ibalizumab HIV

Ibalizumab: First Long Acting HIV Treatment Available Now Via Expanded Access

No one can deny that many patients can now suppress their HIV with effective antiretrovirals (ARVs) that cause fewer side effects. However, a vulnerable and often forgotten minority of people are still struggling with multi-drug resistant HIV (MDR-HIV) while they anxiously wait for access to lifesaving ARVs that would finally control their viral replication. Although some of these patients may have developed resistant HIV due to lack of adherence or other issues, many of them have been strictly following their doctors’ orders for years.

They’re often veterans of drug development research who have accumulated HIV resistance as they repeatedly joined ARV studies or traditional expanded access programs of a single new drug out of desperation to control their HIV viral load. As they signed up for studies that helped companies get their drugs approved by the FDA (U.S. Food and Drug Administration), many of these patients were exposed to suboptimal HIV regimens (namely, functional monotherapy or the addition of a single new active ARV to a failing HIV regimen).

Currently, the U.S. Department of Health and Human Services (DHHS) adult HIV treatment guidelines recommend three ARVs be given in combination to suppress HIV. But many patients have HIV that has mutated rendering their virus multi-drug resistant. Those with MDR-HIV cannot construct a viable HIV suppressive regimen with current FDA-approved and commercially available ARVs.

A new HIV medication called Ibalizumab may be approved this year for patients with limited treatment options.  It has a completely new mode of action, so most patients should respond to it when using it with at least one other active agent. It is different from the entry inhibitor maraviroc (Selzentry, Celsentri) in that it blocks the CD4 receptor on T cells rather than blocking the CCR5 co-receptor. This means it could be effective against virus that uses either the CCR5 or CXCR4 co-receptor. It is a genetically engineered monoclonal antibody administered once every two weeks intravenously.

In the manufacturer’s website (Taimed Bilogics), the drug is described as : “TMB-355(Ibalizumab) is a humanized monoclonal antibody (mAb) and a member of an emerging class of HIV therapies known as viral-entry inhibitors. This drug candidate is distinct from other entry inhibitors in that it binds to the CD4 molecule, the primary receptor for HIV infection, thereby interfering with the penetration of the virus into the cell. It is the first entry-blocking humanized mAb to treat HIV/AIDS. TMB-355 caught the attention of the scientific community in February 2003, when results from the phase-1, single-dose, intravenous infusion (i.v.) clinical trial showed a transient but clinically significant reduction in the patients’ viral load. Moreover, it was well tolerated with no evidence of adverse effects on CD4 T-cells of treated subjects unlike the majority of approved drugs for HIV. U.S. FDA granted TMB-355 fast track status in October 2003. The phase-2a clinical trial was successfully completed in 2006, with the results showing a clean safety profile and clear antiviral activity (10-fold reduction in viral load). The Phase-2b clinical trial was also successfully completed in 2011, with the confirmation of a good safety profile and strong antiviral activity in HIV patients with multidrug resistance (MDR). U.S. FDA granted orphan drug designation of TMB-355 for HIV patients with multidrug resistance in 2014. Moreover, TaiMed received breakthrough therapy designation from the U.S. FDA for TMB-355 in 2015, which provides the privilege for a rolling biologics license application (BLA) submission. A pivotal phase-3, single-arm clinical trial with patient number of 40 had completed in October, 2016. The clinical trial results, along with other available CMC, pre-clinical, and clinical data, will be submitted as BLA package in 2016 under rolling review. TaiMed Biologics also developed a subcutaneous injection (s.c.) dosage form and the phase-1 human pharmacokinetics bridging study was completed in 2012. Currently, TMB is also developing an intramuscular injection (i.m.) dosage form and a phase-1/2 study for HIV-negative and naive HIV-positive subjects had completed in 2016.” Source

The manufacturer of this biologics product is now providing free access of this treatment option via their expanded program.

Talk to your doctor about this option if you have been told that your virus has resistance to nucleosides, non-nucleosides and protease inhibitors.  Remember: This product needs to be used with at least one more active drug to which your virus has not developed resistance.  Failure to do so will result in resistance to ibalizumab.


Note from Nelson Vergel:  I have been on this product for over 5 years and attribute it to saving my life.


More information:


Ibalizumab: First HIV Drug to Get Orphan Drug Status for Salvage Patients

Shares of TaiMed Biologics Inc, which manufactures drugs to treat AIDS, soared 12.93 percent yesterday after its new TMB-355 drug for intravenous injection was granted orphan drug status in the US.
The company’s shares closed at NT$151.2 yesterday, outperforming the over-the-counter benchmark index, which ended up 0.56 percent.
The granting of orphan status could shorten the time it takes for TMB-355 to enter the US market, TaiMed financial controller Jack Chen said over the telephone yesterday.
“By getting orphan status, we are able to negotiate with the US Food and Drug Administration to see if we can waive the phase-three clinical trials for the drug, or conduct them on a smaller scale,” Chen said.
An orphan drug is one that satisfies an unfilled medical need for a specific group of people numbering less than 200,000, TaiMed said, adding that as a result, clinical trials for such drugs do not require as many patients as those for other pharmaceuticals.

New HIV Drugs and Formulations in the Near Future (CROI 2013 Presentation)

All of the presentations in this section were great.
The one on new drugs is contained in the last set of slides (blue slides at 1:22:46)

For individual reports on each drug (Thanks to Natap.org):


Six Promising HIV Drugs in the Pipeline (2013-2014)

