Generic Combivir is used for treating HIV infection in combination with other medicines.
Other names for this medication:
Also known as: Lamivudine\Zidovudine.
Generic Combivir is an antiviral combination. Lamivudine and Zidovudine are both nucleoside analogues that work together to slow the growth of HIV by blocking an enzyme needed by the virus to reproduce.
Generic Name of Generic Combivir is Lamivudine plus Zidovudine.
Combivir is also known as Lamivudine, Zidovudine, Duovir.
Brand name of Generic Combivir is Combivir.
Generic Combivir is available in tablets which should be taken orally.
Take Generic Combivir with or without food.
Continue to use Generic Combivir even if you feel well. Do not miss any doses.
Take Generic Combivir at the same time each day.
Do not stop taking it suddenly.
If you overdose Generic Combivir and you don't feel good you should visit your doctor or health care provider immediately.
Store between 2 and 30 degrees C (36 and 86 degrees F) away from moisture and heat. Keep the container tightly closed. Throw away any unused medicine after the expiration date. Keep out of the reach of children.
The most common side effects associated with Combivir are:
Side effect occurrence does not only depend on medication you are taking, but also on your overall health and other factors.
Be careful with Generic Combivir while you are pregnant or have nurseling. Generic Combivir can pass in breast milk and harm your baby.
Do not use Generic Combivir if you are allergic to Generic Combivir components.
Do not use Generic Combivir if you are taking stavudine, zalcitabine, or other medicines containing lamivudine or zidovudine.
Do not use Generic Combivir if you have severe kidney problems, decreased liver function, abnormal liver function tests, or high levels of lactic acid in the blood (lactic acidosis).
Be careful with Generic Combivir if you weigh less than 66 lbs (30 kg) .
Be careful with Generic Combivir if you have a history of liver problems (eg, abnormal liver function tests, hepatitis B infection) or lactic acidosis, kidney problems, a bone marrow disorder, pancreas problems, abnormal blood cell counts, or nerve or muscle problems.
Be careful with Generic Combivir if you are significantly overweight.
Be careful with Generic Combivir if you take interferon alfa or ribavirin because serious liver problems may occur; stavudine because its effectiveness may be decreased by Generic Combivir; clarithromycin, doxorubicin, rifampin, or zalcitabine because they may decrease Generic Combivir 's effectiveness; acetaminophen, ganciclovir, ibuprofen, methadone, probenecid, trimethoprim/sulfamethoxazole, valproic acid, vancomycin, or zalcitabine because they may increase the risk of Generic Combivir 's side effects or toxic effects.
Do not stop taking it suddenly.
HAART was given to 12 patients (combivir + nevirapin). The number of CD+ lymphocytes (by median) 1 month after the treatment increased by 185 cells/mcl, 3 months after the treatment--by 215 cells/mcl. After 1-month therapy viral load (median) diminished by 2.02 log10 copy/ml, after 3 months--by 2.31 log10 copy/ml. 71% patients had HIV RNA under 400 copy/ml. Untreated patients showed changes neither in CD4+ lymphocytes number nor in viral load. The study continues.
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MERIT was a randomized trial comparing maraviroc (MVC) + Combivir versus efavirenz (EFV) + Combivir in drug-naive patients screened as having R5 HIV-1 by the original Trofile assay (OTA). We retrospectively evaluated treatment response after rescreening for viral tropism using population-based V3-loop sequencing.
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For the last several years, the combination of ddI (didanosine, Videx) and d4T (stavudine, Zerit) as a backbone of three-drug therapy has been popular both in treatment and in research. Together, the two nucleoside analog reverse transcriptase inhibitor (NARTI) drugs offered relatively high strength and fairly simple use. Despite this, some researchers have long questioned the wisdom of the combination as it violates one of the key rules of combining drugs: combine only drugs with different side effect profiles. Both drugs are associated with the development of peripheral neuropathy and pancreatitis. Pancreatitis is more commonly seen with ddI and neuropathy with d4T, but both occur to a significant degree with each drug and to a higher degree than was seen with other drugs of their class. However, few if any studies were run comparing the ddI/d4T combination to alternatives such as AZT/3TC (Combivir) or even 3TC/d4T. Both ddI and d4T come from the same company, Bristol Myers Squibb.
Compared with other published studies the completion rate of HIV-PEP in our study was high. The uptake and adverse events of HAART in this scenario were similar to previously published studies. A multidisciplinary approach to the management of this patient group will improve adherence to PEP.
Eleven electronic databases were searched from inception to December 2007.
