The HIV Prevention Pill: A Free Webcast on July 29, 6:30 PM (EDT)

The HIV Prevention Pill: A Free Webcast on July 29, 6:30 PM (EDT)

Activists and educators Damon Jacobs and Nelson Vergel will answer questions about the use of Truvada for HIV Pre-Exposure Prophylaxis (PrEP) covering research facts, misconceptions and access of this highly effective prevention tool. This webcast is of interest to the lay person and clinicians. Please RSVP by clicking "Yes" under "Are you going?" on this Google hangout page:

https://plus.google.com/events/c64qqi8hb0c6j05b1s93r5r5mtc

For those who cannot attend the live event, it will be posted on youtube when it concludes.

Damon L. Jacobs is a New York-based Licensed Marriage and Family Therapist and HIV prevention specialist who focuses his work on health, love, and pleasure. He is  the author of the books RATIONAL RELATING and ABSOLUTELY SHOULD-LESS.

He is best known for championing the use of HIV pre-exposure prophylaxis (PrEP) through his work on social media, news print, broadcast TV appearances, is featured as one of 35 “Leading HIV Activists” by The Advocate Magazine, and one of the Ten “Most Captivating Voices of 2014” by HIV Equal. His trainings have helped thousands learn practical skills for successfully implementing PrEP and increasing adherence.

Nelson Vergel is a chemical engineer who, by his own necessity, has become a leading advocate in the past 30 years for sports nutrition, supplementation, hormone and therapies, and the promotion of wellness for people regardless of HIV status. His HIV activism work at the FDA, NIH and industry advisory groups has brought progress in the areas of metabolic disorders, salvage therapies and drug development in HIV.

He is the author of "Testosterone: A Man's Guide" and co-author of the book "Built to Survive"; the founder of the nonprofit organizations Body Positive Wellness Clinic and Program for Wellness Restoration; the Nutrition and Exercise forum expert at TheBody.com; and an international speaker on health and wellness. His latest project, ExcelMale.com, provides a trusted exchange platform for men's health in a moderated environment.

Impaired sperm motility in HIV-infected men: an unexpected adverse effect of efavirenz?

Impaired sperm motility in HIV-infected men: an unexpected adverse effect of efavirenz?

Frapsauce C, et al. Hum Reprod. 2015.

Authors

Frapsauce C1, Grabar S2, Leruez-Ville M3, Launay O4, Sogni P5, Gayet V6, Viard JP7, De Almeida M8, Jouannet P8, Dulioust E1.

Author information

• ¹Laboratoire de Biologie de la Reproduction, Hôpital Broca-Cochin-Hôtel Dieu, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, France emmanuel.dulioust@cch.aphp.fr cynthia.frapsauce@gmail.com.
• ²Service de Biostatistiques et Epidémiologie, Hôpital Broca-Cochin-Hôtel Dieu, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, France.
• ³Laboratoire de Virologie, Hôpital Necker-Enfants Malades, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, France.
• ⁴Service de Médecine Interne - CIC de Vaccinologie Cochin-Pasteur, Hôpital Broca-Cochin-Hôtel Dieu, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, France.
• ⁵Hépatologie, Hôpital Broca-Cochin-Hôtel Dieu, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, France.
• ⁶Service d'Obstétrique, Gynécologie et Médecine de la Reproduction, Hôpital Broca-Cochin-Hôtel Dieu, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, France.
• ⁷Centre de Diagnostic et de Thérapeutique, Hôpital Broca-Cochin-Hôtel Dieu, Assistance Publique-Hôpitaux de Paris, EA 7327, Université Paris Descartes, Sorbonne Paris Cité, Paris, France.
• ⁸Laboratoire de Biologie de la Reproduction, Hôpital Broca-Cochin-Hôtel Dieu, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, France.

Citation

Hum Reprod. 2015 Jun 16. pii: dev141. [Epub ahead of print]

Abstract

STUDY QUESTION: Are antiretroviral therapies associated with semen alterations in HIV-infected men?

SUMMARY ANSWER: Antiretroviral regimens that included the non-nucleosidic reverse transcriptase inhibitor efavirenz were associated with a significant impairment of sperm motility, whereas regimens without efavirenz were not associated with significant semen changes.