By Warren Tong
December 5, 2012
What new HIV medications do we have to look forward to over the next few years? How will these newer drugs improve upon the older ones? To shed some light on these questions, Roy Gulick, M.D., provided an overview at ID Week 2012 of drugs in development.
Since the first HIV medication, zidovudine (AZT, Retrovir), was approved in 1987, 26 other antiretrovirals have been made available in the U.S. for treating HIV — a history that Gulick recapped in song during this conference. Our best regimens today are potent, convenient and relatively non-toxic.
However, according to Gulick, there is potential to make medications even better than those we have today. Newer drugs should build upon some of these aspects, he said:
  • Improve convenience (reduce dosage frequency, less than once a day).
  • Improve tolerability and reduce toxicity (even the best drugs today still have some of these issues).
  • Penetrate reservoirs more effectively (such as the genital tract and central nervous system).
  • Exploit new targets, thereby improving activity (particularly against drug-resistant viruses).
  • Improve formulation.
The list of drugs in the pipeline continues to be full of antiretroviral agents, whether they are in early development or undergoing clinical trials.
Gulick highlighted six of the most promising drugs.
GS-7340 (Also Known as Tenofovir Alafenamide, or TAF)
GS-7340 is an investigational nucleoside agent that is a prodrug of the approved formulation of tenofovir (TFV, Viread). A prodrug is a medication that, when metabolized in the blood, breaks down into the active form of the compound. The NRTI sold under the brand name Viread is actually tenofovir disoproxil fumarate (TDF), a prodrug that breaks down into tenofovir.
GS-7340’s antiretroviral activity was first presented in a study by Martin Markowitz, M.D., and others at CROI 2011. In a small, 14-day study, Markowitz and his team found that GS-7340 performed slightly better than the “old” TDF, with greater decreases in HIV RNA at lower dosages (GS-7340 at 50 or 150 mg vs. TDF at 300 mg).
These findings were further supported by study results from Peter Ruane, M.D., and others at CROI 2012. Ruane and his team compared GS-7340 (at dosages of 8, 25 and 40 mg) with TDF (at 300 mg) in 38 treatment-naive patients over 10 days of monotherapy. GS-7340 again performed better than TDF, showing 0.76, 0.94 and 1.08 log reductions in HIV RNA, respectively, while TDF only showed a 0.48 log reduction in HIV RNA. The findings were statistically significant for the 25-mg (P = .017) and 40-mg (P = .01) dosages.
Ruane and his group also found that the plasma concentrations of tenofovir, when the prodrugs were metabolized, were 10 to 100 times higher for TDF than for any of the three dosages of GS-7340. This finding suggests that, because GS-7340 delivers less compound to target tissues, it could reduce toxicity levels in the organs, Gulick said.
On the other hand, when comparing intracellular concentrations of tenofovir in peripheral mononuclear cells like lymphocytes (which is where we want the drugs to be), GS-7340 achieved up to 20 times higher levels than TDF, Gulick noted.
In both of these studies, GS-7340 was generally well tolerated and no serious adverse events were reported.
A third study of GS-7340 was presented at ICAAC 2012. It found that GS-7340 had high potency against 26 HIV-1 isolates representing 7 subtypes. The drug also showed high potency against three HIV-2 isolates. In addition, GS-7340 maintained its viral potency longer than TDF, showing its better stability.
Further GS-7340 studies are in progress. Particularly because of its low dosage and high potency, it can be readily co-formulated with other agents.
Gulick pointed out two studies exploring such coforumulations. The first study will compound GS-7340 with emtricitabine (FTC, Emtriva) plus elvitegravir (EVG) plus cobicistat, and compare that to elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild). The second study will compound GS-7340 with emtricitabine, darunavir (Prezista) and cobistat (which would be the first one-pill, once-a-day protease inhibitor-based regimen), and compare that to tenofovir/emtricitabine (Truvada) plus darunavir plus cobicistat.
Dolutegravir (DTG)
Of the six highlighted compounds, Gulick stated that dolutegravir is the furthest along in development. Dolutegravir is an investigational integrase inhibitor, but it has distinguished itself from the two approved integrase inhibitors, raltegravir (Isentress) and elvitegravir.
Dolutegravir has a long half-life of 15 hours, indicating it can be taken once a day. Gulick emphasized that it does not require pharmacokinetic boosting. He noted that resistance does occur, but that dolutegravir showed activity against raltegravir- and elvitegraivr-resistant viral strains.
Its antiviral potency was shown in a phase-2a study by Sherene Min, M.D., and others. In 28 treatment-naive patients receiving either 2, 10 or 50 mg of dolutegravir, there was an average of a 1.51 to 2.46 log reduction in viral load after only 10 days of once-daily dosing. Seven of the 10 patients receiving 50 mg dosages achieved a viral load less than 50 copies/mL. Min and her team reported low pharmacokinetic variability and good short-term tolerability (the most common side effects were diarrhea, fatigue, and headache; adverse events were mild to moderate in severity).
According to Gulick, phase-3 results are complete and will be submitted to the U.S. Food and Drug Administration by the end of the year.
One of the phase-3 studies, known as SPRING 2, found dolutegravir to be non-inferior to raltegravir. The study followed 827 treatment-naive patients with a viral load above 1,000 copies/mL over 48 weeks. They were given either 50 mg of dolutegravir or 400 mg of raltegravir. Both groups were successful at achieving viral loads below 50 copies/mL (88% for dolutegravir and 85% for raltegravir). Both drugs were also very well tolerated, with only 2% in each group having to discontinue treatment because of adverse events.
Furthermore, a dolutegravir-based regimen consisting of abacavir/lamivudine (Epzicom, Kivexa) plus dolutegravir was actually found to be superior to tenofovir/emtricitabine plus efavirenz (Sustiva, Stocrin), according to the results of a companion phase-3 study by Sharon Walmsley, M.D., and others. In 822 treatment-naive patients studied over 48 weeks, 88% of the dolutegravir group achieved a viral load below 50 copies/mL, compared to 81% of the efavirenz group.
Gulick pointed out that the difference was because of tolerability: 10% of the efavirenz group discontinued treatment because of adverse events, compared to just 2% of the dolutegravir group. He commented that this would mark the first real challenger to efavirenz’s long-held dominance in treatment-naive studies with a 48-week primary endpoint.
In terms of renal safety, the study found dolutegravir did interfere with tubular secretion of creatinine. However, Gulick noted, the increase in creatinine was only about .1 to .15 mg/dL, and occurred only within the first two weeks after starting dolutegravir, then stabilized over the rest of the 48-week study. As the Walmsley study noted, dolutegravir does not affect actual glomerular filtration rate.
In terms of resistance, dolutegravir appears to have a higher barrier to resistance than the other integrase inhibitors. In the Walmsley study, among both the dolutegravir and efavirenz groups, only 4% experienced virologic failure (18 and 17 individuals, respectively). Of the nine in each group that had genotypic test results available, “You see no nucleoside and no integrase mutations in the dolutegravir group. And as you would expect in the efavirenz [regimen], there were some nucleoside and non-nucleoside mutations detected,” Gulick stated.
Because dolutegravir showed activity against elvitegraivr- and raltegravir-resistant viral strains, as shown in a study by Masanori Kobayashi and others, Joseph Eron, M.D., and others studied the use of dolutegravir for patients who had developed resistance to raltegravir. Their pilot study, known as VIKING, followed 51 patients with three or more class resistances, including demonstration of raltegravir mutations. The patients were given 50 mg of dolutegravir, either once or twice a day, for 10 days. A virologic response was defined as either a viral load below 400 copies/mL or a 0.7 log reduction. As Gulick explained, “The best responses were in the twice-a-day group. Whether you looked at all patients, those with the specific Q148 or other mutations, you can see response rates, over a short 10 days of therapy, exceeding 90%.”
The VIKING study went on to follow the patients over 24 weeks. After the initial two weeks, the patients added an optimized background regimen. These follow-up results were presented by Vincent Soriano, M.D., Ph.D., at the 2011 European AIDS Conference. Soriano and his team found that by the end of the 24-week period, 41% of the once-a-day group and 75% of the twice-a-day group were able to re-suppress their viral load below 50 copies/mL.
Further studies of dolutegravir in the setting of other integrase inhibitor resistance are ongoing.
S/GSK-1265744 (or simply “744”)
