Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3624
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VIDEX (Powder, For Solution)
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Dosage: VIDEX should be administered on an empty stomach, at least
30 minutes before or 2 hours after eating. Adults: The preferred dosing frequency of VIDEX is
twice daily because there is more evidence to support the effectiveness of
this dosing regimen. Once-daily dosing should be considered only for adult
patients whose management requires once-daily dosing of VIDEX . The
daily dose in adult patients is dependent on weight as outlined in Table 13. Pediatric Patients: The recommended dose of VIDEX
(didanosine) in pediatric patients between 2 weeks and 8 months of age is
100 mg/mtwice daily, and the recommended VIDEX
dose for pediatric patients older than 8 months is 120 mg/mtwice
daily. Dosing recommendations for VIDEX in patients less than 2 weeks
of age cannot be made because the pharmacokinetics of didanosine in these
children are too variable to determine an appropriate dose. There are no data
on once-daily dosing of VIDEX in pediatric patients.<br/>Dose Adjustment: Clinical and laboratory signs suggestive of pancreatitis
should prompt dose suspension and careful evaluation of the possibility of
pancreatitis. VIDEX use should be discontinued in patients with confirmed
pancreatitis (see WARNINGS and PRECAUTIONS:
Drug Interactions). Patients with symptoms of peripheral neuropathy may tolerate a
reduced dose of VIDEX after resolution of the symptoms of peripheral neuropathy
upon drug discontinuation. If neuropathy recurs after resumption of VIDEX,
permanent discontinuation of VIDEX should be considered. Concomitant Therapy: Tenofovir disoproxil
fumarate. A dose reduction of VIDEX to 250 mg (adults weighing���60
kg with creatinine clearance���60 mL/min) or 200 mg (adults weighing<60 kg with creatinine clearance���60 mL/min) once daily is recommended.
VIDEX and tenofovir may be taken together in the fasted state. Alternatively,
if tenofovir is taken with food, VIDEX should be taken on an empty stomach
(at least 30 minutes before food or 2 hours after food). The appropriate
dose of VIDEX coadministered with tenofovir in patients with creatinine clearance<60 mL/min has not been established. [See CLINICAL
PHARMACOLOGY: Drug Interactions and PRECAUTIONS:
Drug Interactions; see the complete prescribing information
for VIDEX EC (enteric-coated formulation of didanosine) for results of drug
interaction studies of tenofovir with reduced doses of the enteric-coated
formulation of didanosine.] Renal Impairment: In adult patients with impaired
renal function, the dose of VIDEX should be adjusted to compensate for the
slower rate of elimination. The recommended doses and dosing intervals of
VIDEX in adult patients with renal insufficiency are presented in Table 14. Urinary excretion is also a major route of elimination of didanosine
in pediatric patients; therefore, the clearance of didanosine may be altered
in children with renal impairment. Although there are insufficient data to
recommend a specific dose adjustment of VIDEX in this patient population,
a reduction in the dose and/or an increase in the interval between doses should
be considered. Patients Requiring Continuous Ambulatory Peritoneal Dialysis
(CAPD) or Hemodialysis: For patients requiring CAPD or hemodialysis,
follow dosing recommendations for patients with creatinine clearance less
than 10 mL/min, shown in Table 14. It is not necessary to administer a supplemental
dose of VIDEX following hemodialysis. Hepatic Impairment and Toxicity: See WARNINGS.<br/>Method of Preparation:<br/>VIDEX Pediatric Powder for Oral Solution: Prior to dispensing, the pharmacist must constitute dry powder
with Purified Water, USP, to an initial concentration of 20 mg/mL and immediately
mix the resulting solution with antacid to a final concentration of 10 mg/mL
as follows: 20 mg/mL Initial Solution: Constitute the product
to 20 mg/mL by adding 100 mL or 200 mL of Purified Water, USP, to the 2 g
or 4 g of VIDEX powder, respectively, in the product bottle. 10 mg/mL Final Admixture: 1. Immediately mix one
part of the 20 mg/mL initial solution with one part of Maximum Strength Mylanta Liquid
for a final dispensing concentration of 10 mg VIDEX per mL. For patient home
use, the admixture should be dispensed in appropriately sized, flint-glass
or plastic (HDPE, PET, or PETG) bottles with child-resistant closures. This
admixture is stable for 30 days under refrigeration, 36��to 46��F (2��to 8��C). 2. Instruct the patient to shake the admixture thoroughly prior
to use and to store the tightly closed container in the refrigerator, 36��to 46��F (2��to 8��C), up to 30 days.