WHAT IS KNOWN ALREADY: Semen alterations including decreased ejaculate volume and sperm motility have been reported in HIV-infected men. The hypothesis ascribing reduced sperm motility to damages induced in sperm mitochondria by nucleosidic (or nucleotidic) reverse transcriptase inhibitors (NRTIs) has not been confirmed in HIV-infected patients and the effects of antiretroviral treatments on semen parameters remain unclear.

STUDY DESIGN, SIZE, DURATION: This case-control study compared semen characteristics across 378 HIV-1 infected patients receiving different antiretroviral regimens or never treated by antiretroviral drugs, in whom an initial semen analysis was done between 2001 and 2007.

PARTICIPANTS/MATERIALS, SETTING, METHODS: The patients were partners from serodiscordant couples requesting medical assistance to procreate safely. Their status with regard to antiretroviral therapy at the time of semen analysis was categorized as follows: 1/ never treated patients (n = 66); 2/ patients receiving NRTIs only (n = 49); 3/ patients receiving a NRTIs + protease inhibitor (PI) regimen (n = 144); 4/ patients receiving a NRTIs + non-nucleosidic reverse transcriptase inhibitor (NNRTI) regimen (n = 119). Semen parameters were assessed through standard semen analysis. Additional analyses included measurement of sperm motion parameters using computer-assisted semen analysis, seminal bacteriological analysis, seminal biochemical markers and testosterone plasmatic levels. All analyses were performed in the Cochin academic hospital. The data were analyzed through multivariate analysis.

MAIN RESULTS AND THE ROLE OF CHANCE: Sperm motility was the only semen parameter which significantly varied according to treatment status. The median percentage of rapid spermatozoa was 5% in the group of patients receiving a regimen including efavirenz versus 20% in the other groups (P < 0.0001). Accordingly, sperm velocity was reduced by about 30% in this group (P < 0.0001). The role of chance was minimized by the strict definition and the size of the study population, which included a large enough group of never treated patients, the controlled conditions of semen collection and analysis, the multivariate analysis, the specificity and the high significance level of the observed differences.

LIMITATIONS, REASONS FOR CAUTION: The design of the study did not allow demonstrating a causal link between exposure to efavirenz and sperm motility.

WIDER IMPLICATIONS OF THE FINDINGS: As efavirenz is widely used in current antiretroviral therapy, these findings may concern many HIV-infected men wishing to have children. This justifies further assessment of the consequences on fertility of the exposure to efavirenz. Moreover, the possibility of common cellular impacts underlying adverse effects of efavirenz in sperm cells and neurons deserved investigation.

STUDY FUNDING/COMPETING INTERESTS: No external funding was used for this study. None of the authors has any conflict of interest to declare.

HIV Activist Raises Hope and Warnings in New Attachment Inhibitor Trial.

Video: HIV Activist Raises Hope and Warnings in New Attachment Inhibitor Trial.



Leading HIV activist Nelson Vergel raises hopes but also warns HIV salvage patients and their physicians about functional monotherapy risks in the Bristol-Meyers Squibb (BMS) new attachment inhibitor study (Fostemsavir, BMS-663068) currently enrolling (2015-2016). This innovative drug, along with Taimed's ibalizumab, can be the last hope for HIV+ patients who have no remaining treatment options. However, like any HIV drug, you have to combine with at least one more medication that can control your virus. If your doctor has told you that you have no more HIV medications left to bring your HIV viral load to undetectable, please email powertx@aol.com
More information on www.SalvageTherapies.org and http://www.thebody.com/Forums/AIDS/Nu...

BMS attachment inhibitor: https://clinicaltrials.gov/ct2/show/N...

