Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1637
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EPZICOM (Tablet)
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A Medication Guide and Warning Card that provide information about recognition of hypersensitivity reactions should be dispensed with each new prescription and refill. To facilitate reporting of hypersensitivity reactions and collection of information on each case, an Abacavir Hypersensitivity Registry has been established. Physicians should register patients by calling 1-800-270-0425. The recommended oral dose of EPZICOM for adults is one tablet daily, in combination with other antiretroviral agents (see INDICATIONS AND USAGE: Description of Clinical Studies, PRECAUTIONS, MICROBIOLOGY, and CLINICAL PHARMACOLOGY). EPZICOM can be taken with or without food.<br/>Dose Adjustment: Because it is a fixed-dose tablet, EPZICOM should not be prescribed for patients requiring dosage adjustment such as those with creatinine clearance<50 mL/min, those with hepatic impairment, or those experiencing dose-limiting adverse events. Use of EPIVIR Oral Solution and ZIAGEN Oral Solution may be considered.
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EPZICOM: EPZICOM Tablets contain the following 2 synthetic nucleoside analogues: abacavir sulfate (ZIAGEN, also a component of TRIZIVIR) and lamivudine (also known as EPIVIRor 3TC) with inhibitory activity against HIV. EPZICOM Tablets are for oral administration. Each orange, film-coated tablet contains the active ingredients 600 mg of abacavir as abacavir sulfate and 300 mg of lamivudine, and the inactive ingredients magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The tablets are coated with a film (Opadry orange YS-1-13065-A) that is made of FD&C Yellow No. 6, hypromellose, polyethylene glycol 400, polysorbate 80, and titanium dioxide.<br/>Abacavir Sulfate: The chemical name of abacavir sulfate is (1S,cis)-4-[2-amino-6-(cyclopropylamino)-9H-purin-9-yl]-2-cyclopentene-1-methanol sulfate (salt) (2:1). Abacavir sulfate is the enantiomer with 1S, 4R absolute configuration on the cyclopentene ring. It has a molecular formula of (CHNO)���HSOand a molecular weight of 670.76 daltons. It has the following structural formula: Abacavir sulfate is a white to off-white solid with a solubility of approximately 77 mg/mL in distilled water at 25��C. In vivo, abacavir sulfate dissociates to its free base, abacavir. All dosages for abacavir sulfate are expressed in terms of abacavir.<br/>Lamivudine: The chemical name of lamivudine is (2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2���,3���-dideoxy, 3���-thiacytidine. It has a molecular formula of CHNOS and a molecular weight of 229.3 daltons. It has the following structural formula: Lamivudine is a white to off-white crystalline solid with a solubility of approximately 70 mg/mL in water at 20��C.
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Pharmacokinetics in Adults:<br/>EPZICOM: In a single-dose, 3-way crossover bioavailability study of 1 EPZICOM Tablet versus 2 ZIAGEN Tablets (2 x 300 mg) and 2 EPIVIR Tablets (2 x 150 mg) administered simultaneously in healthy subjects (n = 25), there was no difference in the extent of absorption, as measured by the area under the plasma concentration-time curve (AUC) and maximal peak concentration (C), of each component.<br/>Abacavir: Following oral administration, abacavir is rapidly absorbed and extensively distributed. After oral administration of a single dose of 600 mg of abacavir in 20 patients, Cwas 4.26��1.19 mcg/mL (mean��SD) and AUCwas 11.95��2.51 mcg���hr/mL. Binding of abacavir to human plasma proteins is approximately 50% and was independent of concentration. Total blood and plasma drug-related radioactivity concentrations are identical, demonstrating that abacavir readily distributes into erythrocytes. The primary routes of elimination of abacavir are metabolism by alcohol dehydrogenase to form the 5���-carboxylic acid and glucuronyl transferase to form the 5���-glucuronide.<br/>Lamivudine: Following oral administration, lamivudine is rapidly absorbed and extensively distributed. After multiple-dose oral administration of lamivudine 300 mg once daily for 7 days to 60 healthy volunteers, steady-state C(C) was 2.04��0.54 mcg/mL (mean��SD) and the 24-hour steady-state AUC (AUC) was 8.87��1.83 mcg���hr/mL. Binding to plasma protein is low. Approximately 70% of an intravenous dose of lamivudine is recovered as unchanged drug in the urine. Metabolism of lamivudine is a minor route of elimination. In humans, the only known metabolite is the trans-sulfoxide metabolite (approximately 5% of an oral dose after 12 hours). The steady-state pharmacokinetic properties of the EPIVIR 300-mg Tablet once daily for 7 days compared with the EPIVIR 