绥美凯要注意什么？

GlaxoSmithKline (GSK) recently announced that its joint venture ViiV Healthcare’s single-tablet compound preparation Inbec (chemical name: dolutegravir) for the treatment of HIV, which is based on the new generation of integrase inhibitor Tevicai (chemical name: dolutegravir), has officially been launched in mainland China. 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 (Inbec)?

Things to note about Suimeikai:

1. Spread HIV

Although viral suppression with antiretroviral therapy has been shown to significantly reduce the risk of sexual transmission, residual risks cannot be excluded. Precautions should be taken to prevent transmission in accordance with national guidance.

2. Body weight and metabolic parameters (blood lipids and blood sugar)

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.

3. Liver disease

The safety and effectiveness of Trimax have not been established in patients with pre-existing severe liver disease. Suimeikan 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.

4. 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.

5. Opportunistic infections

Patients should be informed that HIV infection cannot be cured by Trimax 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.

6. 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.

Suimeikai 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 Trimax is used to treat patients co-infected with hepatitis B, another antiviral drug is generally required. Treatment guidelines should be consulted.

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

6. 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.

7. 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 used, measures should be taken to minimize all modifiable risk factors (e.g., smoking, hypertension, and hyperlipidemia).