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In the development strategies of new drug products and generic drug products, the simultaneous in-vitro dissolution behavior of oral dosage formulations is the most important indication for the quantitative estimation of efficiency and biopharmaceutical characteristics of drug substances. This is to force the related field's scientists to improve very powerful analytical methods to get more reliable, precise and accurate results in the quantitative analysis and dissolution testing of drug formulations. In this context, two new chemometric tools, partial least squares (PLS) and principal component regression (PCR) were improved for the simultaneous quantitative estimation and dissolution testing of zidovudine (ZID) and lamivudine (LAM) in a tablet dosage form. The results obtained in this study strongly encourage us to use them for the quality control, the routine analysis and the dissolution test of the marketing tablets containing ZID and LAM drugs.
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Of 50 participants recruited (23 to LPVr/ZDV/3TC), 48 started therapy, and 37 participants (19 on LPVr/ZDV/3TC) enrolled in the substudy. At 36 months, the LPVr/ZDV/3TC group had significantly lower limb fat [6.4 kg (0.26) versus 7.3 kg (0.31), P = 0.017] and a trend toward lower abdominal SAT compared to the LPVr/NVP group [131 cm (6.86) versus 146 cm (6.33), P = 0.097]. Over 36 months, mtDNA declined in the LPVr/ZDV/3TC group [mtDNA region 1: -190 (95) copies/cell, P = 0.053, region 2: -269 (106) copies/cell, P = 0.016] but not within the LPVr/NVP group [region 1: +28 (99) copies/cell, P = 0.78, region 2: +51 (111) copies/cell, P = 0.65, between-group difference P < 0.01 for both measurements]. mtDNA was significantly lower in the LPVr/ZDV/3TC group at 36 months.
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It has been proposed that antiretroviral therapies (ART) possess both antiviral and immunomodulatory activities when used in HIV infected patients. Few studies have addressed whether these putative immunomodulatory effects are also seen in HIV negative patients, for example, when used for post exposure prophylaxis (PEP). We chose to evaluate immunologic function in HIV negative patients who received Nelfinavir and Combivir (AZT and 3TC) as PEP. Lymphocytes from patients taken immediately before, during, and after PEP were analyzed. No changes were seen in absolute or percent CD4 or CD8 T lymphocyte numbers, nor in markers of activation, memory, or co-stimulatory molecules. Surface expression of apoptosis-related ligands and receptors were unaltered, but apoptosis susceptibility was significantly inhibited by PEP (P less than 0.05). These data confirm in vitro that apoptosis susceptibility is altered by ART, including in HIV-negative patients who take PEP.
This study was a prospective, nonrandomized observational study conducted from March 1999 until September 2002. Subjects (age <19 years) who presented to a pediatric emergency room within 72 hours of a sexual assault were eligible for enrollment. A 28-day PEP regimen of zidovudine and lamivudine was given.
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In umbilical cords from six of nine infants born to HIV-1-infected mothers taking Combivir moderate to severe mitochondrial morphological damage was observed (P = 0.011), while none of seven unexposed infants showed similar damage. Compared to unexposed infants, statistically significant mtDNA depletion was observed in umbilical cord (P = 0.006) and cord blood (P = 0.003) from drug-exposed infants.
Consecutive patients (aged >18 years) with serologically documented HIV infection, who had received HAART for at least 2 years and who had been diagnosed with lipodystrophy, were followed up as outpatients at the metabolic clinic of the University of Modena and Reggio Emilia, Modena, Italy. Patients received stable nevirapine therapy plus fixed-dose combinations of tenofovir disoproxil fumarate plus emtricitabine (Truvada(®); TVD), zidovudine plus lamivudine (3TC) [Combivir(®); CBV], or abacavir plus lamivudine (Kivexa(®); KVX). Multivariate regression analyses were performed to analyse predictors of four components of lipodystrophy: lipoatrophy using leg fat mass measured by dual-emission x-ray absorptiometry (DXA), fat accumulation using waist circumference, dyslipidaemia using apolipoprotein (Apo)B/ApoA1 ratio, and glucose intolerance using the Homeostasis Model Assessment for Insulin Resistance (HOMA-IR).