Starting HIV Medications Within First Weeks of Infection Decreases Hidden Virus

1. Clin Infect Dis. (2015) doi: 10.1093/cid/civ171First published online: March 3, 2015

Impact of the Earliness of Antiretroviral Therapy Initiation During Primary HIV-1 Infection on the Decay of Cell-Associated HIV-DNA

Moussa Laanani1,2,

1Inserm, CESP Centre for Research in Epidemiology and Population Health, U1018, Paris-Sud University, Le Kremlin-Bicêtre, France

2APHP, Department of Epidemiology and Public Health, Bicêtre Hospital, Le Kremlin-Bicêtre, France

Abstract

Background. Combined antiretroviral therapy (cART) initiation during primary HIV infection (PHI) yields larger decrease in cell-associated HIV-DNA (CA-HIV-DNA) than initiation during the chronic phase. Our objective was to model the short and long-term decay of CA-HIV-DNA blood reservoir in patients initiating cART during PHI and to assess the impact of the earliness of cART initiation on CA-HIV-DNA decay.

Methods. We included patients enrolled during PHI in the ANRS PRIMO cohort, treated within the month following enrollment and achieving sustained virological response. The decay of CA-HIV-DNA over time while on successful cART was modeled with a 3-slope linear mixed-effects model according to the delay between estimated date of infection and cART initiation.

Results. 327 patients were included, accounting for 1,305 CA-HIV-DNA quantifications. Median time between infection and cART initiation was 41 days (IQR: 33-54). Median follow-up under cART was 2.3 years (range: 0.4-16.6). The earliness of cART initiation had significant impact on the first slope of decrease: the earlier cART was initiated after HIV infection, the faster CA-HIV-DNA level decreased during the first 8 months of cART: -0.171, -0.131, and -0.068 log10 copies/106 PBMC/month when cART was initiated 15 days, 1 month and 3 months after infection, respectively.

Conclusions. This study provides strong arguments in favor of cART initiation at the earliest possible time point after HIV infection.

Most Important HIV Research Reports from CROI 2015

From Jules Levin: perhaps the biggest stories out of CROI from my perspective are the development of 2 new HIV therapies - the new attachment inhibitor & the new maturation inhibitors, as well as the safety & efficacy of TAF, and an important message out of CROI is that TAF can also be used in HCV coinfected patients as a replacement for TDF in their ART regimen which will likely provide key safety improvements. Equally important are the HCV coinfection study results from Harvoni, daclatasvir+sofosbuvir, and Abbvie’s 3D Viekira Pak, and at CROI are a number of presentations on use of simeprevir+sofosbuvir as this therapy was the most potent HCV therapy available in 2014. Merck is in phase 3 with their 2 HCV drug regimen and developing a triple drug regimen with the study of the 2-drug regimen in combination with the nuke they acquired from Idenix. J&J is studying the nukes they acquired from Alios, they have GSK’s NS5A inhibitor, and they have a non-nuke polymerase in-house as well as simeprevir. Abbvie & Merck reported 2nd/3rd generation drugs at AASLD in pre & early clinical - protease, NS5A. Achillion reported high SVR rates in their early clinical studies with their potent nuke, potent NS5A & they have 2 protease inhibitors. Aging & comorbidities were a focus at CROI as well, particularly noteworthy is the research from the Mass General group reported again that subclinical heart disease is ever present in HIV+, that it can results in plaque buildup, particularly of note in HIV+ it results in non calcified plaque buildup which can rupture; they reported Atorvastatin reduced coronary artery noncalcified plaque and that plaque buildup is associated with a leaky gut, microbial translocation. Statins got quite a bit of attention with several reports including one from Grace McComsey that Rosuvaststin arrests progression of carotid intima media thickness in HIV+. Ken Lichtenstein reported the 4 heart disease algorithms underestimate risk for heart disease in HIV+ based on the SUN cohort. Bone disease is highlighted as well with Michael Yin reported modified FRAX underestimates risk for fractures among HIV+, and from HIV+ WIHS women experienced increased risk for fracture. Bigger font titles below indicate key reports, more NATAP reports coming including 9 specialized topical reports by expert researchers. Gilead has introduced a new HIV “cure” drug that appears to induce HIV reservoirs, TLR7, this immune based drug has been in ongoing research for several years at Gilead to treat HBV.

