamivudine are antiviral medications that prevent human immunodeficiency virus (HIV) from multiplying in your body.. Triumeq is used to treat HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS).This medicine is not a cure for HIV or AIDS. Hypersensitivity reactions have been reported in <1% of patients treated with dolutegravir in clinical studies, and were characterized by rash, constitutional findings, and sometimes, organ dysfunction, including severe liver reactions.Abacavir HSR has been well characterised through clinical studies and during post marketing follow-up. In lactating rats that received a single oral dose of 50 mg/kg at 10 days postpartum, dolutegravir was detected in milk at concentrations typically higher than blood. Table 4: Demographics and virologic outcomes of randomized treatment of SPRING-2 (snapshot algorithm)Discontinued study/study drug due to adverse event or death‡ The combination of abacavir/lamivudine has demonstrated decreased susceptibility to viruses with the substitutions K65R with or without the M184V/I substitution, and to viruses with L74V plus the M184V/I substitution.Cross-resistance between dolutegravir or abacavir or lamivudine and antiretrovirals from other classes e.g. Dolutegravir was not carcinogenic in long term studies in the mouse and rat. There are no data available on the safety of abacavir and lamivudine when administered to babies less than three months old.It is recommended that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.There are no data on the effects of dolutegravir, abacavir or lamivudine on human male or female fertility. Data from clinical trials showed limited numbers of myocardial infarction and could not exclude a small increase in risk.
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