Treatment with Lamivudine-Teva should be performed by a doctor with experience in managing patients with HIV infection.
The use of lamivudine as a monotherapy is not recommended.
In patients with impaired renal function of medium and severe degree, the concentration of lamivudine in plasma is increased, due to the decrease in clearance of the drug, therefore dose adjustment is required.
Patients should be cautioned that treatment with antiretroviral drugs, incl. lamivudine, does not prevent the risk of HIV transmission to other people during sexual intercourse or blood transfusion. Therefore, patients must comply appropriate precautions.
In patients receiving lamivudine or other antiretroviral drugs, opportunistic infections or other complications may develop, so they should be carefully monitored by a physician with experience in HIV treatment.
Several cases of pancreatitis developed in patients who received lamivudine. However, it remains unclear whether this complication is caused by lamivudine or HIV infection itself. When there is abdominal pain, nausea, vomiting, or characteristic changes in biochemical parameters in a patient receiving lamivudine, pancreatitis should be excluded. It is necessary to suspend the drug until the diagnosis of pancreatitis is not ruled out.
In HIV-infected patients (predominantly in women) who took antiretroviral preparations from the group of nucleoside analogues as monotherapy or in combination with lamivudine, described cases of lactic acidosis, which was usually accompanied by severe hepatomegaly and fatty liver dystrophy, incl. with a lethal outcome.
Symptoms that may indicate the development of lactic acidosis include general weakness, loss of appetite, sudden unexplained weight loss, abnormalities in the gastrointestinal tract and respiratory system (dyspnea).
Treatment with lamivudine always requires caution and, especially, if the patient has risk factors for developing liver disease.In case of clinical or laboratory signs of lactic acidosis or liver dysfunction (including hepatomegaly and fatty liver dystrophy even in the absence of a marked increase in the activity of "liver" transaminases), lamivudine should be discontinued.
In some patients, combined antiretroviral therapy may be accompanied by a redistribution / accumulation of subcutaneous fat, incl. a decrease in the amount of peripheral fatty tissue and an increase in visceral fat, weight loss of limbs and face, enlargement of the mammary glands and the deposition of fat on the back of the neck and back ("buffalo buffalo"), as well as increased serum lipid concentrations and glucose concentrations in the blood.
Although one or more of the above unwanted reactions associated with a common syndrome, often called lipodystrophy, can cause all drugs from classes of protease inhibitors and nucleoside reverse transcriptase inhibitors, the accumulated evidence suggests that there are differences between individual representatives of these classes of drugs in the ability to induce these unwanted reactions.
It should also be noted that lipodystrophy syndrome has a multifactorial etiology; for example, the stage of HIV infection, the elderly age and the duration of antiretroviral therapy play an important, perhaps synergistic role in the development of this complication.
The long-term effects of these undesirable reactions are not currently established.
Clinical examination of patients should include an assessment of physical signs of fat tissue redistribution. Serum lipids and glucose concentrations in the blood should also be measured. Disorders of lipid metabolism should be adjusted, guided by their clinical manifestations.
Immunodeficiency Syndrome: in HIV-infected patients with severe immunodeficiency during the onset of antiretroviral therapy (Apt) possibly exacerbation of the inflammatory process caused by asymptomatic or sluggish opportunistic infection, which can cause serious deterioration or worsening of symptoms. As a rule, similar reactions were observed in the first weeks or months after the onset Apt. The most significant examples are cytomegalovirus retinitis, generalized and / or focal mycobacterial infection and pneumocystis pneumonia. Any symptoms of inflammation should be immediately identified and start treatment in a timely manner. Also, in conditions of restoration of immunity, the development of autoimmune diseases (Graves' disease, polymyositis, Guillain-Barre syndrome) is possible, however, the development of these diseases can be registered even several months after the start of treatment.
In some patients with chronic hepatitis B, after the withdrawal of lamivudine, clinical or laboratory signs of hepatitis recurrence may appear, which can have serious consequences in decompensating liver function. After the termination of lamivudine therapy in patients with co-infection caused by HIV and hepatitis B virus, it is necessary to monitor biochemical parameters of liver function and markers of hepatitis B virus replication. There have been cases of hepatic decompensation (some fatal) in patients with HIV-1 co-infection / hepatitis B who received combination antiretroviral therapy and interferon alfa together with ribavirin or without ribavirin.Patients receiving this combination therapy should closely monitor the development of toxic effects, especially liver failure. It is possible to convert the use of lamivudine, reduce the dose, or abolish interferon alfa, ribavirin with worsening of clinical symptoms, including liver failure (eg,> 6 Child-Pugh grade).
According to international recommendations, if a person infected with HIV is likely to be infected through the blood (for example, through an injection needle), a combination therapy of zidovudine and lamivudine should be prescribed within 1-2 hours from the moment of infection. In the case of a high risk of infection, a drug from the protease inhibitor group should be included in the antiretroviral regimen. Preventive treatment is recommended for 4 weeks. Data on the effectiveness of preventive treatment after accidental HIV infection have not been accumulated enough; controlled studies were not conducted. Despite the rapid onset of treatment with antiretroviral drugs, seroconversion can not be ruled out.
During the treatment is carried out to monitor patterns of peripheral blood: 1 every 2 weeks during the first 3 months of treatment, then 1 time per month. Hematologic changes appear 4-6 weeks after initiation of therapy: anemia and neutropenia develop more often in patients receiving large doses, with HIV infection started (with a reduced reserve of bone marrow before the start of therapy), neutropenia, anemia, vitamin deficiency B12. With a decrease in hemoglobin by more than 25% or a decrease in the number of neutrophils by more than 50% compared to the baseline, control of blood tests is performed more often. During the treatment period it is necessary to monitor the activity of ALT, ACT, amylase, lipase, serum TG concentration. In patients with impaired renal function, control of the concentration of urea nitrogen, creatinine in the blood serum is necessary.
Mitochondrial dysfunction
Research in vitro and in vivo showed that the analogues of nucleosides and nucleotides can cause a different degree of damage to the mitochondria. Mitochondrial dysfunction was recorded in HIV-negative children who received intrauterine and / or post-nucleoside analogues.The main undesirable reactions were hematologic disorders (anemia, neutropenia), metabolic disorders (hyperlactatemia, hyperlipazemia). These undesirable reactions are often transient. Some neurological disorders with late onset have been reported (muscle hypertension, seizures, behavioral disorders). Whether neurological disorders are transient or persistent is currently unknown. Any child, even HIV-negative, who has undergone intrauterine exposure to nucleotide and nucleotide analogs, must undergo a clinical and laboratory examination to exclude mitochondrial dysfunction in case of revealing the relevant signs or symptoms. The data described do not affect the current national recommendations on the use of antiretroviral therapy in pregnant women, for the prevention of vertical transmission of HIV infection.
Osteonecrosis
Despite the fact that the etiology of this disease is multifactorial (including the intake of glucocorticosteroids, alcohol consumption, severe immunosuppression, high body mass index),cases of osteonecrosis were most often encountered in patients at a late stage of HIV infection and / or for a long time taking a combined antiretroviral therapy. Patients should consult a doctor if they experience pain and joint stiffness or difficulty in moving.