22nd Conference on Retroviruses and Opportunistic InfectionsSeattle WashingtonFeb 23 - 26, 2015

CROI Big Stories: new HIV ARTs attachment & maturation inhibitors; new HCV drugs study results in HIV/HCV coinfected - Harvoni, daclatasvir+sofosbuvir, Abbvie 3D - (Ombitasvir, Paritaprevir Co-dosed With Ritonavir, Dasabuvir, and Ribavirin ) - written by Mark Mascolini - (03/02/15) 

 Preventing one HIV infection in US saves $229,800 in modeling analysis - written by Mark Mascolini - (03/02/15) 

 Linkage to HIV care and viral suppression climb steadily in New York City - improvements to 76%, 73% - written by Mark Mascolini - (03/02/15) 

More time with high viral load, high VACS index, predicts MI in veterans HIV cohort, as well as time-updated viral load & CD4 - written by Mark Mascolini - (03/02/15)  

TAF noninferior to TDF through 48 weeks in elvitegravir combination - written by Mark Mascolini - (03/02/15) 

 Atorvastatin for 1 year trims coronary artery plaque volume and number in placebo trial - written by Mark Mascolini - (03/02/15) 

Varenicline (Chantix) helps French with HIV quit smoking in 48-week placebo trial - written by Mark Mascolini - (03/02/15) 

Modified FRAX tool underestimates fracture rates in older men with HIV - written by Mark Mascolini - (03/02/15) 

TAF easier on kidney and bone signals than TDF in 48-week trials - written by Mark Mascolini - (03/02/15) 

Impact of Specific Antiretroviral Drugs on Non-AIDS Mortality; the D:A:D Study - - written by Mark Mascolini - (03/02/15) 

Smoking and heavy drinking tied to atherosclerosis in MACS men with HIV - written by Mark Mascolini - (03/02/15) 

SVR12 in over 90% of HCV/HIV null responders stating daclatasvir/asunaprevir plus PR - written by Mark Mascolini - (03/02/15) 

Cardiovascular Disease Risk Prediction in the HIV Outpatient Study (HOPS)..... "Among participants with any length of follow-up, the four risk prediction equations underestimated the 10-year risk of CVD" - (03/02/15)

 High cancer risk among the HIV-infected elderly in the United States - (03/02/15) 

HIGH SVR REGARDLESS OF TIME TO SUPPRESSION WITH OMBITASVIR/PARITAPREVIR/R & DASABUVIR + RBV - (03/02/15) 

Fracture incidence is increased in aging HIV-infected women (WIHS) - (03/02/15) 

Cardiovascular Disease in HIV Patients: An Emerging Paradigm and Call to Action - (03/02/15) 

Statin Therapy Reduces Coronary Noncalcified Plaque Volume in HIV-infected Patients: a Randomized Controlled Trial - (03/02/15) 

Calcified Plaque Burden is Associated with Serum Gut Microbiota-Generated Trimethylamine in HIV - (03/02/15) 

Anal high-risk human papillomavirus (HPV) infection among HIV-infected MSM in the SUN Study, 2004-2011 - (03/02/15) 

Daclatasvir in Combination With Sofosbuvir for HIV/HCV Coinfection: ALLY-2 Study - (02/27/15) 

Exposure to antiretrovirals and development of chronic kidney disease - D:A:D Study Group - written by Mark Mascolini - (02/27/15) 

Fat and lean mass changes similar with raltegravir and PIs in ACTG analysis - written by Mark Mascolini - (02/27/15) 

Rosuvastatin halts carotid artery wall thickening in placebo-controlled trial - written by Mark Mascolini - (02/27/15) 

Do gut flora play key role in cardiovascular disease with HIV? - written by Mark Mascolini - (02/27/15) 

Lower CD4 count, higher viral load tied to primary MIs in NA-ACCORD - written by Mark Mascolini - (02/27/15) T

AF easier on kidney and bone signals than TDF in 48-week trials - written by Mark Mascolini - (02/27/15) 

Earlier ART in primary infection leads to bigger drop in cellular HIV DNA - written by Mark Mascolini - (02/27/15) 

Attachment Inhibitor Prodrug BMS-663068 in Antiretroviral-Experienced Subjects: Week 48 Analysis - (02/27/15) 

Treatment with a TLR7 Agonist Induces Transient Viremia in SIV-Infected ART-Suppressed Monkeys - (02/27/15) 

