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Combivir

Generic Combivir is used for treating HIV infection in combination with other medicines.

Other names for this medication:
Lamivudine, Zidovudine

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Also known as:  Lamivudine\Zidovudine.

Description

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.

Dosage

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.

Overdose

If you overdose Generic Combivir and you don't feel good you should visit your doctor or health care provider immediately.

Storage

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.

Side effects

The most common side effects associated with Combivir are:

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Side effect occurrence does not only depend on medication you are taking, but also on your overall health and other factors.

Contraindications

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.

Avoid alcohol.

Do not stop taking it suddenly.

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The HIV/AIDS epidemic, which was first reported on in 1981, progressed in just 10 years to a disease afflicting 10 million people worldwide including 1 million in the US. In 1987, AZT was approved for treating HIV/AIDS. Unfortunately, its clinical usefullness was severly limited by associated toxicities and the emergence of resistance. Three other drugs that were approved in the early 1990s suffered from similar liabilities. In 1990, the Liotta group at Emory University developed a highly diastereoselective synthesis of racemic 3'-thia-2',3'-dideoxycytidine and 3'-thia-2',3'-5-fluorodideoxycytidine and demonstrated that these compounds exhibited excellent anti-HIV activity with no apparent cytotoxicity. Subsequently, the enantiomers of these compounds were separated using enzyme-mediated kinetic resolutions and their (-)-enantiomers (3TC and FTC, respectively) were found to have exceptionally attractive preclinical profiles. In addition to their anti-HIV activity, 3TC and FTC potently inhibit the replication of hepatitis B virus. The development of FTC, which was being carried out by Burroughs Wellcome, had many remarkable starts and stops. For example, passage studies indicated that the compound rapidly selected for a single resistant mutant, M184V, and that this strain was 500-1000-fold less sensitive to FTC than was wild-type virus. Fortunately, it was found that combinations of AZT with either 3TC or FTC were synergistic. The effectiveness of AZT-3TC combination therapy was subsequently demonstrated in four independent clinical trials, and in 1997, the FDA approved Combivir, a fixed dose combination of AZT and 3TC. In phase 1 clinical trials, FTC was well tolerated by all subjects with no adverse events observed. However, the development of FTC was halted by the aquistition of Wellcome PLC by Glaxo PLC in January 1995. In 1996, Triangle Pharmaceuticals licensed FTC from Emory and initiated a series of phase I/II clinical studies that demonstrated the safety and efficacy of the drug. In August 1998, FTC was granted "Fast Track" status, based primarily on its potential for once daily dosing. While the outcomes of two subsequent phase III trials were positive, a third phase III clinical trial involving combinations of 3TC or FTC with stavudine and neviripine had to be terminated due to serious liver-related adverse events. Although analysis of the data suggested that the liver toxicity was due to neviripine, the FDA decided that the study could not be used for drug registration. Ultimately, in January 2003, Gilead Sciences acquired Triangle Pharmaceuticals and completed the development of FTC (emtricitabine), which was approved for once a day, oral administration in July 2003. A year later, Truvada, a once a day, oral, fixed dose combination of emtricitabine and tenofovir disoproxyl fumarate received FDA approval and quickly became the accepted first line therapy when used with a third antiretroviral agent. In July 2006, the FDA approved Atripla, a once a day, oral, fixed dose combination of emtricitabine, tenofovir disoproxyl fumarate, and efavirenz, which represented the culmination of two decades of research that had transformed AIDS from a death sentence to a manageable chronic disease.

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In all, 70 adolescents were evaluated and 33 (31 females and 2 males) were enrolled. The mean age of enrolled subjects was 15 years, 61% were Hispanic, 30% black, and 79% presented to the emergency room within 24 hours of assault. Vaginal exposure was the most common site of penetration (64% [21 of 33]), but 18% (6 of 33) reported anal penetration. Only 9 subjects (27%) took >or=90% of all the medications. All subjects who returned for follow up tested HIV-negative. Adverse events occurred in 48% (16 of 33) of subjects; the most common events were abdominal pain, nausea, or vomiting.

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Conjunctival MC is rare and associated with immune deficiency. To the best of our knowledge, the presented case is the first reported instance of bilateral, multi-lesional MC of the conjunctiva in an HIV-positive patient undergoing HAART. Attention must be paid to the possible complications associated with the restoration of immunocompetence.

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ZDV and 3TC concentrated in BM whereas LPV and RTV did not, possibly due to protein binding and drug transporter affinity. Undetectable to low antiretroviral concentrations in IP suggest prevention of transmission while breastfeeding may be due to antiretroviral effects on systemic or BM HIV RNA in the mother. Low IP 3TC exposure may predispose an infected infant to HIV resistance, necessitating testing and treating infants early.