S/GSK-1265744 is an integrase inhibitor, similar to dolutegravir. Results from two studies presented at ICAAC 2012 found that 744 had high potency and an exceedingly long half-life. When given orally at once-daily doses of 30 mg, patients showed a median 2.6 log reduction in viral load.
More impressive, when using nanotechnology to formulate 744 to be injected subcutaneously or intramuscularly, a single dose showed a half-life between 21 and 50 days.
Remarkably, after a single dose, patients still had detectable levels of 744 up to 48 weeks after injection.
Similar to dolutegravir, 744 seems to have a high barrier to drug resistance. According to Gulick, using site-directed molecular clones (molecules created with specific mutations) associated with integrase inhibitor resistance, these mutations showed high levels of resistance to raltegravir and elvitegravir, but remained susceptible to 744 and dolutegravir.
In terms of safety, there were some injection site reactions and nodules associated with subcutaneous dosing. But conceivably, 744 could be taken as infrequently as every three months for treatment, or even as PrEP (pre-exposure prophylaxis). Research is ongoing.
HIV Entry Inhibitors
HIV entry inhibitors block HIV at the point at which they attach to CD4 cells. Many of the other classes of drugs, including protease inhibitors, NRTIs and NNRTIs, fight HIV after it has infected a CD4 cell.
Among the entry inhibitors, there are presently three sub-classes. We already have approved drugs in the first two sub-classes: CCR5 antagonists and fusion inhibitors. In the CCR5 antagonist sub-class, we already have maraviroc (Selzentry, Celsentri), and a new drug called cenicriviroc is being investigated. The fusion inhibitor class has long featured only enfuvirtide (Fuzeon), but a new drug called albuvirtide is being studied.
The third sub-class is an investigational one: CD4 attachment inhibitors. These new drugs are being developed to either bind at the location of HIV’s gp120 protein (such as BMS-663068) oron the CD4 receptor itself (such as ibalizumab, a once- or twice-a-day drug that’s still under investigation for both treatment and prevention).
Gulick offered a closer look at a few of these drugs in his overview.
Cenicriviroc (CVC)
Cenicriviroc is an investigational CCR5 antagonist. Not only does it antagonize CCR5 binding, it also antagonizes CCR2 binding. CCR2 is a receptor that sits on the surface of macrophages and may be involved in inflammation.
Cenicriviroc showed potent antiretroviral activity in a small study by Jacob Lalezari, M.D., and others. They followed treatment-experienced patients who had not been on treatment for at least six weeks, had a CD4+ cell count above 250 and a viral load above 5,000 copies/mL. They were randomized to receive either 25, 50, 75, 100 or 150 mg of once-daily cenicriviroc. At the highest doses, after 10 days, patients showed a 1.5 log reduction in viral load.
An update on the follow-up study was discussed by David Martin, M.D., at CROI 2012. In Martin et al’s phase-2b study, they randomized 150 treatment-naive patients into three groups to receive tenofovir/emtricitabine with either cenicriviroc (at 100 or 200 mg) or efavirenz. Cenicriviroc was administered using a new, 50-mg formulation. In preliminary data from 18 patients, cenicriviroc was found to be well-absorbed and within the expected therapeutic range of potency. Further study will assess the safety, efficacy and effect of CCR2 inhibition on inflammatory biomarkers.
The only approved fusion inhibitor, enfuvirtide, offers a lot of activity against HIV, but the obvious downside is that it requires twice-daily injections. Albuvirtide, on the other hand, is an investigational fusion inhibitor that when given intravenously has a long average half-life of 11 days, warranting weekly dosing.
Albuvirtide has a similar design to enfuvirtide. It is a peptide that is an analogue of gp41, one of the envelope proteins on HIV’s surface, and thereby blocks HIV through CD4 membrane fusion.
Two proof-of-concept studies by Dong Xie and others were presented at ICAAC 2012. In the first study, albuvirtide was given to 54 treatment-naive patients in a single dose; doses ranged from 20 to 640 mg. They found that albuvirtide’s half-life ranged between 10 and 13 days, and that the drug suppressed plasma viremia for between 6 and 10 days. Albuvirtide was generally well tolerated, with no injection-site reactions and no serious adverse events.
In the second study, albuvirtide was given to 12 treatment-naive patients in multiple doses of either 160 or 320 mg. Doses were given on days 1, 2, 3, 8 and 15. The participants averaged viral load decreases of 0.68 log copies/mL (at 160 mg) and 1.05 log copies/mL (at 320 mg). Similar to the first study, there were no injection-site reactions and no serious adverse events. No anti-albuvirtide antibodies were detected in patients for up to 42 days.
BMS-663068 (a.k.a. BMS-068)
BMS-068 is an HIV attachment inhibitor. It is an oral prodrug that breaks down into the active compound BMS-626529 (a.k.a. BMS-529). It inhibits CD4 binding by specifically binding to gp120, one of HIV’s envelope proteins that binds to CD4 cells. Gulick stated BMS-068 could be taken once or twice a day without boosting, but noted, “There is decreased baseline susceptibility in some patients due to envelope polymorphisms.”
BMS-068 taken over 8 days with or without ritonavir (Norvir) resulted in substantial declines in plasma HIV RNA levels and was generally well tolerated, according to a study by Richard Nettles, M.D., and others. The study followed 50 patients with a CD4+ cell count above 200 cells/mL and a viral load above 5,000 copies/mL. They were either treatment-naive or not taking any treatment. The median change in viral load ranged from a 1.21 to a 1.73 log reduction, demonstrating that CD4 attachment inhibition can be quite potent and effective.
In terms of resistance, a study presented by Neelanjana Ray, M.D., at CROI 2012, found little resistance after the eight days of monotherapy. Ray and his team analyzed the changes in phenotypic susceptibility and known attachment inhibitor resistance substitutions that may have occurred during the Nettles study. Of the 48 patients that completed the study, 42 had at least a 1 log drop in viral load, showing that BMS-068 was effective. However, the other six (about 12%) had no virologic response, even though their baseline IC50 (a measure of the effectiveness of a compound in inhibiting a biochemical function) levels were quite high.
“When they took a close look and they sequenced gp160, which is broken down into gp120, they showed that a mutation (M426L) was associated with resistance,” explained Gulick. “You can see that in patients with virologic response, very few (only 6%) have this mutation, whereas in those without virologic response, 5 of the 6 had this mutation. So it looks like this will be important in screening for activity of this compound as its development moves forward.”
New Fixed-Dose Combination and Antiretroviral Formulations
Gulick pointed out three one-pill, once-a-day formulations being developed:
  • GS-7340/FTC/elvitegravir/cobicistat.
  • GS-7340/FTC/darunavir/cobicistat.
  • Abacavir/lamivudine (3TC, Epivir)/dolutegravir.
In addition, three other in-development formulations that Gulick mentioned were:
  • Lopinavir/ritonavir/lamivudine.
  • Atazanavir (Reyataz)/cobicistat and darunavir/cobicistat (both in clinical trials).
  • Rilpivirine long-acting (RPV-LA).
Regarding the last drug in those lists, a small pilot study presented at CROI 2012 found that RPV-LA could potentially be given once a month in its long-acting nano-formation. It would likely need to be paired with other drugs, but research is ongoing for its use in treatment and prevention.
Warren Tong is the research editor for TheBody.com and TheBodyPRO.com.
Copyright © 2012 Remedy Health Media, LLC. All rights reserved.
 This article missed the drug ibalizumab:
 TMB-355(Ibalizumab) is a humanized monoclonal antibody (mAb) and a member of an emerging class of HIV therapies known as viral-entry inhibitors. This drug candidate is distinct from other entry inhibitors in that it binds to the CD4 molecule, the primary receptor for HIV infection, thereby interfering with the penetration of the virus into the cell. It is the first entry-blocking humanized mAb to treat HIV/AIDS. TMB-355 caught the attention of the scientific community in February 2003, when results from the phase-1, single-dose clinical trial showed a transient but clinically significant reduction in the patients’ viral load. Moreover, it was well tolerated with no evidence of adverse effects on CD4 T-cells of treated subjects unlike the majority of approved drugs for HIV. The U.S. FDA granted TMB-355 fast track status in October 2003. The phase-2a clinical trial was successfully completed in 2006, with the results showing a clean safety profile and clear antiviral activity (10-fold reduction in viral load).  The Phase-2b clinical trial was also successfully completed in 2011. TaiMed Biologics is concurrently developing a subcutaneous injection dosage form and a phase 1 human pharmacokinetics bridging study is completed in 2012. Currently, TMB is developing a phase I/II study for HIV-negative and new HIV-positive subjects to begin by the end of 2012.