150-mg Tablet twice daily for 7 days were assessed in a crossover study in 60 healthy volunteers. EPIVIR 300 mg once daily resulted in lamivudine exposures that were similar to EPIVIR 150 mg twice daily with respect to plasma AUC; however, Cwas 66% higher and the trough value was 53% lower compared with the 150-mg twice-daily regimen. Intracellular lamivudine triphosphate exposures in peripheral blood mononuclear cells were also similar with respect to AUCand C; however, trough values were lower compared with the 150-mg twice-daily regimen. Inter-subject variability was greater for intracellular lamivudine triphosphate concentrations versus lamivudine plasma trough concentrations. The clinical significance of observed differences for both plasma lamivudine concentrations and intracellular lamivudine triphosphate concentrations is not known. In humans, abacavir and lamivudine are not significantly metabolized by cytochrome P450 enzymes. The pharmacokinetic properties of abacavir and lamivudine in fasting patients are summarized in Table 1.<br/>Effect of Food on Absorption of EPZICOM: EPZICOM may be administered with or without food. Administration with a high-fat meal in a single-dose bioavailability study resulted in no change in AUC, AUC, and Cfor lamivudine. Food did not alter the extent of systemic exposure to abacavir (AUC���), but the rate of absorption (C) was decreased approximately 24% compared with fasted conditions (n = 25). These results are similar to those from previous studies of the effect of food on abacavir and lamivudine tablets administered separately.<br/>Special Populations:<br/>Impaired Renal Function:<br/>Impaired Hepatic Function:<br/>Pregnancy: See PRECAUTIONS: Pregnancy.<br/>Nursing Mothers: See PRECAUTIONS: Nursing Mothers.<br/>Pediatric Patients:<br/>Geriatric Patients: The pharmacokinetics of abacavir and lamivudine have not been studied in patients over 65 years of age.<br/>Gender:<br/>Race:<br/>Drug Interactions: See PRECAUTIONS: Drug Interactions. The drug interactions described are based on studies conducted with the individual nucleoside analogues. In humans, abacavir and lamivudine are not significantly metabolized by cytochrome P450 enzymes nor do they inhibit or induce this enzyme system; therefore, it is unlikely that clinically significant drug interactions will occur with drugs metabolized through these pathways.<br/>Abacavir: Fifteen HIV-infected patients were enrolled in a crossover-designed drug interaction study evaluating single doses of abacavir (600 mg), lamivudine (150 mg), and zidovudine (300 mg) alone or in combination. Analysis showed no clinically relevant changes in the pharmacokinetics of abacavir with the addition of lamivudine or zidovudine or the combination of lamivudine and zidovudine. Lamivudine exposure (AUC decreased 15%) and zidovudine exposure (AUC increased 10%) did not show clinically relevant changes with concurrent abacavir. In a study of 11 HIV-infected patients receiving methadone-maintenance therapy (40 mg and 90 mg daily), with 600 mg of ZIAGEN twice daily (twice the currently recommended dose), oral methadone clearance increased 22% (90% CI 6% to 42%). This alteration will not result in a methadone dose modification in the majority of patients; however, an increased methadone dose may be required in a small number of patients.<br/>Lamivudine: No clinically significant alterations in lamivudine or zidovudine pharmacokinetics were observed in 12 asymptomatic HIV-infected adult patients given a single dose of zidovudine (200 mg) in combination with multiple doses of lamivudine (300 mg q 12 hr). Lamivudine pharmacokinetics are not significantly affected by abacavir.<br/>Ribavirin: In vitro data indicate ribavirin reduces phosphorylation of lamivudine, stavudine, and zidovudine. However, no pharmacokinetic (e.g., plasma concentrations or intracellular triphosphorylated active metabolite concentrations) or pharmacodynamic (e.g., loss of HIV/HCV virologic suppression) interaction was observed when ribavirin and lamivudine (n = 18), stavudine (n = 10), or zidovudine (n = 6) were coadministered as part of a multi-drug regimen to HIV/HCV co-infected patients (see WARNINGS).
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EPZICOM Tablets are contraindicated in patients with previously demonstrated hypersensitivity to abacavir or to any other component of the product (see WARNINGS). Following a hypersensitivity reaction to abacavir, NEVER restart EPZICOM or any other abacavir-containing product. Fatal rechallenge reactions have been associated with readministration of abacavir to patients with a prior history of hypersensitivity reaction to abacavir (see WARNINGS and PRECAUTIONS). EPZICOM Tablets are contraindicated in patients with hepatic impairment (see CLINICAL PHARMACOLOGY).
