多替阿巴拉米片是什么呢？

The name is Triumeq, and its ingredients are dolutegravir 50mg (dolutegravir) + abacavir 0.6g (abacavir) + lamivudine 0.3g (lamivudine). It is used for the treatment of HIV-1 infection. It is the only three-in-one compound drug containing dolutegravir. It takes one tablet once a day. It has the characteristics of high efficiency, good tolerance, high resistance barrier and few drug interactions.

If the patient misses a dose of this product and there are more than 4 hours before the next dose, the patient should take this product as soon as possible. If the next dose is less than 4 hours away, patients should not take the missed dose and simply resume their usual dosing schedule.

Medication for special populations:

elderly patients

There are limited data on the use of dolutegravir, abacavir, and lamivudine in patients 65 years and older. There is no evidence that older patients require different dosages than younger adult patients. Taking into account age-related changes, such as decreased renal function and changes in hematological parameters, special caution is recommended when administering the drug in this age group.

kidney damage

Patients whose creatinine clearance is less than 50 mL/min are not recommended to take this product.

liver damage

Abacavir is primarily metabolized by the liver. There are no clinical data in patients with moderate or severe hepatic impairment and therefore its use is not recommended unless deemed necessary. For patients with mild hepatic impairment (Child-Pugh score 5-6), close monitoring is required, including monitoring of abacavir plasma levels if feasible.

children crowd

The safety and effectiveness of this product in children under 12 years of age have not been established. No data yet.

Dosing method

Oral

This product can be taken with or without food.

Adverse Reactions: There are limited clinical data on this product. The most commonly reported adverse reactions that are possibly or probably related to dolutegravir and abacavir/lamivudine (pooled data from 679 antiretroviral drug-naïve subjects who received this combination in Phase IIb to IIIb clinical trials) are nausea (12%), insomnia (7%), dizziness (6%), and headache (6%).

Things to note:

Body weight and metabolic parameters (lipids and blood glucose)

During antiretroviral therapy, weight gain and elevated blood lipid and blood glucose levels may occur. These changes may be related in part to disease control and lifestyle. In some cases, there is evidence of treatment effects on lipids, but there is no clear evidence that weight gain is associated with any particular treatment. Monitoring of lipids and blood glucose should refer to established HIV treatment guidelines. Dyslipidemia should be treated appropriately based on the clinical situation.

Liver disease

The safety and effectiveness of this product have not been established in patients with pre-existing severe liver disease. This product is not recommended for patients with moderate to severe liver damage.

Patients with pre-existing hepatic dysfunction, including those with chronic active hepatitis, develop hepatic dysfunction with increased frequency during combined antiretroviral therapy and should be monitored according to standard protocols. If in these patients there is evidence of worsening liver disease, withholding or discontinuing treatment should be considered.

Patients with chronic hepatitis B or hepatitis C

Patients with chronic hepatitis B or hepatitis C who receive combination antiretroviral therapy are at increased risk for serious and potentially fatal hepatic adverse effects. If you are also taking antiviral treatment for hepatitis B or hepatitis C, please refer to the relevant product information for these medicines.

This product contains lamivudine, which is effective against hepatitis B. Abacavir and dolutegravir lack such effects. It is generally believed that lamivudine monotherapy is not an adequate treatment for hepatitis B because of the high risk of developing hepatitis B virus resistance. Therefore, if this product is used to treat patients co-infected with hepatitis B, another antiviral drug is generally required. Treatment guidelines should be consulted.

If patients co-infected with hepatitis B virus discontinue this product, regular monitoring of liver function and HBV replication markers is recommended, as discontinuation of lamivudine may lead to an acute exacerbation of hepatitis.

immune reconstitution inflammatory syndrome

In severely immunodeficient HIV-infected patients when initiating combination antiretroviral therapy (CART), an inflammatory response to asymptomatic or residual opportunistic pathogens may occur, leading to severe clinical illness or symptom exacerbation. Such reactions are usually observed in the weeks or months before starting CART therapy. Relevant examples include cytomegalovirus retinitis, systemic and/or focal mycobacterial infections, and Pneumocystis jiroveci pneumonia. Symptoms of inflammation should be evaluated and treated if necessary. Autoimmune disorders (e.g., Graves' disease) have also been reported during immune reconstitution; however, the reported timing of onset is inconsistent and these events may occur many months after initiation of therapy.

