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  • TITLE:

 

             HIV Infection Seroreversion Cases and Clinical Improvement Case Series Reporting of Patients on an Herbal   Remedy   Intervention

   (U.S. Patent Nos. 7,556,830; 7,674,483; 8,053,002; 8,067,401; 8,404,284;

other patents pending, issued and allowed)

 

          A case series report outlining a safer and more effective first-line treatment and possible cure for the vast majority of HIV-infected patients, which also serves as an adjunctive treatment for patients on antiretroviral (ARV) therapy.

 

 By: Dr. Maria Medina

 

  • INTRODUCTION:

 

          Antiretrovirals (ARVS) have been the only treatment historically approved by the USFDA in controlling HIV infection.  They have been instrumental in the conversion of HIV/AIDs from a fatal disease into a chronic manageable one – at least for a time.  Unfortunately, either singly or in any combination of the six classes of antiretrovirals[1], in virtually all patients, the prospect of being cured from HIV infection with the use of antiretrovirals appears to be out of reach.  However, in a promising new development from Kenya, an herbally-based medicine is producing undoubted multiple cures, through a different mechanism of action, which is not yet fully understood, but is worthy of further evaluation and investigation.

 

         In 2013, there were two case reportings of patients who were “functionally cured” – a functional cure being defined as maintaining as undetectable viral load and normal cd4 count [2] after withdrawing treatment for as significant period of time, measured in months or years.     In a case report 14 patients in France were treated during the acute or early phase of HIV infection [3].  The scientists attributed virological remission to the early diagnosis and prompt treatment with the full regimen of three antiretrovirals during the early stage of the infection.  Whether treating all early-diagnosis HIV cases will achieve virological remission in all such patients remains to be seen.  Factors like age, poor nutrition, stress, genetics, HIV subtypes and the size of the inoculum can affect the progress of any infectious disease.

 

          In a resource-poor settings such as Kenya, and in any location where HIV+ status is still associated with stigma, many persons defer or even avoid getting tested for HIV.  In the clinic from which the instant case series reports emanate, it is often observed that patients travel considerable distances to get tested in the subject clinic just to avoid being seen near their local VCT (Voluntary Counseling and Testing) Center.  Further, around 25% of patients who get infected with HIV do not experience symptoms in the acute phase[4] and therefore progression to chronic infection occurs long before antiretroviral treatment can even be contemplated, let alone commenced.

 

          Other limitations of using antiretrovirals include their inherent toxicity.  Also, many ARV regimens eventually fail, leading to viral resistance.  A combination of additional drugs from different classes of antiretrovirals can worsen an already-existing toxic effect or add to other toxic effects.  It may also occur that, by deploying multiple ARV’s, multiply-resistant strains of HIV may develop, leading to epidemiological disaster.

 

            The case reports mentioned above may signal an improved approach to treatment of HIV in newly-infected patients in resource-rich countries, but these techniques have no relevance to those who have had the disease for years or for those already on second or third line antiretroviral regimens, in addition to having either limited or no application to resource-poor settings.

 

                           Herbal Remedy Intervention - US Patent No. 7,556,830 et. al.

 

          In 2005, a professor in chemistry from Chepkoilel Campus of Moi University, now known as Chepkoilel University, approached my husband, Mitchell Medina, an inventor with 29 US patents, with an invention.  Professor Paul Chepkwony had been experimenting with zones of inhibition created by extracts of certain traditional plants from his native Kipsigis culture on lab cultures of certain bacteria.

 

               A relative of Prof. Chepkwony had become infected with HIV, and could not tolerate ARV’s.  Prof. Chepkwony found that his relative subjectively improved when given a mixture of the 14 herbs that had the highest zones of bacterial inhibition in his lab studies.

 

               Encouraged by this serendipitous result, Prof Chepkwony began offering his herbal remedy to other HIV+ patients.  They also reported improvement.  Although Professor Chepkwony’s basis for the herb selection depended on bacterial studies instead on viral studies, even in the early stages when he was dispensing the herbal mixture, a few of the patients turned HIV-negative.

 

             A toxicity animal study was done in Moi University and was submitted to the Kenyan Pharmacy and Poisons Board. The results can be furnished upon request, but to summarize, no toxicity was found.

 

             Our team has now been dispensing Prof. Chepkwony’s herbal remedy for 9 years now.  A significant improvement to the herbal remedy was made by Dr. Maria Medina in 2010 by adding Low Dose Naltrexone to the herbal mix (See U.S. Patent No. 8,404,284; Kenya counterpart Patent 552).   Over 1000 individuals have received either the original or the improved form of the therapy.  Although all patients have been advised not to have unprotected sex, six pregnant patients have been recorded to have taken the herbal remedy from conception to delivery.  All offspring were normal and no abnormalities in their development have been reported.

 

 

 

[1]  [1] Entry Inhibitors;  [2] Fusion Inhibitors;  [3] Integrase Inhibitors (INIs);  [4] Reverse Transcriptase Inhibitors: a) Nucleotide/Nucleoside Reverse Transcriptase Inhibitors, b) Non-nucleoside Reverse Transcriptase Inhibitors;  [5] Protease Inhibitors (PIs); [6] Multi-class Combination Products

Source: U.S. Department of Health and Human Services, National Institute of Allergy and Infectious Disease

http://www.niaid.nih.gov/topics/HIVAIDS/Understanding/Treatment/pages/arvdrugclasses.aspx

 

 

[2] CD4+ cells  or T helper cells are the cells that the human immunodeficiency virus destroy. The normal count is 500 to 1,500 cells/mm3  of blood.