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195 subjects (131 men, 64 women), median age 34 years, were randomized: 98 received combivir/abacavir and 97 combivir/nelfinavir. Baseline median plasma HIV-1 RNA was 4.2 log10 copies/ml [Interquartile range (IQR): 3.7-4.5.2] and 4.1 log10 copies/ml (IQR: 3.8-4.6), respectively. Baseline median CD4 cell count was 387 cells/mm3 (IQR: 194-501) and 449 cells/mm3 (IQR: 334-605), respectively. Nine patients (3 vs 6, respectively) did not start treatment or did not have any available efficacy data. At week 48, using the intent to treat analysis (switch/missing equals failure), plasma HIV-1 RNA was <50 copies/ml in 54/95 (57%) and 53/91 (58%) of subjects, respectively. Median CD4 increase was +110 and +120 cells/mm3, respectively. Possible hypersensitivity reactions to abacavir were reported in four subjects (4%).
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Maraviroc (UK-427 857), an antagonist of the CCR5 receptor with potent anti-HIV activity, was recently approved for use in treatment-experienced patients infected with CCR5-tropic HIV-1. The aim of this study was to evaluate the effect of selected commonly used antiretroviral therapy (ART) combinations on the pharmacokinetics of a single oral dose of maraviroc 300 mg in HIV-positive subjects compared with historical controls.
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A retrospective cohort study was conducted in Yunnan and Shanxi Provinces, where HAART and all medical care are provided free to HIV-positive patients. Health expenditures and costs in the first treatment year were collected from medical records and prescriptions at local hospitals between January and June 2007. Multivariate linear regression was used to determine the factors associated with the actual expenditures in the first antiretroviral (ARV) treatment year.
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Healthcare workers (HCWs) worldwide risk occupational exposure to HIV and other blood-borne pathogens. Post-exposure prophylaxis (PEP) may decrease the risk of seroconversion after occupational or sexual exposure. Current guidelines recommend immediate PEP with at least 2 drugs following HIV exposure. In high-risk exposures, the guidelines recommend the use of a protease inhibitor (PI) as well as 2 reverse transcriptase inhibitors. Protease inhibitors have been associated with dyslipidaemias, other metabolic abnormalities and lipodystrophy syndromes in AIDS patients. We report a case of new transient lipid abnormalities in a HCW receiving PEP after HIV exposure. HIV medications may produce occult metabolic abnormalities in HIV-negative individuals receiving PEP. This risk should be considered during follow-up evaluation for PEP.
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Although established in controlled studies that there is no advantage to 4-drug highly active antiretroviral therapy (HAART) or regimens with or without protease inhibitors (PIs), we questioned this finding in a clinical setting (ie, no inclusion criteria). Ours is a single clinic retrospective study including all participants >18 years of age during their first year of HAART. A total of 190 participants were reviewed, with 168 (88%) attaining a viral load <400 copies/mL at the end of a year of HAART; 144 of 164 (88%) succeeded with 3 drugs and 24 of 26 (92%) with 4 drugs (P = .51). In all, 59 of 71 (83%) succeeded using a PI versus 109 of 119 (92%) without a PI (P = .08). Male gender and exposure time to HAART were significant variables for a successful outcome. Failures were due to side effects (50%), nonadherence (45%), and drug allergy (5%). Our results support current guidelines recommending 3-drug HAART.
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The recommended guidelines were adhered to for the majority of patients initiated on antiretrovirals at the UHWI. The treatment outcomes achieved at the UHWI were similar to those achieved in developed countries. This gives substantial evidence in support of international efforts to make antiretroviral therapy available in developing countries.
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Under the conditions of this gavage study, there was clear evidence of carcinogenic activity of AZT alone in male heterozygous F1 p53+/- mice based on increased incidences of hepatocellular adenoma. There was clear evidence of carcinogenic activity of AZT in combination with 3TC, and AZT in combination with 3TC and NVP in male heterozygous F1 p53+/- mice based on increased incidences of hepatocellular adenoma and hepatocellular adenoma or carcinoma (combined). The occurrence of malignant lymphoma may have been related to treatment with AZT alone and with AZT in combination with 3TC. There was no evidence of carcinogenic activity of 3TC alone in male heterozygous F1 p53+/- mice administered 150 mg/kg. There was no evidence of carcinogenic activity of NVP alone in male heterozygous F1 p53+/- mice administered 168 mg/kg. There was equivocal evidence of carcinogenic activity of NVP alone, AZT in combination with 3TC, and AZT in combination with 3TC and NVP in female heterozygous F1 p53+/- mice based on the occurrence of malignant lymphoma. There was equivocal evidence of carcinogenic activity of 3TC alone in female heterozygous F1 p53+/- mice based on the occurrence of mammary gland adenoacanthoma or adenocarcinoma (combined). There was no evidence of carcinogenic activity of AZT alone in female heterozygous F1 p53+/- mice administered 240 mg/kg. Synonyms: (3'-AZIDO-3'-DEOXYTHYMIDINE) 3'-azido-2',3'-dideoxythymidine; azidodeoxythymidine; azidothymidine; 3'-azidothymidine; AZT; BW A509U; Compound S; 3'-deoxy-3'-azidothymidine; 3'-deoxy-(8CI) (9CI); ZDV; zidovudine. Trade name: Retrovir® [Combivir® with 3TC] Synonyms: (2',3'-DIDEOXY-3'-THIACYTIDINE) 3TC; 4-amino-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]-1,2-dihydropyrimidin-2-one; L-2',3'-dideoxy-3'-thiacytidine; lamivudine Trade name: Epivir® [Combivir® with AZT] Synonyms: (NEVIRAPINE) NVP; 11-cyclopropyl-4-methyl-5,11-dihydro-6H- dipyrido[3,2-b:2',3'-e][1,4]diazepin-6-one Trade name: Viramune®
A province-wide standardized program of universal HIV counselling and offering of PEP to sexual assault survivors with frequent follow up was successfully implemented and feasible.