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VIDEX (didanosine) is a brand name
for didanosine (ddI), a synthetic purine nucleoside analogue active against
the Human Immunodeficiency Virus (HIV). VIDEX Pediatric Powder for Oral Solution is supplied for oral administration
in 4- or 8-ounce glass bottles containing 2 or 4 grams of didanosine, respectively. Didanosine is also available as an enteric-coated formulation (VIDEX EC
Delayed-Release Capsules). Please consult the prescribing information for
VIDEX EC (didanosine). The chemical name for didanosine is 2���,3���-dideoxyinosine. The
structural formula is: Didanosine is a white crystalline powder with the molecular formula
CHNOand
a molecular weight of 236.2. The aqueous solubility of didanosine at 25��C
and pH of approximately 6 is 27.3 mg/mL. Didanosine is unstable in acidic
solutions. For example, at pH<3 and 37��C, 10% of didanosine decomposes
to hypoxanthine in less than 2 minutes.
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Animal Toxicology: Evidence of a dose-limiting skeletal muscle toxicity has been observed
in mice and rats (but not in dogs) following long-term (greater than 90 days)
dosing with didanosine at doses that were approximately 1.2 to 12 times the
estimated human exposure. The relationship of this finding to the potential
of VIDEX (didanosine) to cause myopathy in humans is unclear. However, human
myopathy has been associated with administration of VIDEX and other nucleosideanalogues.<br/>Pharmacokinetics: The pharmacokinetic parameters of didanosine are summarized in
Table 1. Didanosine is rapidly absorbed, with peak plasma concentrations generally
observed from 0.25 to 1.50 hours following oral dosing. Increases in plasma
didanosine concentrations were dose proportional over the range of 50 to 400
mg. Steady-state pharmacokinetic parameters did not differ significantly from
values obtained after a single dose. Binding of didanosine to plasma proteins in
vitro was low (<5%). Based on data from in vitro and
animal studies, it is presumed that the metabolism of didanosine in man occurs
by the same pathways responsible for the elimination of endogenous purines. Effect of Food on Absorption of Didanosine: Didanosine
peak plasma concentrations (C) and area under the
plasma concentration time curve (AUC) were decreased by approximately 55%
when VIDEX tablets were administered up to 2 hours after a meal. Administration
of VIDEX tablets up to 30 minutes before a meal did not result in any significant
changes in bioavailability. VIDEX should be taken on an empty stomach, at
least 30 minutes before or 2 hours after eating. (See DOSAGE
AND ADMINISTRATION.)<br/>Special Populations: Renal Insufficiency: It is recommended that the VIDEX
(didanosine) dose be modified in patients with reduced creatinine clearance
and in patients receiving maintenance hemodialysis (see DOSAGE
AND ADMINISTRATION). Data from two studies in adults indicated
that the apparent oral clearance of didanosine decreased and the terminal
elimination half-life increased as creatinine clearance decreased (see Table 2). Following oral administration, didanosine
was not detectable in peritoneal dialysate fluid (n=6); recovery in hemodialysate
(n=5) ranged from 0.6% to 7.4% of the dose over a 3-4 hour dialysis period.
The absolute bioavailability of didanosine was not affected in patients requiring
dialysis. Pediatric Patients: The pharmacokinetics of didanosine
have been evaluated in HIV-exposed and -infected pediatric patients from birth
to 19 years of age (see Table 1). Overall, the
pharmacokinetics of didanosine in pediatric patients are similar to those
of didanosine in adults. Didanosine plasma concentrations appear to increase
in proportion to oral doses ranging from 25 to 120 mg/min
pediatric patients less than 5 months old and from 80 to 180 mg/min
children above 8 months old. For information on controlled clinical studies
in pediatric patients, see INDICATIONS AND USAGE:
Clinical Studies and PRECAUTIONS:
Pediatric Use. Geriatric Patients: Didanosine pharmacokinetics have
not been studied in patients over 65 years of age. Gender: The effects of gender on didanosine pharmacokinetics
have not been studied. Drug Interactions: Ribavirin has been shown in
vitro to increase intracellular triphosphate levels of didanosine,
which could cause or worsen clinical toxicities (see PRECAUTIONS:
Drug Interactions). Tables 3 and 4 summarize the effects on AUC and C,
with a 90% or 95% confidence interval (CI) when available, following coadministration
of VIDEX (didanosine) with a variety of drugs. For most of the listed drugs,
no clinically significant pharmacokinetic interactions were observed. Clinical
recommendations based on drug interaction studies for drugs in bold font are
included in PRECAUTIONS: Drug Interactions and DOSAGE AND ADMINISTRATION (for tenofovir).