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The CCR102881 (ASCENT) study evaluated the antiviral activity of the novel CCR5 entry inhibitor aplaviroc plus a fixed-dose combination of lamivudine-zidovudine (Combivir) in drug-naïve human immunodeficiency virus type 1-infected subjects with only CCR5-tropic virus detected in plasma. Although the trial was stopped prematurely due to idiosyncratic hepatotoxicity, eight subjects met protocol-defined virologic failure criteria. Clonal analyses of the viral envelope tropism, aplaviroc susceptibility, and env sequencing were performed on plasma at baseline and at the time of virologic failure. Molecular evolutionary analyses were also performed. The majority of the subjects with virologic failure (six of eight) acquired the lamivudine resistance-associated mutation M184V, and none had evidence of reduced susceptibility to aplaviroc at the time of virologic failure, even at the clonal level. Six subjects with virologic failure maintained CCR5 tropism, while two exhibited a change in population tropism readout to dual/mixed-tropic with R5X4-tropic clones detected prior to therapy. Two evolutionary patterns were observed: five subjects had no evidence of population turnover, while three subjects had multiple lines of evidence for env population turnover. The acquisition of the M184V mutation is the primary characteristic of virologic failure in first-line therapy with aplaviroc plus lamivudine-zidovudine, regardless of the envelope tropism.

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In contrast to resource-rich countries, most HIV-infected patients in resource-limited countries receive treatment without virological monitoring. There are few long-term data, in this setting, on rates of viral suppression or switch to second-line antiretroviral therapy. The DART trial compared clinically driven monitoring (CDM) versus routine laboratory (CD4/haematology/biochemistry) and clinical monitoring (LCM) in HIV-infected adults initiating therapy. There was no virological monitoring in either study group during follow-up, but viral load was measured in Ugandan participants at trial closure. Two thousand three hundred and seventeen (2317) participants from this country initiated antiretroviral therapy with zidovudine/lamivudine plus tenofovir (n = 1717), abacavir (n = 300), or nevirapine (n = 300). Of 1896 (81.8%) participants who were alive and in follow-up at trial closure (median 5.1 years after therapy initiation), 1507 (79.5%) were on first-line and 389 (20.5%) on second-line antiretroviral therapy. The overall switch rate after the first year was 5.6 per 100 person-years; the rate was substantially higher in participants with low baseline CD4 counts (<50 cells/mm3). Among 1207 (80.1%) first-line participants with viral load measured, HIV RNA was <400 copies/ml in 963 (79.8%), 400-999 copies/ml in 37 (3.1%), 1,000-9,999 copies/ml in 110 (9.1%), and ≥10,000 copies/ml in 97 (8.0%). The proportion with HIV RNA <400 copies/ml was slightly lower (difference 7.1%, 95% CI 2.5 to 11.5%) in CDM (76.3%) than in LCM (83.4%). Among 252 (64.8%) second-line participants with viral load measured (median 2.3 years after switch), HIV RNA was <400 copies/ml in 226 (89.7%), with no difference between monitoring strategies. Low switch rates and high, sustained levels of viral suppression are achievable without viral load or CD4 count monitoring in the context of high-quality clinical care.

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Switching from ZDV/3TC to FTC/TDF led to an improvement in FMR, compared with progressive worsening of FMR in subjects receiving ZDV/3TC, showing that fat mass not only increased but was also distributed in a healthier way after the switch.

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Morphological abnormalities (lipoatrophy and central fat accumulation) and metabolic changes (dyslipidaemia and glucose regulation impairment) have emerged as components of lipodystrophy and as major tolerability issues with long-term use of highly active antiretroviral therapy (HAART) in HIV-positive patients. Protease inhibitors (PIs) are recognized as having the greatest impact in terms of metabolic complications, followed by nucleoside reverse transcriptase inhibitors, while the non-nucleoside reverse transcriptase inhibitors (NNRTIs) have the least impact. In particular, regimens based on the NNRTI nevirapine have been shown to achieve significant metabolic benefits and may help to improve dyslipidaemia. Improvements in body shape changes associated with lipodystrophy have also been reported when nevirapine replaced a PI in long-term triple therapy.

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This study confirms a specific association between in utero exposure to ZDV and CHDs, and a long-lasting postnatal myocardial remodeling in girls. A potential common mechanism, including the involvement of mitochondrial dysfunction, must be explored, and long-term consequences on cardiac function warrant specific attention.