In patients with co-infection with hepatitis B or hepatitis C virus, elevated liver chemistries consistent with immune reconstitution inflammatory syndrome have been observed upon initiation of dolutegravir therapy. In patients with hepatitis B and/or hepatitis C virus infection, monitoring of liver chemistry test values ​​is recommended.

Mitochondrial dysfunction following in utero exposure

Nucleosides and nucleoside analogs may affect mitochondrial function to varying degrees, with the effects being most significant when combined with stavudine, didanosine, and zidovudine. Mitochondrial dysfunction has been reported in HIV-negative infants exposed to nucleoside analogues in utero and/or postnatally, primarily in association with zidovudine-containing treatment regimens. The main adverse reactions reported were hematological disorders (anemia, neutropenia) and metabolic disorders (hyperlactemia, hyperlipidemia). These reactions are often short-lived. Some late-onset neurological disorders (hypertonia, convulsions, behavioral abnormalities) are rarely reported. It is unclear whether the neurological condition is temporary or permanent. These results should be considered in children exposed to nucleosides and nucleoside analogues in utero who have severe clinical symptoms of unknown etiology, especially neurological symptoms. These results do not affect current national guidelines for the use of antiretrovirals in pregnant women to prevent vertical transmission of HIV.

myocardial infarction

Observational studies have demonstrated an association between myocardial infarction and abacavir use. The patients participating in the study were mainly those who had received antiretroviral therapy. Clinical trial data show a limited number of myocardial infarctions and a small increase in risk cannot be ruled out. Overall, there are some inconsistencies between observational cohort data and randomized trial data, so a causal relationship between abacavir treatment and the risk of myocardial infarction cannot be confirmed or denied. To date, there is no precise biological mechanism to explain the possible increased risk. When using this product, steps should be taken to minimize all modifiable risk factors (such as smoking, hypertension, and hyperlipidemia).

osteonecrosis

Although the etiology is thought to be multifactorial (including use of corticosteroids, bisphosphonates, alcohol consumption, severe immunosuppression, and high body mass index), cases of osteonecrosis have been reported, particularly in patients with advanced HIV disease and/or long-term exposure to CART. Patients should be advised to seek medical attention if they experience joint pain, joint stiffness, or difficulty moving.

Opportunistic infections

Patients should be informed that HIV infection cannot be cured by this product or any other antiretroviral therapy and that they may still develop opportunistic infections and other complications of HIV infection. Therefore, patients should be under close clinical observation by physicians experienced in treating HIV-related diseases.

Resistant

Because the recommended dose of dolutegravir in patients who are resistant to integrase inhibitors is 50 mg twice daily, dolutegravir is not recommended for use in patients who are resistant to integrase inhibitors.

drug interactions

When administered concomitantly with etravirine (without potentiating protease inhibitors), efavirenz, nevirapine, rifampicin, tipranavir/ritonavir, carbamazepine, phenytoin, phenobarbital, and St. John's wort, the recommended dose of dolutegravir is 50 mg twice daily, so TRIUMEQ is not recommended in patients taking these medications.

TRIUMEQ should not be administered concurrently with antacids containing polyvalent cations. It is recommended to take TRIUMEQ 2 hours before or 6 hours after these medications.

It is recommended to take TRIUMEQ 2 hours before or 6 hours after dosing calcium or iron supplements.

Dolutegravir may increase metformin concentrations. If dolutegravir is administered concurrently with metformin, the metformin dose may need to be adjusted when therapy is initiated and discontinued to maintain glycemic control.

Metformin is eliminated by the kidneys, so renal function must be monitored when coadministered with dolutegravir. Coadministration may increase the risk of lactic acidosis in patients with moderate renal impairment (stage 3a, creatinine clearance [CrCl] 45-59 mL/min) and a conservative approach is recommended. Metformin dose reduction is strongly recommended.

Coadministration of lamivudine with cladribine is not recommended.

TRIUMEQ should not be taken with other medicines containing dolutegravir, abacavir, lamivudine, or emtricitabine.

Effects on ability to drive and operate machinery

Patients should be informed that dizziness has been reported during treatment with dolutegravir. The patient's clinical status and TRIUMEQ's adverse effect profile should be kept in mind when considering a patient's ability to drive or operate machinery.

Storage:

This product should be sealed and stored in the original packaging below 30°C to prevent the tablets from absorbing moisture. Seal the vial tightly and do not remove the desiccant.