TLR7 Agonist GS-9620 Activates HIV-1 in PBMCs from HIV-Infected Patients on cART - (02/26/15) 

BMS-955176: Antiviral Activity and Safety of a Second-Generation HIV-1 Maturation Inhibitor - (02/27/15) Renal and Bone Safety of Tenofovir Alafenamide vs Tenofovir Disoproxil Fumarate - (02/27/15) 

Ledipasvir/sofosbuvir for 12 Weeks in Patients Coinfected With HCV and hiv-1: ION-4- (02/27/15)

 Renal and Bone Safety of Tenofovir Alafenamide vs Tenofovir Disoproxil Fumarate - (02/27/15) 

GILEAD ANNOUNCES SVR12 RATES FROM PHASE 3 STUDY EVALUATING HARVONI® FOR THE TREATMENT OF CHRONIC HEPATITIS C IN PATIENTS CO-INFECTED WITH HIV - (02/27/15) 

Study of Next-Generation Investigational HIV-1 Maturation Inhibitor Shows Positive Results in Preventing Viral Replication via Different Mechanism of Action Than Current Therapies - (02/27/15) 

HIGH SVR REGARDLESS OF TIME TO SUPPRESSION WITH OMBITASVIR/PARITAPREVIR/R & DASABUVIR + RBV - (02/27/15) 

Gilead Announces Phase 3 Results for Investigational Once-Daily Single Tablet HIV Regimen Containing Tenofovir Alafenamide (TAF) - (02/27/15) S

afety of Tenofovir Alafenamide in Renal Impairment - (02/27/15)

 Tenofovir Alafenamide (TAF) in a Single-Tablet Regimen in Initial HIV-1 Therapy - (02/26/15) 

HIV-1 Attachment Inhibitor Prodrug BMS-663068: Pharmacokinetics, Pharmacodynamics and Model-Based Dose Selection - (02/26/15) 

HIV-1 Attachment Inhibitor Prodrug BMS-663068: Interactions with DRV/r and/or ETR - (02/26/15) 

Little or no DNA reservoir draining with chemo plus autologous stem-cell transplant - written by Mark Mascolini - (02/26/15) 

Size of active HIV reservoir predicts rebound when antiretroviral therapy stops - written by Mark Mascolini - (02/26/15) 

Viral load above 1500 copies 23% of time in CDC study of 6 clinics - written by Mark Mascolini - (02/26/15) 

Levonorgestrel contraception fails in 15% of women taking efavirenz - written by Mark Mascolini - (02/26/15) 

NCI sees "sizeable absolute risk" of cancer in elderly with HIV - written by Mark Mascolini - (02/26/15) 

Lower CD4 count, higher viral load tied to primary MIs in NA-ACCORD - written by Mark Mascolini - (02/26/15) 

Almost half of US women with HIV not in regular care in CDC analysis - written by Mark Mascolini - (02/26/15) 

Little or no DNA reservoir draining with chemo plus autologous stem-cell transplant - written by Mark Mascolini - (02/26/15) 

Drug Interactions Between the anti-HCV Regimen Ledipasvir/Sofosbuvir and Ritonavir Boosted Protease Inhibitors plus Emtricitabine/Tenofovir DF- (02/23/15) 

HCV recurrence after SVR 20 times more frequent with HIV/HCV than HCV alone - written by Mark Mascolini - (02/23/15) 

As-Needed PrEP Cuts HIV Rate 86% in French-Canadian Ipergay Trial - written by Mark Mascolini - (02/23/15) 

Pre-Exposure Prophylaxis for HIV Prevention: What we know and What we still need to know for implementation - (02/23/15) 

Daily TDF/FTC PrEP Provides 86% Protection From HIV in Gay British Men - written by Mark Mascolini - (02/23/15) 

PrEP plus ART yields "near elimination" of HIV in Partners cohort - written by Mark Mascolini - (02/23/15) 

Wider PrEP Use in San Francisco Could Cut New HIV Rate by 70% - written by Mark Mascolini - (02/23/15) 

