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Take Action! Tuesday, July 18, is National HIV Call-In Day!

We know we have asked you to do a lot over the last several months. You have faithfully called... read more

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... read more

Probiotic Visbiome improves gut barrier function in patients with HIV

“Probiotic supplementation improved the physical and immunological integrity of the intestinal mucosal barrier in HIV-1-positive patients being treated with... read more

New HIV Drugs in the Pipeline- 2017: CROI Review by Dr Pablo Tebas

Gilead presented some data about a new capsid formation inhibitor (GS-CA1), a total new drug class that looks incredibly... read more

HIV Cure Update 2017: Interview with Leading Research Advocates

Nelson Vergel (PowerUSA.org) moderates a webcast with two leading HIV Cure research activists: Richard Jeffreys and Robert Reinhard. They... read more

aging with HIV

Good News in Aging with HIV

David Alain Wohl, MD – The University of North Carolina at Chapel Hill —————————– “HIV medicine has transitioned from an oncological... read more

Aerobic Exercise Increases Cognition and Brain Volume in HIV+ People

Background: HIV infected (HIV+) individuals are now reaching an advanced age, through stable treatment with highly active anti-retroviral therapy... read more

HIV Lipodystrophy Update: Interview with Researcher Dr. Grace McComsey

HIV Lipodystrophy Update: Interview with Researcher Dr. Grace McComsey Dr. Grace McComsey has been involved in HIV research for 16... read more


Timeline

July 2017

Take Action! Tuesday, July 18, is National HIV Call-In Day!

We know we have asked you to do a lot over the last several months. You have faithfully called Congress time and again to tell them to #KillTheBill. We thank you! We know that you may be feeling fatigued. That is EXACTLY what the Republicans want to happen. We CANNOT let up. We CANNOT stop pushing. We must continue to RESIST if we are to #ProtectOurCare. With your help we will #KillTheBill once and for all! Please keep up the pressure this week and keep those calls to your Senators coming!

Join the National HIV Call-In Day Tuesday, July 18!

The new Senate bill is even worse than the last version. Your senators need to hear from everyone. Call 866-246-9371 to connect to your senators. You can tell them:

“My name is _____ and I live in [city, zip]. I’m a person [living with/concerned about] HIV and I’m calling to urge Senator ____ to reject the BCRA. The changes that have been made to the bill do not change the fact that it will slash Medicaid, allow discrimination against people with preexisting conditions and make insurance coverage more expensive and less comprehensive. We are counting on Senator ____ to stand up for his/her constituents and vote no on the BCRA!”

Want to do more?

· Organize a phone bank! Do you work or volunteer for an organization that provides services for or advocates for people who would be affected by the changes to health care? Have some friends and family who are also worried about the impending health care disaster? Use this toolkit to organize your own phone bank to #KillTheBill. Calls are particularly needed to the following senators:

o Targets most likely to vote no: Collins (ME), Heller (NV), Murkowski (AK), Capito (WV)

o Targets expressing reservations; could be persuaded: Flake (AZ); /McCain (AZ); Portman (OH)
Cassidy (LA);

o Targets unlikely to vote no in final vote, but could help stall: Cotton (AR); Boozman (AR); Gardner (CO); Young (IN); Grassley (IA); Ernst (IA); Rounds (SD); Hoeven (ND); Moran (KS); Graham (SC)
Corker (TN)

· Join the Occupy TrumpCare action in D.C. July 19! Email KillTheBillJ19@gmail.com to learn more.

· Visit Positive Women’s Network-USA #KillTheBill Resource page for the latest tools and talking points to support your advocacy.

Learn more!

· This editorial from the New York Times summarizes quite neatly why the revised bill is in many ways even worse than the last version.

· Here is more comprehensive detail on what is and is not in the new bill, as well as where key Senators may land on it.

· Find out where your Senators stand on the bill on this page, which is being updated in real time.

May 2017

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
 


Grid

Take Action! Tuesday, July 18, is National HIV Call-In Day!

We know we have asked you to do a lot over the last several months. You have faithfully called Congress time and again to tell them to #KillTheBill. We thank you! We know that you may be feeling fatigued. That is EXACTLY what the Republicans want to happen. We CANNOT let up. We CANNOT stop pushing. We must continue to RESIST if we are to #ProtectOurCare. With your help we will #KillTheBill once and for all! Please keep up the pressure this week and keep those calls to your Senators coming!