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Long-term use of cocaine (⩾15 years) and antiretroviral therapy (ART) have been implicated in cardiovascular complications. Nevertheless, the individual and combined effects of ART and cocaine use on silent coronary artery disease have not been fully investigated.Methods: Computed tomography coronary angiography was performed for 165 human immunodeficiency virus (HIV)– infected African American study participants aged 25–54 years in Baltimore, Maryland, with contrast-enhanced 64-slice multidetector computed tomography imaging.Result: Significant (⩾50%) coronary stenosis was detected in 24 (15%) of 165 participants. The prevalence of significant stenosis among those who had used cocaine for ⩾15 years and had received ART for ⩾6 months was 42%. Exact logistic regression analysis revealed that long-term cocaine use(adjusted odds ratio, 7.75; 95% confidence interval, 2.26–31.2) and exposure to ART for ⩾6 months(adjusted odds ratio, 4.35; 95% confidence interval, 1.30–16.4) were independently associated with the presence of significant coronary stenosis. In addition, after controlling for confounding factors,both stavudine use for ⩾6 months or combivir use for ⩾6 months were independently associated with the presence of significant coronary stenosis.Conclusions: Long-term exposure to ART may be associated with silent coronary artery disease;however, the magnitude of increased risk associated with ART was much lower than the risk associated with cocaine use or traditional risk factors. Cardiovascular monitoring and aggressive modification of cardiovascular risk factors are essential for reducing the risk of coronary artery disease in HIV-infected individuals. Extensive efforts should also be made to develop effective cocaine use cessation programs for HIV-infected cocaine users.
Adherence may be facilitated by reducing perceptual and practical barriers to antiretroviral therapy (ART). Practical barriers include the complexity of daily dosing, while perceptual barriers include perceptions of the need for treatment and concerns about adverse effects. The study aim was to assess the effect of switching zidovudine plus lamivudine twice-daily (Combivir, CBV) to once-daily tenofovir DF plus emtricitabine (Truvada, TVD), each plus efavirenz (EFZ), on adherence, beliefs about ART and quality of life (QoL). Subjects stable on CBV + EFV were randomised 1:1 to continue this regimen or switch to TVD + EFV. Adherence was measured using the Medication Adherence Self-Report Inventory at 4, 12, 24 and 48 weeks. Beliefs about ART (perceptions of necessity and concerns about adverse effects), treatment intrusiveness and QoL were measured by questionnaire at baseline 4, 12, 24 and 48 weeks. Viral load was assessed at each visit. Two hundred and thirty-four subjects initiated treatment. At week 48, the proportion of subjects reporting high adherence (≥95% taken as prescribed) was significantly greater in the TVD arm (p=0.049). Low adherence (reporting taking <95% as prescribed, discontinuing the study or having missing data) was associated with doubts about necessity (p=0.020), stronger concerns about adverse effects (p=0.010), greater treatment intrusiveness (p=0.010) and poorer mental health related QoL (p=0.008). At week 48, both concerns about ART (p=0.038) and treatment intrusiveness (p=0.004) were lower among those who switched to TVD. Furthermore, there was a decline in both concerns about ART (p=0.007) and treatment intrusiveness (p=0.057) over the 48 weeks among those who switched to TVD. There were no significant differences in necessity beliefs, QoL or viral load between randomised groups. Switching from CBV to TVD may improve patient reported outcomes including slightly better adherence, a greater reduction in concerns about adverse effects and less treatment intrusiveness.
