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:

LONG-ACTING IBALIZUMAB IN PATIENTS WITH MULTI-DRUG RESISTANT HIV-1: A 24-WEEK STUDY
 

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

By Warren Tong
December 5, 2012
Introduction
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.
Albuvirtide
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.

WORLD AIDS DAY: Time to Help Victims of HIV Drug Studies and Resistance

We have repeatedly heard the following statements about multi-drug resistant HIV (MDR-HIV) patients in a host of meetings on treatment access and HIV research: “These patients no longer exist – they’re either dead or have responded to the latest ARVs”; “Only patients who do not adhere to their HIV regimens have MDR-HIV”; and “Our clinic cannot provide expanded access programs (EAPs) due to cost and staff restraints.” However, after surveying physicians around the country, we have found that although these patients are in a minority, they do exist and are anxiously waiting for access to viable regimens that could save their lives.

No one can deny that many patients can now suppress their HIV with effective regimens that cause fewer side effects. However, a vulnerable and often forgotten minority of people are still struggling with MDR-HIV while they anxiously await for access to life-saving regimens that would finally control their virus 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 doctor’s orders for years.

They’re often veterans of drug development research who have accumulated HIV resistance as they repeatedly joined antiretroviral (ARV) studies or traditional EAPs 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, 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). It is time to create a new paradigm to break the vicious cycle of single drug access that has failed these patients.

More: http://www.poz.com/pdfs/gmhc_treatmentissues_2012_12.pdf

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


FOR
IMMEDIATE RELEASE: February 9, 2012

Contact:
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
access
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
form.
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