Patients should be informed of the risk of concurrent use of Retrovir® with other drugs and that the use of Retrovir® does not prevent HIV infection through sexual contact or through infected blood. Appropriate safety measures are required. RetroVir® does not cure HIV, and patients remain at risk for developing opportunistic infections and malignant tumors, due to immunosuppression. Although zidovudine reduces the risk of developing opportunistic infections, data on the risk of developing neoplasms, including lymphomas, against the background of the use of the drug are limited. The available data on patients who received treatment for HIV infection in advanced stages indicate that the risk of developing lymphoma corresponds to that of patients who have not received treatment. In patients with an early stage of HIV infection receiving long-term treatment, the risk of developing lymphoma is unknown.
Pregnant women considering the possibility of using zidovudine during pregnancy to prevent the transmission of HIV to their children should be informed that in some cases transmission can occur even despite treatment.
Emergency prophylaxis for possible contamination
According to international recommendations, if there is a probable contact with HIV-infected blood, for example, when a needle is pricked, it is necessary to prescribe combination therapy with zidovudine and lamivudine within 1-2 hours from the moment of infection. In the case of a high risk of infection, a drug from the HIV group of HIV should be included in the treatment regimen. Preventive treatment is recommended for 4 weeks.Data on the effectiveness of preventive treatment after accidental HIV infection have not been accumulated enough, no controlled studies have been conducted. Despite the rapid onset of treatment with antiretroviral drugs, seroconversion can not be ruled out. Undesirable reactions from the hematopoiesis system
Anemia (usually observed 6 weeks after the start of the use of Retrovir®, but sometimes it may develop earlier), neutropenia (usually occurs 4 weeks after initiation of treatment with Retrovir®, but sometimes occurs earlier), leukopenia (usually of a secondary nature due to neutropenia) may occur in patients receiving Retrovir® and having reduced bone marrow hematopoies before treatment, especially with advanced HIV infection.
During the administration of Retrovir® in patients with a developed clinical picture of HIV infection, it is necessary to monitor hematologic indices at least once every 2 weeks during the first 3 months of therapy, and then monthly. In the early stages of HIV infection (with unexhausted reserves of bone marrow hematopoiesis), undesirable reactions from the hematopoiesis system are rare.General blood tests can be performed less often, depending on the general condition of the patient (for example, 1 time in 1-3 months). If the hemoglobin content is reduced to 75-90 g / l (4.65-5.59 mmol / l), or the neutrophil count decreases to 0.75-1.0x109 / l, the daily dose of Retrovir® should be reduced to the recovery of blood or Retrovir® is canceled for 2-4 weeks before recovery of blood counts. Normally, the blood picture will be normalized after 2 weeks, after which the retrovir® preparation in a reduced dose can be reassigned. Despite a reduction in the dose of Retrovir®, severe anemia may require blood transfusion.
Lactic acidosis and severe hepatomegaly with steatosis
These complications can be fatal both with monotherapy with Retrovir® and with the use of Retrovir® as a combination therapy. The risk of these complications increases in women. Clinical signs of these complications may include gastrointestinal symptoms (nausea, vomiting and abdominal pain), general weakness, anorexia, lack of appetite, rapid unexplained weight loss, respiratory symptoms (dyspnea and tachypnea), or neurologic symptoms (including motor weakness).The use of nucleoside analogues should be discontinued if symptomatic hyperlactatemia and metabolic acidosis / lactic acidosis, progressive hepatomegaly, or a rapid increase in aminotransferase activity occur.
Caution should be exercised when prescribing Retrovir® to patients (especially women with excessive body weight), with hepatomegaly, hepatitis, or other known risk factors for liver damage and steatosis of the liver (including the use of certain medications and alcohol use). Patients with co-infection with hepatitis C and patients who are treated with interferon alfa and ribavirin may be at a particular risk group. Patients with an increased risk require special attention. RetroVir ® should be withdrawn in all cases of clinical or laboratory signs of lactic acidosis with or without hepatitis, which may include hepatomegaly with steatosis, even in the absence of an increase in transaminase activity.
Redistribution of subcutaneous fat
Redistribution and / or accumulation of subcutaneous fat, including the central type of obesity,an increase in the fat layer on the back of the neck ("buffalo buffalo"), a decrease in the subcutaneous fat layer on the face and extremities, an increase in the mammary glands, an increase in serum lipids and glucose in the blood was noted both in the complex and separately in some patients who received combined APT.
To date, all drugs from the HIV and NRTI class have been associated with one or more specific adverse events associated with a common syndrome, often called lipodystrophy. However, the data show differences in the risk of developing this syndrome between specific representatives of the therapeutic classes.
In addition, lipodystrophy syndrome has a multifactorial etiology, for example, factors such as the stage of HIV infection, old age and duration of APT, play an important, possibly synergistic role.
The long-term consequences of this phenomenon are currently unknown. Clinical examination should include a physical examination to assess the presence of redistribution of subcutaneous fat. It should be recommended to study the concentration of serum lipids and glucose in the blood.Lipid disorders should be treated according to clinical indications.
Immunodeficiency Syndrome
In HIV-infected patients with severe immunodeficiency during the onset of APT, inflammation may aggravate against an asymptomatic or residual opportunistic infection, which can lead to serious worsening or worsening of the symptoms. Typically, such reactions have been described in the first weeks or months of onset of APT. The most significant examples are cytomegalovirus retinitis, generalized and / or focal mycobacterial infection, and pneumonia caused by Pneumocystis jiroveci (R. carinii). Any symptoms of inflammation should be immediately identified and, if necessary, started treatment. Autoimmune diseases (such as Graves' disease, polymyositis and Guillain-Barre syndrome) were observed against the background of restoration of immunity, but the time of primary manifestations varied, and the disease could occur many months after the initiation of therapy and have an atypical course.
Concomitant viral hepatitis C
An increase in ribavirin-induced anemia in HIV-infected patients receiving zidovudine therapy was reported. But the exact mechanism of this phenomenon is unknown.Therefore, the combined use of ribavirin and zidovudine is not recommended. You should change the APT mode. applying a scheme that does not contain zidovudine, especially in patients with a history of zidovudine-induced anemia.
In patients infected with HIV and hepatitis C virus and receiving combined APT for HIV and interferon alfa in combination with ribavirin or without it, hepatic insufficiency (sometimes with lethal outcome) was observed. It is necessary to ensure that patients receiving interferon alfa with or without ribavirin, and Retrovir®, in order to identify the toxic effects associated with treatment, especially the development of hepatic insufficiency, neutropenia and anemia. In such cases, discontinuation of Retrovir® should be considered. Also consider the possibility of reducing the dose or stopping the use of interferon alfa, ribavirin, or both drugs in case of increased clinical toxicity, including the development of liver failure (for example, more than 6 on the Child-Pugh scale) (see the instructions for use for interferon alfa and ribavirin) .
Allergy to latex
The rubber stopper of the vial containing Retrovir, a solution for intravenous infusion, contains dry natural latex, which can cause allergic reactions in latex-sensitive patients.
Myopathy and myositis
Myopathy and myositis with pathological changes characteristic of the course of HIV infection were associated with prolonged use of Retrovir®.
Joint use with zidovudine-containing drugs
Retrovir ® should not be taken with drugs containing zidovudine, as one of the components (for example, the drug Combivir (lamivudine and zidovudine) or the drug Trizivir (abacavir, lamivudine and zidovudine)).