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VIDEX (didanosine) Pediatric Powder for Oral Solution is
supplied in 4- and 8-ounce glass bottles containing 2 g or 4 g of VIDEX, respectively. The bottles of powder should be stored at 59��to 86��F (15��to
30��C). The VIDEX admixture may be stored up to 30 days in a refrigerator,
36��to 46��F (2��to 8��C). Discard any unused portion after 30 days. The NDC numbers for the previously described VIDEX products are: US Patent Nos: 4,861,759, 5,254,539, 5,616,566, and 5,880,106.
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WARNING: FATAL AND NONFATAL PANCREATITIS HAVE OCCURRED DURING THERAPY
WITH VIDEX USED ALONE OR IN COMBINATION REGIMENS IN BOTH TREATMENT-NAIVE AND
TREATMENT-EXPERIENCED PATIENTS, REGARDLESS OF DEGREE OF IMMUNOSUPPRESSION.
VIDEX SHOULD BE SUSPENDED IN PATIENTS WITH SUSPECTED PANCREATITIS AND DISCONTINUED
IN PATIENTS WITH CONFIRMED PANCREATITIS . LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS,
INCLUDING FATAL CASES, HAVE BEEN REPORTED WITH THE USE OF NUCLEOSIDE ANALOGUES
ALONE OR IN COMBINATION, INCLUDING DIDANOSINE AND OTHER ANTIRETROVIRALS. FATAL
LACTIC ACIDOSIS HAS BEEN REPORTED IN PREGNANT WOMEN WHO RECEIVED THE COMBINATION
OF DIDANOSINE AND STAVUDINE WITH OTHER ANTIRETROVIRAL AGENTS. THE COMBINATION
OF DIDANOSINE AND STAVUDINE SHOULD BE USED WITH CAUTION DURING PREGNANCY AND
IS RECOMMENDED ONLY IF THE POTENTIAL BENEFIT CLEARLY OUTWEIGHS THE POTENTIAL
RISK (SEE WARNINGS AND PRECAUTIONS:
PREGNANCY, REPRODUCTION, AND FERTILITY).
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Frequency of Dosing: The preferred dosing frequency of VIDEX is twice daily because
there is more evidence to support the effectiveness of this dosing frequency.
Once-daily dosing should be considered only for adult patients whose management
requires once-daily dosing of VIDEX (see INDICATIONS
AND USAGE: Clinical Studies). VIDEX should be taken on an empty stomach, at least 30 minutes
before or 2 hours after eating.<br/>Peripheral Neuropathy: Peripheral neuropathy, manifested by numbness, tingling, or pain
in the hands or feet, has been reported in patients receiving VIDEX therapy.
Peripheral neuropathy has occurred more frequently in patients with advanced
HIV disease, in patients with a history of neuropathy, or in patients being
treated with neurotoxic drug therapy, including stavudine. Peripheral neuropathy,
which was severe in some cases, has been reported in HIV-infected patients
receiving hydroxyurea in combination with antiretroviral agents, including
didanosine, with or without stavudine (see ADVERSE
REACTIONS).<br/>Fat Redistribution: Redistribution/accumulation of body fat including central obesity,
dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting,
breast enlargement, and���cushingoid appearance���have been observed
in patients receiving antiretroviral therapy. The mechanism and long-term
consequences of these events are currently unknown. A causal relationship
has not been established.<br/>Immune Reconstitution Syndrome: Immune reconstitution syndrome has been reported in patients treated
with combination antiretroviral therapy, including VIDEX. During the initial
phase of combination antiretroviral treatment, patients whose immune system
responds may develop an inflammatory response to indolent or residual opportunistic
infections (such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis
jiroveci pneumonia [PCP], or tuberculosis), which may necessitate
further evaluation and treatment.<br/>General: Patients with Renal Impairment: Patients with renal
impairment (creatinine clearance<60 mL/min) may be at greater risk of
toxicity from VIDEX due to decreased drug clearance (see CLINICAL
PHARMACOLOGY). A dose reduction is recommended in these patients
. Hyperuricemia: VIDEX has been associated with asymptomatic
hyperuricemia; treatment suspension may be necessary if clinical measures
aimed at reducing uric acid levels fail.<br/>Information for Patients (see Patient Information Leaflet): Patients should be informed that a serious toxicity of VIDEX used
alone and in combination regimens is pancreatitis, which may be fatal. Patients should be informed that the preferred dosing frequency
of VIDEX is twice daily because there is more evidence to support the effectiveness
of this dosing frequency. Once-daily dosing should be considered only for
adult patients whose management requires once-daily dosing of VIDEX. Patients should also be aware that peripheral neuropathy, manifested
by numbness, tingling, or pain in hands or feet, may develop during therapy
with VIDEX. Patients should be counseled that peripheral neuropathy occurs
with greatest frequency in patients with advanced HIV disease or a history
