SUSTIVA SUMMARY
SUSTIVA® (efavirenz) is a human immunodeficiency virus type 1 (HIV-1) specific, non-nucleoside, reverse transcriptase inhibitor (NNRTI).
SUSTIVA (efavirenz) in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection. This indication is based on two clinical trials of at least one year duration that demonstrated prolonged suppression of HIV RNA.
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NEWS HIGHLIGHTSMedia Articles Related to Sustiva (Efavirenz)
SUSTIVA® (Efavirenz) Receives US FDA SNDA Approval For Use In HIV-1 Infected Pediatric Patients
Source: HIV / AIDS News From Medical News Today [2013.05.08]
Approval offers a once-daily option as part of a regimen for HIV-1 infected infants as young as three months and weighing at least 3.5 kg. "Capsule sprinkle" administration allows dosing in patients who cannot swallow capsules or tablets. Bristol-Myers Squibb Company have announced that the U.S...
Synthetic Agents Related To Active Ingredient In Marijuana Weaken HIV Infection
Source: HIV / AIDS News From Medical News Today [2013.05.04]
HIV, the virus that causes AIDS, is notorious for hiding within certain types of cells, where it reproduces at a slowed rate and eventually gives rise to chronic inflammation, despite drug therapy...
Baby "Cured" of HIV Infection
Source: MedicineNet Human Immunodeficiency Virus (HIV, AIDS) Specialty [2013.04.03]
Title: Baby "Cured" of HIV Infection
Category: Doctor's & Expert's views on Symptoms
Created: 4/3/2013 6:12:00 PM
Last Editorial Review: 4/3/2013 6:12:53 PM
Everyone Aged 15 To 65 Should Receive HIV Testing, New Guidelines Say
Source: HIV / AIDS News From Medical News Today [2013.04.30]
Clinicians are now recommended to screen all patients aged 15 to 65, and other teens or older adults who are at an elevated risk for HIV infection, according to new guidelines released today. The guidelines were part of the final recommendation statement on screening for HIV by the U.S...
Latest HIV Vaccine Fails In The US, Government Stops Study
Source: HIV / AIDS News From Medical News Today [2013.04.26]
A study testing the latest experimental HIV vaccine has been stopped after an independent review board found that it did not prevent HIV infection and did not decrease the amount of HIV in the blood. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, announced that they will stop giving doses of this experimental vaccine...
Published Studies Related to Sustiva (Efavirenz)
Efficacy and safety of rilpivirine (TMC278) versus efavirenz at 48 weeks in
treatment-naive HIV-1-infected patients: pooled results from the phase 3
double-blind randomized ECHO and THRIVE Trials. [2012]
THRIVE trials comparing rilpivirine (TMC278) and efavirenz... CONCLUSIONS: At week 48, rilpivirine 25 mg once daily and efavirenz 600 mg once
Efficacy and safety of once-daily nevirapine- or efavirenz-based antiretroviral therapy in HIV-associated tuberculosis: a randomized clinical trial. [2011.10]
BACKGROUND: Nevirapine (NVP) can be safely and effectively administered once-daily but has not been assessed in human immunodeficiency virus (HIV)-infected patients with tuberculosis (TB). We studied the safety and efficacy of once-daily NVP, compared with efavirenz (EFV; standard therapy); both drugs were administered in combination with 2 nucleoside reverse-transcriptase inhibitors... CONCLUSIONS: Compared with a regimen of didanosine, lamivudine, and EFV, a regimen of once-daily didanosine, lamivudine, and NVP was inferior and was associated with more frequent virologic failure and death. Clinical Trials Registration. NCT00332306.
Comparative effectiveness of continuing a virologically effective first-line boosted protease inhibitor combination or of switching to a three-drug regimen containing either efavirenz, nevirapine or abacavir. [2011.08]
OBJECTIVES: To compare virological effectiveness in patients who continued on a virologically successful first-line boosted protease inhibitor (PI)-containing combination antiretroviral therapy (cART) regimen or who switched to a PI-free cART including efavirenz, nevirapine or abacavir... CONCLUSIONS: Switching from a virologically successful first-line boosted PI-containing cART regimen to a non-nucleoside reverse transcriptase inhibitor-containing cART regimen containing either efavirenz or nevirapine is virologically safe, while switching to abacavir-containing cART should be avoided.
A randomized cross-over study to compare raltegravir and efavirenz (SWITCH-ER study). [2011.07.31]
CONCLUSION: Half of patients previously on a stable EFV preferred to switch to RAL, after double-blind exposure to RAL for 2 weeks. Substitution of EFV by RAL significantly impacted on lipid levels, stress, and anxiety scores.
Rilpivirine versus efavirenz with tenofovir and emtricitabine in treatment-naive adults infected with HIV-1 (ECHO): a phase 3 randomised double-blind active-controlled trial. [2011.07.16]
BACKGROUND: Efavirenz with tenofovir-disoproxil-fumarate and emtricitabine is a preferred antiretroviral regimen for treatment-naive patients infected with HIV-1. Rilpivirine, a new non-nucleoside reverse transcriptase inhibitor, has shown similar antiviral efficacy to efavirenz in a phase 2b trial with two nucleoside/nucleotide reverse transcriptase inhibitors. We aimed to assess the efficacy, safety, and tolerability of rilpivirine versus efavirenz, each combined with tenofovir-disoproxil-fumarate and emtricitabine... INTERPRETATION: Rilpivirine showed non-inferior efficacy compared with efavirenz, with a higher virological-failure rate, but a more favourable safety and tolerability profile. FUNDING: Tibotec. Copyright (c) 2011 Elsevier Ltd. All rights reserved.
