多替阿巴拉米片注意事项有哪些？

GlaxoSmithKline (GSK) recently announced that its joint venture ViiV Healthcare’s single-pill compound preparation Suimeikan (chemical name: Dolutegravir), which is based on the new generation integrase inhibitor Tevicai (chemical name: dolutegravir), is officially launched in mainland China for the treatment of HIV. This is the first single-pill compound preparation with a complete treatment plan in the field of HIV treatment in mainland China. As an innovative single-tablet compound preparation with obvious clinical therapeutic advantages, Dolutegra Abalamid Tablets can provide great convenience for the treatment of HIV-infected patients. In addition, what are the precautions for taking Abalami Tablets?

Transmitting HIV: Although viral suppression with antiretroviral treatment has been shown to significantly reduce the risk of sexual transmission, residual risks cannot be ruled out. Precautions should be taken to prevent transmission in accordance with national guidance. Hypersensitivity reactions: Both abacavir and dolutegravir have a risk of triggering a hypersensitivity reaction (HSR) and share some common characteristics, such as fever and/or rash and other symptoms indicating involvement of multiple organs. It is clinically impossible to determine whether abacavir or dolutegravir is the cause of a hypersensitivity reaction that occurs with dolutegravir. Hypersensitivity reactions have been observed to occur more commonly with abacavir, some of which can be life-threatening and, in rare cases, fatal if not managed appropriately. Patients who test positive for the HLA-B*5701 allele are at higher risk of developing abacavir hypersensitivity reactions. However, abacavir hypersensitivity reactions are reported less frequently in patients who do not carry this allele. Therefore, the following measures should be followed: HLA-B*5701 status must be confirmed before starting treatment. In patients with a positive HLA-B5701 status, or patients with a negative HLA-B5701 status who have had suspected abacavir hypersensitivity reactions when previously receiving abacavir-containing treatment regimens, they should not be treated with dolutea abacavir tablets. If a hypersensitivity reaction is suspected, even if the HLA-B*5701 allele is not present, dolutegravir should be discontinued without delay. After a hypersensitivity reaction, if treatment with Dolutegra is not discontinued immediately, a life-threatening reaction may occur immediately. Clinical status, including hepatic aminotransferases and bilirubin, should be monitored. Dolutegravir or any other medicine containing abacavir or dolutegravir should never be reintroduced after discontinuation of dolutegravir due to suspected hypersensitivity reaction. After a suspected hypersensitivity reaction to abacavir, symptoms may return within hours if abacavir-containing medicines are restarted. Relapses are generally more severe than the initial episode and may include life-threatening hypotension and death. To avoid readministration of abacavir and dolutegravir, patients with suspected hypersensitivity reactions should be instructed to discard remaining dolutegravir tablets. Clinical Description of Hypersensitivity Reactions: In clinical studies, <1% of patients receiving dolutegravir have reported hypersensitivity reactions, manifesting as rash, systemic symptoms, and sometimes organ dysfunction, including severe hepatic reactions. Hypersensitivity reactions to abacavir have been well characterized during clinical studies and post-marketing surveillance. Symptoms generally occur within the first six weeks after starting abacavir treatment (median time to onset is 11 days), but these reactions may occur at any time during treatment. Nearly all hypersensitivity reactions to abacavir include fever and/or rash. Other signs and symptoms observed as part of abacavir hypersensitivity reactions include respiratory and gastrointestinal symptoms. Importantly, these symptoms may lead to misdiagnosis of a hypersensitivity reaction as a respiratory illness (pneumonia, bronchitis, pharyngitis) or gastroenteritis. Continuing treatment can worsen symptoms associated with hypersensitivity reactions and may be life-threatening. These symptoms generally resolve after discontinuation of abacavir. Rarely, life-threatening reactions may occur within hours of restarting abacavir in patients who have discontinued abacavir for reasons other than symptoms of a hypersensitivity reaction. In such patients, abacavir therapy must be restarted in an environment where immediate medical attention is available. Weight and metabolic parameters (lipids and blood glucose): During antiretroviral therapy, weight gain and increased blood lipids 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. Hepatic Disease: The safety of dolutegravir has not been established in patients with pre-existing severe hepatic disease. For patients with moderate to severe hepatic impairment, the use of doptabalamid tablets is not recommended. 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 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 reactions.If you are also taking antiviral treatment for hepatitis B or hepatitis C, please refer to the relevant product information for these medicines. Dotiabalamid tablets contain 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 dolutea 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 dolutegravir tablets, regular monitoring of liver function and HBV replication markers is recommended, as discontinuation of lamivudine may lead to 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 analogues may affect mitochondrial function to varying degrees, with the effects being most significant when used in combination 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 the use of abacavir. 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. Steps should be taken to minimize all modifiable risk factors (e.g. smoking, hypertension, hyperlipidemia) while using dolutea. Osteonecrosis: Although the etiology is thought to be multifactorial (including corticosteroid use, bisphosphonates, alcohol consumption, severe immunosuppression, 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 is not cured by Dolutegra or any other antiretroviral treatment 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. Resistance: Because the recommended dose of dolutegravir in patients with resistance to integrase inhibitors is 50 mg twice daily, its use in patients with resistance to integrase inhibitors is not recommended.