Join the National HIV Call-In Day Tuesday, July 18!

The new Senate bill is even worse than the last version. Your senators need to hear from everyone. Call 866-246-9371 to connect to your senators. You can tell them:

“My name is _____ and I live in [city, zip]. I’m a person [living with/concerned about] HIV and I’m calling to urge Senator ____ to reject the BCRA. The changes that have been made to the bill do not change the fact that it will slash Medicaid, allow discrimination against people with preexisting conditions and make insurance coverage more expensive and less comprehensive. We are counting on Senator ____ to stand up for his/her constituents and vote no on the BCRA!”

Want to do more?

· Organize a phone bank! Do you work or volunteer for an organization that provides services for or advocates for people who would be affected by the changes to health care? Have some friends and family who are also worried about the impending health care disaster? Use this toolkit to organize your own phone bank to #KillTheBill. Calls are particularly needed to the following senators:

o Targets most likely to vote no: Collins (ME), Heller (NV), Murkowski (AK), Capito (WV)

o Targets expressing reservations; could be persuaded: Flake (AZ); /McCain (AZ); Portman (OH)
Cassidy (LA);

o Targets unlikely to vote no in final vote, but could help stall: Cotton (AR); Boozman (AR); Gardner (CO); Young (IN); Grassley (IA); Ernst (IA); Rounds (SD); Hoeven (ND); Moran (KS); Graham (SC)
Corker (TN)

· Join the Occupy TrumpCare action in D.C. July 19! Email KillTheBillJ19@gmail.com to learn more.

· Visit Positive Women’s Network-USA #KillTheBill Resource page for the latest tools and talking points to support your advocacy.

Learn more!

· This editorial from the New York Times summarizes quite neatly why the revised bill is in many ways even worse than the last version.

· Here is more comprehensive detail on what is and is not in the new bill, as well as where key Senators may land on it.

· Find out where your Senators stand on the bill on this page, which is being updated in real time.

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
 

Probiotic Visbiome improves gut barrier function in patients with HIV

“Probiotic supplementation improved the physical and immunological integrity of the intestinal mucosal barrier in HIV-1-positive patients being treated with antiretroviral therapy, according to new research.

 

Probiotics for HIV

The researchers sought to evaluate the effects of a high potency multistrain probiotic — marketed in the U.S. as Visbiome (ExeGi Pharma) and Vivomixx in Europe — on intestinal immunity in HIV-1 patients on antiretroviral therapy. They performed a sub-study of a pilot longitudinal, non-randomized, single arm trial of 10 patients who received the supplement twice daily for 6 months between May 2014 and February 2015. All patients were white men with a median age of 42 years, and were all on antiretroviral therapy for a median of 6 years.

The investigators concluded that these findings demonstrate the potential benefits of probiotic supplementation for restoring mucosal intestinal barrier integrity in HIV-1 patients treated with antiretroviral therapy, but emphasized that the results should not be generalized to all probiotics, as “it is the probiotic strain itself which determines the efficacy of the product and hence the associated findings.” This is especially important in immunocompromised patients, they added.”

 

Source


Medium

Take Action! Tuesday, July 18, is National HIV Call-In Day!

We know we have asked you to do a lot over the last several months. You have faithfully called Congress time and again to tell them to #KillTheBill. We thank you! We know that you may be feeling fatigued. That is EXACTLY what the Republicans want to happen. We CANNOT let up. We CANNOT stop pushing. We must continue to RESIST if we are to #ProtectOurCare. With your help we will #KillTheBill once and for all! Please keep up the pressure this week and keep those calls to your Senators coming!

Join the National HIV Call-In Day Tuesday, July 18!

The new Senate bill is even worse than the last version. Your senators need to hear from everyone. Call 866-246-9371 to connect to your senators. You can tell them:

“My name is _____ and I live in [city, zip]. I’m a person [living with/concerned about] HIV and I’m calling to urge Senator ____ to reject the BCRA. The changes that have been made to the bill do not change the fact that it will slash Medicaid, allow discrimination against people with preexisting conditions and make insurance coverage more expensive and less comprehensive. We are counting on Senator ____ to stand up for his/her constituents and vote no on the BCRA!”

Want to do more?

