多替阿巴拉米片要注意什么？

The ingredients of Suimeikai 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. In 2015, a clinical application was submitted for dolutea palamid tablets in China; on January 20, 2017, it applied for import and obtained priority review qualification; on August 1, 2017, it was approved by the CFDA. At present, dolutea palamid tablets have been approved for marketing in 50 countries and regions, and are recommended by many European and American academic institutions and guidelines as the first-line first-line treatment for patients with HIV infection.

What do patients need to pay attention to when using doptabalamid tablets?

Spread HIV

Although effective 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.

hypersensitivity reaction

Both abacavir and dolutegravir carry the 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 responsible for a hypersensitivity reaction occurring with the use of this product. 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-B5701 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:

Before starting treatment, HLA-B5701 status must be confirmed.

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, should not be treated with this product.

If a hypersensitivity reaction is suspected, this product should be discontinued without delay even if the HLA-B5701 allele is not present. After a hypersensitivity reaction occurs, if treatment with this product is not stopped immediately, a life-threatening reaction may occur immediately. Clinical status, including hepatic aminotransferases and bilirubin, should be monitored.

After discontinuation of this product due to suspected hypersensitivity reaction, this product or any other medicinal product containing abacavir or dolutegravir should never be reintroduced.

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 re-dosing abacavir and dolutegravir, patients with suspected hypersensitivity reactions should be instructed to discard remaining Abacavir tablets.

Clinical description of hypersensitivity reactions

In clinical studies, <1% of patients treated with dolutegravir reported hypersensitivity reactions, manifesting as rash, systemic symptoms, and sometimes organ dysfunction, including severe liver 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.

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.

Opportunistic infections

Patients should be informed that HIV infection will not be cured by 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.