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EPZICOM is available as tablets. Each tablet contains 600 mg of abacavir as abacavir sulfate and 300 mg of lamivudine. The tablets are orange, film-coated, modified capsule-shaped, and debossed with GS FC2 on one side with no markings on the reverse side. They are packaged as follows: Bottles of 30 Tablets (NDC 0173-0742-00). Store at 25��C (77��F); excursions permitted to 15��to 30��C (59��to 86��F) (see USP Controlled Room Temperature).
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WARNINGS EPZICOM contains 2 nucleoside analogues (abacavir sulfate and lamivudine) and is intended only for patients whose regimen would otherwise include these 2 components. Hypersensitivity Reactions: Serious and sometimes fatal hypersensitivity reactions have been associated with abacavir sulfate, a component of EPZICOM. Hypersensitivity to abacavir is a multi-organ clinical syndrome usually characterized by a sign or symptom in 2 or more of the following groups: (1) fever, (2) rash, (3) gastrointestinal (including nausea, vomiting, diarrhea, or abdominal pain), (4) constitutional (including generalized malaise, fatigue, or achiness), and (5) respiratory(including dyspnea, cough, or pharyngitis). Discontinue EPZICOM as soon as a hypersensitivity reaction is suspected. Permanently discontinue EPZICOM if hypersensitivity cannot be ruled out, even when other diagnoses are possible. Following a hypersensitivity reaction to abacavir, NEVER restart EPZICOM or any other abacavir-containing product because more severe symptoms can occur within hours and may include life-threatening hypotension and death. Reintroduction of EPZICOM or any other abacavir-containing product, even in patients who have no identified history or unrecognized symptoms of hypersensitivity to abacavir therapy, can result in serious or fatal hypersensitivity reactions. Such reactions can occur within hours (see WARNINGS and PRECAUTIONS: Information for Patients). Lactic Acidosis and Severe Hepatomegaly: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including abacavir, lamivudine, and other antiretrovirals (see WARNINGS). Exacerbations of Hepatitis B: Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and human immunodeficiency virus (HIV) and have discontinued lamivudine, which is one component of EPZICOM. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue EPZICOM and are co-infected with HIV and HBV. If appropriate, initiation of anti-hepatitis B therapy may be warranted (see WARNINGS).
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dailymed-ingredient:FD&C_Yellow_No._6,
dailymed-ingredient:hypromellose,
dailymed-ingredient:magnesium_stearate,
dailymed-ingredient:microcrystalline_cellulose,
dailymed-ingredient:polyethylene_glycol_400,
dailymed-ingredient:polysorbate_80,
dailymed-ingredient:sodium_starch_glycolate,
dailymed-ingredient:titanium_dioxide
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Therapy-Experienced Patients:<br/>Abacavir: In clinical trials, patients with prolonged prior NRTI exposure or who had HIV-1 isolates that contained multiple mutations conferring resistance to NRTIs had limited response to abacavir. The potential for cross-resistance between abacavir and other NRTIs should be considered when choosing new therapeutic regimens in therapy-experienced patients (see MICROBIOLOGY: Cross-Resistance).<br/>Patients With HIV and Hepatitis B Virus Co-infection:<br/>Lamivudine: Safety and efficacy of lamivudine have not been established for treatment of chronic hepatitis B in patients dually infected with HIV and HBV. In non-HIV-infected patients treated with lamivudine for chronic hepatitis B, emergence of lamivudine-resistant HBV has been detected and has been associated with diminished treatment response (see EPIVIR-HBV package insert for additional information). Emergence of hepatitis B virus variants associated with resistance to lamivudine has also been reported in HIV-infected patients who have received lamivudine-containing antiretroviral regimens in the presence of concurrent infection with hepatitis B virus.<br/>Patients With Impaired Renal Function:<br/>EPZICOM: Since EPZICOM is a fixed-dose tablet and the dosage of the individual components cannot be altered, patients with creatinine clearance<50 mL/min should not receive EPZICOM.<br/>Patients With Impaired Hepatic Function:<br/>EPZICOM: EPZICOM is contraindicated in patients with hepatic impairment since it is a fixed-dose tablet and the dosage of the individual components cannot be altered.<br/>Immune Reconstitution Syndrome: Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including EPZICOM. 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 jirovecii pneumonia [PCP], or tuberculosis), which may necessitate further evaluation and treatment.<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/>Information for Patients:<br/>Abacavir:<br/>Lamivudine: Patients co-infected with HIV and HBV should be informed that deterioration of liver disease has occurred in some cases when treatment with lamivudine was discontinued. Patients should be advised to discuss any changes in regimen with their physician.