As-Needed PrEP Cuts HIV Rate 86% in French-Canadian Ipergay Trial - full slide presentation below - written by Mark Mascolini - (02/23/15) 

Early ART, continuous suppression, tied to lower HIV DNA in CHER trial children - written by Mark Mascolini - (02/23/15) 

Poor kidney function predicts neurocognitive decline with undetectable viral load - written by Mark Mascolini - (02/23/15) 

Doubled risk of virologic failure with 3TC vs FTC in Dutch cohort analysis - written by Mark Mascolini - (02/23/15)

 Anal cancer diagnosed earlier in HIV+ men, but cancer-specific survival similar to HIV- men - written by Mark Mascolini - (02/23/15) 

Poor balance confidence--not physical function--predicts falls in older men with HIV - written by Mark Mascolini - (02/23/15) 

Extensive cervical lesions common in HIV-positive women screened for ACTG trial - written by Mark Mascolini - (02/23/15)

Prezcobix and Evotaz: Two New HIV Fixed Dose Combinations Approved this Week

January 29, 2015

Janssen Therapeutics, Division of Janssen Products, LP (Janssen), today announced the U.S. Food and Drug Administration (FDA) has approved PREZCOBIX™ (darunavir 800 mg/cobicistat 150 mg) tablets, an HIV-1 protease inhibitor combined with a CYP3A4 inhibitor, for the treatment of human immunodeficiency virus (HIV-1) in combination with other antiretroviral agents for treatment-naive and treatment-experienced adults with no darunavir resistance-associated substitutions.

PREZCOBIX™ is a once-daily, fixed-dose antiretroviral combination tablet containing 800 mg of darunavir, marketed as PREZISTA® in the United States, and 150 mg of cobicistat, a pharmacokinetic enhancer or "boosting" agent, developed and marketed as Tybost by Gilead Sciences, Inc., taken orally with other HIV-1 medications and with food.

Bristol-Myers Squibb Company  announced today that the U.S. Food and Drug Administration (FDA) has approved Evotaz (atazanavir 300 mg and cobicistat 150 mg) tablets in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. Evotaz is coformulated to be one pill, once-daily, combining the protease inhibitor atazanavir, which is marketed as Reyataz (atazanavir 200 mg/300 mg) capsules, and cobicistat, a pharmacokinetic enhancer marketed by Gilead Sciences, Inc. Today’s approval offers patients living with HIV an innovative treatment option that delivers proven suppression of HIV replication.

Cost Effectiveness of Current HIV Cure Approaches

• Published: November 14, 2014
• DOI: 10.1371/journal.pone.0113031

Abstract

Background

We examined efficacy, toxicity, relapse, cost, and quality-of-life thresholds of hypothetical HIV cure interventions that would make them cost-effective compared to life-long antiretroviral therapy (ART).

Methods

We used a computer simulation model to assess three HIV cure strategies: Gene Therapy, Chemotherapy, and Stem Cell Transplantation (SCT), each compared to ART. Efficacy and cost parameters were varied widely in sensitivity analysis. Outcomes included quality-adjusted life expectancy, lifetime cost, and cost-effectiveness in dollars/quality-adjusted life year ($/QALY) gained. Strategies were deemed cost-effective with incremental cost-effectiveness ratios <$100,000/QALY.

Results

For patients on ART, discounted quality-adjusted life expectancy was 16.4 years and lifetime costs were $591,400. Gene Therapy was cost-effective with efficacy of 10%, relapse rate 0.5%/month, and cost $54,000. Chemotherapy was cost-effective with efficacy of 88%, relapse rate 0.5%/month, and cost $12,400/month for 24 months. At $150,000/procedure, SCT was cost-effective with efficacy of 79% and relapse rate 0.5%/month. Moderate efficacy increases and cost reductions made Gene Therapy cost-saving, but substantial efficacy/cost changes were needed to make Chemotherapy or SCT cost-saving.

Conclusions

Depending on efficacy, relapse rate, and cost, cure strategies could be cost-effective compared to current ART and potentially cost-saving. These results may help provide performance targets for developing cure strategies for HIV.

Full paper:
http://www.plosone.org/article/info:doi/10.1371/journal.pone.0113031