Fw: Hot Topics at The Body’s “Ask the Experts” Forums

From: “News at The Body” <update@news.thebody.com>
Date: 06 Mar 2012 15:17:15 -0500
To: <nelsonvergel@yahoo.com>
ReplyTo: “News at The Body” <update@news.thebody.com>
Subject: Hot Topics at The Body’s “Ask the Experts” Forums

If you have trouble reading this e-mail, you can see the online version at: www.thebody.com/topics.html
March 6, 2012 Visit the Forums “Hot Topics” Library Change/Update Subscription


 Are You Giving Up on the Cure?
I was reading your last response about a functional HIV cure in which you claimed that it would most likely take more than 10 years to develop a cure. Reading your previous responses on the issue you seemed much more optimistic. What happened?

Nelson Vergel responds in the “Aging With HIV” forum


 How Much of a Risk Are We Taking With Unprotected Oral Sex?
I’m an HIV-negative man and my girlfriend is HIV positive with a viral load of 200,000 and a CD4 count of 750. Oral sex is very important to both of us. I’ve performed unprotected oral sex on her multiple times, and vice versa, and we’re careful about sores and cuts; we always use condoms for intercourse. I’ve read literature that says anything from there’s no HIV risk with unprotected oral sex to I’m most likely already infected. What do you think? Do you know of any documented cases of someone contracting HIV from oral sex on a female?

Shannon R. Southall responds in the “Safe Sex and HIV Prevention” forum


 How Can I Get Health Coverage Back for My Registered Domestic Partner?
I’m a retiree in California and have health coverage through my (former) employer, a large California-based aerospace company. My registered domestic partner has had health coverage for the past five years as my dependent. For 2012 my employer is denying coverage for domestic partners. Any idea why they can now refuse coverage, and what we can do about it?

Jacques Chambers, C.L.U., responds in the “Workplace and Insurance Issues” forum

 Two Chiropractors Refused to Treat Me: What Can I Do?
Two different chiropractors have refused to treat me due to my HIV status, directly stating that they didn’t have the proper gloves or facilities to treat “people like me.” Are there grounds to sue based on this type of discrimination? What actions can I take?

Christa Douaihy, Esq., responds in the “Legal Issues and HIV” forum

the latest in hiv research: croi 2012 @ thebody.com
Seattle What’s coming down the pipeline in HIV treatment, prevention and care? CROI is the largest annual science meeting in HIV, where researchers and clinicians go to learn the most important lessons and developments in the field. The gathering began this weekend, and TheBodyPRO.com — TheBody.com’s sister site for health professionals — will be on hand to bring you wide-ranging coverage.

Visit our CROI 2012 home page frequently this week for key study summaries and a discussion of conference highlights!


