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Prevention at IAS: (1) PrEP / (2) EARLY ART START Study - (3) Early ART (TaSP - Study HPTN052 in serodiscordant couples - Treatment as Prevention to prevent sexual transmission)
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from Jules: PrEP or prevention was perhaps the #1 story out of IAS 2015 in Vancouver. The final result official conference presentations on HPTN052 highlighted that early ART in serodiscordant couples can prevent HIV sex transmission, were major highlight of the conference, presented by Myron Cohen, and data on characterization of infections by Susan Eshlemen. The presentation by Jens Lundgren on the START Study was also a major highlight at IAS, that "ART should be started for everyone regardless of CD4". This has been in place in the US DHHS Guidelines for several years - based on a conglomeration of studies [but the START Study confirms this based on their prospective study] - for several reasons including of note that early ART plays an important role in repairing & restoring the HIV-damaged immune system & thus early ART having a major beneficial benefit to help in preventing comorbidities - ART (suppressing HIV & increasing CD4s) suppresses not just viral load but also inflammation & immune activation which plays a key role in the onset of comorbidities (Bone, Heart, kidney, Cancer, Brain/neurologic/cognitive function etc diseases). Now, there are many factors involved in the problem - that HIV+ individuals are often experiencing earlier onset of comorbidities & they occur more often compared to HIV-negatives - and relevant factors include nadir CD4, genes/family history, exercise/diet and of lifestyle including history of substance abuse which can have a negative affect. But early ART & its full suppression of HIV viral load & maximizing the CD4 increase are perhaps the MOST important in repairing the HIV-damaged immune system & having the best affect possible on the potential onset for comorbidities. Of course also important at IAS were the 5-6 presentations on new HIV drugs which of note included the new BMS attachment inhibitor (in Phase 3 now) & the new BMS maturation inhibitor, both new classes of drugs that are to be useful for patients with drug resistance who have gone through other classes of drugs & need a new effective drug to suppress viral load to undetectable, and there was a presentation on the new Merck NNRTI (in phase 3 now) which is potent, more tolerable, and in vitro effective against NNRTI resistance mutations to be tested in patients. there also was a summary report on Dolutegravir studies. The WAVES Study was presented comparing in women who were treatment naive Stribild (elvitegravir/cobi/FTC/tenofovir) to Reyataz+FTC/TDF. ALSO, 2 important TAF studies were presented, the largest switch study of patients switching from tenofovir to TAF, which found continued suppression of viral load and improved renal & bone function. TAF is expected to be FDA approved by the end of 2015. A second TAF study in patients with renal impairment who switched from tenofovir to TAF, they found improvements in renal & bone markers. Also of note was a key constellation of studies of the new HCV DAAs in coinfected including Harvoni ION-4 Study, Abbvie 3D, daclatasvir+sofosbuvir - The French Cohort Update - (this coincided with FDA approval of daclatasvir+sofosbuvir for genotype 3), Merck's coinfection study results of Grazoprevir+Elbasvir, FDA approval expected in first QTR 2016. Both the daclatasvir & Harvoni studies coincided with publications in journals which are included in NATAP reports below. Of note there was a very important study from Spain of patients with rather advanced disease HIGHLIGHTED the IMPORTANCE of EARLY HCV TREATment - & the study found of note that despite achieving an SVR patients who delayed therapy until they had cirrhosis or more advanced disease who achieve an SVR only about 50% actually achieve HCV disease regression & these patients who don't achieve HCV regression despite achieving an SVR are at greater risk for liver disease complications, liver-related death & overall death. AS well, there were a lot of studies on comorbidities, aging including heart disease, bone, cancers and cognitive impairment.