of peripheral neuropathy, and that dose modification and/or discontinuation
of VIDEX may be required if toxicity develops. Patients should be informed that when VIDEX is used in combination
with other agents with similar toxicities, the incidence of adverse events
may be higher than when VIDEX is used alone. These patients should be followed
closely. Patients should be cautioned about the use of medications or other
substances, including alcohol, that may exacerbate VIDEX toxicities. VIDEX (didanosine) is not a cure for HIV infection, and patients
may continue to develop HIV-associated illnesses, including opportunistic
infection. Therefore, patients should remain under the care of a physician
when using VIDEX. Patients should be advised that VIDEX therapy has not been
shown to reduce the risk of transmission of HIV to others through sexual contact
or blood contamination. Patients should be informed that the long-term effects
of VIDEX are unknown at this time. Patients should be informed that redistribution or accumulation
of body fat may occur in patients receiving antiretroviral therapy and that
the cause and long-term health effects of these conditions are not known at
this time.<br/>Drug Interactions (see also CLINICAL PHARMACOLOGY: Drug Interactions): Drug interactions that have been established based on drug interaction
studies are listed with the pharmacokinetic results in CLINICAL PHARMACOLOGY:
Drug Interactions (Tables 3 and 4). The clinical recommendations based
on the results of these studies are listed in Table 6. Coadministration of VIDEX with drugs that are known to cause
pancreatitis may increase the risk of this toxicity (see WARNINGS:
Pancreatitis). Because VIDEX is mixed with an antacid before
administration, interactions may be anticipated with drugs whose absorption
can be affected by the level of acidity in the stomach and with drugs that
have been demonstratedto interact with antacids containing magnesium, calcium,
or aluminum. Predicted drug interactions with VIDEX are listed in Table 7.<br/>Nucleoside/nucleotide analogues:<br/>Carcinogenesis and Mutagenesis: Lifetime carcinogenicity studies were conducted in mice and rats
for 22 and 24 months, respectively. In the mouse study, initial doses of
120, 800, and 1200 mg/kg/day for each sex were lowered after 8 months to 120,
210, and 210 mg/kg/day for females and 120, 300, and 600 mg/kg/day for males.
The two higher doses exceeded the maximally tolerated dose in females and
the high dose exceeded the maximally tolerated dose in males. The low dose
in females represented 0.68-fold maximum human exposure and the intermediate
dose in males represented 1.7-fold maximum human exposure based on relative
AUC comparisons. In the rat study, initial doses were 100, 250, and 1000
mg/kg/day, and the high dose was lowered to 500 mg/kg/day after 18 months.
The upper dose in male and female rats represented 3-fold maximum human exposure. Didanosine induced no significant increase in neoplastic lesions
in mice or rats at maximally tolerated doses. Didanosine was positive in the following genetic toxicology assays:
1) the Escherichia coli tester strain WP2 uvrA bacterial
mutagenicity assay; 2) the L5178Y/TK+/- mouse lymphoma mammalian cell gene
mutation assay; 3) the in vitro chromosomal aberrations assay
in cultured human peripheral lymphocytes; 4) the in vitro chromosomal
aberrations assay inChinese Hamster Lung cells; and 5) the BALB/c 3T3 in
vitro transformation assay. No evidence of mutagenicity was observed
in an Ames Salmonella bacterial mutagenicity assay or in
rat and mouse in vivo micronucleus assays.<br/>Pregnancy, Reproduction, and Fertility: Pregnancy Category B. Reproduction studies have been performed
in rats and rabbits at doses up to 12 and 14.2 times the estimated human exposure
(based upon plasma levels), respectively, and have revealed no evidence of
impaired fertility or harm to the fetus due to didanosine. At approximately
12 times the estimated human exposure, didanosine was slightly toxic to female
rats and their pups during mid and late lactation. These rats showed reduced
food intake and body weight gains but the physical and functional development
of the offspring was not impaired and there were no major changes in the F2
generation. A study in rats showed that didanosine and/or its metabolites
are transferred to the fetus through the placenta. Animal reproduction studies
are not always predictive of human response. There are no adequate and well-controlled studies of didanosine
in pregnant women. Didanosine should be used during pregnancy only if the
potential benefit justifies the potential risk. Fatal lactic acidosis has been reported in pregnant women who received
the combination of didanosine and stavudine with other antiretroviral agents.