 What’s New With Ibalizumab?
I’ve had very good luck with ibalizumab, the drug in development (TNX-355, formerly known as Tanox). Can you give me an update on what’s going on with this drug in 2012? Are there any new developments we should know about?

Nelson Vergel responds in the “Nutrition and Exercise” forum

 Do Calcium and Magnesium Have a Negative Effect on Isentress?
I switched to a regimen of Isentress (raltegravir) and Truvada (tenofovir/FTC) recently and am doing very well on it so far. Every morning I usually drink a glass of milk after taking Isentress. I also take vitamin D and calcium supplements. I heard somewhere that calcium and magnesium can affect the effectiveness of Isentress. Is it true? Should I stop drinking milk when I take Isentress as well?

Benjamin Young, M.D., Ph.D., responds in the “Choosing Your Meds” forum

 Another Time Around With Hepatitis C Meds: For How Long Will I Be Treated?
I’m a 55-year-old man with hepatitis C genotype 1B (my initial viral load was 3.8 million) and in otherwise good health. I’m currently 20 weeks into triple therapy with Incivek (telaprevir), peginterferon and ribavirin, and my hepatitis C viral load was undetectable at four, eight and 12 weeks. I’ve been unsuccessful on dual therapy before. What does this mean for the length of my treatment course now?

Barbara McGovern, M.D., responds in the “Hepatitis and HIV Coinfection” forum


 Positive Anal Pap Smear but Negative HRA: What’s Going On?
I’ve been HIV positive for four years, with a CD4 count of 330 and an undetectable viral load for the past three and a half years. Recently I had a high-resolution anoscopy (HRA) and the examination didn’t show any abnormalities, so I was relieved at that. However, my anal Pap smear result showed anal intraepithelial neoplasia (AIN 2). Should I be worried about precancerous changes in my anal canal? How do you interpret these results? If I have HPV (human papillomavirus), how long would it take an HIV-positive person like me to get rid of it?

Nelson Vergel responds in the “Aging With HIV” forum

 How Do I Know if I’m Depressed?
I take Isentress (raltegravir), Selzentry (maraviroc, Celsentri) and Viramune (nevirapine). I’ve been HIV positive for 22 years and I’m doing well. However, lately I’ve been losing my drive to exercise and eat well, as I have for the past several decades. I still go dancing every weekend and have a great group of friends, but being single and keeping healthy just for myself is getting hard at age 63. Is this the state of mind the younger generation calls depression? Could it be a side effect of HIV meds? Do you think I’d take better care of myself if I were in a relationship?

David Fawcett, Ph.D., L.C.S.W., responds in the “Mental Health and HIV” forum

Connect With Others Pen Pal for a Poz Friend in Prison?
(A recent post from the “Living With HIV” board)

A friend of mine is HIV positive and has been in prison for the past 27 years for a crime he didn’t commit. Recently the Innocence Project has taken his case and they have hopes of having my friend released. He became HIV positive while being held in protective custody in 1985. I am hoping to connect him with someone who would like to be a pen pal / friend to him and answer some of his questions about living with HIV. Would anyone out there be interested in contacting him? — DawnW

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 Can a Person With Hepatitis C Donate Organs?
Could someone living with hepatitis C (hep C) donate their organs (besides their liver) to others in general? Could they give organs to other people living with hep C?

Benjamin Young, M.D., Ph.D., responds in the “Choosing Your Meds” forum

 Why Was I Tested for HIV?
I just officially found out I’m pregnant. I already took a preliminary, preconception HIV test six months ago and it came back negative, but I was sent out for another test today. Why would they do this, since my husband and I are completely monogamous with each other and have participated in no other risky behavior since my last test? Is it possible that the first test was a false negative or was not done correctly? Do I need to be concerned?

Shannon R. Southall responds in the “Safe Sex and HIV Prevention” forum

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ViiV Announces Expanded Access of New Integrase Inhibitor…But Activists Are Concerned About Its Potential Misuse

The dolutegravir expanded access program (EAP) has been designed to provide free access to Shionogi-ViiV Healthcare’s investigational integrase inhibitor, dolutegravir (DTG, S/GSK1349572) in an open-label protocol program to adults living with HIV who have documented raltegravir or elvitegravir resistance, who have limited treatment options, and who require DTG to construct a viable antiretroviral regimen for therapy. The dose is 50 mg twice a day for patients with multi drug resistance (the drug will also be eventually approved for once daily use for treatment naive patients)

But before you consider the use of this new drug, read the following warning: Activists Advise Caution About Access Program

Who can participate in the dolutegravir EAP (ING114916)?

The dolutegravir EAP is available to adults living with HIV who (Note: Not all inclusion criteria are listed):
  • Are male or female age 18 years or older (female patients of child-bearing potential should use every precaution to prevent pregnancy)
  • Have documented plasma HIV-1 RNA levels ≥400 copies/mL within 3 months prior to the screening visit
  • Have documented raltegravir or elvitegravir resistance
  • Are unable to construct a viable background regimen of anti-retroviral therapy with commercially available medications.
The dolutegravir EAP is not available to adults living with HIV who (Note: Not all exclusion criteria are listed):
  • Have estimated creatinine clearance (CrCl) <30 mL/min
  • Are pregnant or breastfeeding
  • Have had a known or suspected allergic reaction to an integrase inhibitor
  • Have an alanine aminotransferase (ALT) level >5 times the upper limit of normal (ULN)
  • Have an ALT >3 times ULN and total bilirubin >1.5 times ULN
  • Have evidence of severe hepatic impairment
  • Are eligible for, and have access to, an actively enrolling DTG Phase III clinical trial
  • Have any condition (including but not limited to alcohol and drug use) or any active clinically significant disease or findings during screening of medical history or physical examination, which, in the opinion of the treating physician would interfere with safety or compliance
  • Requires or is anticipated to require any of the prohibited concomitant therapy.
*Please note: country specific criteria may also apply.
The dolutegravir EAP is now open and accepting participants in the USA and Canada.
For Europe and the International region, it’s expected that the EAP will start to open in March/April 2012 as local regulatory and ethics approvals are obtained.

How to apply for participation

For adults living with HIV: Please discuss your possible participation with your healthcare professional. If the EAP is available in your country, check with your healthcare provider if he or she is a participating site. If not, your healthcare provider may contact PAREXEL for further details on how to access the program.
For healthcare professionals treating HIV: If you have an eligible patient(s), please contact PAREXEL at dolutegravir-eap@parexel.com for further details about the program.