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The total number of prescriptions for antiretrovirals increased from 168,914 in 1991 to 2.0 million in 1998, and 3.0 million in 2005, a 16.7-fold increase over 15 years. The number of prescriptions for NRTIs reached 1.6 million in 2005. Prescriptions for PIs increased from 114 in 1995 to 932,176 in 2005, while the number of prescriptions for NNRTIs increased from 1,339 in 1996 to 401,272 in 2005. The total payment for antiretroviral drugs in the U.S. Medicaid Program increased from US$ 30.6 million in 1991 to US$ 1.6 billion in 2005, a 49.8-fold increase. In 2005, NRTIs as a class had the highest payment market share. These drugs alone accounted for US$ 787.9 million in Medicaid spending (50.8 percent of spending on antiretrovirals). Payment per prescription for each drug, with the exception of Agenerase, increased, at least somewhat, over time. The relatively expensive drugs in 2005 included Trizivir ($1040) and Combivir ($640), as well as Reyataz ($750), Lexiva ($700), Sustiva ($420), Viramune ($370), and Fuzeon ($1914).

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In a prospective and randomized study, antiretroviral-naive patients received either EFV+ddl+3TC (once-a-day regimen; OD), or EFV+Combivir (twice-a-day and low-pill burden regimen; BID-low) or NFV+Combivir (twice-a-day and high-pill burden regimen; BID-high). Primary outcome was the proportion of patients with viral load <50 copies/ml at week 52 of follow-up. Results were evaluated according to intention-to-treat and on-treatment analysis.

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Pneumocystis jirovecii pneumonia has historically been one of the most common opportunistic pneumonias and life-threatening infectious complications in HIV-infected patients. After the introduction of combination antiretroviral therapy, the incidence of Pneumocystis pneumonia and other opportunistic infections has decreased dramatically. Nowadays Pneumocystis pneumonia still occurs in patients unaware of their HIV status, in those not receiving combination antiretroviral therapy, or in those in whom it is ineffective due to resistance. Age factor is the diagnosis delaying one: patients aged more than 50 years are diagnosed with AIDS later than younger persons. Pneumocystis was thought to be a species of protozoa. Over the last 20 years, Pneumocystis has been shown to be a fungus, to be genetically diverse, host species specific, to colonize individuals with minor immunosuppression, and to cause clinical disease by "new" infection in addition to reactivation of latent childhood-acquired infection. Recently, the microorganism Pneumocystis carinii causing disease in humans has been renamed to Pneumocystis jirovecii. This article presents a clinical case of late diagnosis of Pneumocystis jirovecii pneumonia in a 62-year-old patient unaware of her HIV status and a review of literature reflecting epidemiological issues of Pneumocystis jirovecii and latest discoveries related to Pneumocystis as well as the rationale for renaming it.

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Eleven electronic databases were searched from inception to December 2007.

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The Chinese government has provided health services to those infected by the human immunodeficiency virus (HIV) under the acquired immunodeficiency syndrome (AIDS) care policy since 2003. Detailed research on the actual expenditures and costs for providing care to patients with AIDS is needed for future financial planning of AIDS health care services and possible reform of HIV/AIDS-related policy. The purpose of the current study was to determine the actual expenditures and factors influencing costs for untreated AIDS patients in a rural area of China after initiating highly active antiretroviral therapy (HAART) under the national Free Care Program (China CARES).

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combivir pediatric dosing 2016-10-04

Fifty-three HIV-1 infected pregnant women who had Urispas 200 Mg 60 Tablet received 4-12 weeks of antenatal AZT followed by Nevirapine during delivery and Combivir [AZT + 3TC] for 1 week postpartum (group-1, n = 48) or who come at the time of delivery and received Nevirapine followed by Combivir for 1 week (group-2, n = 5) were recruited. Samples were collected prior to the start of the prophylaxis and 5-8 weeks postpartum. In addition, a third sample was collected between 26-65 weeks postpartum from 7 women. Amplification of HIV-1 pol gene and drug resistance analysis was done.

buy combivir online 2015-04-09

In the Treatment Options Preservation Study (TOPS) trial, 4 or 7 days of Combivir (CBV; zidovudine/lamivudine) with maternal single-dose nevirapine (sdNVP) significantly reduced the emergence of NVP resistance as determined by virus population genotyping. To detect NVP resistance with greater sensitivity, we analysed TOPS samples by allele-specific real-time Claritin Generic Brand PCR (ASP).

combivir generic launch 2016-09-25

The Artane Medication Trihexyphenidyl 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.

generic combivir price 2015-04-05

A 25-year-old HIV-infected woman participating in a study of the effects of hormonal contraception on HIV disease progression was started on antiretroviral therapy-Combivir & Nevirapine (NVP) on May 27, 2004. NVP was 200mg daily initially for two weeks to be increased to 200mg bid thereafter. On day twelve, she presented with a mild skin rash on the trunk, purulent conjunctivitis, pharyngitis and fever. She was treated symptomatically and sent home. The following day she returned with a generalized erythematous eruption. She was admitted to JCRC (Joint Bactroban Nasal Ointment Dosage Clinical and Research Centre) on June 14 and was diagnosed with Stevens - Johnson syndrome (SJS). Antiretroviral therapy was stopped. By July 05, 2004, she had improved and was discharged. After recovery she was restarted on Combivir and Efavirenz and is subsequently doing well on this regimen.