<br/>EPZICOM: Inform patients that some HIV medicines, including EPZICOM, can cause a rare, but serious condition called lactic acidosis with liver enlargement (hepatomegaly). EPZICOM is not a cure for HIV infection and patients may continue to experience illnesses associated with HIV infection, including opportunistic infections. Patients should remain under the care of a physician when using EPZICOM. Advise patients that the use of EPZICOM has not been shown to reduce the risk of transmission of HIV to others through sexual contact or blood contamination. Inform patients 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. EPZICOM Tablets are for oral ingestion only. Patients should be advised of the importance of taking EPZICOM exactly as it is prescribed.<br/>Drug Interactions:<br/>EPZICOM: No clinically significant changes to pharmacokinetic parameters were observed for abacavir or lamivudine when administered together.<br/>Abacavir: Abacavir has no effect on the pharmacokinetic properties of ethanol. Ethanol decreases the elimination of abacavir causing an increase in overall exposure (see CLINICAL PHARMACOLOGY: Drug Interactions). The addition of methadone has no clinically significant effect on the pharmacokinetic properties of abacavir. In a study of 11 HIV-infected patients receiving methadone-maintenance therapy (40 mg and 90 mg daily), with 600 mg of ZIAGEN twice daily (twice the currently recommended dose), oral methadone clearance increased 22% (90% CI 6% to 42%). This alteration will not result in a methadone dose modification in the majority of patients; however, an increased methadone dose may be required in a small number of patients.<br/>Lamivudine: Trimethoprim (TMP) 160 mg/sulfamethoxazole (SMX) 800 mg once daily has been shown to increase lamivudine exposure (AUC). No change in dose of either drug is recommended. The effect of higher doses of TMP/SMX on lamivudine pharmacokinetics has not been investigated (see CLINICAL PHARMACOLOGY). Lamivudine and zalcitabine may inhibit the intracellular phosphorylation of one another. Therefore, use of EPZICOM in combination with zalcitabine is not recommended. See CLINICAL PHARMACOLOGY for additional drug interactions.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility:<br/>Carcinogenicity:<br/>Mutagenicity:<br/>Impairment of Fertility: Abacavir or lamivudine induced no adverse effects on the mating performance or fertility of male and female rats at doses producing systemic exposure levels approximately 8 or 130 times, respectively, higher than those in humans at the recommended dose based on body surface area comparisons.<br/>Pregnancy: Pregnancy Category C. There are no adequate and well-controlled studies of EPZICOM in pregnant women. Reproduction studies with abacavir and lamivudine have been performed in animals (see Abacavir and Lamivudine sections below). EPZICOM should be used during pregnancy only if the potential benefits outweigh the risks.<br/>Abacavir: Studies in pregnant rats showed that abacavir is transferred to the fetus through the placenta. Fetal malformations (increased incidences of fetal anasarca and skeletal malformations) and developmental toxicity (depressed fetal body weight and reduced crown-rump length) were observed in rats at a dose which produced 35 times the human exposure, based on AUC. Embryonic and fetal toxicities (increased resorptions, decreased fetal body weights) and toxicities to the offspring (increased incidence of stillbirth and lower body weights) occurred at half of the above-mentioned dose in separate fertility studies conducted in rats. In the rabbit, no developmental toxicity and no increases in fetal malformations occurred at doses that produced 8.5 times the human exposure at the recommended dose based on AUC.<br/>Lamivudine: Studies in pregnant rats showed that lamivudine is transferred to the fetus through the placenta. Reproduction studies with orally administered lamivudine have been performed in rats and rabbits at doses producing plasma levels up to approximately 35 times that for the recommended adult HIV dose. No evidence of teratogenicity due to lamivudine was observed. Evidence of early embryolethality was seen in therabbit at exposure levels similar to those observed in humans, but there was no indication of this effect in the rat at exposure levels up to 35 times those in humans.<br/>Antiretroviral Pregnancy Registry: To monitor maternal-fetal outcomes of pregnant women exposed to EPZICOM or 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 breastfeed their infants to avoid risking postnatal transmission of HIV infection.<br/>Abacavir: Abacavir is secreted into the milk of lactating rats.<br/>Lamivudine: Lamivudine is excreted in human breast milk and into the milk of lactating rats. Because of both the potential for HIV transmission and the potential for serious adverse reactions in nursing infants, mothers should be instructed not to breastfeed if they are receiving EPZICOM.<br/>Pediatric Use: Safety and effectiveness of EPZICOM in pediatric patients have not been established.<br/>Geriatric Use: Clinical studies of abacavir and lamivudine did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. EPZICOM is not recommended for patients with impaired renal function or impaired hepatic function (see PRECAUTIONS and DOSAGE AND ADMINISTRATION).