It is unclear if pregnancy augments the risk of lactic acidosis/hepatic steatosis
syndrome reported in nonpregnant individuals receiving nucleoside analogues
(see WARNINGS: Lactic Acidosis/Severe Hepatomegaly
with Steatosis). The combination of didanosine and stavudine should
be used with caution during pregnancy and is recommended only if the potential
benefit clearly outweighs the potential risk. Health care providers
caring for HIV-infected pregnant women receiving didanosine should be alert
for early diagnosis of lactic acidosis/hepatic steatosis syndrome. Antiretroviral Pregnancy Registry: To monitor maternal-fetal
outcomes of pregnant women exposed to didanosine and other antiretroviral
agents, an Antiretroviral Pregnancy Registry has been established. Physicians
are encouraged to register patients by calling 1-800-258-4263.<br/>Nursing Mothers: The Centers for Disease Control and Prevention recommend
that HIV-infected mothers not breast-feed their infants to avoid risking postnatal
transmission of HIV. A study in rats showed that following oral administration,
didanosine and/or its metabolites were excreted into the milk of lactating
rats. It is not known if didanosine isexcreted in human milk. Because of
both the potential for HIV transmission and the potential for serious adverse
reactions in nursing infants, mothers should be instructed not to breast-feed
if they are receiving VIDEX.<br/>Pediatric Use: Use of VIDEX in pediatric patients from 2 weeks of age through
adolescence is supported by evidence from adequate and well-controlled studies
of VIDEX in adults and pediatric patients (see INDICATIONS
AND USAGE: Clinical Studies, CLINICAL PHARMACOLOGY, ADVERSE REACTIONS, and DOSAGE
AND ADMINISTRATION). Dosing recommendations for VIDEX in patients less than 2 weeks
of age cannot be made because the pharmacokinetics of didanosine in these
children are too variable to determine an appropriate dose.<br/>Geriatric Use: In an Expanded Access Program for patients with advanced HIV infection,
patients aged 65 years and older had a higher frequency of pancreatitis (10%)
than younger patients (5%) .
Clinical studies of didanosine did not include sufficient numbers of subjects
aged 65 years and over to determine whether they respond differently than
younger subjects. Didanosine is known to be substantially excreted by the
kidney, and the risk of toxic reactions to this drug may be greater in patients
with impaired renal function. Because elderly patients are more likely to
have decreased renal function, care should be taken in dose selection. In
addition, renal function should be monitored and dosage adjustments should
be made accordingly (see DOSAGE AND ADMINISTRATION:
Dose Adjustment).
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There is no known antidote for VIDEX (didanosine) overdosage. In
phase 1 studies, in which VIDEX was initially administered at doses ten times
the currently recommended dose, toxicities included: pancreatitis, peripheral
neuropathy, diarrhea, hyperuricemia, and hepatic dysfunction. Didanosine
is not dialyzable by peritoneal dialysis, although there is some clearance
by hemodialysis .