What is dolutegravir?

Dolutegravir (DTG, GSK1349572) is an integrase inhibitor under development as a treatment for HIV-1 infection. Phase III studies to assess the safety and efficacy of dolutegravir in antiretroviral naïve and experienced adults living with HIV are currently underway. The safety and efficacy of dolutegravir has not yet been fully established or thoroughly evaluated by regulatory agencies.

Activists Caution HIV+ Patients and their Physicians About Monotherapy in Upcoming Access Program

IMMEDIATE RELEASE: February 9, 2012

Nelson Vergel (NelsonVergel@yahoo.com)
Activists Caution HIV+ Patients and their Physicians About
Monotherapy in Upcoming Access Program
New York, February 9, 2012—AIDS activists and physician advocates welcome
the news that ViiV Healthcare will be providing 
expanded access of dolutegravir (DTG), a new investigational integrase
inhibitor for HIV patients with few remaining HIV treatment options.  However, they warn patients and physicians to
avoid functional monotherapy, or the introduction of dolutegravir as an
“add-on” to a failing treatment regimen if the patient’s virus is
resistant to all other currently available antiretroviral drugs (ARVs).  Functional monotherapy has been shown to
permit rapid HIV resistance to new medications, which can result in more rapid
disease progression, health deterioration, and death.
Currently, the
U.S. Department of Health and Human Services (DHHS) adult HIV treatment guidelines
recommend three ARVs be given in combination to suppress HIV.  But many patients have HIV that has mutated
rendering their virus multi-drug resistant (MDR-HIV).  Those with MDR-HIV cannot construct a viable
HIV suppressive regimen with current FDA-approved and commercially available
ARVs.  “The DHHS guidelines specify
that patients that have developed
HIV drug resistance to all commercially available antiretrovirals require
access to at least two new active drugs to maximize their chances for treatment
response.  However, “another new drug to
combine with dolutegravir will not be commercially available for at least two
years, and some patients cannot wait that long,” said Nelson Vergel, an
activist founder of SalvageTherapies.org. 
“For them, access to another research drug in combination with DTG
is the only hope for survival,” added Vergel.
In studies to date, dolutegravir (DTG) appears to be
the most potent integrase inhibitor soon to enter the ARV market.  Unlike Gilead’s upcoming elvitegravir, DTG
has been shown to be effective against HIV that has developed resistance to
Merck’s Isentress (raltegravir), the only FDA-approved integrase inhibitor currently
on the market.
Fortunately, another new ARV that can help patients with
MDR-HIV is in active development and clinical trials.  Ibalizumab, a monoclonal antibody from a
small biotech firm, Taimed Biologics, may soon be available via patient participation
in research studies.  While ibalizumab
has yet to enter phase three studies, it can also be provided to patients at
risk of death via a named (or single) patient
application permitted by the FDA via a physician’s direct
request to Taimed.  However, it is for
the company to approve such requests for compassionate access.
There are no documented estimates of how many people have
MDR-HIV in the United States.  A report in the Journal of Clinical
Infectious Diseases
estimates that about 260,000 patients are being
treated with HIV in the United States. 
However, it is virtually impossible to know how many are now without
sufficient treatment options since no registry for such patients exists.  But most experts agree that this population
is probably small – possibly up to 10% of the total in treatment.
“With little immune function left and resistance to all
approved HIV medications, I have tried desperately to get access to two new
drugs to help save my life,” said Christopher Cacioppo, a patient with MDR-HIV
in  San Diego who believes he is running
out of time. “My doctor tells me that I have little choice but to wait for the
dolutegravir expanded access program and some as yet unknown and unavailable
second new drug.”
A coalition of activists and physicians have been in
discussions with Taimed and ViiV for nearly two years to obtain
compassionate-use access to their new ARVs in combination for those with
MDR-HIV in greatest need of new treatment options.  The AIDS Community Research Initiative of
America (ACRIA), a New York City-based community research and education organization, and physicians in
San Francisco have proposed solutions to overcome this “two-drug access
barrier” in an effort to secure urgent access to patients across the country.
Physicians and providers with patients with
MDR-HIV in need of two new ARVs are urged to complete this

For Doctors: How You Can Help Your Patients Who Are Running Out of HIV Treatment Options

July 6, 2011

In a previous blog post, I reviewed the current situation for the minority of patients with HIV who have run out of treatment options.
Of the HIV medications in development with potential activity against highly resistant HIV (i.e., patients with GSS=0), two may become available within the next year: ibalizumab (formerly TNX-355), a monoclonal antibody currently under development by TaiMed Biologics, and dolutegravir (formerly GSK1349572), a second-generation integrase inhibitor made by ViiV Healthcare).
Ibalizumab has a completely new mode of action, so most patients should respond to it when using it with at least one other active agent. It is different from the entry inhibitor maraviroc (Selzentry, Celsentri) in that it blocks the CD4 receptor on T cells rather than blocking the CCR5 co-receptor. This means it could be effective against virus that uses either the CCR5 or CXCR4 co-receptor. It is a genetically engineered monoclonal antibody administered once every two weeks intravenously. TaiMed has finished its dosing phase 2b study and will be presenting the data in the near future. TaiMed is also developing a subcutaneous administration of ibalizumab; phase 3 studies should take place involving HIV-infected patients in eight to 12 months.
Dolutegravir has shown activity against many raltegravir (Isentress)-resistant viruses at a dose of 50 mg twice a day. Dolutegravir’s phase 3 study, which is seeking patients with raltegravir resistance, is now enrolling nationwide. However, patients are required to have a GSS=1 to join the study. For those who do not meet the entry criteria, but need help, there may be another option: The company is planning to open an expanded access program for its drug by year’s end.
However, “year’s end” is not near enough for patients who are in dire need of new, active antiretrovirals. There are many patients who cannot join the phase 3 studies, and who cannot wait eight to 12 months for both drugs to become available through their respective expanded access programs.
In these extreme cases, physicians can apply for “single patient Investigational New Drug (IND)” access to either or both of these antiretrovirals. Both TaiMed and ViiV/GlaxoSmithKline have shown good faith in helping patients in deep salvage, and they are willing to provide their drugs for patients with declining health and high mortality risk.
The following steps must be followed by physicians for each drug they want to access on behalf of one of their patients.