IAS: HCV/HIV Coinfection at IAS Vancouver 2015 July 19-23 - (07/30/15)
IAS: New HIV Drugs at IAS 2015 Vancouver July 19-23 - (07/27/15)
IAS: Elvitegravir (EVG)/Cobicistat (COBI)/Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF) Is Superior to Ritonavir (RTV)-Boosted Atazanavir (ATV) Plus FTC/TDF in Treatment-Naïve Women With HIV-1 Infection (WAVES Study) - (07/21/15)
IAS 2015: 8th IAS Conference on HIV Pathogenesis Treatment and Prevention - Vancouver Canada 18-22 July 2015
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PrEP Aug 8 2015 Video - (08/10/15)
START Study - Early ART......"These results support treating everyone irrespective of CD4+ T-cell count." Tony Fauci, NIH
Start HIV Treatment Regardless of CD4 Count, NIH Funded Study Finds......http://www.natap.org/2015/newsUpdates/052915_01.htm........Fauci/NIH....."These results support treating everyone irrespective of CD4+ T-cell count."......Jens Lundgren, M.D., of the University of Copenhagen and one of the co-chairs of the START study. "We now have strong evidence that early treatment is beneficial to the HIV-positive person. These results support treating everyone irrespective of CD4+ T-cell count".
IAS: START Trial: Initiation of Antiretroviral Therapy in Early Asymptomatic HIV Infection......The START trial was designed and conducted by the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)..... - (07/24/15) NEJM July 2015
"In conclusion, we found a significant benefit in the immediate initiation of antiretroviral therapy in patients with HIV infection regardless of CD4+ count."....."A beneficial effect of immediate antiretroviral therapy was evident for both serious AIDS-related and serious non-AIDS-related events, and no increased rate of adverse effects associated with this strategy was observed.....The composite primary end point was reported in 42 patients in the immediate-initiation group and in 96 in the deferred-initiation group (Table 2 and Figure 2a). The estimated hazard ratio in the immediate-initiation group, as compared with the deferred-initiation group, was 0.43 (95% confidence interval [CI], 0.30 to 0.62; P<0.001)"....."The results support global goals set by the World Health Organization and the Joint United Nations Programme on HIV/AIDS to expand the use of antiretroviral therapy to all HIV-positive patients in order to improve their health and as part of efforts to reduce the future spread of HIV.22-24,47,48......."Most of the AIDS-related and non-AIDS-related events occurred when patients had a high CD4+ count. Immediate antiretroviral therapy benefited even those with a latest CD4+ count of more than 500 cells per cubic millimeter, which may indicate that a substantial part of the beneficial effect of immediate treatment is due to changes induced by antiretroviral therapy in markers other than the CD4+ count."
IAS: Strategic Timing of AntiRetroviral Treatment (START) Study Primary Results - (07/22/15) oral presentation by Jens Lundgren
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TaSP - Early ART is Highly Effective for Prevention of Sex Transmission......HPTN study in serodiscordant couples........"The benefit of early ART in HIV prevention among HIV-serodiscordant couples is durable" "No index-to-partner (linked) HIV transmissions were observed when the index participant was stably suppressed" "ART is highly effective for prevention of sexual transmission of HIV"
IAS: Antiretroviral Treatment Prevents HIV Transmission: Final Results from the HPTN 052 Randomized Controlled Trial - (07/22/15)......Myron S. Cohen representing the HPTN 052 Study Team; 3 START publications from 2011, 2014......"The benefit of early ART in HIV prevention among HIV-serodiscordant couples is durable" "No index-to-partner (linked) HIV transmissions were observed when the index participant was stably suppressed" "ART is highly effective for prevention of sexual transmission of HIV"
IAS: Treatment as Prevention: Characterization of partner infections in the HIV Prevention Trials Network 052 trial - (07/27/15) " No index-to-partner events were observed when index was stably suppressed on ART"
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PrEP
IAS: ATN 110: An HIV PrEP Demonstration Project and Safety Study for Young Men (18-22) who Have (high-risk) Sex with Men in the United States, in 12 cities.....successfully identified & engaged in project - (08/03/15)
