Treatment with lamivudine should be performed by a doctor who has experience in managing patients with HIV-infection.
In children under 3 years of age, the use of tableted dosage forms is not recommended, therefore, for the treatment of children and those patients who have difficulty in swallowing tablets, a medicinal form for oral administration is intended. The use of lamivudine as a monotherapy is not recommended.
Patients should be warned that antiretroviral t.ch. lamivudine, does not prevent the risk of HIV transmission to other people during sexual intercourse or blood transfusion.Therefore, patients should take appropriate precautions.
In patients receiving lamivudine or other antiretroviral drugs may opportunistic infections or other complications develop, so they should be carefully monitored by a doctor who has experience in HIV treatment.
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.
Several cases of pancreatitis developed in patients who received lamivudine. However, it remains unclear whether this complication is caused by lamivudine or the HIV-infection. When there is abdominal pain, nausea, vomiting, or characteristic changes in biochemical parameters in a patient receiving lamivudine, it should be deleted pancreatitis. You should stop taking the drug until the diagnosis of pancreatitis is not ruled out.
In HIV-infected patients (predominantly in women) who took antiretroviral drugs from the group of nucleoside analogues as monotherapy or in combination with lamivudine,described cases of lactic acidosis, which is usuallyaccompanied by severe hepatomegaly and fatty liver dystrophy, incl. from lethal outcome.
Symptoms that may indicate the development of lactic acidosis include general weakness, loss of appetite, sudden unexplained weight loss, side gastrointestinal tract and respiratory system (dyspnea).
Treatment with lamivudine always requires caution, and especially when The patient has risk factors for developing liver disease. In case of appearance clinical or laboratory signs of lactic acidosis or liver dysfunction (including hepatomegaly and fatty liver dystocia, even in the absence of pronounced increased activity of hepatic transaminases), lamivudine should be discontinued.
In some patients, combined antiretroviral therapy may accompanied by redistribution / accumulation of subcutaneous fat, incl. decrease quantities peripheral fatty cellulose and increase visceral fat, weight loss of limbs and face, enlargement of the mammary glands and fat deposition on the back of the neck and back ("buffalo buffalo"), and increased serum lipid concentrations and blood glucose levels.
Although one or more of the above undesirable reactions associated with common syndrome, which the often is called lipodystrophy, may call all preparations from classes of protease inhibitors and nucleoside reverse inhibitors transcripts, the accumulated data indicate the existence of differences between individual representatives of these classes of drugs in the ability to cause these unwanted reactions.
It should also be noted that lipodystrophy syndrome has a multifactorial etiology; eg, stage HIV infection, elderly age and Duration antiretroviral therapy play an important, possibly synergistic role in the development of this complication.
The long-term consequences of these undesirable reactions are not currently installed.
Clinical examination of patients should include an assessment of physical signs redistribution of adipose tissue. It is also necessary to measure lipid concentrations in serum and level glucose at blood. Violations lipid exchange of is necessary correct, guided by their clinical manifestations.
Syndrome of restoration of immunity: in HIV-infected patients with severe immunodeficiency in time start antiretroviral of therapy (ART) perhaps 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 of ART. The most significant examples are cytomegalovirus retinitis, generalized and / or focal mycobacterial infection and pneumocystis pneumonia. Any symptoms of inflammation are necessary immediately identify and immediately begin treatment. Also in conditions of recovery immunity is possible the development of autoimmune diseases (Graves' disease, polymyositis, Guillain-Barre syndrome), however, the development of these diseases can be registered and a few months from the start of treatment.
Mixed infection caused by HIV and hepatitis B virus
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 end of therapy lamivudine in patients with co-infection caused by HIV and hepatitis virus In, it is necessary to monitor biochemical indicators of liver function and markers replication of the hepatitis B virus. There have been cases of hepatic decompensation (some with fatal outcome) in patients with co-infection with HIV-1 / hepatitis B who received combination antiretroviral therapy and interferon alfa together with ribavirin or without ribavirin. In patients receiving this combination therapy, you should closely monitor the development of toxic effects, especially liver failure. It is possible to stop the use of lamivudine, reduce the dose or abolish interferon alfa, ribavirin when worsening clinical symptoms, including hepatic insufficiency (for example,> 6 points on the Child-Pugh classification).
Preventive maintenance after probable infection of a HIV
According to international recommendations (Center for Disease Control - June 1998), with a possible infection through the blood of an HIV-infected person (for example, through an injection needle), it is necessary urgently (within 1-2 hours from the moment of infection) prescribe combination therapy with zidovudine and lamivudine. In the case of high infection in the antiretroviral therapy regimen should be included groups of protease inhibitors. Preventive treatment is recommended for 4 weeks. Data on the effectiveness of preventive treatment after accidental HIV infection is not accumulated enough; controlled studies was 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 after 4-6 weeks from the start of therapy: anemia and neutropenia develop more often in patients receiving high doses, with started HIV infection (with reduced bone marrow reserve prior to therapy), neutropenia, anemia of vitamin B12 deficiency. 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, AST, amylase, lipase, concentration of TG in serum. In patients with impaired renal function control of the concentration of urea nitrogen, creatinine in the blood serum.
Mitochondrial dysfunction
In vitro and in vivo studies showed that the analogues of nucleosides and nucleotides can cause a different degree of damage to the mitochondria. Have been recorded cases of mitochondrial dysfunction in HIV-negative children who received intrauterine and / or post-nucleoside analogues. The main undesirable reactions were hematologic disorders (anemia, neutropenia), disorders with side of metabolism (hyperlactatemia, hyperlipazemia). These undesirable reactions are often transient. Some neurological disorders with late onset (muscle hypertension, seizures, violation behavior). Whether neurological disorders are transient or persistent is currently unknown. Any child, even HIV-negative, who has undergone intra-uterine exposure to nucleoside and nucleotide analogues, must undergo Clinical and laboratory examination to exclude mitochondrial Dysfunction in case of revealing of corresponding signs or symptoms. Described the data do not influence 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 reception of glucocorticosteroids, alcohol consumption, severe immunosuppression, high body mass index), cases of osteonecrosis were most often seen in patients at a late stage of HIV infection and / or who took long-term combined antiretroviral therapy. Patients should consult a doctor if they experience pain and joint stiffness or difficulty in moving.