Bisher AKIL, MD

Archive for the ‘HIV’ Category

Generic Nevirapine is here!

In HIV on May 31, 2012 at 7:15 pm

The FDA approved Nevirapine tablets of 200 mg strength and Nevirapine oral suspension of 50 mg/5 ml strength .  Companies plans to launch the generic equivalent of Boehringer Ingelheim Pharmaceutical’s Viramune tablets and oral suspension, in the same strengths, in the US market shortly. A total of ten companies received approvals, and the medication is now available in pharmacies from some of those companies.

Comments: The generic viramune (nevirapine) is a twice a day pill _ the Viramune XR (once a day 400 mg tablet) remains brand (non-generic). BA

Transmission of HIV-1 Infection could be prevented with Early Antiretroviral Therapy

In HIV on July 20, 2011 at 12:49 am

A study published online by the New England Journal of Medicine , enrolled 1763 couples in which one partner was HIV-1–positive and the other was HIV-1–negative; 54% of the subjects were from Africa, and 50% of infected partners were men. HIV-1–infected subjects with CD4 counts between 350 and 550 cells per cubic millimeter were randomly assigned in a 1:1 ratio to receive antiretroviral therapy either immediately (early therapy at the time of enrollment in this study – median CD4 was 442 cells/ml3) or after a decline in the CD4 count or the onset of HIV-1–related symptoms (delayed therapy when CD4 counts were below 250 cells/ml3). Results: As of February 21, 2011, a total of 39 HIV-1 transmissions were observed (incidence rate, 1.2 per 100 person-years; 95% confidence interval [CI], 0.9 to 1.7); of these, 28 were virologically linked to the infected partner (incidence rate, 0.9 per 100 person-years, 95% CI, 0.6 to 1.3). Of the 28 linked transmissions, only 1 occurred in the earlytherapy group (hazard ratio, 0.04; 95% CI, 0.01 to 0.27; P<0.001). Authors conclusion: The early initiation of antiretroviral therapy reduced rates of sexual transmission of HIV-1 and clinical events, indicating both personal and public health benefits from such therapy [ This article (10.1056/NEJMoa1105243) was published on July 18, 2011, at NEJM.org.]. Comment: this, with previously published studies, are strong evidence for early treatment, decreased transmission between discordant couple and controlled HIV replication _ I believe this is much more useful data that pre-exposure prophylaxis data, where we treat the healthy! BA

AIDS Vaccine that works?

In HIV on September 29, 2009 at 12:34 am

or the first time ever, an investigational vaccine regimen has shown some efficacy, albeit modest, in preventing HIV acquisition. The prime-boost regimen involves a combination of two previously tested vaccines — ALVAC-HIV and AIDSVAX B/E — that were designed to protect against clades B and E. ALVAC-HIV consists of three genetically engineered HIV genes (env, gag, and pro) and a live-canarypox vector, whereas AIDSVAX B/E consists of genetically engineered gp120. The regimen was tested in a phase III trial in Thailand among more than 16,000 adults aged 18 to 30 at average risk for HIV infection. Half received two doses of ALVAC-HIV alone, followed by two doses of both ALVAC-HIV and AIDSVAX B/E, over a 6-month period; the other half received placebos. For the next 3 years, all participants underwent HIV testing and behavioral counseling every 6 months.During follow-up, 51 of the 8197 people in the vaccine group acquired HIV infection, compared with 74 of the 8198 in the placebo group. The difference — which represents an absolute reduction of 0.3% and a relative reduction of 31% — was statistically significant. Vaccination did not appear to reduce viral load among those who became infected. The vaccine regimen was safe and well tolerated, and there was no evidence that participants increased high-risk behavior during the trial. Source: Journal Watch, 9/28/2009. Ref: McNeil DG Jr. For first time, AIDS vaccine shows some success.New York Times . Sep 24 , 2009. (http://www.nytimes.com/2009/09/25/health/research/25aids.html) & HIV vaccine study first to show some effectiveness in preventing HIV [press release]. Rockville, MD: U.S. Military HIV Research Program; Sep 24 , 2009. (https://www01.hjf.org/apps/internet/hivnewscenter.nsf/phase3pressrelease) & U.S. Military HIV Research Program. FAQs: Frequently asked questions regarding the RV144 phase III HIV vaccine trial. Sep 24 , 2009.https://www01.hjf.org/apps/internet/hivnewscenter.nsf/phase3resources/$FILE/RV144-FAQs-20090924.pdf). Comments: A great early and promising step although the information we have so far is scarse and not from peer-reviewed journal or even a medical conference. I think we should withhold judgement until information are made available for scrutiny. BA