· Organize a phone bank! Do you work or volunteer for an organization that provides services for or advocates for people who would be affected by the changes to health care? Have some friends and family who are also worried about the impending health care disaster? Use this toolkit to organize your own phone bank to #KillTheBill. Calls are particularly needed to the following senators:

o Targets most likely to vote no: Collins (ME), Heller (NV), Murkowski (AK), Capito (WV)

o Targets expressing reservations; could be persuaded: Flake (AZ); /McCain (AZ); Portman (OH)
Cassidy (LA);

o Targets unlikely to vote no in final vote, but could help stall: Cotton (AR); Boozman (AR); Gardner (CO); Young (IN); Grassley (IA); Ernst (IA); Rounds (SD); Hoeven (ND); Moran (KS); Graham (SC)
Corker (TN)

· Join the Occupy TrumpCare action in D.C. July 19! Email KillTheBillJ19@gmail.com to learn more.

· Visit Positive Women’s Network-USA #KillTheBill Resource page for the latest tools and talking points to support your advocacy.

Learn more!

· This editorial from the New York Times summarizes quite neatly why the revised bill is in many ways even worse than the last version.

· Here is more comprehensive detail on what is and is not in the new bill, as well as where key Senators may land on it.

· Find out where your Senators stand on the bill on this page, which is being updated in real time.

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
 


Large

Take Action! Tuesday, July 18, is National HIV Call-In Day!

We know we have asked you to do a lot over the last several months. You have faithfully called Congress time and again to tell them to #KillTheBill. We thank you! We know that you may be feeling fatigued. That is EXACTLY what the Republicans want to happen. We CANNOT let up. We CANNOT stop pushing. We must continue to RESIST if we are to #ProtectOurCare. With your help we will #KillTheBill once and for all! Please keep up the pressure this week and keep those calls to your Senators coming!

Join the National HIV Call-In Day Tuesday, July 18!

The new Senate bill is even worse than the last version. Your senators need to hear from everyone. Call 866-246-9371 to connect to your senators. You can tell them:

“My name is _____ and I live in [city, zip]. I’m a person [living with/concerned about] HIV and I’m calling to urge Senator ____ to reject the BCRA. The changes that have been made to the bill do not change the fact that it will slash Medicaid, allow discrimination against people with preexisting conditions and make insurance coverage more expensive and less comprehensive. We are counting on Senator ____ to stand up for his/her constituents and vote no on the BCRA!”

Want to do more?

· Organize a phone bank! Do you work or volunteer for an organization that provides services for or advocates for people who would be affected by the changes to health care? Have some friends and family who are also worried about the impending health care disaster? Use this toolkit to organize your own phone bank to #KillTheBill. Calls are particularly needed to the following senators:

o Targets most likely to vote no: Collins (ME), Heller (NV), Murkowski (AK), Capito (WV)

o Targets expressing reservations; could be persuaded: Flake (AZ); /McCain (AZ); Portman (OH)
Cassidy (LA);

o Targets unlikely to vote no in final vote, but could help stall: Cotton (AR); Boozman (AR); Gardner (CO); Young (IN); Grassley (IA); Ernst (IA); Rounds (SD); Hoeven (ND); Moran (KS); Graham (SC)
Corker (TN)

· Join the Occupy TrumpCare action in D.C. July 19! Email KillTheBillJ19@gmail.com to learn more.

· Visit Positive Women’s Network-USA #KillTheBill Resource page for the latest tools and talking points to support your advocacy.

Learn more!

· This editorial from the New York Times summarizes quite neatly why the revised bill is in many ways even worse than the last version.

· Here is more comprehensive detail on what is and is not in the new bill, as well as where key Senators may land on it.

· Find out where your Senators stand on the bill on this page, which is being updated in real time.

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
 


Large Alt

Take Action! Tuesday, July 18, is National HIV Call-In Day!

We know we have asked you to do a lot over the last several months. You have faithfully called Congress time and again to tell them to #KillTheBill. We thank you! We know that you may be feeling fatigued. That is EXACTLY what the Republicans want to happen. We CANNOT let up. We CANNOT stop pushing. We must continue to RESIST if we are to #ProtectOurCare. With your help we will #KillTheBill once and for all! Please keep up the pressure this week and keep those calls to your Senators coming!

Join the National HIV Call-In Day Tuesday, July 18!