Clinical Trials Related to Sustiva (Efavirenz)
Modification of Doses of Efavirenz According to Its Blood Concentration in HIV Patients [Active, not recruiting]
This is a study on the utility of the modification of doses of efavirenz guided by its plasma
concentration (therapeutic drug monitoring) in HIV-infected patients initiating treatment
with Sustiva.
Sustiva Levels With Use of a Gel Capsule [Recruiting]
We are studying if putting a gel capsule over a standard HIV drug changes the ability of the
body to absorb the drug. This is important because we want to be able to study new HIV drugs
against the most common drugs used today and the most common is Sustiva, which is also
called efavirenz. We will give you Sustiva every day for 5 days and draw blood to see how
much is absorbed. Then we will give you Sustiva that has a gel capsule over it for 5 days
and we will draw blood to see how much is absorbed.
Phase I Pharmacokinetic Interaction Study of Efavirenz and American Ginseng in Healthy Volunteers [Not yet recruiting]
This is a 4-week sequential drug interaction study to measure the effects of American
ginseng on efavirenz pharmacokinetics using steady-state 24-hour AUC and Cmax as the primary
comparison measures in healthy male volunteers. Efavirenz Cmin, T1/2, tmax, and clearance
will also be assessed as secondary outcome measures. This study is a phase I, prospective,
within-subject, fixed-order, two-period, multiple dose, open label, drug interaction study,
to determine the stead-state plasma pharmacokinetic profile of efavirenz before and after
concurrent treatment with American ginseng. The investigators hypothesis is that concurrent
oral administration of American ginseng for up to 14 days will not significantly alter the
steady-state plasma pharmacokinetic of efavirenz.
Efavirenz Comparative Bioavailability [Not yet recruiting]
The primary objective of this study is to determine the average bioequivalence of a generic
efavirenz 600 mg tablet (test formulation)compared with Stocrin(R) 600 mg tablets (Reference
formulation).The study is designed as an open label, randomized, crossover, 2-treatments,
2-period, 2-sequence, single dose pharmacokinetic study conducted in healthy volunteers.
Subjects will be randomized to receive generic efavirenz 600 (Test formulation) or
Stocrin(R) 600 tablets (Reference formulation)on study day 1 (period 1). Subjects will
undergo a 24 hour intensive pharmacokinetic evaluation after ingesting a single dose of
either the Test or Reference formulation. Subjects will provide additional pharmacokinetic
samples 36, 48, 72, 120 and 192 hours postdose, respectively. Subjects will complete a wash
out period from day 8 to day 28 during wich no study drug will be ingested. On day 29
subjects will ingest either the Test or the Reference formulation (opposite to the
formulation received on period 1). All subjects undergo another 24 hour intensive
pharmacokinetic evaluation and pharmacokinetics samples on days 36, 48, 72, 120, 192 pos
dose, respectively. Adverse events and and concomitant medication will be documented
throughout the study.
PK Switch Efavirenz to Maraviroc in Patients Initially Suppressed on an Efavirenz-containing Regimen [Recruiting]
The purpose of the study aims is to help determine whether it is safe to change directly
from efavirenz to maraviroc in patients who are stable on an efavirenz-containing regimen.
The pharmacokinetics (drug levels) of efavirenz and maraviroc when efavirenz is stopped and
maraviroc is started will be assessed.
Both the study patients and the study team will know which treatment is being taken at all
times in the study.
Reports of Suspected Sustiva (Efavirenz) Side Effects
Polyhydramnios (9),
Lipodystrophy Acquired (8),
Rash (7),
Nervous System Disorder (7),
Tubulointerstitial Nephritis (6),
Foetal Exposure During Pregnancy (6),
Cholestasis (6),
Glomerulonephritis Membranous (6),
Polyneuropathy (6),
Adverse Event (6), more >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 1 ratings/reviews, Sustiva has an overall score of 1. The effectiveness score is 8 and the side effect score is 2. The scores are on ten point scale: 10 - best, 1 - worst.
| | Sustiva review by 45 year old male patient | | | Rating |
| Overall rating: | |   |
| Effectiveness: | | Considerably Effective |
| Side effects: | | Extremely Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | HIV |
| Dosage & duration: | | 600mg taken 1xday for the period of 1 month |
| Other conditions: | | None |
| Other drugs taken: | | Abacavir epivir tenofovir | | |
Reported Results |
| Benefits: | | Lowered viral load and increased t cell count. Also a benefit was the once a day dosing. |
| Side effects: | | Hallucinations and disturbing dreams. These effects were supposed to be temporary and only last a couple of weeks. I was still experiencing them after a month. The whole experience was extremely disturbing. |
| Comments: | | Taken as directed (once a day at night) resulted in nightmarish dreams and waking hallucinations. |
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Page last updated: 2013-05-08
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