How to Apply for Single Patient IND Access to an Investigational Drug

If the patient’s HIV has evidence of resistance to all commercially available antiretrovirals and his/her viral load suggests that his/her HIV is not responding to the current drug regimen, a phenotypic resistance test needs to be performed along with a tropism test. It is important to also know if phenotypic resistance to enfuvirtide (T-20, Fuzeon) is present. Additionally, genotypic integrase mutations need to be characterized to assess the patient’s potential response to dolutegravir.
Once the test results have confirmed that the patient has developed resistance to all commercially available or expanded access HIV medications, and provided the patient’s health is at risk (i.e., CD4+ cell count under 100 cells/mL and declining clinical outlook), physicians can follow this procedure required by the U.S. Food and Drug Administration (FDA). (Note that the FDA has also changed its regulations to accept patient access for small groups of patients, which could save a lot of paperwork.)

  1. The treating physician should call the company that is developing the investigational antiretroviral to find out if it is willing to provide the drug for free before it has been approved. (Drugs have to have gone through dosing and safety studies before they can be made available in this manner. Also, antiretroviral interaction data are valuable, although ViiV and TaiMed do not expect negative drug-drug interactions from the combination of dolutegravir and ibalizumab.)
  2. After each manufacturer agrees to provide its respective investigational drug via single patient IND, the doctor should follow the procedure described on this FDA Web page to fill the required forms and get institutional review board (IRB) approval.

This procedure is hardly used by doctors in HIV care due to lack of information or concerns about its complexity. But in actuality, it’s very straightforward: three simple forms, a signed patient consent form and IRB approval are needed. Many local IRBs will even expedite approval of this kind of request due to its urgency.
Also, single patient IND can be approved verbally by the FDA if the patient has an expected survival of less than 30 days (this is called emergency IND). This will allow the drug company to ship the drug in an expedited manner, but the forms I mention above will still need to be processed while drug shipment is taking place.
If you need a sample patient consent form and cover letter for IRB submission, I recommend using these, which were used in the past for access to darunavir (TMC114, Prezista) and etravirine (TMC125, Intelence) while they both were investigational drugs:

ViiV and TaiMed can also make copies of consent forms for their drugs available if requested by the physician applying for access on behalf of his/her patient.
I welcome e-mails from physicians who need more information or would like additional help gaining access to investigational drugs for their HIV-infected patients whose virus is resistant to all currently available drugs. Please send e-mails to nelsonvergel@gmail.com.

This article was provided by The Body PRO. You can find this article online by typing this address into your Web browser:

At the End of Your Rope?

October / November 2010

At the End of Your Rope?

by Tim Murphy

Ironically, the success of today’s antiretroviral treatments has hindered the development of new options for longtime survivors with drug-resistant HIV.

Chad Kenney, 56, was always aggressive when it came to his HIV treatment. Shortly after his 1987 diagnosis, the Denver native started a treatment newsletter, Resolute, that quickly became a survival guide for people living with HIV/AIDS in Colorado. He was always game to try to raise his CD4 levels with the latest drug (they’ve never been above the 400s), whether it was Retrovir, the first HIV med; Compound Q, a failed hope; or the very first protease inhibitor. He remembers attending a lecture in the late ’80s given by the late legendary treatment activist Martin Delaney. “[Delaney] asked, ‘If you had a diagnosis of cancer, would you wait and see if it got worse [before] you started 
to treat it?’” remembers Kenney. “So I decided that I was going to try whatever agent I could find [to fight my HIV].”

But what neither Kenney nor HIV experts knew at the time was that adding just one new drug to a failing HIV regimen is usually not enough to quash viral replication. And, doing so often leads to the rapid development of HIV resistance to one new drug after another.

An accumulation of drug-resistant mutations certainly hasn’t made things easy for Kenney. Despite using a power regimen consisting of Truvada, Isentress and Selzentry, his viral load stayed in the hundreds of thousands.

It was only when he added another new drug, Prezista, that his CD4 cell count rose to 145 and his viral load fell to 69—just above the “undetectable” viral load threshold.

He’s hoping these numbers will stick, if not improve. “I’ve lived with uncertainty for a long, long time,” he says, “so I try not to ride an emotional roller coaster.” But the scary truth is, if his viral load creeps back up, there’s no new HIV drug on the market he can add to his regimen.

Just five years ago, tens of thousands of HIV treatment veterans were in the same boat Kenney finds himself in today. The volume of people facing treatment failure was enough to spur drug companies to develop a new wave of antiretrovirals strong and innovative enough to keep drug-resistant HIV in check. Many of those drugs on the market today—including Aptivus, Fuzeon, Intelence, Isentress, Prezista and Selzentry—have lowered the number of people with HIV who are fully resistant to treatment. Based on most good accounts, there are just a few thousand such people nationwide.

Good news, unless you are a member of this large handful of people—which is expected to grow in size in the future—who still need new options. The number of patients who currently need resistance-busting antiretrovirals is so small that pharmaceutical drug companies have little financial incentive to invest the billions of dollars arguably necessary to develop new drugs, including entirely new classes of compounds.

“HIV drug development is about to come to a halt,” says Jay Lalezari, MD, a San Francisco HIV doc who works on creating new HIV drugs and says that of 1,000 patients in his HIV practice, only about 40 “are waiting for something better to come along.”

Nelson Vergel, a longtime HIV survivor in Houston, only recently got his viral load undetectable, thanks to TaiMed Biologics’ experimental drug ibalizumab (TMB-355). He has devoted his life to finding similarly situated patients and connecting them with the trial drugs they need to suppress their HIV.

During the past 15 years, new options continued to come along for survivors like himself. But today? “They’re in deep shit,” Vergel says. “I’m really angry.”

Why angry? For one thing, the current drugs keeping millions of people alive were tested on the very folks who currently need, or may soon need, new treatment options. “The drug industry owes them a big debt,” says Steven Deeks, MD, another San Francisco HIV doc who works on the issue of drug resistance. “We should not forget this generation of people living with HIV,” he says, adding that we need to provide them with new drugs as soon as possible.

The current pipeline, however, has only a few contenders. Two notable hopefuls: the aforementioned ibalizumab, which blocks a key protein on CD4 cells so HIV can’t bind to it, is gearing up for Phase III studies; and GlaxoSmithKline’s S/GSK-572, which is currently in Phase II studies and shows some promise for folks who’ve developed resistance to Merck’s first-generation integrase inhibitor Isentress.

