The use of lamivudine as a monotherapy is not recommended.
Transmission of HIV infection
Patients should be warned that treatment with antiretroviral drugs, including lamivudine, does not prevent the risk of HIV transmission to other people during sexual intercourse or blood contamination. Therefore, patients should take appropriate precautions.
Opportunistic infections
In patients receiving lamivudine or other antiretroviral drugs, opportunistic infections or other complications of HIV infection may develop, so patients should be carefully monitored by a physician with experience in treating patients with HIV-associated diseases.
Impaired renal function
In patients with impaired renal function of medium and severe degree, the concentration of lamivudine in plasma is increased due to reduced clearance of lamivudine, therefore dose adjustment is required.
Pancreatitis
In patients who took lamivudine, rare cases of development of pancreatitis are described. However, it is not established whether this complication is caused by medications or the underlying disease - HIV infection. Treatment with lamivudine should be stopped immediately if clinical symptoms or laboratory evidence of pancreatitis develop (abdominal pain, nausea, vomiting, or increased biochemical markers). It is necessary to stop taking the drug before the diagnosis of pancreatitis is excluded.
Lactic acidosis and severe hepatomegaly with steatosis
There are reports of the development of lactic acidosis, severe hepatomegaly with steatosis, including fatal outcomes due to antiretroviral therapy with nucleoside analogues in the form of individual drugs, including lamivudine or a combination thereof. Similar phenomena were observed, mainly, in women. Clinical signs of developing lactic acidosis are general weakness, anorexia,rapid unexplained weight loss, symptoms of gastrointestinal tract damage (nausea, vomiting, abdominal pain) and respiratory system (rapid and / or deep breathing), neurological symptoms (including motor weakness)).
Treatment with nucleoside analogues should be discontinued if symptomatic hyperlactatemia and metabolic acidosis / lactic acidosis develop, progressive hepatomegaly, or a rapid increase in aminotransferase levels.
Caution should be exercised when using nucleoside analogs to treat any patient (especially obese women) with hepatomegaly, hepatitis, or other known risk factors for liver damage and liver steatosis (including the use of certain drugs and alcohol use).
Patients with co-infection with hepatitis C and patients who receive treatment with alpha interferon and ribavirin may constitute a special risk group.
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 observed 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 tone increase, convulsions, behavioral disorders). Whether these neurological disorders are transient or persistent is currently unknown.
Any child, even HIV-negative, exposed to prenatal exposure to nucleoside and nucleotide analogues, must undergo a clinical and laboratory examination in order to exclude mitochondrial dysfunction in case of revealing the corresponding signs or symptoms. These data do not affect the current national guidelines for the use of antiretroviral therapy in pregnant women to prevent the vertical transmission of HIV infection.
Lipodystrophy
In some patients receiving combined antiretroviral therapy, there may be a redistribution and / or accumulation of subcutaneous fat, including central obesity, dorsocervical fat deposition ("buffalo buffalo"), a reduction in the subcutaneous fat layer on the face and extremities, enlargement of the mammary glands , increased serum lipid concentrations and glucose concentrations, both individually and collectively.
Although all preparations from classes of protease inhibitors and NRTIs can cause one or more of the abovementioned unwanted reactions associated with a common syndrome, often called lipodystrophy, the accumulated evidence suggests that there are differences between individual representatives of these classes of drugs in the ability to induce these undesirable 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, possibly synergistic role in the development of this complication.
The long-term consequences of these undesirable phenomena are still unknown.
During the clinical examination, attention should be paid to the signs of redistribution of subcutaneous fat. It is necessary to closely monitor the serum lipids concentration and blood glucose concentration. If the lipid metabolism is disturbed, an appropriate treatment is prescribed.
Immunodeficiency Syndrome
If HIV-infected patients with severe immunodeficiency have asymptomatic opportunistic infections or their residual effects at the time of initiation of antiretroviral therapy, such therapy may lead to an increase in the symptoms of opportunistic infections or other severe consequences. Typically, these reactions occur within the first weeks or months after initiation of antiretroviral therapy. Typical examples are cytomegalovirus retinitis, generalized or focal infection caused by mycobacteria, and pneumonia caused by Pneumocystis jiroveci (R. carinii). The appearance of any symptoms of inflammation requires immediate examination and, if necessary, treatment.
Autoimmune diseases (such as Graves' disease, polymyositis and Guillain-Barre syndrome) were observed against the background of restoration of immunity,However, the time of primary manifestations varied, and the disease could occur many months after initiation of therapy to have an atypical current.
Co-infection of HIV and viral hepatitis B
Clinical studies and post-registration data on the use of lamivudine suggest that in some patients with concomitant viral hepatitis B (HBV), clinical or laboratory signs of hepatitis recurrence may appear after stopping lamivudine, which may have more severe consequences in patients with uncompensated liver damage. 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.
Diseases of the liver
Patients with pre-existing liver dysfunction, including active chronic hepatitis, have an increased incidence of liver dysfunction during combined antiretroviral therapy and should be monitored in accordance with accepted practice.It is necessary to consider the possibility of suspending or stopping treatment in cases of manifestations of worsening liver disease in such patients.
Osteonecrosis
Although 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 who took long-term combined antiretroviral therapy. Patients should consult a doctor if they experience pain and stiffness in the joints or difficulty moving.
Preventive maintenance after probable infection of a HIV
According to international recommendations, if a person infected with HIV is to be infected through the blood (for example, through an injection needle), a combination therapy with zidovudine and lamivudine should be prescribed urgently (within 1-2 hours from the time 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, no controlled studies have been conducted.
Despite the rapid onset of treatment with antiretroviral drugs, seroconversion can not be ruled out.
Triple Nucleoside Therapy
There were reports of a high incidence of virological failure and early-onset resistance when co-administered lamivudine in combination with tenofovir disoproxil fumarate and abacavir, and with tenofovir disoproxil fumarate and didanosine once a day.
Lamivudine should not be used concomitantly with any medication containing lamivudine or emtricitabine.