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DIDANOSINE
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VIDEX (Powder, For Solution)
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A SERIOUS TOXICITY OF VIDEX (didanosine) IS PANCREATITIS, WHICH
MAY BE FATAL . OTHER
IMPORTANT TOXICITIES INCLUDE LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS;
RETINAL CHANGES AND OPTIC NEURITIS; AND PERIPHERAL NEUROPATHY . When VIDEX is used in combination with other agents with
similar toxicities, the incidence of these toxicities may be higher than when
VIDEX is used alone. Thus, patients treated with VIDEX in combination with
stavudine, with or without hydroxyurea, may be at increased risk for pancreatitis
and hepatotoxicity, which may be fatal, and severe peripheral neuropathy . Adults: Selected clinical adverse events that occurred
in adult patients in clinical studies with VIDEX are provided in Tables 8
and 9. Pancreatitis resulting in death was observed in one patient
who received VIDEX (didanosine) plus stavudine plus nelfinavir in Study Al454-148
and in one patient who received VIDEX plus stavudine plus indinavir in the
START 2 study. In addition, pancreatitis resulting in death was observed in
2 of 68 patients who received VIDEX plus stavudine plus indinavir plus hydroxyurea
in an ACTG clinical trial . The frequency of pancreatitis is dose related. In phase 3 studies,
incidence ranged from 1% to 10% with doses higher than are currently recommended
and from 1% to 7% with recommended dose. Selected laboratory abnormalities in clinical studies with VIDEX
are shown in Tables 10-12. Observed During Clinical Practice: The following events
have been identified during postapproval use of VIDEX (didanosine). Because
they are reported voluntarily from a population of unknown size, estimates
of frequency cannot be made. These events have been chosen for inclusion
due to their seriousness, frequency of reporting, causal connection to VIDEX,
or a combination of these factors. Pediatric Patients: In clinical trials, 743 pediatric
patients between 2 weeks and 18 years of age have been treated with VIDEX.
Adverse events and laboratory abnormalities reported to occur in these patients
were generally consistent with the safety profile of didanosine in adults. In pediatric phase 1 studies, pancreatitis occurred in 2 of 60
(3%) patients treated at entry doses below 300 mg/m/day
and in 5 of 38 (13%) patients treated at higher doses. In study ACTG 152,
pancreatitis occurred in none of the 281 pediatric patients who received didanosine
120 mg/mq12h and in<1% of the 274 pediatric
patients who received didanosine 90 mg/mq12h
in combination with zidovudine (see INDICATIONS
AND USAGE: Clinical Studies). Retinal changes and optic neuritis have been reported in pediatric
patients.
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VIDEX (didanosine) in combination with other antiretroviral
agents is indicated for the treatment of HIV-1 infection (see Clinical
Studies).<br/>Clinical Studies:<br/>Combination Therapy: START 2 was a multicenter, randomized, open-label study comparing
VIDEX (200 mg twice daily)/stavudine/indinavir to zidovudine/lamivudine/indinavir
in 205 treatment-naive patients. Both regimens resulted in a similar magnitude
of suppression of HIV RNA levels and increases in CD4 cell counts through
48 weeks. Study A1454-148 was a randomized, open-label, multicenter study
comparing treatment with VIDEX (400 mg once daily) plus stavudine (40 mg twice
daily) and nelfinavir (750 mg three times daily) versus zidovudine (300 mg
twice daily) plus lamivudine (150 mg twice daily) and nelfinavir (750 mg three
times daily) in 756 treatment-naive patients, with a median CD4 cell count
of 340 cells/mm(range 80 to 1568 cells/mm)
and a median plasma HIV-1 RNA of 4.69 logcopies/mL
(range 2.6 to 5.9 logcopies/mL) at baseline. Median
CD4 cell count increases at 48 weeks were 188 cells/mmin
both treatment groups. Treatment response and outcomes through 48 weeks are
shown in Figure 1 and Table 5.<br/>Monotherapy: The efficacy of VIDEX was demonstrated in two randomized, double-blind
studies comparing VIDEX, given on a twice-daily schedule, to zidovudine, given
three times daily, in 617 (ACTG 116A, conducted 1989-1992) and 913 (ACTG 116B/117,
conducted 1989-1991) patients with symptomatic HIV infection or AIDS who were
treated for more than one year. In treatment-naive patients (ACTG 116A),
the rate of HIV disease progression or death was similar between the treatment
groups; mortality rates were 26% for patients receiving VIDEX and 21% for
patients receiving zidovudine. Of the patients who had received previous zidovudine
treatment (ACTG 116B/117), those treated with VIDEX had a lower rate of HIV
disease progression or death (32%) compared to those treated with zidovudine
(41%); however, survival rates were similar between the treatment groups. Efficacy in pediatric patients was demonstrated in a randomized,
double-blind, controlled study (ACTG 152, conducted 1991-1995) involving 831
patients 3 months to 18 years of age treated for more than 1.5 years with
zidovudine (180 mg/mq6h), VIDEX (120 mg/mq12h),
or zidovudine (120 mg/mq6h) plus VIDEX (90 mg/mq12h).
Patients treated with VIDEX or VIDEX plus zidovudine had lower rates of HIV
disease progression or death compared with those treated with zidovudine alone. Studies have demonstrated that the clinical benefit of monotherapy
with antiretrovirals, including VIDEX, was time limited.
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VIDEX
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