What is Aptivus?
Aptivus is a medicine that contains the active substance tipranavir. It is available in pink capsules (250 mg) and as an oral solution (100 mg / ml).
What is Aptivus used for?
Aptivus is an antiviral drug used to treat patients aged 2 years or older with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immunodeficiency syndrome (AIDS). Aptivus is used in combination with low-dose ritonavir (another antiviral drug) and with other antiviral drugs.
Aptivus should only be used in the absence of alternative treatments. It is used in patients who have already been treated with other antiviral medicines against HIV infection and who do not respond to several other medicines of the same class as Aptivus (protease inhibitors). Doctors should only prescribe Aptivus after considering the previous medicines. antivirals taken by the patient and the likely response of the virus to the medicine.
The medicine can only be obtained with a prescription.
How is Aptivus used?
Aptivus therapy should be initiated by a physician experienced in the treatment of HIV-1 infection.
In patients 12 years of age or older, the recommended dose of Aptivus is 2 capsules twice a day. Boys between the ages of two and 12 should use the oral solution. The dose of the oral solution depends on the body surface area (calculated from the child's weight and height). Each dose of Aptivus should be taken with ritonavir and with food. For more information, see the package leaflet.
How does Aptivus work?
The active substance in Aptivus, tipranavir, is a protease inhibitor. That is, it blocks an enzyme called protease that is involved in the reproduction of HIV. If the enzyme is blocked, the virus is unable to reproduce normally, which slows the spread of the infection.
Ritonavir is another protease inhibitor, which is used as a 'booster'. It slows the rate at which tipranavir is assimilated, thereby increasing its concentration in the blood. This allows less tipranavir to be used to achieve the same antiviral effect.
Aptivus, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level. Aptivus does not cure HIV infection or AIDS, but it can delay damage to the immune system and the onset of AIDS-associated infections and diseases.
How has Aptivus been studied?
Aptivus has been studied in two main studies involving 1,483 adults who had previously taken several other anti-HIV medicines and who were unresponsive to ongoing treatment including a protease inhibitor. Both studies compared the effects. of Aptivus with those of another protease inhibitor chosen on the basis of previous therapies followed by patients and expected response. The main measures of effectiveness were the number of patients who responded to therapy, and the amount of time it took for therapy to stop. to take effect, in the first 48 weeks of the same. A "response" meant a reduction in HIV levels in the blood (viral load) of 90% or more maintained through the 48-week period.
Aptivus has also been studied in a study involving 63 children between the ages of two and 12, 52 adolescents between the ages of 12 and 18, almost all of whom have had HIV treatment in the past. All patients started oral solution therapy, while adolescents taking the full adult dose switched to capsules after four weeks. The studies looked at the safety and efficacy of Aptivus and the level of the drug in the patients' blood.
In all three studies, all patients were also given ritonavir and a combination of other anti-HIV drugs chosen based on the best chance they had of reducing HIV levels in their blood.
What benefit has Aptivus shown during the studies?
Aptivus capsules, taken in combination with ritonavir, were more effective than the comparator medicine in patients with few remaining alternatives for effective HIV treatment. In the two adult studies taken together, 34% of patients who took Aptivus ( 251 out of 746) responded to treatment, compared with 16% of patients taking comparator protease inhibitors (113 out of 737). On average, it took 113 days for treatment to stop working in adults taking Aptivus. was compared with an average of zero days for those who took the comparator, which means that most patients who took the comparator did not respond to treatment.
In the studies in children and adolescents, 31% of the adolescents who took the capsules (9 of 29) and 50% of the children who took the oral solution (31 of 62) achieved and maintained viral loads below 400 copies / ml after 48 weeks.
What is the risk associated with Aptivus?
In adults, the most common side effects with Aptivus in combination with ritonavir (seen in more than 1 in 10 patients) are diarrhea and nausea. Similar side effects have been seen in children and adolescents, although vomiting, rash and pyrexia (fever) were seen more commonly than in adults. For the full list of side effects reported with Aptivus, see the package leaflet.
Aptivus must not be used in people who may be hypersensitive (allergic) to tipranavir or any of the other ingredients. Aptivus must not be used in patients with moderate to severe liver problems or on any of the following medicines:
- rifampicin (for the treatment of tuberculosis);
- St. John's wort (herbal preparation used in the treatment of depression);
- medicines which are metabolized in the same way as Aptivus or ritonavir and which are dangerous if they reach high concentrations in the blood. For the complete list of these medicines, see the Package Leaflet.
As with other HIV medicines, patients receiving Aptivus may be at risk for lipodystrophy (changes in the distribution of body fat), osteonecrosis (death of bone tissue) or immune reactivation syndrome (inflammatory symptoms caused by reactivation of the immune system) . Patients with liver problems (including hepatitis B or C infection) may be at an increased risk of liver damage if they take Aptivus.
Why has Aptivus been approved?
The Committee for Medicinal Products for Human Use (CHMP) noted that the studies supported the use of Aptivus capsules in adults. Although the Committee had concerns about how the study was designed in children and adolescents, it found that the results of the study supported the use of the capsules in adolescents and the oral solution in children between the ages of 2 and 12 years. The CHMP therefore decided that the benefits of Aptivus capsules, when given together with ritonavir in low doses, are greater than its risks compared to the combination of antiretroviral treatment for HIV-1 infection in adults and adolescents aged 12 years or older undergoing pre-intensive treatment with viruses resistant to multiple protease inhibitors. The Committee also decided that the benefits of Aptivus oral solution are greater than its risks in pre-intensive children aged 2 to 12 years. however, there was insufficient information to support the use of the oral solution in patients at least 12 years of age.
The Committee recommended the granting of a marketing authorization for Aptivus. However, the Committee concluded that the drug should only be used as a 'last resort' therapy when no other protease inhibitor is expected to be effective.
Aptivus was originally authorized under 'Exceptional Circumstances' as, for scientific reasons, it had not been possible to obtain complete information on the medicine. Since the company provided the additional information requested, the condition referring to "exceptional circumstances" was removed on April 15, 2008.
Other information about Aptivus:
On 25 October 2005, the European Commission granted Boehringer Ingelheim International GmbH a "Marketing Authorization" for Aptivus, valid throughout the European Union.
For the full version of the Aptivus EPAR, click here.
Last update of this summary: 05-2009
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