The new Senate bill is even worse than the last version. Your senators need to hear from everyone. Call 866-246-9371 to connect to your senators. You can tell them:

“My name is _____ and I live in [city, zip]. I’m a person [living with/concerned about] HIV and I’m calling to urge Senator ____ to reject the BCRA. The changes that have been made to the bill do not change the fact that it will slash Medicaid, allow discrimination against people with preexisting conditions and make insurance coverage more expensive and less comprehensive. We are counting on Senator ____ to stand up for his/her constituents and vote no on the BCRA!”

Want to do more?

· Organize a phone bank! Do you work or volunteer for an organization that provides services for or advocates for people who would be affected by the changes to health care? Have some friends and family who are also worried about the impending health care disaster? Use this toolkit to organize your own phone bank to #KillTheBill. Calls are particularly needed to the following senators:

o Targets most likely to vote no: Collins (ME), Heller (NV), Murkowski (AK), Capito (WV)

o Targets expressing reservations; could be persuaded: Flake (AZ); /McCain (AZ); Portman (OH)
Cassidy (LA);

o Targets unlikely to vote no in final vote, but could help stall: Cotton (AR); Boozman (AR); Gardner (CO); Young (IN); Grassley (IA); Ernst (IA); Rounds (SD); Hoeven (ND); Moran (KS); Graham (SC)
Corker (TN)

· Join the Occupy TrumpCare action in D.C. July 19! Email KillTheBillJ19@gmail.com to learn more.

· Visit Positive Women’s Network-USA #KillTheBill Resource page for the latest tools and talking points to support your advocacy.

Learn more!

· This editorial from the New York Times summarizes quite neatly why the revised bill is in many ways even worse than the last version.

· Here is more comprehensive detail on what is and is not in the new bill, as well as where key Senators may land on it.

· Find out where your Senators stand on the bill on this page, which is being updated in real time.

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
 


Full

Take Action! Tuesday, July 18, is National HIV Call-In Day!

We know we have asked you to do a lot over the last several months. You have faithfully called Congress time and again to tell them to #KillTheBill. We thank you! We know that you may be feeling fatigued. That is EXACTLY what the Republicans want to happen. We CANNOT let up. We CANNOT stop pushing. We must continue to RESIST if we are to #ProtectOurCare. With your help we will #KillTheBill once and for all! Please keep up the pressure this week and keep those calls to your Senators coming!

Join the National HIV Call-In Day Tuesday, July 18!

The new Senate bill is even worse than the last version. Your senators need to hear from everyone. Call 866-246-9371 to connect to your senators. You can tell them:

“My name is _____ and I live in [city, zip]. I’m a person [living with/concerned about] HIV and I’m calling to urge Senator ____ to reject the BCRA. The changes that have been made to the bill do not change the fact that it will slash Medicaid, allow discrimination against people with preexisting conditions and make insurance coverage more expensive and less comprehensive. We are counting on Senator ____ to stand up for his/her constituents and vote no on the BCRA!”

Want to do more?

· Organize a phone bank! Do you work or volunteer for an organization that provides services for or advocates for people who would be affected by the changes to health care? Have some friends and family who are also worried about the impending health care disaster? Use this toolkit to organize your own phone bank to #KillTheBill. Calls are particularly needed to the following senators:

o Targets most likely to vote no: Collins (ME), Heller (NV), Murkowski (AK), Capito (WV)

o Targets expressing reservations; could be persuaded: Flake (AZ); /McCain (AZ); Portman (OH)
Cassidy (LA);

o Targets unlikely to vote no in final vote, but could help stall: Cotton (AR); Boozman (AR); Gardner (CO); Young (IN); Grassley (IA); Ernst (IA); Rounds (SD); Hoeven (ND); Moran (KS); Graham (SC)
Corker (TN)

· Join the Occupy TrumpCare action in D.C. July 19! Email KillTheBillJ19@gmail.com to learn more.

· Visit Positive Women’s Network-USA #KillTheBill Resource page for the latest tools and talking points to support your advocacy.

Learn more!

· This editorial from the New York Times summarizes quite neatly why the revised bill is in many ways even worse than the last version.

· Here is more comprehensive detail on what is and is not in the new bill, as well as where key Senators may land on it.

· Find out where your Senators stand on the bill on this page, which is being updated in real time.

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