How many times have you started to have a conversation with someone about Hepatitis C only to have it blow up in your face? Have you ever heard someone say something about Hep C that didn't seem quite right to you? You were probably right something was amiss. A discussion about Hepatitis C can...
As per Wikipedia, the definition of a stigma is as follows: "Stigma is a word that originally means a "sign", "point", or "branding mark"." Wikipedia goes on to call stigma "A badge of shame, a physical mark of infamy or disgrace." Damn that w...
Recently, the CDC (Center for Disease Control) issued a statement that all Baby Boomers should be tested for Hepatitis C. The question often comes up as to why this particular segment of people is so vulnerable. What does being born between 1945 and 1965 have to do with Hepatitis C? What was di...
Buyer Beware! There are several snake oil salesmen out there who are claiming to have cured their own Hepatitis C with herbs, supplements and parking lot gravel. Okay, maybe not the parking lot gravel but it might as well be. What you need to remember is that there are two different types of...
Most every adult woman (and an occasional man) has enjoyed a manicure and a pedicure at a nail salon or spa. That 30 minute pedicure can be so relaxing but are you aware of the danger lurking in that nail salon? Although few individuals recognize the medical risks associated with this common pr...
Presidio Pharmaceuticals, Inc. announced today successful completion of Phase 1b clinical testing of its lead HCV NS5A inhibitor in patients with HCV genotype-1 infection, with positive efficacy and safety observations supporting advancement of PPI-668 to Phase 2 combination studies.
The randomized, blinded Phase 1b trial of PPI-668 involved sequential cohorts of treatment-naïve HCV genotype-1 patients who received oral doses of PPI-668 of 40, 80, 160 or 240 mg, once daily for three consecutive days. Within each 10-patient cohort, patients were randomized 8:2 to PPI-668 or placebo.
In all of the Phase 1b dose cohorts, PPI-668 was well tolerated with no serious or severe adverse events, no premature treatment discontinuations and no apparent pattern of treatment-related clinical side effects or laboratory abnormalities.
The Phase 1 clinical results indicate that PPI-668 had a favorable pharmacokinetic (PK) profile that included rapid achievement of high (micromolar) plasma levels, prolonged maintenance of potentially effective levels between doses, and achievement of steady-state pharmacokinetics after the first dose.
The Phase 1b efficacy observations indicated consistently rapid, marked reductions in patients’ serum viral load (HCV RNA levels), that were dose-related. Patients’ HCV RNA reductions typically exceeded 3 log10 IU/ml (99.9%) by Day 2. During the 3-day treatment period, mean maximal HCV RNA reductions for the 4 dosing groups were:
There was only one minimal-responder in the trial. A patient in the 240 mg dose group was found to be fully resistant at baseline with 100% of this patient’s pre-treatment HCV RNA containing 3 genetically linked NS5A resistance mutations. This patient was excluded from the efficacy analysis of the 240 mg cohort, since he was pre-resistant and could not contribute to dose-response inferences.
Five other patients with detectable resistance mutations at baseline, including those harboring the relatively common L31M variant, responded well to PPI-668 treatment, with multi-log HCV RNA reductions.
A protocol amendment has been completed to explore the pan-genotypic clinical efficacy of PPI-668 in HCV genotype-2a/3a patients. Recruitment is currently underway for this added cohort.
“The rapid 3.5 to 3.7 log10 HCV RNA reductions observed with PPI-668 at the three higher dose levels and the encouraging safety profile support advancement of PPI-668 to Phase 2 combination studies with other promising HCV antiviral agents,” said Nathaniel A. Brown, M.D., Presidio’s Chief Medical Officer. “The PK profile of PPI-668 appears to be a major factor in its efficacy profile, with rapid achievement of potentially effective plasma levels and with inter-dose plasma concentrations exceeding those needed to inhibit both wild-type HCV and many naturally-occurring HCV variants.”
Detailed results of the completed trial are expected to be presented at a scientific meeting in the fall of 2012.
Please sign the ATC Salvage Therapy Petition Join us in asking Congressman Alcee Hastings and Congresswomen Maxine Waters to send a ‘Dear Colleague’ letter to Anthony Fauci, Director of NIAID, asking for the federal facilitation of apricitabine (ATC). ATC is a phase III nucleoside reverse transcriptase inhibitor (NRTI) that has been shown to be safe and effective in treating people with HIV. It works against viruses that are resistant to several other nukes and could ...
Researchers from Johns Hopkins Children’s Center, the University of Mississippi Medical Center and the University of Massachusetts Medical School announced today at CROI2013 the discovery of the first infant functionally cured of HIV. The baby, a female now two and a half years old, received 3 HIV medications when brought to the hospital at 30 hours old. Viral load tests were performed during the first few weeks that showed a rapidly decreasing viral load which reached ...
At the 19th International AIDS Conference (AIDS 2012) in Washington D.C., the CDC reported that only 1 out of 4 HIV patients in the U.S. have HIV under control, which is defined as complete viral suppression. Warning bells should be ringing in the scientific and HIV advocacy communities. While much progress has been made in the last three decades in the treatment of HIV, tens of thousands of people living with HIV (PLWH) are currently struggling to construct viable treat...
Paige Rawl is 17 and HIV positive, but while her life has been shaped by HIV it isn't ruled by it. When Paige Rawl starts her senior year at Indianapolis’s Herron High School next month, she'll be cheer captain and a member of the student government and prom committee. This summer, the 17-year-old held down a part-time job at Hollister, hawking the popular Southern California-inspired clothing brand. The all-American girl — who happens to be HIV positive. Paige was in...
The HIV community has been abuzz with the August FDA approval of what had been termed “the Quad”, the second one-pill-once-a-day combination antiretroviral drug. Marketed by Gilead under the name Stribild, the drug contains two NRTIs (tenofovir and emtricitabine), an integrase inhibitor (elvitegravir) and an integrase booster (cobicistat) and is approved for use in treatment naïve patients with either drug resistant or wild type virus. In comparison to Atripla, the first...

Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for SUSTIVA® (efavirenz), including dosing recommendations for...

California and other states would be pressured to amend or repeal criminal laws that single out HIV-positive people under a bipartisan bill co-authored and introduced this week by Rep. Barbara...
Mission Statement
At HIV Haven we wish to provide our readers with vital cutting edge information to help expand HIV knowledge and promote activism, particularly that which works towards an end to the HIV pandemic. It is our desire to bring to you the scientific, medical and social advances that given the appropriate attention and support, could change the course of the HIV pandemic, lessen the devastating effects of HIV and AIDS, better the quality and quantity of life for people living with HIV and even yield an eventual end to the HIV pandemic. We also provide the basics of HIV transmission and treatment.
We will focus on issues such as innovative drug development, strategic activist campaigns, HIV relationships and novel HIV and HIV cure research. We also will bring you advances in Hepatitis C (HCV), a common HIV co-infection. Whether you are living with HIV/AIDS, HIV and HCV, love someone who is, are an activist, advocate, researcher, physician or just an interested party, we hope here at HIV Haven we can help you find what you are looking for.