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For first-line therapy, in this observational setting, EFV, LPV/r and NVP, when added to the combivir backbone, were more likely to drive viral load < 500 copies/ml. LPV/r showed the best immunological effectiveness.
The exclusion of ∼8% of patients with CXCR4-using virus by population-based sequencing would likely have resulted in noninferior responses in the MVC twice-daily and EFV arms. Rescreening by ESTA and population-based sequencing predicted similar virological response.
Aggressive treatment has been advocated for the management of primary HIV infection (PHI), but the composition and the optimal duration of therapy are still to be determined. In addition, time to undetectable viral load (VL), rate and duration of VL suppression as well as subsequent therapeutic choices remain issues widely debated. We evaluated the rate and duration of VL suppression in 12 consecutive patients with PHI given triple-drug treatment with zidovudine, lamivudine and indinavir (highly active antiretroviral therapy, HAART) at onset of the acute illness and subsequently switched to a simplified 2-NRTI-based regimen once VL suppression was maintained for at least 6 months. Throughout the study, no patient discontinued treatment because of symptoms attributed to the study medications. In the study population, undetectable VL was achieved after a median of 84 days (range: 67-135) on HAART and was maintained for a median of 194 days (range: 179-205) before simplification. After switching to simplified maintenace, undetectable VL was maintained in all patients for at least 6 months. Only one patient experienced virological failure, plasma HIV-RNA remaining suppressed for a median foliow-up of 33 months (15-54) and T-CD4+ being steadily higher than 500/mL in the remaining patients. Our results suggest that simplification of HAART in patients promptly treated during PHI and maintaining undetectable VL for at least 6 months before simplification may be a valid option capable of controlling viral replication and maintaining an optimal immunological profile for a prolonged time.
The non-nucleoside reverse transcriptase inhibitors (NNRTIs) are commonly used in combination antiretroviral therapy and are associated with hypersensitivity reactions on induction therapy. We report a case of recurrent hypersensitivity associated with Combivir, when there was a delay in determining the cause as the NNRTIs were considered to be the more likely cause.
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Overall, 219 patients treated with once-daily didanosine/lamivudine/efavirenz and 409 patients receiving twice-daily zidovudine/lamivudine (Combivir) plus efavirenz were evaluated. By intent-to treat analysis (non-completers and therapeutic change=failure), time to treatment failure was similar in both groups of treatment: 40.0 months (95% CI 23.3-56.8 months) among patients on didanosine/lamivudine/efavirenz and 33.3 months (95% CI 25.6-41.1 months) in patients treated with zidovudine/lamivudine/efavirenz (P=0.253). The risk of failure due to treatment change was almost double among patients treated with zidovudine/lamivudine/efavirenz compared with those who received didanosine/lamivudine/efavirenz.
A single-class NRTI regimen after successful induction with standard ART had similar antiviral efficacy compared to continuation of a PI-based regimen at 96 weeks after baseline, with improved serum lipids.
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Highly active antiretroviral therapy (HAART) has been advocated for the management of primary HIV-1 infection. We investigated the use of a nonnucleoside reverse transcriptase inhibitor (NNRTI)-based regimen in this setting.
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A total of 55 patients who were on Combivir and 39 on a control regimen were examined.
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Thirty-four patients in each arm were enrolled. Baseline characteristics were similar in the three groups. The proportion of patients with viral load <50 copies/ml at week 52 were 74.4, 74.4 and 50.0% for OD group, BID-low group and BID-high group, respectively (P=0.02, ITT analysis). According to on-treatment analysis, the same figures were 88.9, 85.7 and 60% (P<0.02). Overall, 26 (25.5%) patients discontinued treatment for different reasons and immune recovery was similar in all study arms.
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One hundred and forty-seven patients were randomized 2:2:1 to one of two APL dosing regimens or efavirenz (EFV). All dosage arms were administered twice daily and in combination with lamivudine/zidovudine (3TC/ZDV; Combivir, COM). Efficacy, safety, and pharmacokinetic parameters were assessed.
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Although most uninfected infants born to women infected with HIV-1 show no clinical evidence of mitochondrial compromise, mitochondrial dysfunction has been reported in children born to women receiving zidovudine and/or lamivudine during pregnancy. In this pilot study we examined mitochondrial integrity in HIV-1-uninfected infants born to HIV-1-infected women receiving Combivir during pregnancy.
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