 

 

[3] Sáez-Cirión A et al. Post-Treatment HIV-1 Controllers with a Long-Term Virological Remission after the Interruption of Early Initiated Antiretroviral Therapy ANRS VISCONTI Study.  Plos Pathogens.  2013 Mar  14; doi: 10.1371/journal.ppat.1003211

http://www.plospathogens.org/article/info%3Adoi%2F10.1371%2Fjournal.ppat.1003211

 

 

[4] Valenti W. Acute Retroviral Syndrome: A Challenge for Primary Care

 AIDS Reader.  2008 Jun 12008;18:294-296

http://www.theaidsreader.com/display/article/1145619/1359019

 

KERICHO  GROUP

 

The Kericho patients in the instant case series received the herbal remedy in tea form.  A few patients obtained some lab tests from the Walter Reed ARV Treatment Program which is associated with Kericho District Hospital, and so their HIV-positive status and laboratory reports were documented.  Some of these patients have agreed to be interviewed on video.   Other patients were referred directly by VCT Centers in Kericho County......... 

READ MORE......

MUKURU  GROUP

 

Thirty HIV-infected patients were recruited from Mukuru slum from the industrial part of Nairobi at the latter part of 2009.  The thirty patients had never taken ARV’s and were started on the herbal regimen and given some food supply and multivitamins to improve their health conditions............

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RUARAKA  GROUP

The patients in this group comprise of paying individuals, for whom detailed medical files are maintained.  As of January 2014, there were around 550 patients.  All of them are adults.  However, compliance is intermittent due to lack of funds on the part of the patients.  The investigators rely on those patient funds to sustain the experiment.   Sadly, this paradigm has created a situation in which around one-third of the patients are lost to follow up.  When contacted by phone, these drop-outs say that they are clinically well, but can’t afford continued treatment.   Almost all of the patients who are consistent in the Ruaraka program report subjective health improvement, and lab tests reflect gains over time...............

 

READ MORE......

 

  • DISCUSSION:

.

          The main finding in this case reports series is that the herbal remedy is able to restore the function of the immune system at any stage of the HIV-infection, even when AIDS or advanced HIV infection sets in as in Case 1C.   And in cases like in the Kericho group, where some patients have been on the therapy for a long time (three to six years), it is possible for patients to even turn HIV-negative or be cured.  

 

         Although the herbal remedy’s mode of action on replicating HIV viruses is unknown at this time, for an intervention to work at the advanced stage of HIV infection where the immune system is already overwhelmed, a drug should be able to directly destroy the replicating viruses and not just “assist” the immune system so than it can be restored. 

 

         The herbal remedy’s phytoalexins  (plant antibiotics) have been analyzed to contain 40 alkaloids, 26 terpenoids and 20 steroid glycosides.  The complexity and the number of these components would require numerous numbers of mutations before viral resistance is formed.  The 40 alkaloids are disclosed in U.S. Patent No. 8,067,401.  A U.S. Patent will soon issue on the terpenoid components of the 14 herbs (U.S. application Ser. No. 20120190734).  The steroid glycloside chemical analysis has been published as U.S. Application Ser. No. 20130023487, which is pending.  The work done to date establishes that there is no single herb nor isolated chemical magic bullet that produces the beneficial effects of the herbal mixture.  

 

          In animal studies, the mixture has not shown any side-effects.  The herbal remedy as low-dose therapy has been used by several women from conception to delivery and there have been no known abnormalities in their offspring.

 

        Based on the findings in these case series reports, this now-standardized herbal therapy for HIV/AIDS deserves further investigation.  It may well be the ideal first-line therapy, since it cures at least some individuals, helps almost everybody and has minimal toxic effects. 

 

            In the current paradigm for treating HIV with ARV’s, in resource-poor settings, first-line therapy is to watch and wait until patient CD4 count falls below 350.  Then, when the various classes of ARV’s are serially invoked, the drugs are highly toxic, and at best suppress the viruses for a time.  The herbally-based therapy deployed in the cases summarized above seems to have the ability to actually eradicate HIV viruses, at least in some subjects.

 

        It is currently urged in some quarters that ARV’s be deployed earlier for better treatment results.  However, the potential epidemiological consequences of such a paradigm shift are unknown, and, if it is implemented, highly resistant strains of HIV may develop.

 

          In the instant case series, the herbally-based therapy has been co-deployed with ARV’s and found to be useful.  Numerous patients have successfully been weaned from HIV to purely herbal therapy while clinical condition and test results have remained satisfactory.  Because the early deployment of the instant herbally-based therapy produces health gains in HIV patients which seem to be beyond the reach of ARV’s, and because ARV’s, as a conventionally-accepted therapy, can be insulated by the use of the instant herbally-based therapy as a first-line approach, our team’s work deserves further study.

 

        We would like to see an independent institution work with our therapeutic materials as a first line treatment for recently diagnosed HIV-AIDS patients.  Also, we seek reliable funding that can fill the gaps created by the irregular patient funds that are currently sustaining our team’s treatment model.

 

         It wouldn’t take much, and it could be a medical miracle. 

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