IAS: Adherence, sexual behavior and HIV/STI incidence among men who have sex with men (MSM) and transgender women (TGW) in the US PrEP demonstration (Demo) project - (08/04/15) SF, Miami, Washington DC
IAS: HPTN 067/ADAPT Background and Methods and Cape Town Results: - (08/07/15)
IAS: A Comparison of Daily and Non-daily Pre-exposure Prophylaxis Dosing in Thai Men Who Have Sex With Men, Bangkok - HPTN 067 / ADAPT Study - (08/07/15)
IAS: Facilitators and barriers affecting PrEP adherence among Thai men who have sex with men in the HPTN 067/ADAPT study - (07/27/15)
IAS: Patterns of sex and PrEP in Bangkok MSM (HPTN 067/ADAPT Study) - (08/07/15)
IAS: Feasibility of Intermittent PrEP Among US MSM: Data from the Harlem Site - HPTN 067: ADAPT Study - (08/05/15)
IAS: Patterns of Sex and PrEP in Harlem MSM: A qualitative study (HPTN 067) [Stigma/adherence/Sex] - (08/05/15)
IAS: PrEP, Sex, and the Paradoxes of Prevention: Qualitative data from a cohort of New York City MSM participating in HPTN 067/ADAPT [Harlem, NY, USA] - (07/27/15)
IAS: Pre-exposure prophylaxis (PrEP) uptake and associated factors among MSM and TGW in the PrEP Brasil demonstration project - (08/03/15)
IAS: Ipergay Analysis Suggests Both Pre- and Postsex TDF/FTC PrEP Doses Needed for Full Protection - written by Mark Mascolini - (07/21/15)
.......Researchers instructed sexually active HIV-negative gay and bisexual men to take two TDF/FTC tablets 2 to 24 hours before sex, one tablet 24 hours after sex, and one tablet 24 hours after that. Thus men would take four tablets over 3 days to cover one sex act. All men reported condom-free anal sex with at least 2 partners in the past 6 months. They had a median of 10 sex acts in the past 4 weeks and a median of 8 partners in the past 2 months........Like the British PROUD study, the 400-man double-blind, placebo-controlled Ipergay trial demonstrated 86% protection from HIV acquisition with TDF/FTC PrEP [2]. Unlike other PrEP trials in gay men, Ipergay asked participants to take two TDF/FTC pills before sex and two after sex.......Through an average 13 months of follow-up, 16 men became infected, 14 in the placebo arm (incidence 6.6 per 100 person-years) and 2 in the TDF/FTC arm (incidence 0.9 per 100 person-years). Those rates translated into an 86% relative reduction in HIV incidence (95% confidence interval 40% to 98%, P = 0.0019). The 2 infected men in the TDF/FTC arm had not taken their PrEP pills for months while continuing to have sex.
IAS: HPTN 067/ADAPT: 'PrEP Ubuntu' and experiences with open-label PrEP among South African women - (08/07/15)
IAS: PrEP experiences among South African women in the HPTN067 (ADAPT) study: Healthy paranoia (skepticism), Ubuntu, champions and challenges to resolving PrEP dissonance...... - (08/07/15)
IAS: HPTN 067/ADAPT: 'PrEP Ubuntu' and experiences with open-label PrEP among South African women - (08/07/15)
IAS: Characteristics and Oral PrEP Adherence in the TDF2 Open-Label Extension in Botswana - (08/07/15)
IAS: Over 80% of MSM Don't Discuss PrEP With Their Clinician--and Many Don't Talk About Sex - Mark Mascolini - (07/31/15)
IAS: PrEP - "Starting & Stopping PrEP: Lessons from Pharmacology" - Dosing/Adherence..... "In summary, this study indicates that approximately 1 week of daily PrEP is expected to confer high PrEP activity for MSM. Although a high level of protection may persist for several days after stopping PrEP from steady state, 4 weeks of continued PrEP dosing is reasonable relative to the last potential HIV exposure."......
PrEP at IAS Vancouver 2015 July 19-22.....Daily PrEP Appears Most Effective....more NATAP PrEP IAS Reports coming - (07/27/15)
Tenofovir PrEP Adherence/Protection-After Drug Cessation - (06/26/15)
......Here are 2 studies relevant to the question about tenofovir PrEP regarding adherence, how many pills one can miss & perhaps still be covered, remember this is research not absolutely established, but apparently meaningful......There were no infections at visits where tenofovir diphosphate concentration was 700 fmol per punch or greater, suggesting the use of four to seven tablets per week (table 2)......."Twenty-four, 36, 48 and 72h after stopping drug, 6%, 0%, 1% and 4% of predicted TFV-DP and 56%, 78%, 83% and 83% of FTC-TP were <16fmol/106 cells and 3.7pmol/106 cells, respectively (iPrEx HIV prevention targets)."
Summary Report by
Jared Baeten, MD PhD, Connie Celum, MD MPH, University of Washington
IAS: HIV Prevention at IAS 2015 Vancouver - (08/07/15)
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