In recent months, two other experimental HIV drugs—Avexa’s apricitabine and Myriad Genetics’ bevirimat—were shelved. Both were casualties of weak early test results and lack of a profit motive.

In a unique activist-doctor partnership, Vergel, Deeks and Lalezari are working with the developers of TMB-355 and S/GSK-572, as well as with the U.S. Food and Drug Administration, on a program to enable patients who really need new options to go on both drugs simultaneously, before the FDA approves them, to beef up the chance of success. They hope this program will launch by mid-2011.

Kenney, who takes a fistful of meds three times a day, says he’ll only sign up for the new drug program if his current regimen doesn’t hold out, but he’s hoping it does. Meanwhile, life goes on. And though he and others like him may dream of “undetectable,” their lab numbers don’t necessarily reflect how they feel day to day.

Many patients with no options left remain in good health, living functional lives despite low CD4 counts and high viral loads. The trick, it seems, is to stay on the best HIV regimen possible rather than going off HIV meds completely. (See “Safety Nets” on page 18.) Lalezari mentions a patient who’s had one CD4 cell for the past five years. “Somehow the lethality of the virus has been weakened by all the drugs he’s on,” he says, adding that lab CD4 counts are a weak marker of immune health because they detect only CD4s circulating in blood, not in lymph tissues and other compartments.

Kenney hopes to visit his boyfriend this winter in Thailand. For now, he hits the gym daily and eats healthy. And there’s love in his life in Denver. “My brother lives two blocks away, and I have friends that go back more than 20 years,” he says. And at day’s end? “My 7-year-old Lab retriever, Kasandra, sleeps on my bed. She’s very, very affectionate—and incredibly demanding!” Sounds a bit like her owner.

Safety Nets
Detectable virus doesn’t mean doom! Here’s how to survive and thrive at the end of your treatment rope while waiting for new options.

Research shows that people with multidrug-resistant virus and detectable viral loads do better when they stay on their “failing” HIV meds rather than going off them. Talk to your doctor about finding the best regimen possible. And it’s OK to ask for a second opinion. The indefatigable Nelson Vergel can put you in touch with an expert in your area.

If you have genital herpes (HSV-2), stick to your anti-herpes meds like acyclovir or talk to your provider about taking it. Research shows these meds also help reduce HIV viral load.

It’s important to use condoms to avoid contracting sexually transmitted infections, because getting STIs can inflame your immune system and make your HIV viral load go up. You’ll also want to protect your partners from drug-resistant HIV.

Eat right, exercise, take quality vitamins and reduce stress with yoga, acupuncture, support groups, a pet—whatever works for you. “Keep a positive outlook,” Vergel says. He should know—he’s had detectable virus most of his 27 years with HIV, and he’s still going strong!

Connect with Vergel at salvagetherapies.org or e-mail him directly at nelsonvergel@yahoo.com. He’s your link to the latest resources for folks seeking new options.

Search aidsmeds.com and clinicaltrials.gov for the latest updates on experimental drugs ibalizumab, S/GSK-572 and other agents making their way into clinical trials. 

What am I going to do now, Nelson?

What am I going to do now, Nelson?
Aug 6, 2010
Hi Nelson, I hope all is well. Last year you told me about the trial with ibalizumab at ACRIA and I received the meds for about 1 year. In the beginning of thet trial the virus became undectadable but then it started to go up again and they took me out of the study. I was in the trial for about 1 year. My doctor changed my regimen to recycle meds…I’m resistant to all of them. I am now on Aptivus, Viread, Norvir and Trizivir. Do you know of any other trials in NYC? Thanks for your help.
Response from Mr. Vergel

I am so sorry that your virus developed resistance to ibalizumab (Taimed’s intravenous CD4 monoclonal antibody that may be given once every two weeks).
I am working with ACRIA and two San Francisco doctors in setting up a small expanded access pilot to combine two investigational agents by early summer 2011, but we are still waiting for data. But it is not a done deal. However, one of the drugs may be ibalizumab.
GSK-ViiV are testing a second generation integrase inhibitor (GSK572) in phase II now and we are really hoping it can help people with raltegravir resistance. Some preliminary data show that it may help those with certain integrase mutations. GSK is also testing two non nucleosides in early phase 2. So, it will take at least 8 months to know where we are going with these agents.
AVEXA, an Australian company that has an interesting nucleoside, may be back in the picture after their board reconsidered not dropping their drug due to activist pressure. I am following that drug closely also.
BMS seems to have an entry inhibitor but they are a company that does not like to share information with treatment activists, so it has been a challenge to get them to tell us anything. It is unfortunate that in 2010 we still have this lack of communication going (but they are rare among companies).
Progenics also had a once a week subcutaneous entry inhibitor that looks very exciting. They are also a company that has refused to meet with treatment activists. They are small and may not understand the power that activists have in the present to help advocate for new drugs.
Koronis (http://www.koronispharma.com/KP1461forHIV.html) also has an interesting nucleoside that works very differently than the ones we have right now, but they have not tested it in people like you with a failing regimen.
Some of these companies may or may not agree to provide drug in a compassionate manner for one patient (but remember that you need at least two new active drugs to avoid functional monotherapy). But if your doctor wants to ask them, the FDA has set up a way to do so provided that the companies are willing to help. The FDA procedure is http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm163982.htm
It is getting harder and harder for companies to justify spending money on new drugs that attack new targets since they perceive the treatment experienced market to be too small to justify the investment. And many doctors are telling them that people like you and me do not exist anymore. So, it is more important than ever not to fall asleep in treatment activism.
I am focusing a lot of my energies in helping people like you who may fall through the cracks if we do not provide at least two drugs at the same time that your virus does not have resistance to.
One more thing. This is anecdotal but I have seen people in salvage’s viral load go down a lot with good daily prophylaxis for herpes (acyclovir, Valtrx, or Famvir) (http://www.aidsmap.com/page/1431675/) twice a day and also with the use of an antibiotic called minoxycline ( http://www.aidsmap.com/page/1438246/), plus their HIV drug regimen. Talk to your doctor about these if you are not taking them already.
Keep in contact with me. I will keep everyone informed through this column as things progress.
Hang in there and please keep in touch with me.