combivir reviews 2016-11-02

Women using Combivir(®) (zidovudine [ZDV] + lamivudine [3TC]) +Aluvia(®) (lopinavir/ritonavir [LPV/RTV]) were enrolled. Breast Bactroban Dosage milk (BM), mother plasma (MP) and infant plasma (IP) samples were obtained over 6 h after observed dosing at 6, 12 or 24 weeks post-partum for drug concentrations and HIV RNA.

combivir pep dose 2017-04-08

To establish the clinical equivalence (noninferiority) of one tablet containing abacavir 300 mg-lamivudine 150 mg-zidovudine 300 mg (Trizivir) versus a tablet containing lamivudine 150 mg-zidovudine 300 mg (Combivir) given with one abacavir (ABC) 300-mg tablet, administered twice/day, in antiretroviral-experienced, human immunodeficiency Celebrex 7767 200 Mg virus (HIV)-1-infected patients.

combivir storage 2015-08-30

Patients were randomized 1 : 1 : 1 Zofran Maximum Daily Dose Pregnancy to TZV twice daily (n = 85), COM/NFV 1250 mg twice daily (n = 88), or d4T 40 mg+3TC 150 mg+NFV 1250 mg twice daily (n = 81) for 96 weeks. Treatments were compared using analysis of covariance (ANCOVA) with regard to changes from baseline in fasting lipids in the total population and in sex and ethnic subgroups. The proportions of patients achieving HIV-1 RNA <50 and <400 copies/mL were compared using a 95% confidence interval (CI) on the difference between proportions.

combivir tab 2016-03-01

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 Nexium 5000 Plus Tires Reviews 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.

generic combivir cost 2015-06-17

NOD.c3c4 mice were treated with combination antiretroviral therapy. Response to treatment was studied by measuring MMTV RNA in the liver, liver enzyme levels in serum and liver histology using a modified Voltaren Gel Dosage Card Online Ishak score.

combivir generic cost 2015-05-28

To determine the prevalence of dyslipidemia Lipitor Dosage Every Other Day in HIV-infected patients using the first-line antiretroviral (ARV) drugs triple regimen.

combivir drug class 2016-09-29

Contradicting results on the effect of abacavir (ABC) on hepatitis C virus (HCV) treatment responses in HIV/HCV co-infected patients have been reported. We evaluated the influence of ABC on the response to pegylated interferon (pegIFN) and ribavirin (RBV)-containing HCV treatment in HIV/HCV co-infected patients in a large European cohort collaboration, including data from different European countries.

combivir cost per month 2015-02-28

The difference in adherence observed between once-nightly and twice-daily dosing was driven by a difference in persistence with treatment. Psychological preparation for starting HAART should address patients' perceptions of necessity for HAART and concerns about adverse effects to maximize persistence with treatment.

combivir renal dosing 2016-09-22

Hyperthyroidism has been described after highly active antiretroviral therapy for AIDS and has been attributed to late onset immune reconstitution. The team reports a young Polynesian man with AIDS who responded to highly active antiretroviraltherapy. However, 15 months after initiation of antiretroviral therapy, he was hospitalized for hypokalemic thyrotoxic periodic paralysis, an unusual manifestation of hyperthyroidism which typically occurs in young Asian males.

combivir price per tablet 2016-07-28

The clinical diagnosis of conjunctival MC was confirmed histopathologically. Six months after the induction of HAART, the untouched lesion (right eye) had regressed and there was pronounced local injection of the conjunctiva. MC lesions did not recur after excision (left eye), and signs of inflammation were absent.

combivir cost 2016-09-09

Sixty-five men were randomized and treated (28 in the FTC/TDF arm and 37 in the ZDV/3TC arm), and 57 completed the study (25 and 32 in each arm, respectively). In the FTC/TDF arm, adjusted mean FMR decreased by 0.52 at week 72 (P = 0.014), and in the ZDV/3TC arm it increased by 0.13 (P = 0.491; P between arms = 0.023). Among subjects with lipoatrophy (baseline FMR ≥ 1.5), adjusted FMR decreased by 0.76 (P = 0.003) in the FTC/TDF arm and increased by 0.21 (P = 0.411; P between arms = 0.009) in the ZDV/3TC arm. Baseline FMR and treatment group were significant predictors (P < 0.05) of post-baseline changes in FMR.