Side effects, which are often observed when using various therapeutic regimens with stavudine:
Peripheral neuropathy, lactic acidosis (including fatal), pancreatitis (including fatal), hepatitis, steatosis of the liver, liver failure (including fatal), lipoatrophy.
Below is the frequency of adverse reactions with stavudine in the form of combination therapy according to the generally accepted classification:
Very often (> 1/10), often (> 1/100; <1/10); infrequently (> 1/1000; <1/100), rarely (> 1/10000; <1/1000), very rarely (<1/10000).
On the part of the endocrine system: infrequently - gynecomastia;
On the part of the digestive system: often - diarrhea, abdominal pain, nausea, dyspepsia; infrequently - pancreatitis,vomiting, hepatitis, jaundice;
Metabolic disorders: often - lipoatrophy. lipodystrophy; infrequently - lactate-acidosis (sometimes with muscle weakness), anorexia;
From the musculoskeletal system: infrequently - arthralgia. myalgia;
From the side of the nervous system: often - depression, peripheral neuropathy, paresthesia, peripheral neuritis, dizziness, pathological dreams, headache, insomnia, drowsiness, pathological thoughts, anxiety, emotional lability;
From the rut and podkolsioy fiber: often - a rash, itching; infrequently - hives. The body as a whole: often - fatigue; infrequently, asthenia.
Stavudinelamivudine+ indinavir:
On the part of the digestive system: very often - diarrhea, nausea, vomiting;
From the nervous system: very often - peripheral neuropathy, paresthesia, peripheral neuritis, headache;
On the part of the digestive system: very often - diarrhea, nausea, vomiting;
From the side of the nervous system: very often - peripheral neuropathy, paresthesia, peripheral neuritis;
From the rut and podkolsioy fiber: very often - a rash.
Postmarketing data on the side effects reported with stavudine
On the part of the blood system and hemopoiesis:
Rarely, anemia. Very rarely - neutropenia. frequency unknown: - macrocytosis, thrombocytopenia;
Metabolic disorders: often - lipoatrophy, lipodystrophy, asymptomatic hyperlactatemia: rarely - lactic acidosis, anorexia;
From the endocrine system: rarely - hyperglycemia; very rarely - diabetes mellitus;
From the gastrointestinal tract: often - diarrhea, abdominal pain, nausea, dyspepsia; rarely - pancreatitis, vomiting.
From the liver: rarely - steatosis of the liver, hepatitis, jaundice; very rarely liver failure;
From the side of the nervous system: often - peripheral neurological symptoms, including peripheral neuropathy, paresthesia and peripheral neuritis; dizziness, pathological dreams, headache, insomnia, pathological thinking, drowsiness; very rarely - severe muscle weakness (most often with hyperlactatemia or lactic acidosis);
From the side of the psyche: often - depression; rarely - increased excitability,
emotional lability.
From the rut and subcutaneous tissue: very often - rash, itching; rarely - hives. From the musculoskeletal system: infrequently - arthralgia, myalgia;
General: fatigue, asthenia.
The immune reconstitution syndrome was described in HIV-infected patients receiving combined antiretroviral therapy (ARVT), including
stavudine (see section "Special instructions"). 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.
Lipodystrophy and metabolic disorders. In patients receiving antiretroviral therapy, there were cases of redistribution / accumulation of fatty tissue (lipodystrophy / lipoatrophy), which manifested itself as obese by the central type, an increase in the amount of fat in the dorso-corvic zone, a decrease in the amount of fatty tissue in the limbs and face, augmentation of the chest, "cushingoid face" . In each specific case, the risk ratio of lipodystrophy / lipoatrophy and the benefit of treatment should be consideredstavudine-containing regimens; At a high risk level, consideration should be given to the use of alternative treatment regimens. A thorough monitoring of the symptoms of lipodystrophy / lipoatrophy in all patients taking
stavudine (see section "Special instructions").
Combined antiretroviral therapy is associated with the development of metabolic disorders, such as: hypertriglyceridemia, hypercholesterolemia, insulin resistance, hyperglycemia and hyperlactatemia.
Osteonecrosis. Cases of osteonecrosis were noted in patients taking
stavudine, especially with prolonged treatment with antiretroviral drugs.
Mitochodrial dysfunction: results of postmarketing studies confirm possible damage to mitochondria of different degrees. The main
manifestations of mitochondrial dysfunction were: anemia, neutropenia,
thrombocytopenia, hyperlactatemia, increased lipase activity and "hepatic" transaminases in blood plasma, hypertriglyceridemia. There were also later manifestations of this disorder: hypertonicity of skeletal muscles, convulsions, behavioral anomalies.
Changes in laboratory parameters registered with combined therapy with stavudine with other drugs:
Combination Therapy
stavudinelamivudine+ indinavir: bilirubin> 2.6 x VGN (upper limit of normal) (7%); ACT (aspartate aminotransferase)> 5 x VGN (5%); ALT (alanine aminotransferase)> 5 x VGN (6%); lipase> 2 x VGN (6%);
Combination Therapy
stavudinedidanosine+ iidinavir: bilirubin> 2.6 x VGN (16%); ACT> 5 x VGN (7%); ALT> 5 x VGN (8%); lipase> 2 x VGN (5%);
Changes in laboratory indicators recorded in patients receiving antiretroviral therapy for the first time:
Combination Therapy
stavudinelamivudine+ efavirenz: ACT> 5 x VGN (3%); ALT> 5 x VGN (3%); lipase> 2 x VGN (3%).
Children: In clinical trials, the side effects of the drug in children (from birth to puberty) and adult patients were similar. The development of peripheral neuropathy in children was less common than in adults, but its symptoms in children are more difficult to identify.