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Abacavir: There is no known antidote for abacavir. It is not known whether abacavir can be removed by peritoneal dialysis or hemodialysis.<br/>Lamivudine: One case of an adult ingesting 6 grams of lamivudine was reported; there were no clinical signs or symptoms noted and hematologic tests remained normal. It is not known whether lamivudine can be removed by peritoneal dialysis or hemodialysis.
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abacavir sulfate and lamivudine
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EPZICOM (Tablet)
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Abacavir:<br/>Hypersensitivity Reaction: Serious and sometimes fatal hypersensitivity reactions have been associated with abacavir sulfate, a component of EPZICOM. In one study, once-daily dosing of ZIAGEN was associated with more severe hypersensitivity reactions (see WARNINGS and PRECAUTIONS: Information for Patients).<br/>Therapy-Naive Adults: Treatment-emergent clinical adverse reactions (rated by the investigator as moderate or severe) with a���5% frequency during therapy with ZIAGEN 600 mg once daily or ZIAGEN 300 mg twice daily, both in combination with lamivudine 300 mg once daily and efavirenz 600 mg once daily are listed in Table 4.<br/>Laboratory Abnormalities: Laboratory abnormalities observed in clinical studies of ZIAGEN were anemia, neutropenia, liver function test abnormalities, and elevations of CPK, blood glucose, and triglycerides. Additional laboratory abnormalities observed in clinical studies of EPIVIR were thrombocytopenia and elevated levels of bilirubin, amylase, and lipase. The frequencies of treatment-emergent laboratory abnormalities were comparable between treatment groups in Study CNA30021.<br/>Other Adverse Events: In addition to adverse reactions listed above, other adverse events observed in the expanded access program for abacavir were pancreatitis and increased GGT.<br/>Observed During Clinical Practice: The following reactions have been identified during post-approval use of abacavir and lamivudine. 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 a combination of their seriousness, frequency of reporting, or potential causal connection to abacavir and/or lamivudine.<br/>Abacavir: Suspected Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in patients receiving abacavir primarily in combination with medications known to be associated with SJS and TEN, respectively. Because of the overlap of clinical signs and symptoms between hypersensitivity to abacavir and SJS and TEN, and the possibility of multiple drug sensitivities in some patients, abacavir should be discontinued and not restarted in such cases. There have also been reports of erythema multiforme with abacavir use.<br/>Abacavir and Lamivudine:
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EPZICOM Tablets, in combination with other antiretroviral agents, are indicated for the treatment of HIV-1 infection. Additional important information on the use of EPZICOM for treatment of HIV-1 infection: See WARNINGS, ADVERSE REACTIONS, and Description of Clinical Studies.<br/>Description of Clinical Studies:<br/>EPZICOM: There have been no clinical trials conducted with EPZICOM (see CLINICAL PHARMACOLOGY for information about bioequivalence of EPZICOM). One EPZICOM Tablet given once daily is an alternative regimen to EPIVIR Tablets 300 mg once daily plus ZIAGEN Tablets 2 x 300 mg once daily as a component of antiretroviral therapy. The following study was conducted with the individual components of EPZICOM.<br/>Therapy-Naive Adults: CNA30021 was an international, multi-center, double-blind, controlled study in which 770 HIV-infected, therapy-naive adults were randomized and received either ZIAGEN 600 mg once daily or ZIAGEN 300 mg twice daily, both in combination with EPIVIR 300 mg once daily and efavirenz 600 mg once daily. The double-blind treatment duration was at least48 weeks. Study participants had a mean age of 37 years, were: male (81%), Caucasian (54%), black (27%), and American Hispanic (15%). The median baseline CD4+ cell count was 262 cells/mm(range: 21 to 918 cells/mm) and the median baseline plasma HIV-1 RNA was 4.89 logcopies/mL (range: 2.60 to 6.99 logcopies/mL). The outcomes of randomized treatment are provided in Table 3. After 48 weeks of therapy, the median CD4+ cell count increases from baseline were 188 cells/mmin the group receiving ZIAGEN 600 mg once daily and 200 cells/mmin the group receiving ZIAGEN 300 mg twice daily. Through Week 48, 6 subjects (2%) in the group receiving ZIAGEN 600 mg once daily (4 CDC classification C events and 2 deaths) and 10 subjects (3%) in the group receiving ZIAGEN 300 mg twice daily (7 CDC classification C events and 3 deaths) experienced clinical disease progression. None of the deaths were attributed to study medications.
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EPZICOM
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