HIV infection, inflammation and heart disease

In Heart, HIV on May 20, 2009 at 5:22 pm

Growing evidence suggests that the risk for atherosclerosis is higher among HIV-infected individuals than among HIV-negative persons; potential explanations include deleterious effects of antiretroviral therapy (ART), virus-induced endothelial injury, and chronic inflammation. To examine the role of these factors, investigators studied carotid intima-media thickness (IMT; a measure of atherosclerosis) and C-reactive protein (CRP; a marker for systemic inflammation) levels in HIV elite controllers (infected patients who maintain undetectable viral loads without taking ART), untreated HIV-infected patients, HIV-infected patients on ART, and HIV-negative controls (total, 494 participants). The median carotid IMT was significantly higher in HIV-infected patients than in HIV-negative individuals, even after adjustment for cardiovascular risk factors. The median carotid IMT in elite controllers was significantly higher than that in HIV-negative individuals and was similar to that in untreated HIV-infected patients. The median CRP level was significantly higher in HIV-infected patients, including controllers, than in HIV-negative patients. Published in Journal Watch. Hsue PY et al. Role of viral replication, antiretroviral therapy, and immunodeficiency in HIV-associated atherosclerosis. AIDS 2009 Apr 22. Comments: these data and others seems to suggest that HIV infection by itself , not medications, cause inflammation maybe due to viral replication (with and without treatment for HIV); this inflammation can lead to atherosclerosis and heart disease. People with HIV infection should be screened for heart disease early and aggressively _BA

C-Reactive Protein (CRP) and Heart Disease in HIV

In Heart, HIV on May 14, 2009 at 7:26 pm

Inflammation is suspected to contribute to increased risk for both AIDS- and non–AIDS-related outcomes in HIV-positive patients. To evaluate how HIV infection and elevated C-reactive protein (CRP) levels each influence risk for acute myocardial infarction (MI), investigators reviewed data from a large patient registry in Massachusetts. Analysis included 487 HIV-infected patients and 69,870 HIV-uninfected patients, all of whom had CRP data available from between 1997 and 2006. Patients who had an MI were eligible for analysis only if their most recent CRP level was obtained 3 years to 1 week before the MI. In a univariate analysis, HIV infection and elevated CRP levels were each significantly associated with increased risk for acute MI (odds ratios, 2.1 and 2.5, respectively). In a model adjusted for age, sex, race, hypertension, diabetes, and dyslipidemia, both of these associations remained significant (ORs, 1.9 and 2.1, respectively). HIV-infected patients with elevated CRP levels were four times more likely to have an acute MI than HIV-uninfected patients with normal CRP levels. Overall, these findings suggest that CRP levels might help predict MI risk in HIV-positive patients. Published in Journal Watch and original paper: Triant VA et al. Association of C-reactive protein and HIV infection with acute myocardial infarction. J Acquir Immune Defic Syndr2009 Apr 21. Comments: There is a bias in this trial, since only patients with CRP levels were included. To better evaluate the role of CRP and other inflammatory markers, a study of all comers is more useful. In the meantime, this is something to watch _ BA

One tablet or more?

In HIV on May 14, 2009 at 7:15 pm

Many patients have heard about the one-a-day treatment for HIV, and wondered if they could switch to  it. To answer that, here is a 48-week, multicenter, open-label trial, 306 patients who had viral loads <200 copies/mL on stable PI- or NNRTI-based ART were randomized to either stay on their baseline regimen or simplify to once-daily efavirenz/tenofovir/FTC (Atripla). Per study protocol, all patients were either receiving their first ART regimen or had documented virologic suppression on a PI-based regimen before switching to their baseline regimen. Study participants were primarily young, healthy men who had demonstrated ≥96% adherence to ART (median duration, 3 years; 53% PI based). Several members of the research team were employees of the makers of efavirenz/tenofovir/FTC.

Treatment simplification was noninferior to treatment continuation, with 89% and 88% of each group, respectively, maintaining viral loads <200 copies/mL at 48 weeks. Similar results were seen with a more stringent threshold for virologic suppression (<50 copies/mL) and in analyses stratified by baseline treatment regimen (PI based vs. NNRTI based). Discontinuation rates were similar between the treatment arms. The most common reasons for discontinuation were adverse effects in the simplification group (5%; primarily nervous system or psychiatric symptoms in patients previously treated with PIs) and withdrawal of consent in the continuation group (7%).

Adherence rates remained high in both groups throughout the study. Not surprisingly, patients randomized to simplification preferred the new regimen and reported improvements in quality of life, as well as in symptoms related to HIV treatment, such as diarrhea, abdominal bloating, body image, and sexual dysfunction. Published in Journal Watch. Original article: DeJesus E et al. Simplification of antiretroviral therapy to a single-tablet regimen consisting of efavirenz, emtricitabine, and tenofovir disoproxil fumarate versus unmodified antiretroviral therapy in virologically suppressed HIV-1–infected patientsJ Acquir Immune Defic Syndr 2009 Apr 7;

Comments: Although we have over 23 different medications to treat HIV, the number of combination are in fact much less than that. A change of a regimen is usually advised when the regimen fails, or the patient is not compliant with the treatment and there is a concern about that regimen failing. In this study, neither situation exists. This is mainly a post marketing study sponsored by a company who wishes many more people would take their drug over their existing and functioning regimen. BA